Optimizing Functional Recovery of Breast Cancer Survivors

Study Overview
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Brief Summary
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This study is a randomized controlled trial (RCT) to test the efficacy of a Behavioral Activation and Problem Solving (BA/PS) approach to improving activity participation over time as compared to an attention control condition within a sample of 300 breast cancer survivors reporting reduced activity participation after completing cancer treatment.

Detailed Description
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Assessments will be administered via telephone by a research assistant blind to group assignment. Participants will complete outcome assessments upon enrollment (T1) and at 8 weeks (T2), 20 weeks (T3) and 44 weeks (T4) later. The T2 assessment captures the short-term outcomes of the most intensive part of the intervention (i.e., after six weekly sessions). The T3 assessment will capture the short-term outcomes at the end of the full intervention. The T4 assessment explores the sustained effect of BA/PS (six months after BA/PS ends). The study aim is to test whether the BA/PS intervention affects the slope of functional recovery over time. With the longitudinal data, the investigators will also be able to explore the pace of improvement and whether the two groups differ at these clinically relevant time points.

Official Title
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A Phase III, Randomized, Single Blind, Attention Controlled, Multi-center Study of the Effects of a Rehabilitation Intervention on Participation Restrictions of Female Breast Cancer Survivors

Conditions
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Breast Cancer Female

Intervention / Treatment
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* Behavioral: The Behavioral Activation/ Problem Solving Intervention
* Behavioral: Attention Control Condition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18 years or older. Experiencing reduced participation (i.e., a score greater than or equal to 10 on the Work and Social Adjustment Scale). Females diagnosed with Stage 1-3 breast cancer and within one year of completion of locoregional treatment and/or chemotherapy with curative intent and absence of disease recurrence Exclusion Criteria: Non-English speaking. Non-correctable hearing loss. Moderate-severe cognitive impairment indicated by a score < 3 on a 6-item cognitive screener. History of severe mental illness (i.e., schizophrenia, bipolar disorder), current major depressive disorder, active suicidal ideation, or active substance misuse documented within the medical record.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The investigators will recruit 300 women over the age of 18 reporting participation restrictions after completing curative treatment for Stage 1-3 breast cancer within the past year. Half of the participants will be randomized to the 4-month BA/PS intervention which consists of 6 weekly telephone calls followed by 3 monthly telephone calls. BA/PS is designed to teach problem-solving and action planning to promote functional recovery. The other half of participants will be assigned to an attention control condition providing education about survivorship topics. This control condition will allow us to account for the effect of time and history, and the non-specific effects of attention
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Behavioral Activation/ Problem Solving Intervention<br>BA/PS teaches survivors to a) systematically examine the reasons an activity is challenging, b) set achievable short-term goals that have the potential to improve participation, c) brainstorm solutions including activity adaptations and environmental modifications, d) construct and implement a detailed action plan, and e) evaluate the results and level of goal attainment. The structured process gives participants repeated practice in goal reengagement that leads them progressively closer to their long-term functional goals. The BA/PS framework integrates the cognitive-behavioral therapies of Behavioral Activation and Problem-solving Treatment and incorporates concepts from an occupational therapy theory called the Person-Environment-Occupational Performance Model. | Behavioral: The Behavioral Activation/ Problem Solving Intervention<br>* The interventionist presents the rationale for BA/PS, promotes a positive problem orientation, and educates about the framework for problem-solving and action planning. The interventionist then administers the Canadian Occupational Performance Measure to elicit participant priorities, motivation, and long-term goals. The interventionist then guides the participant in using the BA/PS framework to set a goal, brainstorm solutions to challenges, and create a detailed action plan for the coming week.<br>|
| Active Comparator: Attention Control Condition<br>Investigators provide education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts. The control condition will match the intervention in terms of the number of sessions, the delivery by telephone, use of an occupational therapist, and the use of homework between sessions (i.e., reading the education materials for the control condition versus executing the action plan for the BA/PS condition). | Behavioral: Attention Control Condition<br>* The interventionist provides education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Participation satisfaction in social roles and activities: PROMIS | Instrument name: PROMIS Satisfaction with Social Roles and Activities Short Form 8a Range (raw score): 8-40. Subscales: N/A. Interpretation: Higher values indicate greater participation. | The overall treatment effect will be computed as the between-group difference in change from baseline (change from baseline averaged over weeks 8, 20, and 44) estimated with a linear contrast. | 
| Change in Participation ability in social roles and activities | Instrument name: Patient reported outcome measurement information system (PROMIS) Ability to Participate in Social Roles and Activities Short Form 8a. Range (raw score): 8-40. Subscales: N/A. Interpretation: Higher values indicate greater participation. | The overall treatment effect will be computed as the between-group difference in change from baseline (change from baseline averaged over weeks 8, 20, and 44) estimated with a linear contrast. | 
| Change in productivity | Instrument name: Disability Days section of the Medical Expenditure Panel Survey (MEPS). Range: 0- 30 days. Subscales: N/A. Interpretation: Higher values indicate lower productivity. | The overall treatment effect will be computed as the between-group difference in change from baseline (change from baseline averaged over weeks 8, 20, and 44) estimated with a linear contrast. | 
| Change in work productivity | Instrument name: Work Limitations Questionnaire-Short Form (WLQ-SF). Range: 0-100. Subscales: time management, physical, mental-interpersonal, and output. demands (each ranges from 0-100). Interpretation: Higher values indicate lower productivity. | The overall treatment effect will be computed as the between-group difference in change from baseline (change from baseline averaged over weeks 8, 20, and 44) estimated with a linear contrast. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of life: Functional Assessment of Cancer Therapy- (FACT-G) | Instrument name: Functional Assessment of Cancer Therapy- (FACT-G). Range: 0-108. Subscales: physical well-bring, social/family well-being, emotional well-being, functional well-being. Interpretation: Higher values indicate better quality of life. | The overall treatment effect will be computed as the between-group difference in change from baseline (change from baseline averaged over weeks 8, 20, and 44) estimated with a linear contrast. |