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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.
- Source :
-
BMC cancer [BMC Cancer] 2019 Jan 18; Vol. 19 (1), pp. 89. Date of Electronic Publication: 2019 Jan 18. - Publication Year :
- 2019
-
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.<br />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.<br />Discussion: This clinical trial will provide valuable evidence regarding the efficacy of the group ACT intervention in community oncology settings.<br />Trial Registration: Clinicaltrials.gov NCT02550925 .
- Subjects :
- Adaptation, Psychological
Adult
Aged
Aged, 80 and over
Female
Humans
Male
Middle Aged
Prospective Studies
Quality of Life
Surveys and Questionnaires
Treatment Outcome
Young Adult
Acceptance and Commitment Therapy methods
Anxiety psychology
Anxiety therapy
Cancer Survivors psychology
Neoplasms psychology
Subjects
Details
- Language :
- English
- ISSN :
- 1471-2407
- Volume :
- 19
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- BMC cancer
- Publication Type :
- Academic Journal
- Accession number :
- 30658621
- Full Text :
- https://doi.org/10.1186/s12885-019-5289-x