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Reducing Metabolic Syndrome Among Breast Cancer Survivors

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ClinicalTrials.gov Identifier: NCT03719677
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Heather Fritz, Barbara Ann Karmanos Cancer Institute

Brief Summary:

Using a pilot 2-arm randomized controlled trial, 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 and preliminary effects of the intervention 48 community-dwelling rural breast cancer survivors (BCS) (ages 40 and older) will be randomly assigned to receive either the intervention or enhanced usual care. The 22-week intervention consists of three home-based face-to-face consultations with the therapist, 10 biweekly 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.


Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Habit development intervention Not Applicable

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 2-arm randomized controlled trial, 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 and preliminary effects of the intervention 48 community-dwelling rural BCS (ages 40 and older) will be randomly assigned to receive either the intervention or enhanced usual care. The 22-week intervention consists of three home-based face-to-face consultations with the therapist, 10 biweekly 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 and the following behavioral and clinical outcome measures will be collected at baseline and post intervention (week 25): habit development (operationalized as behavioral automaticity), MetS, dietary quality, physical activity engagement, self-reported unmet needs, and quality of life. Investigators hypothesize that the intervention will be feasible to implement and satisfactory to participants. The one specific aim is:

Aim 1. To determine the feasibility and acceptability of the intervention for rural BCS. Investigators will evaluate trial randomization, recruitment, trial engagement and retention rates, treatment satisfaction, and the feasibility of the data collection processes for the primary behavioral measures of HD and the primary clinical measures of MetS as well as the secondary measures of improved dietary quality, physical activity engagement, physical and social functioning, self-reported unmet needs, and quality of life.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Reducing Metabolic Syndrome and Unmet Needs Among Rural Breast Cancer Survivors During the Survivorship Transition
Actual Study Start Date : November 6, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Habit development intervention
Lifestyle behavior change intervention targeting physical activity and dietary habit development as well as improving physical and social functioning

No Intervention: Control condition
Participants receive a publicly available informational pamphlet about healthy lifestyle after cancer.



Primary Outcome Measures :
  1. Self Reported behavioral Automaticity Index [ Time Frame: From week 4 to week 8 ]
    Measures changes in habit strength, scores range from 1-7 with higher scores indicating a stronger habit

  2. Self Reported behavioral Automaticity Index [ Time Frame: From week 8 to week 12 ]
    Measures changes in habit strength, scores range from 1-7 with higher scores indicating a stronger habit

  3. Self Reported behavioral Automaticity Index [ Time Frame: From week 12 to week 16 ]
    Measures changes in habit strength, scores range from 1-7 with higher scores indicating a stronger habit

  4. Self Reported behavioral Automaticity Index [ Time Frame: From week 16 to week 20 ]
    Measures changes in habit strength, scores range from 1-7 with higher scores indicating a stronger habit

  5. Self Reported behavioral Automaticity Index [ Time Frame: From week 20 to week 24 ]
    Measures changes in habit strength, scores range from 1-7 with higher scores indicating a stronger habit


Secondary Outcome Measures :
  1. Weight loss [ Time Frame: From baseline to week 25 ]
    Defined as a change in any of the following Body weight measured in pounds

  2. Systolic Blood pressure [ Time Frame: From baseline to week 25 ]
    Defined as a reduction in systolic blood pressure, measures in mm/Hg

  3. Triglycerides [ Time Frame: From baseline to week 25 ]
    Defined as a change in Triglycerides measured in mg/dl

  4. Hemoglobin A1c [ Time Frame: From baseline to week 25 ]
    Defined as a change in Hemoglobin A1c measured in percent

  5. High-density lipoprotein [ Time Frame: From baseline to week 25 ]
    Defined as an change in High-density lipoprotein measured in mg/dl



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

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): NCT03719677


Contacts
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Contact: Heather Fritz 313-577-9499 heather.fritz@wayne.edu
Contact: Jamil Gharib jamil.gharib@wayne.edu

Locations
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United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Jamil Gharib       jamil.gharib@wayne.edu   
Sub-Investigator: Wassim Tarraf         
Sub-Investigator: Terrance Albrecht, Ph.D.         
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
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Principal Investigator: Heather Fritz, PhD Wayne State University

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Responsible Party: Heather Fritz, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT03719677     History of Changes
Other Study ID Numbers: 2018-062
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
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
Metabolic Syndrome
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases