Reducing Metabolic Syndrome Among Breast Cancer Survivors
NCT ID: NCT03719677
Last Updated: 2020-11-20
Study Results
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View full resultsBasic Information
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COMPLETED
NA
7 participants
INTERVENTIONAL
2018-11-06
2020-09-13
Brief Summary
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To determine the feasibility of the intervention 48 community-dwelling rural breast cancer survivors (BCS) (ages 40 and older) will receive the intervention. The 12-week intervention consists of three home-based face-to-face consultations with the therapist, 9 weekly habit tele phone coaching sessions, and the use of implementation intentions, environmental modifications, and tailored text messages to support physical activity and dietary habit formation and address unmet needs.
Detailed Description
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Aim 1. To determine the feasibility and acceptability of the intervention for rural BCS. Investigators will evaluate recruitment, trial engagement and retention rates, treatment satisfaction, and the feasibility of the data collection processes for the primary behavioral measures of HD.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Habit development intervention
Treatment includes occupational therapy evaluation and consultation to address any deficits in physical function, safety, social participation and/or life roles. After the occupational therapy evaluation, the therapist delivers education on physical activity and dietary recommendations and habit development techniques, and uses behavioral skills training to develop habit plans, as well as prompts/cues, environmental modifications, and reminder text messages to reinforce engagement in the plan. The intervention is delivered through 3 face to face sessions, 9 tele coaching calls, and text messages.
Habit development intervention
Lifestyle behavior change intervention targeting physical activity and dietary habit development as well as improving physical and social functioning
Interventions
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Habit development intervention
Lifestyle behavior change intervention targeting physical activity and dietary habit development as well as improving physical and social functioning
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of stage 1-3 histologically confirmed first cancer of the breast
* Reside in a zip code designated as rural by the United States Department of Agriculture Economic Research Service
* Be within the initial 12 months following the end of primary treatment and meet 3 of the following 5 criteria for MetS confirmed via point-of-care testing or documentation in their medical record:
A large waistline \> 35 inches Blood pressure \> 130/85; HbA1c of 5.7%-6.4%; Triglyceride levels \> 150 mg/dL; HDL cholesterol levels \< 50 mg/dL
Exclusion Criteria
* Pregnant patients
* Resistant Hypertension
* Steroid-dependent asthma or Chronic obstructive pulmonary disease
* Cirrhosis or hepatic failure
* A major cardiovascular event (e.g., stroke, myocardial infarction) within the previous 90 days
* Chronic kidney disease on renal replacement therapy
* Type one or two diabetes
* Stage 4 cancer; those with a secondary cancer (except for nonmelanomatous skin cancers and carcinoma of the cervix in situ)
* Taking weight loss medications
* Current involvement in a behavioral program
* Neuropsychiatric disorder or dementia
40 Years
FEMALE
No
Sponsors
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Barbara Ann Karmanos Cancer Institute
OTHER
Responsible Party
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Heather Fritz
Principal Investigator
Principal Investigators
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Heather Fritz, PhD
Role: PRINCIPAL_INVESTIGATOR
Wayne State University
Locations
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Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2018-062
Identifier Type: -
Identifier Source: org_study_id