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

Joanna J Arch, Jill L Mitchell, Sarah R Genung, Robert Fisher, David J Andorsky, Annette L Stanton, Joanna J Arch, Jill L Mitchell, Sarah R Genung, Robert Fisher, David J Andorsky, Annette L Stanton

Abstract

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 .

Keywords: Acceptance; Acceptance and commitment therapy; Anxiety; Cancer; Cancer survivorship; Psycho-oncology; Psychosocial intervention; Supportive care.

Conflict of interest statement

Ethics approval and consent to participate

Ethics approval was received from the University of Colorado Boulder Institutional Review Board and Rocky Mountain Cancer Centers (RMCC) as protocol 15–0313. Written informed consent will be obtained from all study participants.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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