Clinical trial NCT02550925: Acceptance and Commitment Therapy (ACT) for Anxious Cancer Survivors
Official title: A Novel Acceptance-Based Intervention for Anxious Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Cancer survivors
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: Rocky Mountain Cancer Centers
name: University of California, Los Angeles
First posted: 2015-09-16
Enrollment: 139
Sex: ALL
Minimum age (years): 21
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Anxiety symptoms
timeFrame: Baseline to Post and (3- and 6-month) Follow Up
Secondary outcomes:
measure: Depressive symptoms
timeFrame: Baseline to Post and (3- and 6-month) Follow Up
measure: Medical resource use
timeFrame: Baseline to Post and (3- and 6-month) Follow Up
measure: Fear of cancer recurrence
timeFrame: Baseline to Post and (3- and 6-month) Follow Up
measure: Sense of life meaning
timeFrame: Baseline to Post and (3- and 6-month) Follow Up
measure: Fatigue / Vitality
timeFrame: Baseline to Post and (3- and 6-month) Follow Up
measure: Anxiety disorder severity
timeFrame: Baseline to Post and 6-month Follow Up
Other outcomes:
Locations:
city: Boulder
country: United States
facility: University of Colorado Boulder
state: Colorado
Study officials:
References:
citation: 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. No abstract available.
citation: Arch JJ, Mitchell JL, Genung SR, Judd CM, Andorsky DJ, Bricker JB, Stanton AL. Randomized trial of acceptance and commitment therapy for anxious cancer survivors in community clinics: Outcomes and moderators. J Consult Clin Psychol. 2021 Apr;89(4):327-340. doi: 10.1037/ccp0000630.
citation: Arch JJ, Mitchell JL, Genung SR, Fisher R, Andorsky DJ, Stanton AL. A randomized controlled trial of a group acceptance-based intervention for cancer survivors experiencing anxiety at re-entry ('Valued Living'): study protocol. BMC Cancer. 2019 Jan 18;19(1):89. doi: 10.1186/s12885-019-5289-x.