Clinical trial NCT03915548: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Lead sponsor: MGH Institute of Health Professions
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-04-16
Enrollment: 303
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Participation Satisfaction in Social Roles and Activities: PROMIS
timeFrame: 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.
measure: Participation Ability in Social Roles and Activities
timeFrame: The overall treatment effect will be computed as between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.
measure: Productivity
timeFrame: 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.
measure: Work Productivity
timeFrame: 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:
measure: Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)
timeFrame: 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:
measure: Coping
timeFrame: 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.
measure: Goal Adjustment
timeFrame: 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.
measure: Distress
timeFrame: 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.
measure: Occupational Performance
timeFrame: 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.
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: MGH Institute of Health Professionals
name: Kathleen Lyons, ScD
role: PRINCIPAL_INVESTIGATOR
References:
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.