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I HEAL for Breast Cancer Survivors With Diabetes (I HEAL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02970344
First received: October 21, 2016
Last updated: April 17, 2017
Last verified: April 2017
  Purpose
The proposed randomized clinical trial evaluates a diabetes coping skills training (DCST) intervention for improving breast cancer survivors' abilities to manage symptoms and adhere to recommended diabetes self-management. The telephone-based DCST protocol integrates three key strategies to reduce symptoms and improve diabetes self-management: coping skills training for managing symptoms, adherence skills training, and healthy lifestyle skills training. The investigator will test the effects of the DCST intervention by comparing it to diabetes education alone. Physical symptoms, psychological distress, diabetes self-management behaviors, and self-efficacy for managing symptoms and diabetes self-management will be assessed at baseline and 3, 6, and 12 months. Physical activity (i.e., daily steps and distance) will be assessed using wireless activity trackers (Fitbit) and data will be obtained from home blood glucose monitoring devices. Fasting insulin, fasting glucose, and glycosylated hemoglobin (HbA1c) will be assessed at baseline, 6, and 12 months.

Condition Intervention
Diabetes
Behavioral: Diabetes Coping Skills Training (DCST)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Treatment
Official Title: Improving Health Engagement and Lifestyle Management for Breast Cancer Survivors With Diabetes

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in physical symptoms [ Time Frame: baseline, 3 months, 6 months and 12 months ]
    The Checklist measures the severity of different symptoms (e.g., pain, fatigue, numbness and tingling) associated with illness and disease.

  • Change in psychological distress [ Time Frame: baseline, 3 months, 6 months and 12 months ]
    The eight-item Patient Reported Outcomes Information System (PROMIS).

  • Change in psychological distress [ Time Frame: baseline, 3 months, 6 months and 12 months ]
    Anxiety will be assessed using the seven-item GAD-7 Scale.


Secondary Outcome Measures:
  • Accessing change in Diabetes self-management behaviors via self reported medication adherence [ Time Frame: Baseline to 12 months ]
    Participants who receive DCST will exhibit greater improvements in medication adherence compare to the education group.

  • Accessing change in Diabetes self-management behavior via Barriers to taking medication [ Time Frame: Baseline to 12 months ]
    Participants who receive DCST will exhibit greater improvements in medication adherence compare to the education group.

  • Accessing change in Diabetes self-management behavior via Adherence to diabetes self-management behaviors [ Time Frame: Baseline to 12 months ]
    Participants who receive DCST will exhibit greater improvements in physical activity, dietary patterns, medication adherence, and adherence to blood glucose monitoring compare to the education group.

  • Accessing change in Diabetes self-management behavior via Use of home blood glucose monitoring [ Time Frame: Baseline, 6 months and 12 months ]
    Participants who receive DCST will exhibit greater improvements in adherence to blood glucose monitoring compare to the education group.

  • Improved glycemic control [ Time Frame: Baseline, 6 months and 12 months ]
    Participants who receive DCST will show greater improvements in fasting insulin, fasting glucose, and HbA1c compared to the diabetes education alone.

  • Change in self-efficacy [ Time Frame: Baseline, 6 months and 12 months ]
    This contains 5 items that inquire about patients' certainty about degree of pain control, pain during daily activities, controlling pain during sleep, and making pain reductions without extra medication.

  • Change in Physical Activity [ Time Frame: Baseline, 6 months and 12 months ]

    Patient-reported physical activity will be assessed using the well-validated Community Healthy Activities Model Program for Seniors (CHAMPS).

    Participants who receive DCST will show improved self efficacy for managing symptoms and diabetes self-management compared to the diabetes education alone.


  • Assessing change in Physical Activity [ Time Frame: Baseline, 6 months and 12 months ]

    Wireless activity tracking devices (Fitbit) will be used to assess daily steps and distance.

    Participants who receive DCST will show improved self efficacy for managing symptoms and diabetes self-management compared to the diabetes education alone.

    Participants who receive DCST will show improved self efficacy for managing symptoms and diabetPhysical Activity



Estimated Enrollment: 230
Anticipated Study Start Date: April 2017
Estimated Study Completion Date: April 2021
Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diabetes Coping Skills training (DCST)
Twelve sessions are delivered over 6 months using a faded contact model involving 6 weekly sessions, 3 biweekly sessions and 3 monthly sessions.
Behavioral: Diabetes Coping Skills Training (DCST)
Diabetes Coping Skills Training (DCST) consist of twelve 50 minutes sessions delivered over 6 months using a faded contact model ( 6 weekly session, 3 biweekly sessions and 3 monthly sessions)
No Intervention: Diabetes Education
one 60 minute diabetes education session.

Detailed Description:
Together, breast cancer and type 2 diabetes represent a public health crisis. Approximately 20% of the 3.1 million breast cancer survivors in the U.S. have type 2 diabetes, and this number is expected to grow. Breast cancer survivors who have type 2 diabetes are at high risk for cancer recurrence, serious health complications, and premature death. Breast cancer survivors with type 2 diabetes experience more severe, disabling symptoms and psychological distress relative to breast cancer survivors without diabetes. For breast cancer survivors with type 2 diabetes, maintaining glycemic control is critical for decreasing symptoms and preventing serious health problems. Important diabetes self-management strategies include physical activity, dietary modifications, medication, and blood glucose monitoring. Many breast cancer survivors with type 2 diabetes have difficulty maintaining these behaviors and achieving glycemic control. Physical symptoms and psychological distress are often barriers to engaging in diabetes self-management. The proposed study evaluates a novel diabetes coping skills training (DCST) intervention for improving breast cancer survivors' abilities to manage symptoms and adhere to recommended diabetes self-management. The telephone-based DCST protocol is based on our prior work and integrates three key theory-based strategies: coping skills training for managing symptoms, adherence skills training, and healthy lifestyle skills training. The proposed randomized clinical trial (N=230) will test the effects of the DCST intervention by comparing it to diabetes education alone. Physical symptoms, psychological distress, diabetes self-management behaviors, and self-efficacy will be assessed at baseline and 3, 6, and 12 months. Physical activity will be assessed using wireless activity trackers and data will be obtained from home blood glucose monitoring devices. Fasting insulin, fasting glucose, and glycosylated hemoglobin (HbA1c) will be assessed at baseline, 6, and 12 months. The proposed study addresses a critical gap in the care of breast cancer survivors by evaluating a novel behavioral intervention that aims to improve the management of symptoms, adherence, and glycemic control in breast cancer survivors with type 2 diabetes. The findings of this study could lead to significant improvements in clinical care and beneficial outcomes for breast cancer survivors.
  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of Stage I to III breast cancer,
  • diagnosis of diabetes mellitus type 2
  • completed local definitive treatment (i.e., surgical treatment, chemotherapy and/or radiation therapy),
  • physician verification of ability to participate in the intervention,
  • English speaking.

Exclusion Criteria:

  • <21 years of age,
  • cognitive or hearing impairment,
  • unable to provide meaningful consent (i.e., impairment such that descriptions of the research are not clearly understood),
  • presence of a health problem that precludes safe participation in the intervention.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02970344

Contacts
Contact: Rebecca A Shelby, PhD 919-416-3410 rebecca.shelby@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Rebecca A Shelby, PhD    919-416-3410    rebecca.shelby@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Rebecca A Shelby, PhD Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02970344     History of Changes
Other Study ID Numbers: Pro00073234
Study First Received: October 21, 2016
Last Updated: April 17, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:
Coping Skills Training
Diabetes Education

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 27, 2017