Acceptance and Commitment Therapy (ACT) for Anxious Cancer Survivors

March 24, 2020 updated by: Joanna Arch, University of Colorado, Boulder

A Novel Acceptance-Based Intervention 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Boulder, Colorado, United States, 80303
        • University of Colorado Boulder

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 93 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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
  2. 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.
  3. Screen positive for anxiety symptoms on the study screener
  4. Able to speak, read, and write English fluently
  5. Willing and able to participate in an ACT group once a week for 7 weeks
  6. Willing and able to complete online questionnaires and phone interviews at designated assessment points

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual Care
Behavioral: Usual Care
Check in with clinical social worker at oncology care site and obtain list of supportive resources
Experimental: Acceptance and Commitment Therapy Group
Behavioral: Acceptance and Commitment Therapy (ACT) Group
A 7-session Acceptance and Commitment Therapy (ACT) group intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety symptoms
Time Frame: Baseline to Post and (3- and 6-month) Follow Up
Method of assessment: questionnaire
Baseline to Post and (3- and 6-month) Follow Up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptoms
Time Frame: Baseline to Post and (3- and 6-month) Follow Up
Method of assessment: questionnaire
Baseline to Post and (3- and 6-month) Follow Up
Medical resource use
Time Frame: Baseline to Post and (3- and 6-month) Follow Up
Method of assessment: survey of medical care use
Baseline to Post and (3- and 6-month) Follow Up
Fear of cancer recurrence
Time Frame: Baseline to Post and (3- and 6-month) Follow Up
Method of assessment: questionnaire
Baseline to Post and (3- and 6-month) Follow Up
Sense of life meaning
Time Frame: Baseline to Post and (3- and 6-month) Follow Up
Method of assessment: questionnaire
Baseline to Post and (3- and 6-month) Follow Up
Fatigue / Vitality
Time Frame: Baseline to Post and (3- and 6-month) Follow Up
Method of assessment: questionnaire
Baseline to Post and (3- and 6-month) Follow Up
Anxiety disorder severity
Time Frame: Baseline to Post and 6-month Follow Up
Method of assessment: diagnostic interview
Baseline to Post and 6-month Follow Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Boulder

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

July 30, 2015

First Submitted That Met QC Criteria

September 14, 2015

First Posted (Estimate)

September 16, 2015

Study Record Updates

Last Update Posted (Actual)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RSG-15-020-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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