Clinical trial NCT01354041: Fear of Recurrence Pilot Intervention for Women With Breast Cancer
Official title: A Pilot Intervention to Address Fear of Recurrence in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer Recurrence
Keywords: fear and health worries about cancer recurrence
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2011-05-16
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fear of cancer recurrence
timeFrame: Weeks 0, 6, 10, 30
Secondary outcomes:
measure: Anxiety
timeFrame: Weeks 0, 6, 10, 30
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Laura B. Dunn, MD
role: PRINCIPAL_INVESTIGATOR
References: