Optimizing Functional Recovery of Breast Cancer Survivors

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Female
• Intervention / Treatment: Behavioral: The Behavioral Activation/ Problem Solving Intervention; Behavioral: Attention Control Condition

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 303
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-1210
      • University of Alabama at Birmingham
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age of 18 years or older.
2. Experiencing reduced participation (i.e., a score greater than or equal to 10 on the Work and Social Adjustment Scale).
3. 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:

1. Non-English speaking.
2. Non-correctable hearing loss.
3. Moderate-severe cognitive impairment indicated by a score < 3 on a 6-item cognitive screener.
4. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Behavioral Activation/ Problem Solving Intervention; 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; 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.
Active Comparator: Attention Control Condition; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation Satisfaction in Social Roles and Activities: PROMIS	The Patient Reported Outcomes Measurement Information System (PROMIS): Satisfaction with Social Roles and Activities measures satisfaction with daily routines and activities. Raw scores (ranging 8-40) were converted to T-scores (mean = 50, SD = 10) with higher scores indicating better outcomes (i.e., greater satisfaction with daily routines and activities).	The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline) estimated with a linear contrast.
Participation Ability in Social Roles and Activities	The Patient Reported Outcomes Measurement Information System (PROMIS): Ability to Participate in Social Roles and Activities Short Form 8a measures participation with daily routines and activities. Raw scores (ranging 8-40) were converted to T-scores (mean = 50, SD = 10) with higher scores indicating better outcomes (i.e., greater ability to participate in daily routines and activities).	The overall treatment effect will be computed as between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.
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 differences at weeks 8, 20, 44 (adjusted for baseline) estimated with a linear contrast.
Work Productivity	The Work Limitations Questionnaire-Short Form (WLQ-SF) assesses productivity with an overall score indicating the percentage decrement in productivity in the previous two weeks. Scores range 0-100% with higher scores indicating greater decrement in productivity.	The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)	The Functional Assessment of Cancer Treatment (FACT) - General measures quality of life. The physical, social, and functional subscale scores can range 0-28 and the emotional subscale score can range 0-24; higher scores indicate better well-being. Overall score was calculated by summing the four subscales; overall scores can range from 0-108 with higher scores indicating better quality of life.	The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coping	The Brief COPE measures adaptive coping. Range for each subscale (positive reframing, active coping, planning): 2-8; higher values indicate more adaptive coping. Subscales items are summed; no total score.	The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.
Goal Adjustment	Instrument name: Goal Disengagement and Goal Reengagement Scale (GDGRS). Range: 4 to 20 for goal disengagement and 6 to 30 for goal reengagement. Subscales: goal disengagement and goal reengagement (subscale items are averaged, no total score). Higher values indicate greater tendency to disengage or re-engage with goals.	The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.
Distress	Instrument name: Hospital Anxiety and Depression Scale (HADS). Range for each subscale (no total score): 0-21. Subscales: anxiety and depression. Higher values indicate greater anxiety and depression.	The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.
Occupational Performance	Instrument name: Canadian Occupational Performance Scale. The participant rates each activity with Likert scales for three characteristics: satisfaction (1- 10), performance (1-10), and importance (1 - 10). Interpretation: Higher values indicate higher occupational performance.	The overall treatment effect will be computed as the between-group difference from Session 1 (baseline) and Session 9 (approximately week 20), estimated with a linear contrast.

Collaborators and Investigators

• Sponsor: MGH Institute of Health Professions
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Kathleen Lyons, ScD, MGH Institute of Health Professionals

Publications and helpful links

General Publications

• Stevens CJ, Hegel MT, Bakitas MA, Bruce M, Azuero A, Pisu M, Chamberlin M, Keene K, Rocque G, Ellis D, Gilbert T, Morency JL, Newman RM, Codini ME, Thorp KE, Dos Anjos SM, Cloyd DZ, Echols J, Milford AN, Ingram SA, Davis J, Lyons KD. Study protocol for a multisite randomised controlled trial of a rehabilitation intervention to reduce participation restrictions among female breast cancer survivors. BMJ Open. 2020 Feb 13;10(2):e036864. doi: 10.1136/bmjopen-2020-036864.

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2019
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2021P002871; 1R01CA225792-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No