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- Title
Telephone-Based Rehabilitation Intervention to Optimize Activity Participation After Breast Cancer: A Randomized Clinical Trial.
- Authors
Lyons, Kathleen Doyle; Wechsler, Stephen B.; Ejem, Deborah B.; Stevens, Courtney J.; Azuero, Andres; Khalidi, Sarah; Hegel, Mark T.; dos Anjos, Sarah M.; Codini, Megan E.; Chamberlin, Mary D.; Morency, Jamme L.; Coffee-Dunning, Jazmine; Thorp, Karen E.; Cloyd, Danielle Z.; Goedeken, Susan; Newman, Robin; Muse, Colleen; Rocque, Gabrielle; Keene, Kimberly; Pisu, Maria
- Abstract
Key Points: Question: Compared with an attention control condition, what is the effect of a behavioral activation and problem-solving intervention on participation restrictions among breast cancer survivors in the year following treatment? Findings: In this randomized clinical trial that included 284 women, the intervention resulted in significantly greater improvements in self-selected activity participation but did not otherwise accelerate recovery compared with the control condition. Meaning: These results suggest that research is needed to determine whether time or the conditions' common features (eg, support, individualized attention to elicit priorities, and education) led to participation improvements or whether objective measures could better illuminate the intervention's effect on functional recovery. Importance: Following treatment, breast cancer survivors face challenges participating in valued activities. Objective: To determine whether a telephone-based coaching rehabilitation intervention enhances activity participation in the year following breast cancer treatment. Design, Setting, and Participants: In this multisite, single-blind randomized clinical trial (Optimizing Functional Recovery of Breast Cancer Survivors), recruitment occurred between August 28, 2019, and April 30, 2022. Data collection was completed by April 1, 2023. Participants were recruited from 2 cancer centers (Dartmouth College and the University of Alabama at Birmingham) and via social media advertisements. Women aged 18 years or older who had completed primary treatment for stage I to III breast cancer within 1 year and reported participation restrictions were eligible to participate. Randomization was stratified by site, treatment, and time since treatment. Interventions: The intervention, delivered via telephone over 9 sessions, used behavioral activation and problem-solving principles to promote activity participation. The education-based attention control condition was delivered via telephone at matched intervals. Main Outcomes and Measures: The primary outcome was participation, assessed using 5 measures, including Patient-Reported Outcomes Measurement Information System (PROMIS) social participation-satisfaction measure. One individualized outcome allowed participants to specify activities for which they wanted to foster recovery. Outcomes were collected by telephone by blinded coordinators at baseline and at 8, 20, and 44 weeks. The individualized outcome was assessed at the first and last intervention and control session. Results: Among 1996 patients identified, 303 were eligible and enrolled. Of these, 284 women (94%; mean [SD] age, 56.1 [10.2] years) completed baseline assessments and were randomized, and 81% or more of each group completed the final assessment with no adverse events. Of those who completed the final assessment, 118 of 114 (82%) were in the intervention group, and 113 of 140 (81%) were attention control participants. Between-group differences were not statistically significant for the main measures of PROMIS satisfaction (week 20: Cohen d, 0.1 [95% CI, −0.09 to 0.29] and week 44: Cohen d, −0.08 [95% CI, −0.27 to 0.11]) and ability (week 20: Cohen d, 0.15 [95% CI, −0.06 to 0.37] and week 44: Cohen d, −0.08 [95% CI, −0.27 to 0.11]). On the individualized outcome, intervention participants reported significantly greater improvements in activity satisfaction (Cohen d, 0.76 [95% CI, 0.48-1.02]) and performance (Cohen d, 0.60 [95% CI, 0.32-0.87]). Conclusions and Relevance: In this randomized clinical trial, the intervention catalyzed greater improvements in self-selected activity participation and goal disengagement but did not otherwise accelerate recovery compared with the control condition. Future research should determine what intervention features may lead to the greatest reductions in participation restrictions and other measures that may detect functional recovery. Trial Registration: ClinicalTrials.gov Identifier: NCT03915548 This randomized clinical trial assesses the effect of a behavioral activation and problem-solving intervention compared with an attention control condition on participation restrictions among US breast cancer survivors in the year following treatment.
- Subjects
MOTIVATIONAL interviewing; PSYCHOLOGICAL distress; RESEARCH funding; BREAST tumors; STATISTICAL sampling; FUNCTIONAL status; TREATMENT effectiveness; RANDOMIZED controlled trials; PSYCHOLOGICAL adaptation; GOAL (Psychology); DESCRIPTIVE statistics; ODDS ratio; TELEPHONES; CONVALESCENCE; QUALITY of life; CANCER patient psychology; CONFIDENCE intervals; DATA analysis software; PHYSICAL activity; SOCIAL participation
- Publication
JAMA Network Open, 2024, Vol 7, Issue 3, pe242478
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2024.2478