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Your search keyword '"Randomized controlled trial"' showing total 2 results
2 results on '"Randomized controlled trial"'

1. Moxibustion for treating cancer‐related fatigue: A multicenter, assessor‐blinded, randomized controlled clinical trial.

Author

Han, Kyungsun, Kim, Mikyung, Kim, Eun‐Jung, Park, Yeon‐Cheol, Kwon, Ojin, Kim, Ae‐Ran, Park, Hyo‐Ju, Park, Yang‐Chun, Cho, Jung Hyo, Kim, Joo‐Hee, and Lee, Jun‐Hwan

Subjects
*MOXIBUSTION, *CLINICAL trials, *COGNITION disorders, *QUALITY of life, *TREATMENT effectiveness, *CANCER fatigue
Abstract

Cancer‐related fatigue (CRF) is one of the most common chronic symptoms experienced by cancer patients. As moxibustion is a popular traditional therapy for managing fatigue, it can be an alternative strategy to treat CRF as well. Therefore, we rigorously designed a full‐scale, multicenter, assessor‐blinded, randomized controlled trial to evaluate the efficacy and safety of moxibustion treatment for CRF. Ninety‐six subjects suffering from CRF were recruited and randomly assigned to moxibustion group, sham moxibustion group, or usual care group. Both the moxibustion group and the sham group received moxibustion treatment for 8 weeks and the usual care group did not. Brief fatigue inventory (BFI) score and Functional Assessment of Cancer Therapy‐Fatigue score were used to assess CRF at baseline and weeks 5, 9, and 13. Questionnaires for the assessment of cognitive impairment, quality of life, and Cold–Heat and Deficiency–Excess patterns were also evaluated. BFI scores significantly decreased in moxibustion group compared to the usual care group (mean difference of −1.92, p < 0.001 at week 9 and mean difference of −2.36, p < 0.001 at week 13). Although the sham group also showed significant improvement during the treatment period, only the moxibustion group showed improvement after 4 weeks of follow‐up period (mean difference of −1.06, p < 0.001). There were no serious adverse events. Our findings confirmed the efficacy and safety of moxibustion for CRF compared to usual care. We also found that moxibustion has a prolonged treatment effect during 4 weeks of follow‐up period. [ABSTRACT FROM AUTHOR]

Published
2021
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2. Quality of life outcomes from a randomized controlled trial of patient navigation in Latina breast cancer survivors

Author

Alfredo A. Santillan, Dorothy Long Parma, Edgar Munoz, Arely Perez, and Amelie G. Ramirez

Subjects
0301 basic medicine, Health Knowledge, Attitudes, Practice, Cancer Research, Time Factors, law.invention, 0302 clinical medicine, Cancer Survivors, Randomized controlled trial, Quality of life, law, Original Research, education.field_of_study, Hispanic or Latino, Middle Aged, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Culturally Competent Care, Texas, Treatment Outcome, Oncology, 030220 oncology & carcinogenesis, Female, Psychosocial, Adult, medicine.medical_specialty, Population, Breast Neoplasms, Health Promotion, behavioral science, lcsh:RC254-282, 03 medical and health sciences, Breast cancer, breast cancer, Patient Education as Topic, Survivorship curve, medicine, Humans, Patient Navigation, Radiology, Nuclear Medicine and imaging, education, Socioeconomic status, Aged, clinical trials, business.industry, Clinical Cancer Research, medicine.disease, Clinical trial, 030104 developmental biology, quality of life, Physical therapy, business
Abstract

Introduction Breast cancer survivorship is a life‐long process involving challenges to health‐care communities and individuals, especially Latinas. Patient Navigation has shown some success in meeting these challenges. The purpose of this study was to compare the effects of an enhanced Patient Navigation program (Intervention; PN+) vs Control (PN) over time on general cancer and breast cancer‐specific quality of life (QoL) in Latina breast cancer survivors (BCS). Methods We conducted a 2‐year, two‐arm randomized controlled trial of the “Staying Healthy” program among Latina BCS. The design compared PN+ vs PN over time. We recruited 60 patients into each study arm and randomized them by sequential numerical assignment. PN+ participants received culturally tailored educational materials and active, personalized Patient Navigation services, including phone calls, transportation, and care coordination. PN participants were navigated only upon request. Primary outcomes included general cancer (Functional Assessments of Cancer Therapy [FACTS]‐G) and breast cancer‐specific (FACT‐B) QoL. Results PN+ participants had significantly improved QoL measures compared to PN at 6‐month follow‐up on all subscales (P‐values .007‐.04) except physical well‐being (PWB; P = .11). Intervention effect size coefficient (standard error) for FACT‐G overall was 7.9 (3.1); P = .01. For FACT‐B, it was 10.9 (3.9); P = .006. Again, all subscales showed significant effects [range 1.7‐3.1 (0.8‐1.2); P‐values .006‐.04], except for PWB [1.5 (1.0); P = .16] and social/family well‐being (SWB) [2.1 (1.1); P = .06]. There were no differences between groups at baseline. Discussion Multiple cultural, psychosocial, and socioeconomic variables contributing to these intervention effects will be addressed in future studies. As the national BCS population continues to increase, more Patient Navigation‐focused partnerships among patients, health‐care professionals, research groups, and community organizations are needed to improve BCS experiences. The Staying Healthy program has the potential to serve as a national survivorship care model for improving Latina BCS QoL., We evaluated the effect of a two‐year, two‐arm randomized controlled trial (the “Staying Healthy” program) on quality of life (QoL) among Latina breast cancer survivors (BCS). The design compared enhanced Patient Navigation (Intervention; PN+) versus usual (Control; PN) over time. PN+ participants had significantly improved quality of life measures compared to PN at 6‐month follow‐up.

Published
2020

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