Fear of Recurrence Pilot Intervention for Women With Breast Cancer (WiLLoW)
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|ClinicalTrials.gov Identifier: NCT01354041|
Recruitment Status : Completed
First Posted : May 16, 2011
Last Update Posted : January 27, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cancer Recurrence||Behavioral: Acceptance and Commitment Therapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Intervention to Address Fear of Recurrence in Breast Cancer Survivors|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
No Intervention: Treatment-as-usual
Participants in the Treatment as usual (TAU) arm will not receive any specific Fear of Cancer Recurrence (FCR) intervention during the study period. However, they will be offered an optional full-day workshop at the end of the study.
Experimental: Acceptance and Commitment Therapy
Participants in the intervention arm will receive seven sessions of a mindfulness and values-based living intervention, led by a trained licensed facilitator, conducted in groups of 10-12 participants and include components specifically designed to reduce FCR. The intervention arm will include six weekly 90 minute group sessions and one followup 90 minute group session "booster session" held three weeks later. The group sessions will be interactive and experiential and include homework practice for generalizing skills.
Behavioral: Acceptance and Commitment Therapy
Seven weekly sessions of Acceptance and Commitment Therapy (ACT) intervention
Other Name: ACT
- Fear of cancer recurrence [ Time Frame: Weeks 0, 6, 10, 30 ]Multi-dimensional fear of recurrence measure.
- Anxiety [ Time Frame: Weeks 0, 6, 10, 30 ]Validated measure of anxiety.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354041
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Laura B. Dunn, MD||University of California, San Francisco|