NCT02550925

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

3.9 years

First QC Date

July 30, 2015

Last Update Submit

March 24, 2020

Conditions

Cancer

Keywords

Cancer survivors

Outcome Measures

Primary Outcomes (1)

  • Anxiety symptoms

    Method of assessment: questionnaire

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

Secondary Outcomes (6)

  • Depressive symptoms

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

  • Medical resource use

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

  • Fear of cancer recurrence

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

  • Sense of life meaning

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

  • Fatigue / Vitality

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

  • +1 more secondary outcomes

Study Arms (2)

Acceptance and Commitment Therapy Group

EXPERIMENTAL
Behavioral: Acceptance and Commitment Therapy (ACT) Group

Usual Care

ACTIVE COMPARATOR
Behavioral: Usual Care

Interventions

Acceptance and Commitment Therapy (ACT) GroupBEHAVIORAL

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

Acceptance and Commitment Therapy Group
Usual CareBEHAVIORAL

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

Usual Care

Eligibility Criteria

Age21 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Boulder

Boulder, Colorado, 80303, United States

Location

Related Publications (3)

  • 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.

    PMID: 26130586BACKGROUND

  • 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.

    PMID: 34014694DERIVED

  • 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.

    PMID: 30658621DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Note: 139 individuals enrolled. 4 dropped out after consent, before baseline data collection, leaving 135 individuals with data.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Psychology and Neuroscience

Study Record Dates

First Submitted

July 30, 2015

First Posted

September 16, 2015

Study Start

September 1, 2015

Primary Completion

August 1, 2019

Study Completion

December 31, 2019

Last Updated

March 26, 2020

Record last verified: 2020-03

Locations

US(1)