Acceptance and Commitment Therapy (ACT) for Anxious Cancer Survivors

Cancer Clinical Trial

Official title:

A Novel Acceptance-Based Intervention for Anxious Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02550925
• Other study ID #: RSG-15-020-01
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: University of Colorado, Boulder
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: December 31, 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Acceptance and Commitment Therapy (ACT) Group
A 7-session Acceptance and Commitment Therapy (ACT) group intervention
• Usual Care
Check in with clinical social worker at oncology care site and obtain list of supportive resources

Locations

Country	Name	City	State
United States	University of Colorado Boulder	Boulder	Colorado

Sponsors (4)

Lead Sponsor	Collaborator
University of Colorado, Boulder	American Cancer Society, Inc., Rocky Mountain Cancer Centers, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (1)

Arch JJ, Mitchell JL. An Acceptance and Commitment Therapy (ACT) group intervention for cancer survivors experiencing anxiety at re-entry. Psychooncology. 2016 May;25(5):610-5. doi: 10.1002/pon.3890. Epub 2015 Jun 29. — View Citation

Outcome

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