Optimizing Functional Recovery of Breast Cancer Survivors

NCT ID: NCT03915548

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 303 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-28
• Study Completion Date: 2024-03-31

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.

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.

Conditions

Breast Cancer Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

The Behavioral Activation/ Problem Solving Intervention

Intervention Type: 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.

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).

Group Type: ACTIVE_COMPARATOR

Attention Control Condition

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

MGH Institute of Health Professions

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Lyons, ScD, OTR/L

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen Lyons, ScD

Role: PRINCIPAL_INVESTIGATOR

MGH Institute of Health Professionals

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38517442 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32060166 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R01CA225792-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2021P002871

Identifier Type: -

Identifier Source: org_study_id