A Pilot Intervention to Address Fear of Recurrence in Breast Cancer Survivors
18 Years
N/A
Female
Cancer Recurrence
Trial Information
A Pilot Intervention to Address Fear of Recurrence in Breast Cancer Survivors
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Fear of cancer recurrence
Outcome Description:
Multi-dimensional fear of recurrence measure.
Outcome Time Frame:
Weeks 0, 6, 10, 30
Safety Issue:
No
Principal Investigator
Laura B. Dunn, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of California, San Francisco
Authority:
United States: Institutional Review Board
Study ID:
10-01831
NCT ID:
NCT01354041
Start Date:
March 2011
Completion Date:
March 2013
Related Keywords:
- Cancer Recurrence
- fear and health worries about cancer recurrence
- Breast Neoplasms
- Recurrence
Name | Location |
|---|---|
| University of California, San Francisco | San Francisco, California 94143 |
