NCT01354041

Fear of Recurrence Pilot Intervention for Women With Breast Cancer

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer Recurrence

Interventions

Type	Name	Description
BEHAVIORAL	Acceptance and Commitment Therapy	Seven weekly sessions of Acceptance and Commitment Therapy (ACT) intervention

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2011-05-16
• Last updated: 2014-01-27

Locations

1 site across 1 country: United States