- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01354041
Fear of Recurrence Pilot Intervention for Women With Breast Cancer (WiLLoW)
January 23, 2014 updated by: University of California, San Francisco
A Pilot Intervention to Address Fear of Recurrence in Breast Cancer Survivors
The primary objective of this pilot study is to examine the feasibility and acceptability of a randomized, controlled study of a mindfulness and values-based living intervention targeted at reducing fear of recurrence in breast cancer survivors compared to treatment as usual control.
Furthermore, the secondary objective of this randomized, controlled pilot study is to determine preliminary efficacy and effect size of the mindfulness and values-based living intervention compared to the treatment as usual control condition in reducing fear of recurrence in breast cancer survivors.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Fear of cancer recurrence (FCR) is pervasive, distressing and undermines quality of life in cancer survivors.
For subgroups of survivors, FCR is implicated in both treatment non-adherence and medical over-utilization.
Although some degree of FCR is nearly universal among cancer patients, effective psychological interventions have been understudied.
Educational and cognitive approaches that have relied on reassurance may feed into the anxiety by encouraging experiential avoidance, according to behavioral theories of anxiety.
Mindfulness and values based living approaches teach techniques for reducing experiential avoidance allowing patients to break this cycle and focus on functional, satisfying lives.
Interventions based on these techniques offer promise for addressing FCR in breast cancer survivors.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Francisco, California, United States, 94143
- University of California, San Francisco
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Diagnosed with early stage breast cancer within the past 18 months;
- Completed active treatment within the past year
- At least mild anxiety, and/or at least moderate fear of recurrence as measured by screening questionnaires.
- Ability to give written informed consent and willingness to comply with the requirements of the protocol
Exclusion Criteria:
- Presence of clinically significant cognitive impairment, or comorbid psychiatric or physical illness, only if, in the PI's or Co-Is' opinions, such illness would interfere with the ability to participate in and complete the intervention;
- Inability to speak and comprehend English sufficiently to complete the intervention.
- We will use a screening questionnaire (administered over the phone by the Research Associate) to determine that women do not have a comorbid physical or mental illness that is so impairing that they would be unable to participate in the groups or complete the measures.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
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Seven weekly sessions of Acceptance and Commitment Therapy (ACT) intervention
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fear of cancer recurrence
Time Frame: Weeks 0, 6, 10, 30
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Multi-dimensional fear of recurrence measure.
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Weeks 0, 6, 10, 30
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety
Time Frame: Weeks 0, 6, 10, 30
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Validated measure of anxiety.
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Weeks 0, 6, 10, 30
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Laura B. Dunn, MD, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (ACTUAL)
December 1, 2012
Study Completion (ACTUAL)
December 1, 2012
Study Registration Dates
First Submitted
February 24, 2011
First Submitted That Met QC Criteria
May 13, 2011
First Posted (ESTIMATE)
May 16, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
January 27, 2014
Last Update Submitted That Met QC Criteria
January 23, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-01831
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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