Fear of Recurrence Pilot Intervention for Women With Breast Cancer

Completed · Phase 1

Conditions studied: Cancer Recurrence

In brief

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.

Key facts

Study ID

NCT01354041

Run by

University of California, San Francisco

People needed

28

Starts

2011-03-01

Expected to finish

2012-12-01

Last updated by the study team

2014-01-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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