Fear of Recurrence Pilot Intervention for Women With Breast Cancer

Phase 1

Completed

• Conditions: Cancer Recurrence
• Interventions: Behavioral: Acceptance and Commitment Therapy

• Registration Number: NCT01354041
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

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 Timeline

• Study First Submitted: 2011-02-24
• Study Start: 2011-03
• Study First Submitted QC: 2011-05-13
• Study First Posted: 2011-05-16
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-23
• Last Update Posted: 2014-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acceptance and Commitment Therapy	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.

Primary Outcome Measures

Name	Time	Method
Fear of cancer recurrence	Weeks 0, 6, 10, 30	Multi-dimensional fear of recurrence measure.

Secondary Outcome Measures

Name	Time	Method
Anxiety	Weeks 0, 6, 10, 30	Validated measure of anxiety.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States