Fear of Recurrence Pilot Intervention for Women With Breast Cancer

Study Overview
=================
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.

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

Conditions
-----------------
Cancer Recurrence

Intervention / Treatment
-----------------
* Behavioral: Acceptance and Commitment Therapy


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment-as-usual<br>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. | |
| Experimental: Acceptance and Commitment Therapy<br>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<br>* Seven weekly sessions of Acceptance and Commitment Therapy (ACT) intervention<br>* Other names: ACT;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear of cancer recurrence | Multi-dimensional fear of recurrence measure. | Weeks 0, 6, 10, 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Validated measure of anxiety. | Weeks 0, 6, 10, 30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fear and health worries about cancer recurrence