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Reducing Metabolic Syndrome Among Breast Cancer Survivors

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Habit development intervention
Sponsored by
Barbara Ann Karmanos Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • English speaking
  • 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:

  • Will not exclude participants based on hormone receptivity, one exception is that we will exclude HER2 positive BCS
  • 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

Sites / Locations

  • Barbara Ann Karmanos Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Habit development intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Self Reported Behavioral Automaticity Index
Measures changes in habit strength, scores range from 1-7 with higher scores indicating a stronger habit

Secondary Outcome Measures

Full Information

First Posted
October 22, 2018
Last Updated
October 29, 2020
Sponsor
Barbara Ann Karmanos Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03719677
Brief Title
Reducing Metabolic Syndrome Among Breast Cancer Survivors
Official Title
Reducing Metabolic Syndrome and Unmet Needs Among Rural Breast Cancer Survivors During the Survivorship Transition
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 6, 2018 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
September 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Using a pilot 1-arm pre-post design, investigators will implement an intervention that is personalized, low burden (the majority of interactions are telephone coaching sessions), and delivered during the initial survivorship transition. 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
The objective of the present study is to determine the feasibility of a manual, theory based, occupational therapist delivered, preventative intervention to increase habit development (HD) of healthy dietary and physical activity behaviors, and reduce metabolic syndrome (MetS) among high-risk, rural breast cancer survivors (BCS). Using a pilot 1-arm pre-post design, investigators will implement an intervention that is personalized, low burden (the majority of interactions are telephone coaching sessions), and delivered during the initial survivorship transition. To determine the feasibility of the intervention 48 community-dwelling rural 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 telephone 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. Feasibility metrics will be collected throughout the intervention. The one specific aim is: 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Habit development intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Habit development intervention
Intervention Description
Lifestyle behavior change intervention targeting physical activity and dietary habit development as well as improving physical and social functioning
Primary Outcome Measure Information:
Title
Self Reported Behavioral Automaticity Index
Description
Measures changes in habit strength, scores range from 1-7 with higher scores indicating a stronger habit
Time Frame
From week 0-2

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English speaking 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: Will not exclude participants based on hormone receptivity, one exception is that we will exclude HER2 positive BCS 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Fritz, PhD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Reducing Metabolic Syndrome Among Breast Cancer Survivors

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