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Fear of Recurrence Pilot Intervention for Women With Breast Cancer (WiLLoW)

Primary Purpose

Cancer Recurrence

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Acceptance and Commitment Therapy

About this trial

This is an interventional treatment trial for Cancer Recurrence focused on measuring fear and health worries about cancer recurrence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Treatment-as-usual

Acceptance and Commitment Therapy

Arm Description

Participants in the Treatment as usual (TAU) arm will not receive any specific Fear of Cancer Recurrence (FCR) intervention during the study period. However, they will be offered an optional full-day workshop at the end of the study.

Participants in the intervention arm will receive seven sessions of a mindfulness and values-based living intervention, led by a trained licensed facilitator, conducted in groups of 10-12 participants and include components specifically designed to reduce FCR. The intervention arm will include six weekly 90 minute group sessions and one followup 90 minute group session "booster session" held three weeks later. The group sessions will be interactive and experiential and include homework practice for generalizing skills.

Outcomes

Primary Outcome Measures

Fear of cancer recurrence

Multi-dimensional fear of recurrence measure.

Secondary Outcome Measures

Anxiety

Validated measure of anxiety.

Full Information

NCT ID

NCT01354041

First Posted

February 24, 2011

Last Updated

January 23, 2014

Sponsor

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT01354041

Brief Title

Fear of Recurrence Pilot Intervention for Women With Breast Cancer

Acronym

WiLLoW

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer Recurrence

Keywords

fear and health worries about cancer recurrence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment-as-usual

Arm Type

No Intervention

Arm Description

Arm Title

Acceptance and Commitment Therapy

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Acceptance and Commitment Therapy

Other Intervention Name(s)

ACT

Intervention Description

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

Primary Outcome Measure Information:

Title

Fear of cancer recurrence

Description

Multi-dimensional fear of recurrence measure.

Time Frame

Weeks 0, 6, 10, 30

Secondary Outcome Measure Information:

Title

Anxiety

Description

Validated measure of anxiety.

Time Frame

Weeks 0, 6, 10, 30

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura B. Dunn, MD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Fear of Recurrence Pilot Intervention for Women With Breast Cancer

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