Fear of Recurrence Pilot Intervention for Women With Breast Cancer



Status:Completed
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/1/2014
Start Date:March 2011
End Date:March 2013
Contact:Laura B. Dunn, MD
Email:Laura.dunn@ucsf.edu
Phone:(415) 476-7518

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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.

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.
We found this trial at
2
sites
533 Parnassus Ave
San Francisco, California 94122
(415) 476-9000
University of California - San Francisco The leading university exclusively focused on health, UC San...
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533 Parnassus Ave
San Francisco, California 94122
(415) 476-9000
University of California - San Francisco The leading university exclusively focused on health, UC San...
?
mi
from
San Francisco, CA
Click here to add this to my saved trials