biostudies-literatureArch JJAmerican Cancer Society89https://www.ebi.ac.uk/biostudies/studies/S-EPMC6339433biostudies-literatureUnknown19(1)<h4>Background</h4>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.<h4>Methods/design</h4>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.<h4>Discussion</h4>This clinical trial will provide valuable evidence regarding the efficacy of the group ACT intervention in community oncology settings.<h4>Trial registration</h4>Clinicaltrials.gov NCT02550925 .BMC cancerA randomized controlled trial of a group acceptance-based intervention for cancer survivors experiencing anxiety at re-entry ('Valued Living'): study protocol.PMC6339433RSG-15-020-01–CPPBRSG-15-020-01-CPPBFisher RGenung SRAndorsky DJStanton ALArch JJMitchell JLfalseA randomized controlled trial of a group acceptance-based intervention for cancer survivors experiencing anxiety at re-entry ('Valued Living'): study protocol.<h4>Background</h4>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.<h4>Methods/design</h4>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.<h4>Discussion</h4>This clinical trial will provide valuable evidence regarding the efficacy of the group ACT intervention in community oncology settings.<h4>Trial registration</h4>Clinicaltrials.gov NCT02550925 .2019-01-01T00:00:00Z2019 Jan2024-11-09T01:21:11.396Z2019-06-06T20:46:10ZS-EPMC63394333065862110.1186/s12885-019-5289-x