Skip to main content
OpenTrials
Completed

NCT Number: NCT01354041

Fear of Recurrence Pilot Intervention for Women With Breast Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acceptance and Commitment Therapy

Behavioral

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

Other names: ACT

Primary outcomes

  1. Fear of cancer recurrence

    Time frame: Weeks 0, 6, 10, 30

    Multi-dimensional fear of recurrence measure.

Secondary outcomes

  1. Anxiety

    Time frame: Weeks 0, 6, 10, 30

    Validated measure of anxiety.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Acronym: WiLLoW

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 16, 2011
Registry last updated
Jan 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.