Fear of Recurrence Pilot Intervention for Women With Breast Cancer (WiLLoW)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer Recurrence |
Behavioral: Acceptance and Commitment Therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Intervention to Address Fear of Recurrence in Breast Cancer Survivors |
- Fear of cancer recurrence [ Time Frame: Weeks 0, 6, 10, 30 ] [ Designated as safety issue: No ]Multi-dimensional fear of recurrence measure.
- Anxiety [ Time Frame: Weeks 0, 6, 10, 30 ] [ Designated as safety issue: No ]Validated measure of anxiety.
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Laura B. Dunn, MD | (415) 476-7518 | Laura.dunn@ucsf.edu |
| Contact: Dianne Shumay, PhD | (415) 353-9973 | Dianne.shumay@ucsfmedctr.org |
| United States, California | |
| University of California, San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Principal Investigator: Laura B. Dunn, MD | |
| University of California, San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Dianne M. Shumay, PhD 415-353-9973 Dianne.Shumay@ucsfmedctr.org | |
| Contact: Maria Fujiye (415) 353-9973 maria.fujiye@ucsf.edu | |
| Principal Investigator: Laura B. Dunn, MD | |
| Principal Investigator: | Laura B. Dunn, MD | University of California, San Francisco |
More Information
No publications provided
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01354041 History of Changes |
| Other Study ID Numbers: | 10-01831 |
| Study First Received: | February 24, 2011 |
| Last Updated: | February 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
fear and health worries about cancer recurrence |
Additional relevant MeSH terms:
|
Breast Neoplasms Recurrence Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013