Search

BACKGROUND Parents of adolescents and young adults (AYAs) with cancer offer primary support to their children and often experience their own high levels of distress, affecting parent-AYA communication and quality of life. OBJECTIVE To reduce parent distress and improve communication during high-risk cancer treatment, we examined efficacy of a self-care and communication intervention for parents and indirect benefit for AYAs receiving a therapeutic music video (TMV) intervention. METHODS In this study, we conducted a multisite, randomized controlled trial with AYAs and parents enrolled as dyads (n = 110). Parents were randomized to intervention or low-dose control; all AYAs received TMV. Data collection occurred at baseline, 2 weeks post intervention (T2), and 90 days post intervention (T3). RESULTS There were no significant between-group differences on primary outcomes for parents or AYAs. We did find significant differences favoring the parent intervention group on parenting confidence at T2 and marginally better outcomes for family adaptability/cohesion at T3. Both groups exhibited significant within-group improvement for parent distress (state anxiety, T3; perceived stress, T2 and T3; mood, T3), state anxiety (T2) intervention only, and family strengths control group only. Qualitative data demonstrate the parent intervention raised self-awareness and parent confidence in the short term. CONCLUSION Parents found their intervention helpful. Absence of significant results may be due to short intervention duration, need for tailored content, underpowered sample, and potential indirect parent benefit from AYA participation in TMV. The parent intervention did not provide an indirect benefit for AYAs. IMPLICATIONS FOR NURSING Parents identified their own need for communication and support from nurses. Nurses can optimize AYA care by attending to parent needs through supportive listening and encouraging self-care.

Patients with chronic obstructive pulmonary disease (COPD) commonly experience dyspnea, which may limit activities of daily living. Pursed-lip breathing improves dyspnea for COPD patients; however, access to pursed-lip breathing training is limited.The proposed MELodica Orchestra for DYspnea (MELODY) study will be a single-site pilot study to assess the safety, feasibility, and efficacy of a music-based approach to teach pursed-lip breathing. Patients with COPD and moderate-severe dyspnea are randomized to intervention, education-control, or usual care control groups. Intervention patients meet twice weekly for eight weeks for melodica instruction, group music-making, and COPD education. Safety, feasibility, and efficacy is assessed qualitatively and quantitatively.This manuscript describes the rationale and methods of the MELODY pilot project.If pilot data demonstrate efficacy, then a multi-site randomized control trial will be conducted to evaluate program effectiveness and implementation.

Background Although evidence suggests music therapy lowers the heart rate of ill adults undergoing painful procedures and premature infants in the NICU, the effect of music therapy interventions on physiologic response in infants with congenital heart disease (CHD) being cared for in the cardiac intensive care unit (CICU) has not been explored. Objective The purpose of this study was to explore the effect of the music therapy entrainment on physiologic responses of infants with CHD in the CICU. Methods Five infants in the CICU received music therapy entrainment 3-5 times per week for up to 3 weeks. Sessions took place both prior to and after the infant's surgical cardiac repair. Heart rate, respiratory rate, blood pressure, and oxygen saturations were recorded every 15 seconds for 20 minutes prior to the intervention (baseline), during the 20-minute music therapy entrainment (intervention), and for 20 minutes after the intervention (return to baseline). Comparisons of baseline to intervention measures were based on means, standard deviations, and derivatives of the signal. Results Four of 5 infants experienced a decrease in average heart and respiratory rates as well as improvement in the derivative of the heart rate signal. Greater improvements were found when infants were located in the open bay and were receiving sedatives or narcotics. Conclusions Our findings provide initial evidence that music therapy entrainment may be a valuable intervention to support improved physiologic stability in infants with CHD.

Background Supportive music and imagery and music listening interventions have been effective in decreasing distress and improving mood in cancer patients receiving chemotherapy, but it is unclear whether the two interventions differ in their treatment benefits. Furthermore, previous studies have not examined moderators to determine which subgroup(s) of patients may benefit most from each intervention. Objective To examine the effects of supportive music and imagery compared with preferred music listening on responsiveness to music therapy, distress, anxiety and depression, and benefit finding. A secondary purpose was to explore sense of coherence and locus of control as potential moderators of intervention effectiveness. Methods A single-session, two-group comparative effectiveness randomized trial in two cancer centers. Patients were randomized to supportive music and imagery or preferred music listening during outpatient chemotherapy treatment. Data were collected at baseline and immediately after the 45-minute session. ANCOVA models were used to determine main effects of intervention as well as pairing potential moderators with group assignment to explore differences in intervention effects by moderator. Results There were differential effects between the two interventions with the supportive music and imagery group scoring higher in responsiveness to music therapy and benefit finding. The music listening group scores indicated lower distress. The exploratory moderating analyses suggested Health Locus of Control-Internal and Sense of Coherence influenced intervention effectiveness. Conclusions Music and imagery and preferred music listening experiences may serve different therapeutic purposes, access and activate different patient resources, and may be helpful at different stages of treatment.

BACKGROUND To reduce the risk of adjustment problems associated with hematopoietic stem cell transplant (HSCT) for adolescents/young adults (AYAs), we examined efficacy of a therapeutic music video (TMV) intervention delivered during the acute phase of HSCT to: 1) increase protective factors of spiritual perspective, social integration, family environment, courageous coping, and hope-derived meaning; 2) decrease risk factors of illness-related distress and defensive coping; and 3) increase outcomes of self-transcendence and resilience. METHODS This was a multisite randomized, controlled trial (COG-ANUR0631) conducted at 8 Children's Oncology Group sites involving 113 AYAs aged 11-24 years undergoing myeloablative HSCT. Participants, randomized to the TMV or low-dose control (audiobooks) group, completed 6 sessions over 3 weeks with a board-certified music therapist. Variables were based on Haase's Resilience in Illness Model (RIM). Participants completed measures related to latent variables of illness-related distress, social integration, spiritual perspective, family environment, coping, hope-derived meaning, and resilience at baseline (T1), postintervention (T2), and 100 days posttransplant (T3). RESULTS At T2, the TMV group reported significantly better courageous coping (Effect Size [ES], 0.505; P = .030). At T3, the TMV group reported significantly better social integration (ES, 0.543; P = .028) and family environment (ES, 0.663; P = .008), as well as moderate nonsignificant effect sizes for spiritual perspective (ES, 0.450; P = .071) and self-transcendence (ES, 0.424; P = .088). CONCLUSIONS The TMV intervention improves positive health outcomes of courageous coping, social integration, and family environment during a high-risk cancer treatment. We recommend the TMV be examined in a broader population of AYAs with high-risk cancers. Cancer 2014;120:909–917. © 2013 American Cancer Society.

This is the second of two articles comparing music medicine and music therapy studies. The intent was to explore whether music therapy research differs from music medicine research, and if so, to delineate the differences. Studies in oncology were examined. This article describes the Delphi process that was followed to determine the classification of studies that met inclusion criteria. This article also explains why this process can be useful to music therapy and music medicine and discusses its applicability to the current topic. Reasons for and justification for modifications that were made in the Delphi technique are discussed.

Music medicine studies and music therapy studies in oncology are compared in this research article. The intent is to see whether music therapy research differs from music medicine research and, if so, articulate the differences. The studies referred to in this paper might be most useful in highlighting the strong points of each type of practice. Nine music therapy and eight music medicine quantitative or mixed methods studies were selected as exemplary studies in both areas, using a Delphi process. Studies were then examined and compared regarding number of participants; independent and dependent variables; measures used; findings; number, duration, and frequency of sessions; number of participants; presentation of music; number and length of sessions; whether intervention content and an intervention theory were provided; whether music therapists were included as authors; the types of journals in which articles were published; areas of intervention; and whether CONSORT guidelines were followed. Similarities and differences are discussed, as are implications for research and practice.

Hot flashes are prevalent and severe symptoms that can interfere with mood, sleep, and quality of life for women and men with cancer. The purpose of this article is to review existing literature on the risk factors, pathophysiology, and treatment of hot flashes in individuals with cancer. Electronic searches were conducted to identify relevant English-language literature published through June 15, 2012. Results indicated that risk factors for hot flashes in cancer include patient-related factors (eg, age, race/ethnicity, educational level, smoking history, cardiovascular risk including body mass index, and genetics) and disease-related factors (eg, cancer diagnosis and dose/type of treatment). In addition, although the pathophysiology of hot flashes has remained elusive, these symptoms are likely attributable to disruptions in thermoregulation and neurochemicals. Therapies that have been offered or tested fall into 4 broad categories: pharmacological, nutraceutical, surgical, and complementary/behavioral strategies. The evidence base for this broad range of therapies varies, with some treatments not yet having been fully tested or showing equivocal results. The evidence base surrounding all therapies is evaluated to enhance hot flash treatment decision-making by clinicians and patients.

Millions of women experience menopause-related hot flashes or flushes that may have a negative effect on their quality of life. Hormone therapy is an effective treatment, however, it may be contraindicated or unacceptable for some women based on previous health complications or an undesirable risk–benefit ratio. Side effects and the unacceptability of hormone therapy have created a need for behavioral interventions to reduce hot flashes. A variety of complex, multimodal behavioral, relaxation-based interventions have been studied with women (n = 88) and showed generally favorable results. However, currently extensive resource commitments reduce the translation of these interventions into standard care. Slow, deep breathing is a common component in most interventions and may be the active ingredient leading to reduced hot flashes. This article describes the content of an audio-based program designed to teach paced breathing to reduce hot flashes. Intervention content was based on skills training theory and music entrainment. The audio intervention provides an efficient way to deliver a breathing intervention that may be beneficial to other clinical populations.

Breast cancerControlCopingMenopauseSymptom managementVasomotor symptomsBackground: Lower perceived control over hot flashes has been linked to fewercoping strategies, more catastrophizing, and greater hot flash severity and distress inmidlife women, yet this important concept has not yet been studied in breast cancersurvivors.Objective: The aim of this study was to explore perceived control over hotflashes and hot flashes in breast cancer survivors compared with midlife womenwithout cancer. Methods: Ninety-nine survivors and 138 midlife women completedquestionnaires and a prospective, electronic hot flash diary. All data were collectedat a baseline assessment before randomization in a behavioral intervention study.Results: Both groups had moderate perceived control over hot flashes. Control wasnot significantly related to hot flash frequency but was significantly related to hot flashseverity, bother, and interference in both groups. A significantly stronger associationbetween control and hot flash interference was found for survivors than for midlifewomen.Survivorsusinghotflashtreatmentsperceivedlesscontrolthandidsurvivorsnotusing hot flash treatments, whereas the opposite was true in midlife women.Conclusions: Findingsextend our knowledge of perceived control over hot flashes inboth survivors and midlife women. Implications for Practice: Findings emphasizetheimportanceofcontinuedmenopausalsymptomassessmentandmanagement,supportthe importance of continuing nursing care even for survivors who are already using hotflash treatment, and suggest that nursing interventions aimed at improving perceivedcontrol over hot flashes may be more helpful for survivors than for midlife women.Hot Flashes in BCSs and MW

Music-based interventions are used to address a variety of problems experienced by individuals across the developmental lifespan (infants to elderly adults). In order to improve the transparency and specificity of reporting music-based interventions, a set of specific reporting guidelines is recommended. Recommendations pertain to seven different components of music-based interventions, including theory, content, delivery schedule, interventionist, treatment fidelity, setting, and unit of delivery. Recommendations are intended to support Consolidated Standards for Reporting Trials (CONSORT) and Transparent Reporting of Evaluations with Non-randomized Designs (TREND) statements for transparent reporting of interventions while taking into account the variety, complexity, and uniqueness of music-based interventions.

Advances in breast cancer treatment have resulted in improved survival rates and concomitant reports of chemotherapy-related cognitive dysfunction. Music cognition, a form of general cognition, also may be negatively affected by chemotherapy. Moreover, chemotherapy may have general ototoxic effects. The goal of this study was to explore whether breast cancer survivors (BCS) had similar hearing thresholds and music cognition abilities compared with age-matched healthy controls (HC). A total of 56 women (28 BCS and 28 HC) completed the audiometric tests and the Montreal Battery Evaluation of Amusia (MBEA). Results indicate the 2 groups have similar hearing thresholds. A comparison of music cognition variables suggests possible differences in some music cognition tasks, with HC scoring slightly, but not significantly, better in melodic perception. The BCS scored slightly better, though not significantly, on melodic memory. An adequately powered study including cognitive variables is needed for verification of findings and to establish clinical meaningfulness.

The Stories and Music for Adolescent/Young Adult Resilience during Transplant (SMART) study (R01NR008583; U10CA098543; U10CA095861) is an ongoing multi-site Children's Oncology Group randomized clinical trial testing the efficacy of a therapeutic music video intervention for adolescents/young adults (11-24 years of age) with cancer undergoing stem cell transplant. Treatment fidelity strategies from our trial are consistent with the National Institutes of Health (NIH) Behavior Change Consortium Treatment Fidelity Workgroup (BCC) recommendations and provide a successful working model for treatment fidelity implementation in a large, multi-site behavioral intervention study. In this paper, we summarize 20 specific treatment fidelity strategies used in the SMART trial and how these strategies correspond with NIH BCC recommendations in five specific areas: (1) study design, (2) training providers, (3) delivery of treatment, (4) receipt of treatment, and (5) enactment of treatment skills. Increased use and reporting of treatment fidelity procedures is essential in advancing the reliability and validity of behavioral intervention research. The SMART trial provides a strong model for the application of fidelity strategies to improve scientific findings and addresses the absence of published literature, illustrating the application of BCC recommendations in behavioral intervention studies.

BACKGROUND Parents experience high levels of distress during their child's stem cell transplant that can decrease the ability to support their child and effectively communicate with healthcare providers. Because parents are a primary source of support, their perspectives are very important when evaluating supportive care interventions for their adolescents/young adults. OBJECTIVES This study examined parents' perspective of their adolescents or young adults' (AYAs') experience with stem cell transplantation (SCT) and involvement in a therapeutic music video (TMV) intervention. METHODS This was a phenomenological study using parents' interviews. The sample included 7 parents of 6 adolescents/young adults ranging in age from 13 to 21 years hospitalized for SCT for an oncology-related condition. Parents' interviews were conducted 100 days after transplantation. Sessions were audio taped, transcribed, and analyzed using Colaizzi's phenomenological analysis. RESULTS We analyzed more than 350 significant statements from 7 parents. Seven theme categories emerged: (1) humbling, humiliating, horrible: parents' perspectives on the cancer experiences and SCT; (2) gratitude for the benefits of TMV intervention; (3) enhanced communication; (4) connectedness; (5) watching my AYA change and grow; (6) process of parent gaining insight; and (7) and an ironic recognition of both the sad and beautiful: parents' response to the TMV intervention. CONCLUSIONS Parents' narratives suggest that the TMV intervention is a way to buffer the challenges related to SCT, and a larger study is warranted. IMPLICATIONS FOR PRACTICE These preliminary data offer clinicians insight into parent perceptions about the cancer experience, specifically SCT for their AYA child, and can be used to inform and shape clinical care. Findings reinforce the importance of offering AYAs opportunities to experience independence and mastery and engage in meaningful communication during transplant.

Purpose: More physicians need to acquire the skills of primary palliative care. Medical students’ clerkship experiences with death, dying, and palliative care (DDPC), however, may create barriers to learning such skills during residency. Whether professional development is differentially affected by DDPC is unknown. This knowledge gap potentially hinders the development of educational strategies to optimize students’ preparedness for primary palliative care. Method: Third-year students submitted professionalism narratives (N = 4062) during their internal medicine clerkship between 2004 and 2011. We identified DDPC-related narratives and then randomly selected control narratives. Narratives were compared by valence (positive or negative) and professionalism-related themes. Results and Conclusion: Less than 10% of the narratives were related to DDPC, but the majority was positive. There was a significant overlap in professionalism themes between DDPC and control narratives. The results suggest student preparedness for primary palliative care may be improved by addressing the common professionalism challenges of clinical clerkships.

Background Hospice music therapy is delivered in both homes and nursing homes (NH). No studies to date have explored differences in music therapy delivery between home and NH hospice patients. Objective To compare music therapy referral reasons and delivery for hospice patients living in NH versus home. Methods A retrospective, electronic medical record review was conducted from a large U.S. hospice of patients receiving music therapy between January 1, 2006, and December 31, 2010. Results Among the 4,804 patients, 2,930 lived in an NH and 1,847 patients lived at home. Compared to home, NH hospice patients were more likely to be female, older, unmarried, and Caucasian. For home hospice patients, the top referral reasons were patient/family emotional and spiritual support, quality of life, and isolation. The most frequent referral reasons for NH hospice patients were isolation, quality of life, and patient/family emotional and spiritual support. Differences in music therapy delivery depended mainly on patients' primary diagnosis and location of care. Conclusions Results suggest differences in referral reasons and delivery based on an interaction between location of care and patient characteristics. Delivery differences are likely a result of individualized assessment and care plans developed by the music therapist and other interdisciplinary team members to address the unique needs of the patient. Thus, it is important to have professionally trained music therapists assess and provide tailored music-based interventions for patients with different referral reasons and personal characteristics. This study also supports staffing decisions based on patient need rather than average daily census.

Research on prostate cancer and quality of life (QOL) has focused on the effects of treatment type on subsequent QOL, without considering effects of depressive symptoms. The present purpose is to test the independent contribution of depressive symptoms (measured within 4 weeks after treatment) and treatment type in predicting QOL measured 4, 7, and 12 months following treatment for clinically localized prostate cancer.The 105 patients (all Stage I-II) were newly treated with radical prostatectomy, external beam radiation (EBR) or brachytherapy. Age ranged from 42 to 80 (mean = 64); 88% Caucasian and 9% African American. Repeated measures mixed linear models were adjusted for age, race, education, and marital status.Depressive symptoms significantly (p0.01) predicted 8 of 10 disease-specific and 7 of 7 generic QOL outcomes. Treatment type significantly (p0.01) predicted urinary function and bowel bother but no generic QOL outcomes.Depressive symptoms appears to predict a wider range of QOL outcomes (measured 4-12 months after treatment) than treatment type; however, when treatment is significant its effect sizes are slightly larger than depressive symptoms. Health care providers should (1) assess depressive symptoms in prostate cancer patients before and after treatment, and (2) provide psychosocial (e.g., counseling, support groups) and pharmacologic treatment options for improving depressive symptoms.

The reason for lack of routine integration of music therapy into healthcare may be that patients are not comfortable being involved in a music therapy intervention. Therefore, the goal of this study was to examine cancer patients' interest in and preferences for using 2 types of music therapy interventions, music-making and music listening. Sixty-five patients completed the Music Interest Survey in addition to standardized measures of coping, affect, anxiety, and fatigue. Results suggest adult cancer patients are interested in music therapy, especially music listening. Patient interest and preference were associated with negative affect, anxiety, age, perceived intervention-specific benefits, barriers, and self-efficacy. Findings highlight the need for a comprehensive assessment of patient needs and preferences prior to intervention.

Objectives Somatosensory amplification is the experience of sensing everyday bodily sensations as intense, agitating, and unpleasant. Using data from menopausal breast cancer survivors and midlife women without cancer, the study purposes were to (1) explore the psychometric properties of the Somatosensory Amplification Scale and (2) to describe somatosensory amplification and its relationship to menopausal symptoms of hot flashes, mood and sleep disturbance. Study design This was a cross-sectional, descriptive, correlational study using demographic, e-diary, and questionnaire data from 99 breast cancer survivors and 138 midlife women. Main outcome measures Somatosensory amplification, hot flashes (frequency, severity, bother, interference, perceived control), mood, and sleep. Results Cronbach's alphas for the scale were low. When an 8-item version of the scale was evaluated, alphas improved and item-total correlations remained strong or improved. Midlife women and breast cancer survivors did not have significantly different somatosensory amplification total or item scores after adjusting for group differences in demographics. Somatosensory amplification was significantly correlated with hot flash interference, perceived control over hot flashes, and mood and sleep disturbance in both groups but the patterns of correlations differed slightly between groups and depending on whether the 10-item or 8-item scale was used. Conclusion Somatosensory amplification may be a relevant concept to assess in relation to the menopausal symptom experience of midlife women with and without breast cancer as it may represent a potential intervention target to improve the menopausal symptom experience.

Many breast cancer survivors (BCS) take multiple medications for health problems associated with the treated cancer and other noncancer comorbidities. However, there is no published, large-scale descriptive evaluation of medication use in BCS compared to midlife women. The purpose of this study was (1) to compare the number and types of prescription medications and over-the-counter medications between BCS and midlife women without cancer and (2) to assess possible drug-drug interactions by evaluating the cytochrome P450 isoform properties of medications (inductors and inhibitors) in both groups.A cross-sectional, descriptive, comparative design was used. Baseline data from 98 BCS and 138 midlife women without cancer was analyzed from a behavioral intervention trial for menopausal symptoms.BCS were taking significantly more prescription medications and a larger variety of different types of medication classifications (p0.05) after controlling for group differences (race, noncancer comorbid conditions, marital status, income, and smoking) in demographics. Twenty-four women were taking at least one medication considered to be a cytochrome P450 isoforms (CYP) inhibitor or inducer capable of clinical drug-drug interactions with no differences in CYP inhibitors or inducers found between groups.BCS are taking a vast array of medications during survivorship. It is unclear if prescription medications are managed by a single healthcare provider or several providers. Clinical implications are to monitor for possible interactions among the various prescription medications, over-the-counter medications, and supplements. Implications for behavioral and biomedical research are that clinical studies need to carefully assess and account for multiple medication uses. RELEVANCE OF THE STUDY: The findings of this study are relevant to research and practice for both oncology and general practitioners. The importance of assessing medication information provides information about symptom management in individuals surviving cancer. In addition, the potential interaction of drugs impacts efficacy of various treatments and impacts compliance by patients.

Treatment fidelity, also called intervention fidelity, is an important component of testing treatment efficacy. Treatment fidelity is defined as “methodological practices used to ensure that a research study reliably and validly tests a clinical intervention” (Bellg et al., 2004, p. 443). In cognitive behavioral interventions, published recommendations address five components of treatment fidelity: study design, provider training, treatment delivery, treatment receipt, and treatment enactment (Bellg et al., 2004; Borrelli et al., 2005). Strategies are incorporated in these five components to ensure that: theory-based hypotheses can be tested adequately via the study design; the personnel who provide the intervention are competent and consistent; the intervention is delivered as intended without variation; the intervention is received appropriately and understood by participants; and participants enact the intervention as intended in their daily life (Bellg et al., 2004; Borrelli et al., 2005). Capturing measurable data related to treatment fidelity monitoring is important for several reasons. First, variations are likely to occur, given the complexity of cognitive behavioral interventions, range of strategies used to address treatment fidelity components, and resource limitations that can be encountered when conducting clinical trials (Spillane et al., 2007). Second, variations that do occur need to be captured to assess intervention dose adequately (Santacroce, Maccarelli, & Grey, 2004). Third, documenting and evaluating variations in treatment enactment can help in translating interventions from tightly controlled clinical trials to real-world settings (Leventhal & Friedman, 2004). Although examples of the number, type, and complexity of strategies needed to address each of these five components of treatment fidelity have been provided (Resnick et al., 2005; Robb, Burns, Docherty, & Haase, 2011), more data are needed on the variations encountered during fidelity monitoring. The purpose of this report is to describe strategies used and data obtained during treatment fidelity monitoring in the Breathe for Hot Flashes Study (1 R01 CA132927).

Paced respiration has been internationally recommended for vasomotor symptom management, despite limited empirical evidence.To evaluate efficacy of a paced respiration intervention against breathing control and usual care control for vasomotor and other menopausal symptoms.A 16-week, 3-group, partially blinded, controlled trial with 2:2:1 randomization and stratification by group (breast cancer, no cancer), in a Midwestern city and surrounding area.Two hundred and eighteen randomized women (96 breast cancer survivors, 122 menopausal women without cancer), recruited through community mailings and registries (29 % minority).Training, home practice support, and instructions to use the breathing at the time of each hot flash were delivered via compact disc with printed booklet (paced respiration intervention) or digital videodisc with printed booklet (fast shallow breathing control). Usual care control received a letter regarding group assignment.Hot flash frequency, severity, and bother (primary); hot flash interference in daily life, perceived control over hot flashes, and mood and sleep disturbances (secondary). Intervention performance, adherence, and adverse events were assessed.There were no significant group differences for primary outcomes at 8-weeks or 16-weeks post-randomization. Most intervention participants did not achieve 50 % reduction in vasomotor symptoms, despite demonstrated ability to correctly do paced respiration and daily practice. Statistically significant differences in secondary outcomes at 8 and 16 weeks were small, not likely to be clinically relevant, and as likely to favor intervention as breathing control.Paced respiration is unlikely to provide clinical benefit for vasomotor or other menopausal symptoms in breast cancer survivors or menopausal women without cancer.

Introduction To provide an overview of factors related to recruitment of adolescents and young adults (AYA) into research and recruitment rates and reasons for refusal from a multicenter study entitled “Stories and Music for Adolescent/Young Adult Resilience during Transplant” (SMART). Methods A randomized clinical trial study design was used. The settings included 9 hospitals. The sample included AYAs (aged 11-24 years) who were undergoing a stem cell transplant. Several instruments were used to measure symptom distress, coping, resilience, and quality of life in AYA with cancer. Results A total of 113 AYA were recruited (50%) for this study. Strategies were refined as the study continued to address challenges related to recruitment. We provide a description of recruitment strategies and an evaluation of our planning, implementing, and monitoring of recruitment rates for the SMART study. Discussion When designing a study, careful consideration must be given to factors influencing recruitment as well as special considerations for unique populations. Dissemination of strategies specific to unique populations will be helpful to the design of future research studies.

The purpose of this study was to explore the feasibility and preliminary efficacy of a therapeutic music video (TMV) intervention for adolescents and young adults (AYAs) undergoing stem-cell transplantation (SCT). Twelve AYAs (aged 11-24 years) were randomized to the TMV or an audio-book protocol. The TMV was designed to diminish symptom distress and improve coping, derived meaning, resilience, and quality of life by supporting AYAs in exploring thoughts and feelings. Six sessions with a board-certified music therapist were held twice a week for 3 weeks. The Adolescent Resilience Model guided the selection of a large, comprehensive battery of outcome measures. Major data collections occurred before admission, after intervention, and at 100 days after transplantation. Participants completed a brief set of measures at presession/postsessions 2, 4, and 6. Rates of consent, session completion, and questionnaire completion supported feasibility. Immediate follow-up measures suggest positive trends in the TMV group for hope, spirituality, confidence/mastery, and self-transcendence. Positive trends at 100 days include MOS, symptoms distress, defensive coping, spirituality, and self-transcendence. Therapeutic music video participants also demonstrated gains in quality of life. The TMV intervention may buffer the immediate after-effects of the stem-cell transplantation experience, and a larger study is warranted.

Patients receiving intensive chemotherapy can experience increased distressed related to both the cancer diagnosis and treatment isolation. If not addressed, distress can lead to anxiety, depression, and post-traumatic stress disorder. The purpose of this study was to determine the feasibility and possible benefits of a music imagery intervention for patients hospitalized in a protective environment for the treatment of acute leukemia or high-grade non-Hodgkin’s lymphoma. Adults receiving intensive myelosuppressive chemotherapy in a protective environment were randomized to standard care or standard care plus music imagery. The music imagery sessions occurred twice weekly for up to eight sessions. Patients were encouraged to use the music imagery daily. The principal criteria of feasibility were rate of consent, rate of completion of scheduled sessions, and rate of questionnaire completion. Forty-nine out of 78 patients consented, a 63% consent rate. Seventy-two percent of all scheduled music imagery sessions were completed. The rate of questionnaire completion was 60% with missing data because of illness severity and early discharge. The principal outcomes of benefit (e.g., efficacy) were positive and negative affects, fatigue, and anxiety. Both groups improved over time on all outcomes (all p

BACKGROUND Treatments for clinically localized prostate carcinoma are accompanied by sexual, urinary, and bowel dysfunction and other sequelae that can result in significant distress and reduced well being. Methods capable of improving quality of life are needed that can be integrated into clinical practice. To address this need, a nurse-driven, cancer care intervention was developed and tested. METHODS Within 6 weeks after completing treatment, 99 patients, along with their partners, were enrolled into a prospective, controlled trial and were randomized to receive the cancer care intervention or to receive standard care. Participants in the intervention arm met once each month for 6 months with an oncology nurse intervenor, who helped patients identify their quality-of-life needs using an interactive computer program. The intervener then provided education and support tailored to participants' needs. Primary outcome variables included 1) disease-specific quality of life, including sexual, urinary, and bowel outcomes and cancer worry; 2) depression; 3) dyadic adjustment; and 4) general quality of life. Outcomes data were collected prior to randomization and again at 4 months, 7 months, and 12 months posttreatment. RESULTS Patients in the intervention arm experienced long-term improvements in quality-of-life outcomes related to sexual functioning and cancer worry compared with patients who received standard care. Baseline depression moderated the impact of the intervention on several other quality-of-life outcomes. CONCLUSIONS The findings of the current study indicated that a computer-assisted, nurse-driven intervention was capable of providing durable improvements in the quality of life of men who underwent treatment for clinically localized prostate carcinoma. Cancer 2005. © 2005 American Cancer Society.

Background Sample size planning for clinical trials is usually based on detecting a target effect size of an intervention or treatment. Explicit incorporation of costs into such planning is considered in this article in the situation where effects of an intervention or treatment may depend on (interact with) baseline severity of the targeted symptom or disease. Because much larger sample sizes are usually required to establish such an interaction effect, investigators frequently conduct studies to establish a marginal effect of the intervention for individuals with a certain level of baseline severity. Methods We conduct a rigorous investigation on how to determine optimum baseline symptom or disease severity inclusion criteria so that the most cost-efficient design can be used. By using a regression model with an interaction term of treatment by symptom severity, power functions were derived for various levels of baseline symptom severity. Computer algorithms and mathematical optimization were used to determine the most cost-efficient research designs assuming either single- or dual-stage screening procedures. Results In the scenarios we considered, impressive cost savings can be achieved by informed selection of baseline symptom severity via the inclusion criteria. Further cost-savings can be achieved if a two stage screening procedure is used and there are some known, relatively inexpensively collected, pre-screening information. The amount of total cost savings are shown to depend on the ratio of the screening and intervention costs. In our investigation, we assumed that: 1) the cost of approaching available subjects for screening is constant, and 2) all variables are normally distributed. There is a need to carry out further investigations with more relaxed assumptions (e.g., skewed data distribution). Conclusions As cost becomes a more and more prominent issue in modern clinical trials, cost-saving strategies will become more and more important. Strategies, such as the ones we propose here, can help to minimize costs while maximizing knowledge generation.

Patients with acute leukemia who receive intensive chemotherapy often require a prolonged hospitalization in a protective environment. The required isolation may increase the psychological distress related to the diagnosis and intensive chemotherapy treatment. The combination of music and imagery offers an innovative approach to reduce distress. To assess the feasibility and the potential efficacy of a music imagery intervention, we randomly assigned adults to standard care or standard care plus music imagery. The initial music imagery session with a board certified music therapist occurred within two days of admission and then twice weekly for 8 sessions. Each 45-minute session consisted of a relaxation exercise and patient created imagery while listening to music. Patients were encouraged to independently use the music imagery daily. Patients completed the State Anxiety Inventory (SAI), the FACIT-Fatigue, and the Positive Affect Negative Affect Schedule (PANAS) at baseline, then every 7 days until discharge, and at a follow-up outpatient clinic visit. Of the 78 patients approached for participation, 29 refused. The 3 most common reasons cited were: overwhelmed by treatment (9), not interested (8), and too sick (6). Forty-nine individuals were randomized to the intervention (25) or control (24) group. There were 19 men and 30 women and a majority of participants were married (65%). Average age for participants was 52 (SD 15.36) for intervention and 55 (SD 15.87) for control. The median length of stay was 28 and 26 days, respectively. For the intervention group, 8 (32%) individuals received 8 sessions, 5 (20%) received 5–7 sessions, 9 (36%) received 2–4, and 6 (24%) received 0–1 sessions. After adjusting for baseline scores, there was a main time effect in predicting Fatigue, PANAS-PA, PANAS-NA, and Anxiety (all p