Fear of Recurrence Pilot Intervention for Women With Breast Cancer

Cancer Recurrence Clinical Trial

— WiLLoW  

Official title:

A Pilot Intervention to Address Fear of Recurrence in Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01354041
• Other study ID #: 10-01831
• Status: Completed
• Phase: Phase 1
• First received: February 24, 2011
• Last updated: January 23, 2014
• Start date: March 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer Recurrence
• Recurrence

Intervention

Behavioral:
• Acceptance and Commitment Therapy
Seven weekly sessions of Acceptance and Commitment Therapy (ACT) intervention

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fear of cancer recurrence	Multi-dimensional fear of recurrence measure.	Weeks 0, 6, 10, 30	No
Secondary	Anxiety	Validated measure of anxiety.	Weeks 0, 6, 10, 30	No