NCT01164930

Brief Summary

The purpose of this randomized controlled trial is to evaluate the effectiveness of an empirically supported psychosocial treatment, Acceptance and Commitment Therapy, in facilitating improved quality of life, benefit-finding, and cortisol rhythm in breast cancer patients in an outpatient clinical oncology setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

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

Study Start

First participant enrolled

January 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 19, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

October 4, 2021

Status Verified

September 1, 2021

Enrollment Period

1.7 years

First QC Date

July 15, 2010

Last Update Submit

September 27, 2021

Conditions

Breast NeoplasmsSurvivorshipStress

Outcome Measures

Primary Outcomes (1)

  • salivary cortisol

    3-month follow-up

Secondary Outcomes (3)

  • self-reported distress

    3-month follow-up

  • self-reported quality of life

    3-month follow-up

  • self-reported benefit-finding

    3-month follow-up

Study Arms (2)

Acceptance and Commitment Therapy group

EXPERIMENTAL

8-week ACT group

Behavioral: Acceptance and Commitment Therapy

Wait-list control group

NO INTERVENTION

Participants will be offered treatment following wait-list data collection

Interventions

Acceptance and Commitment TherapyBEHAVIORAL

8-week ACT group

Acceptance and Commitment Therapy group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of stage I-III breast cancer
  • prescreen distress score above defined cutoff
  • agreement not to seek other breast cancer support services until study completion

You may not qualify if:

  • previous cancer
  • prior psychiatric treatment for serious mental health disorder (e.g., hospitalization or formal diagnosis of psychosis, major depressive episode, borderline mental retardation, suicidality, or current substance dependence)
  • current use of medications known to interfere with cortisol levels (e.g., dexamethasone)
  • major concurrent medical disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Jose State University

San Jose, California, 95192, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 15, 2010

First Posted

July 19, 2010

Study Start

January 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

October 4, 2021

Record last verified: 2021-09

Locations

US(1)