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A randomized controlled trial of a group acceptance-based intervention for cancer survivors experiencing anxiety at re-entry (‘Valued Living’): study protocol
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A randomized controlled trial of a group acceptance-based intervention for cancer survivors experiencing anxiety at re-entry (‘Valued Living’): study protocol
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A randomized controlled trial of a group acceptance-based intervention for cancer survivors experiencing anxiety at re-entry (‘Valued Living’): study protocol
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Journal Article
A randomized controlled trial of a group acceptance-based intervention for cancer survivors experiencing anxiety at re-entry (‘Valued Living’): study protocol
2019
Overview
Background
Anxiety 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/Design
This 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.
Discussion
This clinical trial will provide valuable evidence regarding the efficacy of the group ACT intervention in community oncology settings.
Trial registration
Clinicaltrials.gov
NCT02550925
.
Publisher
BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
Subject
/ Acceptance and commitment therapy
/ Acceptance and Commitment Therapy - methods
/ Adult
/ Aged
/ Analysis
/ Anxiety
/ Biomedical and Life Sciences
/ Cancer
/ Cancer Survivors - psychology
/ Cognitive-behavioral therapy
/ Fatigue
/ Female
/ Health Promotion and Disease Prevention
/ Humans
/ Male
/ Oncology
/ Randomized Controlled Trials as Topic
/ Survival
/ survivorship and psychosocial oncology
/ Trauma
/ Workers
