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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  • Additional Information
    • Source:
      Publisher: BioMed Central Country of Publication: England NLM ID: 100967800 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2407 (Electronic) Linking ISSN: 14712407 NLM ISO Abbreviation: BMC Cancer Subsets: MEDLINE
    • Publication Information:
      Original Publication: London : BioMed Central, [2001-
    • Subject Terms:
      Acceptance and Commitment Therapy/*methods ; Anxiety/*psychology ; Anxiety/*therapy ; Cancer Survivors/*psychology ; Neoplasms/*psychology; 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
    • 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 .
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    • Grant Information:
      RSG-15-020-01-CPPB American Cancer Society
    • Contributed Indexing:
      Keywords: Acceptance; Acceptance and commitment therapy; Anxiety; Cancer; Cancer survivorship; Psycho-oncology; Psychosocial intervention; Supportive care
    • Molecular Sequence:
      ClinicalTrials.gov NCT02550925
    • Publication Date:
      Date Created: 20190120 Date Completed: 20190429 Latest Revision: 20200225
    • Publication Date:
      20240105
    • Accession Number:
      PMC6339433
    • Accession Number:
      10.1186/s12885-019-5289-x
    • Accession Number:
      30658621