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Completed

NCT Number: NCT02550925

Acceptance and Commitment Therapy (ACT) for Anxious Cancer Survivors

This randomized clinical trial compares group acceptance and commitment therapy (ACT) to usual care for cancer survivors experiencing anxiety following the end of cancer treatment.

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Key information

Conditions

Cancer Neoplasms

Age range

21 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Boulder

Boulder, Colorado, 80303, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults in the Greater Boulder/ Denver, Colorado area who had cancer and completed primary cancer treatment (surgery, chemotherapy, and/or radiation) within the previous 18 months
  • For solid tumor cancers: Show no current evidence of disease for solid-tumor cancers (of any cancer type or initial stage). For lymphoproliferative disorders such as chronic lymphocytic leukemia and indolent non-Hodgkin's lymphoma: In remission or asymptomatic after initial treatment and are followed with active surveillance.
  • Screen positive for anxiety symptoms on the study screener
  • Able to speak, read, and write English fluently
  • Willing and able to participate in an ACT group once a week for 7 weeks
  • Willing and able to complete online questionnaires and phone interviews at designated assessment points

Exclusion criteria

  • Current moderate to high suicide risk
  • History of chronic untreated trauma (unrelated to their cancer)
  • Psychiatric hospitalization or suicide attempt in the past 5 years

Treatment and study plan

Acceptance and Commitment Therapy (ACT) Group

Behavioral

A 7-session Acceptance and Commitment Therapy (ACT) group intervention

Usual Care

Behavioral

Check in with clinical social worker at oncology care site and obtain list of supportive resources

Primary outcomes

  1. Anxiety symptoms

    Time frame: Baseline to Post and (3- and 6-month) Follow Up

    Method of assessment: questionnaire

Secondary outcomes

  1. Depressive symptoms

    Time frame: Baseline to Post and (3- and 6-month) Follow Up

    Method of assessment: questionnaire

  2. Medical resource use

    Time frame: Baseline to Post and (3- and 6-month) Follow Up

    Method of assessment: survey of medical care use

  3. Fear of cancer recurrence

    Time frame: Baseline to Post and (3- and 6-month) Follow Up

    Method of assessment: questionnaire

  4. Sense of life meaning

    Time frame: Baseline to Post and (3- and 6-month) Follow Up

    Method of assessment: questionnaire

  5. Fatigue / Vitality

    Time frame: Baseline to Post and (3- and 6-month) Follow Up

    Method of assessment: questionnaire

  6. Anxiety disorder severity

    Time frame: Baseline to Post and 6-month Follow Up

    Method of assessment: diagnostic interview

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Collaborators

  • American Cancer Society, Inc.
  • Rocky Mountain Cancer Centers
  • University of California, Los Angeles

Registry information

Official study title

A Novel Acceptance-Based Intervention for Anxious Cancer Survivors

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 16, 2015
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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