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Completed

NCT Number: NCT03915548

Optimizing Functional Recovery of 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.

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Key information

Conditions

Breast Cancer Female

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Participation Satisfaction in Social Roles and Activities: PROMIS

    Time frame: 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.

    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).

  2. Participation Ability in Social Roles and Activities

    Time frame: The overall treatment effect will be computed as between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.

    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).

  3. Productivity

    Time frame: 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.

    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.

  4. Work Productivity

    Time frame: 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.

    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.

Secondary outcomes

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

    Time frame: 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.

    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.

Other outcomes

  1. Coping

    Time frame: 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.

    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.

  2. Goal Adjustment

    Time frame: 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.

    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.

  3. Distress

    Time frame: 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.

    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.

  4. Occupational Performance

    Time frame: 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.

    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.

Sponsors and collaborators

Lead sponsor

MGH Institute of Health Professions

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Apr 16, 2019
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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