Fear of Recurrence Pilot Intervention for Women With Breast Cancer

NCT01354041 | Completed Phase 1 DMC

• 1 other identifier: 10-01831
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Recurrence

Keywords

fear and health worries about cancer recurrence

Outcome Measures

Primary Outcomes (1)

• Fear of cancer recurrence

  Multi-dimensional fear of recurrence measure.

  Weeks 0, 6, 10, 30

Secondary Outcomes (1)

• Anxiety

  Weeks 0, 6, 10, 30

Study Arms (2)

Treatment-as-usual

NO INTERVENTION

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.

Acceptance and Commitment Therapy

EXPERIMENTAL

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.

Behavioral: Acceptance and Commitment Therapy

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

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

Also known as: ACT

Acceptance and Commitment Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Interventions

Acceptance and Commitment Therapy

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Laura B. Dunn, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: May 16, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 27, 2014

Record last verified: 2014-01

Locations

US (1)