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Complementary and integrative healthcare (CIH) is increasingly recognized as a valuable approach to empowering and activating cancer patients. Studies have shown that higher patient activation is positively associated with improved health outcomes and reduced healthcare costs. The CCC-Integrativ study aimed to assess the implementation of an evidence-based counseling service on CIH at four Comprehensive Cancer Centers (CCC) in Germany. In this controlled implementation study, the patient-level intervention included three CIH consultations within a 3-month period delivered by interprofessional teams of physicians and nurses. The primary endpoint was patient activation using the PAM-13 at baseline (T1) and post-intervention (T2), and compared between control (CO, receiving routine care) and the intervention group (IG) using an analysis of covariance. Missing data were handled with multiple imputations. Maintenance effects at 6-month follow-up (T3) were investigated using a linear mixed model. A total of n = 1128 oncology patients (CO = 443, IG = 685) with diverse tumor entities and cancer stages were included in the study. The overall mean baseline PAM-13 score was 69.74 (SD = 14.24) (n = 959 (85.0%)). A statistically significant between-group difference in post-intervention PAM-13 scores was observed (F group (1, 1866.82) = 8.634, P = 0.003), with an adjusted mean difference of 2.22 PAM-points. Age, gender, tumor entity, disease stage, or CCC study site did not significantly predict post-treatment PAM-13 scores. The maintenance effect of the intervention was not statistically significant (F timeXgroup (1, 3316.04) = 2.337, P = 0.096). Individually tailored counseling on CIH, offered by specifically trained, interprofessional teams, significantly improved patient activation. Given the established positive effects of higher patient activation, the implementation of such a program at cancer centers may yield beneficial outcomes for both patients and the healthcare system., Competing Interests: Compliance with ethics guidelines. Conflicts of Interest Jan Valentini, Daniela Froehlich, Inka Roesel, Regina Stolz, Cornelia Mahler, Peter Martus, Nadja Klafke, Markus Horneber, Claudia Witte, Klaus Kramer, Christine Greil, Barbara Gruen, Katrin Tomaschko-Ubelaender, and Stefanie Joos declare that they do not have any conflict of interests. The study has been approved by the appropriate Institutional Ethical Committee of the University of Tuebingen (No. 658/2019BO1)., (© 2024. The Author(s).)

Background: Accurate assessment and enhancement of health-related skills among oncology patients are pivotal for optimizing cancer care. The Patient Activation Measure (PAM-13), a questionnaire designed to reflect an individual's knowledge, skills, and confidence in self-healthcare management, has been validated across diverse countries and settings. Concerns have been raised regarding the cross-situational applicability, as patients with specific diseases and cultural backgrounds interpret questionnaire items differently. This study aimed to examine the structural validity and psychometric properties of the PAM-13 in an oncological patient cohort., Methods: Baseline data from a longitudinal non-randomized controlled study involving cancer out-patients (n = 1,125) from Comprehensive Cancer Centres in Southern Germany were analysed. The German version of the PAM-13 was employed. With classical test and item response theory methods data quality, reliability, convergent and structural validity, as well as psychometric properties were assessed. Exploratory (EFA) and confirmatory factor analyses (CFA) were employed to investigate the postulated unidimensionality of the underlying construct. With a partial credit model (PCM) we examined item fit, targeting, local independence and differential item functioning., Results: Participants were predominantly female (73.0%) with a breast cancer diagnosis (41.3%). While items were generally well-accepted, ceiling effects were observed and a high mean PAM-13 score (69.7, SD = 14.2) was noted, potentially compromising responsiveness to interventions. Reliability was adequate (Cronbach's α = 0.81), person and item separation reliability were good to excellent (0.81 and 0.99, respectively). Explorations of the unidimensionality of the construct (EFA, CFA, PCM) yielded inconclusive results, hinting towards a two-factor solution. Item difficulty rankings deviated from the original. No differential item functioning was identified, and local independence was confirmed., Conclusions: While the PAM-13 serves as a valuable instrument for comprehending and promoting health-related skills in cancer patients, the identification of ceiling effects, disordered item-difficulty rankings, and inconclusive findings regarding unidimensionality contribute to the expanding body of evidence, emphasizing the dependency of PAM-13's validity and reliability on distinctive characteristics within the population under investigation. Future research should prioritize refining or adding PAM-13 items to better capture the specific health-related challenges within diverse populations, paving the way for more effective patient engagement strategies in oncology., Trial Registration Number: DRKS00021779., (© 2024. The Author(s).)

Objective: To assess the effectiveness of exercise and education in addition to standard care (SC) compared to SC alone in patients with hip or knee osteoarthritis (OA) during 24 months follow-up., Design: We conducted a quasi-experimental pragmatic clinical trial in care centers of a health insurance company. Overall, 1,030 subjects with hip and/or knee OA were included. The intervention group was recruited from clients participating in a hip/knee training (HKT, n = 515) in addition to SC. The control group (CO, n = 515) receiving SC only was recruited from the insurance database. HKT comprised 8 group sessions (1/week) of exercise and education, complemented by a 11-week structured home-exercise program (2/week). Primary endpoints were change of joint-related pain and function (WOMAC Index, score 0-10) after 3 months. Secondary endpoints related to follow-ups at 6, 12 and 24 months. All patient reported outcome measures were analyzed using linear mixed models (LMMs) investigating a time x treatment effect. A multivariable cox proportional hazards regression model was used to identify differences of joint replacement during follow-up between groups., Results: LMMs revealed statistically significant differences in favor of HKT for the primary outcomes WOMAC pain = 0.47 (CI 0.27-0.66; Effect Size (ES) = 0.22, p < 0.001) and WOMAC function = 0.27 (CI 0.11-0.44; ES = 0.13, p < 0.001). HKT was superior to CO for 6, 12, and 24 months as well (ES < 0.2, p ≤ 0.006). HKT was inferior regarding the first incidence of hip or knee AJR during follow-up in comparison to CO (adjusted hazard ratio, HR = 1.57; CI 1.08-2.30; p = 0.020)., Conclusions: This trial demonstrated short-, mid- and long-term superiority of exercise versus control. However, differences were smaller than those reported in previous efficacy trials, raising questions regarding clinical importance. Responder analysis will follow to identify possible predictors for patient responsiveness on an individual level. Further studies should investigate the frequency and reasons for joint replacement following exercise therapy., Trial Registration: German Clinical Trial Register (DRKS00009251). Registered 10 September 2015., (© 2024. The Author(s).)

This study aimed to compare an individual weight-machine-based strengthening program (MbT) with a group-/homebased training offering strengthening/functional exercises (GHT) in a general health care setting. A total of 657 participants (GHT = 521, MbT = 136) suffering from hip/knee OA were included and analysed with a pre-post design (baseline (T0)/3-months (T1)). Primary outcomes were pain and physical functioning (Western Ontario and McMaster Universities Osteoarthritis Index, range 0-10). Additionally, adherence and perceived patient benefit were measured (T1). Data were analysed with linear mixed models (time, treatment, baseline pain/physical impairment severity) adjusted for patient characteristics. No significant between-group differences in pain reduction/functional improvements (time*treatment*baseline pain/physical impairment severity, pain/function: n.s.; time*treatment, pain: p = 0.884, function: p = 0.067). Within-group improvements were dependent on baseline severity: Higher severity levels demonstrated larger changes from baseline. Perceived patient-benefit (very high to high, GHT: 78%, MbT: 92%) and exercise adherence (Dropouts T1: GHT: 27.8%, MbT: 16.2%; adherence to supervised sessions: GHT: 89%, MbT: 92%) was slightly better in the MbT. In summary, both MbT and GHT, showed positive results for patients with at least moderate disease symptoms. Findings for physical functioning, perceived patient-benefit, exercise adherence hint towards a superiority of MbT. Individual preferences should be considered when prescribing exercise therapy. Trial registration: (1) German Clinical Trial Register DRKS00009251. Registered 10 September 2015. (2) German Clinical Trial Register DRKS00009257. Registered 11 September 2015.

Physical exercise has been shown to be effective in the treatment of non-communicable chronic diseases. However, patients with multiple chronic diseases (multimorbidity) have received little attention in health policy. This pilot trial served as a proof of concept of a 6-months person-oriented exercise intervention for people at risk of or with diagnosed cardiovascular diseases, diabetes mellitus type 2, overweight and/or hip/knee osteoarthritis, regarding effects on health outcomes as well as adherence and safety. The intervention (‘MultiPill-Exercise’) was designed to promote physical exercise participation, considering an individual perspective by addressing personal and environmental factors. Outcomes were assessed at baseline (t0) and after three- (t3) and six-months (t6). The primary outcome was self-reported physical exercise participation in minutes/week comparing t3 and t6 vs. t0. Secondary outcomes included cardio-respiratory fitness (maximum oxygen uptake VO2peak during incremental cycling ergometry), isometric peak torque of knee extensors and flexors, health-related quality of life (Veterans Rand 12 with its subscales of perceived general health (GH), mental health (MCS), and physical health (PCS)) and blood levels. Adherence to exercise (% of attended sessions during the first 12-weeks of the intervention) and adverse events were monitored as well. Data were analyzed using a non-parametric procedure for longitudinal data, estimating rank means (MRank) and relative treatment effects (RTE) as well as linear-mixed effect models for parametric data. The primary endpoint of physical exercise participation was significantly higher at t3 and t6 compared to baseline (t3 vs. t0: MRank = 77.1, p < 0.001, RTE: 0.66; t6 vs. t0: MRank = 70.6, p < 0.001, RTE = 0.60). Improvements at both follow-up time points compared to t0 were also found for relative VO2peak (t3 vs. t0 = 2.6 mL/kg/min, p < 0.001; t6 vs. t0 = 2.0 mL/kg/min, p = 0.001), strength of knee extensors (t3 vs. t0 = 11.7 Nm, p = 0.007; t6 vs. t0= 18.1 Nm, p < 0.001) and GH (t3 vs. t0 = 16.2, p = 0.003; t6 vs. t0 = 13.4, p = 0.008). No changes were found for MCS, PCS and for blood levels. Overall exercise adherence was 77%. No serious adverse events were recorded. Results of this pilot trial represent a first proof of concept for the intervention ‘MultiPill-Exercise’ that will now be implemented and evaluated in a real-world health care setting.

Background: Physical exercise has been found to assert a positive impact on many muscular conditions. Exercise under face-to-face supervision is the gold standard, but access to it is limited, for instance, for economic reasons. App-guided therapy is an intervention that is more affordable and easily accessible. However, attitude toward technology is a key predictor for media adoption and is therefore expected to shape user experience during app-guided therapy. This might be of particular importance for mastery experience, which is crucial for promoting exercise-related self-efficacy and perceived usefulness of the interaction. Both should empower patients to continuously exercise., Objective: This study sought to test whether attitudes toward technology predict mastery experience and perceived usefulness of the interaction after an app- versus a physiotherapist-guided treatment. We expect that attitudes toward technology positively predict both outcomes in case of the app-guided but not in case of the physiotherapist-guided treatment., Methods: Patients (n=54) with clinically diagnosed hip osteoarthritis participated in 2 training sessions with the same exercise intervention, once guided by an app on a tablet computer and once guided by a physiotherapist in a German university hospital. The order of the sessions was randomized. Attitude toward technology was assessed as predictor before the first session, while mastery experience and the global perceived usefulness of interaction as self-reported outcomes after each session., Results: In line with our hypotheses, attitude toward technology predicted mastery experience (b=0.16, standard error=0.07, P=.02) and usefulness of interaction (b=0.17, standard error=0.06, P=.01) after the app-based training but not after the training delivered by a physiotherapist (P>.3 in all cases). Mastery experience was lower for the app-based training but reached a very similar level as the physiotherapist-guided training for those holding a very positive attitude toward technology., Conclusions: The attitude toward technology predicts the extent of mastery experience after app-guided exercise therapy. As mastery experience is highly important for self-efficacy and future exercise behavior, attitudes toward technology should be considered when delivering app-guided exercise treatments., Trial Registration: German Clinical Trials Register DRKS00015759; https://www.drks.de/drks&#95;web/navigate.do?navigationId=trial.HTML&TRIAL&#95;ID=DRKS00015759., (©Kai Sassenberg, Inka Roesel, Gorden Sudeck, Katharina Bernecker, Jennifer Durst, Inga Krauss. Originally published in JMIR Formative Research (https://formative.jmir.org), 18.02.2022.)

Background: The positive impact that physical activity has on patients with cancer has been shown in several studies over recent years. However, supervised physical activity programs have several limitations, including costs and availability. Therefore, our study proposes a novel approach for the implementation of a patient-executed, activity tracker-guided exercise program to bridge this gap., Objective: Our trial aims to investigate the impact that an activity tracker-guided, patient-executed exercise program for patients undergoing radiotherapy has on cancer-related fatigue, health-related quality of life, and preoperative health status., Methods: Patients receiving postoperative radiotherapy for breast cancer (OnkoFit I trial) or neoadjuvant, definitive, or postoperative treatment for other types of solid tumors (OnkoFit II trial) will be randomized (1:1:1) into 3-arm studies. Target accrual is 201 patients in each trial (50 patients per year). After providing informed consent, patients will be randomized into a standard care arm (arm A) or 1 of 2 interventional arms (arms B and C). Patients in arms B and C will wear an activity tracker and record their daily step count in a diary. Patients in arm C will receive personalized weekly targets for their physical activity. No further instructions will be given to patients in arm B. The target daily step goals for patients in arm C will be adjusted weekly and will be increased by 10% of the average daily step count of the past week until they reach a maximum of 6000 steps per day. Patients in arm A will not be provided with an activity tracker. The primary end point of the OnkoFit I trial is cancer-related fatigue at 3 months after the completion of radiotherapy. This will be measured by the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire. For the OnkoFit II trial, the primary end point is the overall quality of life, which will be assessed with the Functional Assessment of Cancer Therapy-General sum score at 6 months after treatment to allow for recovery after possible surgery. In parallel, blood samples from before, during, and after treatment will be collected in order to assess inflammatory markers., Results: Recruitment for both trials started on August 1, 2020, and to date, 49 and 12 patients have been included in the OnkoFit I and OnkoFit II trials, respectively. Both trials were approved by the institutional review board prior to their initiation., Conclusions: The OnkoFit trials test an innovative, personalized approach for the implementation of an activity tracker-guided training program for patients with cancer during radiotherapy. The program requires only a limited amount of resources., Trial Registration: ClinicalTrials.gov NCT04506476; https://clinicaltrials.gov/ct2/show/NCT04506476. ClinicalTrials.gov NCT04517019; https://clinicaltrials.gov/ct2/show/NCT04517019., International Registered Report Identifier (irrid): DERR1-10.2196/28524., (©Franziska Hauth, Barbara Gehler, Andreas Michael Nieß, Katharina Fischer, Andreas Toepell, Vanessa Heinrich, Inka Roesel, Andreas Peter, Mirjam Renovanz, Andreas Hartkopf, Andreas Stengel, Daniel Zips, Cihan Gani. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 22.09.2021.)

We evaluated the short- and longer-term effects of exercise therapy in hip osteoarthritis patients (OA) at baseline, three, six, and 12 months in a randomized setting, followed by a non-randomized setting. The primary randomized intervention (E = exercise, P = placebo-ultrasound, C = control) was followed by a voluntary three-month exercise therapy for P and C (renamed P-E, C-E). Participants randomized to E were not offered treatment again (E-C). Effect sizes (ES; 95% CI) were calculated for within-group effects across time for bodily pain (SF-36) and WOMAC pain, function, and stiffness. ANCOVAs of post-treatment scores were used for group comparison after the group-specific exercise intervention phase. Exercise adherence was assessed and related to post-treatment scores of clinical outcomes. Data of 115 participants of the RCT eligible for follow-up and completing exercise therapy were included into our analyses. Small to medium beneficial long-term effects of cumulative interventional effects, including exercise training, persisted in all groups. Group E-C ( n = 49) showed significant 12 months vs. baseline within-group ES in all outcomes (ES 0.39-0.59) except stiffness. Findings were less prominent for exercise therapy in a non-randomized setting (C-E, P-E, both n = 33). Differences are partially explained by adherence rates, highlighting the relevance of therapy compliance strategies. Short-term between-group differences (ANCOVAs) only showed statistically significant differences for WOMAC function between P-E and E-C in favor of E-C (6.4 (95% CI 1.6-11.2; score range 0-100)).

Background: Hip and knee osteoarthritis is ranked as the 11th highest contributor to global disability. Exercise is a core treatment in osteoarthritis. The model for physical activity-related health competence describes possibilities to empower patients to perform physical exercises in the best possible health-promoting manner while taking into account their own physical condition. Face-to-face supervision is the gold standard for exercise guidance., Objective: The aim of this study was to evaluate whether instruction and guidance via a digital app is not inferior to supervision by a physiotherapist with regard to movement quality, control competence for physical training, and exercise-specific self-efficacy., Methods: Patients with clinically diagnosed hip osteoarthritis were recruited via print advertisements, emails and flyers. The intervention consisted of two identical training sessions with one exercise for mobility, two for strength, and one for balance. One session was guided by a physiotherapist and the other was guided by a fully automated tablet computer-based app. Both interventions took place at a university hospital. Outcomes were assessor-rated movement quality, and self-reported questionnaires on exercise-specific self-efficacy and control competence for physical training. Participants were randomly assigned to one of two treatment sequences. One sequence started with the app in the first session followed by the physiotherapist in the second session after a minimum washout phase of 27 days (AP group) and the other sequence occurred in the reverse order (PA group). Noninferiority was defined as a between-treatment effect (gIG)<0.2 in favor of the physiotherapist-guided training, including the upper confidence interval. Participants, assessors, and the statistician were neither blinded to the treatment nor to the treatment sequence., Results: A total of 54 participants started the first training session (32 women, 22 men; mean age 62.4, SD 8.2 years). The treatment sequence groups were similar in size (PA: n=26; AP: n=28). Seven subjects did not attend the second training session (PA: n=3; AP: n=4). The app was found to be inferior to the physiotherapist in all outcomes considered, except for movement quality of the mobility exercise (gIG -0.13, 95% CI -0.41-0.16). In contrast to the two strengthening exercises in different positions (supine gIG 0.76, 95% CI 0.39-1.13; table gIG 1.19, 95% CI 0.84-1.55), movement quality of the balance exercise was close to noninferiority (gIG 0.15, 95% CI -0.17-0.48). Exercise-specific self-efficacy showed a strong effect in favor of the physiotherapist (gIG 0.84, 95% CI 0.46-1.22). In terms of control competence for physical training, the app was only slightly inferior to the physiotherapist (gIG 0.18, 95% CI -0.14-0.50)., Conclusions: Despite its inferiority in almost all measures of interest, exercise-specific self-efficacy and control competence for physical training did improve in patients who used the digital app. Movement quality was acceptable for exercises that are easy to conduct and instruct. The digital app opens up possibilities as a supplementary tool to support patients in independent home training for less complex exercises; however, it cannot replace a physiotherapist., Trial Registration: German Clinical Trial Register: DRKS00015759; http://www.drks.de/DRKS00015759., (©Jennifer Durst, Inka Roesel, Gorden Sudeck, Kai Sassenberg, Inga Krauss. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 28.09.2020.)