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Optimizing Functional Recovery of Breast Cancer Survivors

Primary Purpose

Breast Cancer Female

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

The Behavioral Activation/ Problem Solving Intervention

Attention Control Condition

About this trial

This is an interventional supportive care trial for Breast Cancer Female

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

University of Alabama at Birmingham
Dartmouth Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

The Behavioral Activation/ Problem Solving Intervention

Attention Control Condition

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03915548

First Posted

April 3, 2019

Last Updated

October 17, 2023

Sponsor

MGH Institute of Health Professions

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT03915548

Brief Title

Optimizing Functional Recovery of Breast Cancer Survivors

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 28, 2019 (Actual)

Primary Completion Date

April 30, 2023 (Actual)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

MGH Institute of Health Professions

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer Female

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Outcomes Assessor

Masking Description

Assessments will be administered via telephone by a research assistant blind to group assignment.

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

The Behavioral Activation/ Problem Solving Intervention

Arm Type

Experimental

Arm Description

Arm Title

Attention Control Condition

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

The Behavioral Activation/ Problem Solving Intervention

Intervention Description

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

Intervention Name(s)

Attention Control Condition

Intervention Description

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 Outcome Measure Information:

Title

Change in Participation satisfaction in social roles and activities: PROMIS

Description

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.

Time Frame

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.

Title

Change in Participation ability in social roles and activities

Description

Time Frame

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.

Title

Change in productivity

Description

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.

Time Frame

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.

Title

Change in work productivity

Description

Time Frame

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 Measure Information:

Title

Change in Quality of life: Functional Assessment of Cancer Therapy- (FACT-G)

Description

Time Frame

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.

Other Pre-specified Outcome Measures:

Title

Change in coping

Description

Instrument name: Brief COPE. Range for each subscale (subscales items are summed; no total score): 0-6. Subscales: positive reframing, active coping, planning. Higher values indicate more adaptive coping.

Time Frame

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.

Title

Change in Goal adjustment

Description

Instrument name: Goal Disengagement and Goal Reengagement Scale (GDGRS). Range: 1 to 4 for goal disengagement and 1 to 6 for goal reengagement. Subscales: goal disengagement and goal reengagement (subscale items are averaged, no total score). Higher values indicate greater goal adjustment.

Time Frame

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.

Title

Change in Distress

Description

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.

Time Frame

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.

Title

Change in Occupational Performance

Description

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.

Time Frame

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.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathleen Lyons, ScD

Organizational Affiliation

MGH Institute of Health Professionals

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294-1210

Country

United States

Facility Name

Dartmouth Hitchcock Medical Center

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32060166

Citation

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.

Results Reference

derived

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Optimizing Functional Recovery of Breast Cancer Survivors

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