Optimizing Functional Recovery of Breast Cancer Survivors

NCT03915548 | Completed Results DMC

• 2 other identifiers: 2021P0028711R01CA225792-01A1
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)

  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 Outcomes (4)

• Coping

  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

  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

  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.

Study Arms (2)

The Behavioral Activation/ Problem Solving Intervention

EXPERIMENTAL

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

Attention Control Condition

ACTIVE COMPARATOR

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

Interventions

The Behavioral Activation/ Problem Solving Intervention BEHAVIORAL

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.

The Behavioral Activation/ Problem Solving Intervention

Attention Control Condition BEHAVIORAL

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.

Attention Control Condition

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• MGH Institute of Health Professions: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-1210, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (2)

• Lyons KD, Wechsler SB, Ejem DB, Stevens CJ, Azuero A, Khalidi S, Hegel MT, Dos Anjos SM, Codini ME, Chamberlin MD, Morency JL, Coffee-Dunning J, Thorp KE, Cloyd DZ, Goedeken S, Newman R, Muse C, Rocque G, Keene K, Pisu M, Echols J, Bakitas MA. Telephone-Based Rehabilitation Intervention to Optimize Activity Participation After Breast Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2024 Mar 4;7(3):e242478. doi: 10.1001/jamanetworkopen.2024.2478.

  PMID: 38517442 DERIVED

• 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.

  PMID: 32060166 DERIVED

Results Point of Contact

• Title: Dr. Kathleen Lyons
• Organization: MGH Institute of Health Professions

klyons2@mghihp.edu

617-643-5372

Study Officials

• Kathleen Lyons, ScD

  MGH Institute of Health Professionals

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessments will be administered via telephone by a research assistant blind to group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 16, 2019
• Study Start: August 28, 2019
• Primary Completion: April 30, 2023
• Study Completion: March 31, 2024
• Last Updated: May 3, 2024
• Results First Posted: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)