A randomized controlled trial of a group acceptance-based intervention for cancer survivors experiencing anxiety at re-entry (‘Valued Living’): study protocol

Abstract

BackgroundAnxiety is a common concern of cancer survivors during the transition from active cancer treatment to cancer survivorship (the re-entry phase). This paper presents the study protocol for a novel group-based behavioral intervention to improve mental health, well-being, and medical use outcomes among anxious cancer survivors at re-entry.Methods/DesignThis two-armed, prospective randomized controlled trial will randomize a minimum of 100 re-entry-phase cancer survivors with moderate to high anxiety to the intervention or a usual care control condition. The intervention is delivered in a group format over 7 weeks; content is based on Acceptance and Commitment Therapy (ACT), an acceptance, mindfulness, and values-based intervention. Participants will be recruited from community cancer care centers and the intervention will be led by the onsite clinical social workers. Participants will be assessed at baseline, mid-intervention, post-intervention, and 3- and 6-month follow-up. ACT participants will complete process measures before the beginning of group sessions 2, 4, and 6; all participants will complete the process measures during the regular assessments. The primary outcome is anxiety symptoms; secondary outcomes include anxiety disorder severity, fear of recurrence, depressive symptoms, cancer-related trauma symptoms, sense of life meaning, vitality/fatigue, and medical utilization.DiscussionThis clinical trial will provide valuable evidence regarding the efficacy of the group ACT intervention in community oncology settings.Trial registrationClinicaltrials.gov NCT02550925.

Randomized trial of acceptance and commitment therapy for anxious cancer survivors in community clinics: Outcomes and moderators.

“…The study was conducted in accordance with the published study protocol (Arch et al, 2019) and was pre-registered within 21 days of enrolling participants (as required by the site) at Clinicaltrials.gov #NCT02550925. The University of Colorado Boulder institutional review board and the University of Colorado Cancer Center approved the study; all participants provided written informed consent.…”

Cancer survivors’ perceived vulnerability to COVID-19 and impacts on cognitive, affective, and behavioral responses to the pandemic

“…Participants were post-treatment cancer survivors (N ¼ 146) recruited from a pool of participants in two previous behavioral randomized controlled trials (RCTs) conducted by the senior author within a community-based oncology care network in Colorado, Rocky Mountain Cancer Centers. For trial details, see Arch 35 and Arch et al 36 Of the 227 total post-treatment cancer survivors in the two prior RCTs, 200 (88.11%) had consented to being contacted for future research. Of these 200 individuals, 146/200 (73%) consented and completed the first survey in May, and 140/146 also completed the second survey in mid-June through early July, a longitudinal retention rate of 95.89%.…”

Alternative Treatments for Cancer Prevention and Cure [Part 1]

“…CBT intervention has the potential to ease acute anxiety during the often-challenging re-entry phase and to prevent the development of chronic, debilitating, and costly anxiety [594]. Physical activity interventions also reduce depressive and anxiety symptoms in breast cancer survivors [595]. Telehealth approaches may improve access to mental health resources especially for those with limited online access or lack of online skill [596].…”