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Optimizing Functional Recovery of Breast Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915548
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : January 6, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kathleen Lyons, Dartmouth-Hitchcock Medical Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Female Behavioral: The Behavioral Activation/ Problem Solving Intervention Behavioral: Attention Control Condition Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Single (Outcomes Assessor)
Masking Description: Assessments will be administered via telephone by a research assistant blind to group assignment.
Primary Purpose: Supportive Care
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
Actual Study Start Date : August 28, 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.

Active Comparator: 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).
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.




Primary Outcome Measures :
  1. Change in Participation satisfaction in social roles and activities: PROMIS [ 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. ]
    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.

  2. Change in Participation ability in social roles and activities [ 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. ]

    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.


  3. Change in 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. ]

    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. Change in work 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. ]

    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 :
  1. Change in Quality of life: Functional Assessment of Cancer Therapy- (FACT-G) [ 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. ]

    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.



Other Outcome Measures:
  1. Change in 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. ]
    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.

  2. Change in 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. ]

    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.


  3. Change in Distress [ 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. ]
    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. Change in 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. ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915548


Contacts
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Contact: Daphne Ellis 603-650-7092 daphne.l.ellis@hitchcock.org
Contact: Tiffany Hunt 603-650-6437 tiffany.l.hunt@hitchcock.org

Locations
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United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Daphne Ellis    603-650-7092    daphne.l.ellis@hitchcock.org   
Contact: Tiffany Hunt    603-650-6437    tiffany.l.hunt@hitchcock.org   
Principal Investigator: Kathleen Lyons, ScD         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Kathleen Lyons, ScD, OTR Dartmouth-Hitchcock Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kathleen Lyons, Scientist, Assistant Professor of Psychiatry, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT03915548    
Other Study ID Numbers: D18167
1R01CA225792-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases