DiabetesI HEALNCT02970344
I HEAL for Breast Cancer Survivors With Diabetes
A study testing Diabetes Coping Skills Training (DCST) in people with Diabetes, run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Diabetes
- What is being tested?
- Diabetes Coping Skills Training (DCST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2017to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- <21 years of age,
- severe 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Improving Health Engagement and Lifestyle Management for Breast Cancer Survivors With Diabetes
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 and data will be obtained from home blood glucose monitoring devices. Glycosylated hemoglobin (HbA1c) will be assessed at baseline, 6, and 12 months.
Read the 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. 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.
- Conditions
- Diabetes
- Being tested
- Diabetes Coping Skills Training (DCST)
- Keywords
- Coping Skills Training, Diabetes Education
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Coping Skills Training (DCST)Behavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Coping Skills training (DCST) | Experimental | Twelve sessions are delivered over 6 months using a faded contact model involving 6 weekly sessions, 3 biweekly sessions and 3 monthly sessions. Receives: Behavioral: Diabetes Coping Skills Training (DCST) |
| Diabetes Education | No intervention | one 60 minute diabetes education session. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical symptoms
The Checklist measures the severity of different symptoms (e.g., pain, fatigue, numbness and tingling) associated with illness and disease.
Measured: baseline, 3 months, 6 months and 12 months
Change in psychological distress
The eight-item Patient Reported Outcomes Information System (PROMIS).
Measured: baseline, 3 months, 6 months and 12 months
Change in psychological distress
Anxiety will be assessed using the seven-item GAD-7 Scale.
Measured: baseline, 3 months, 6 months and 12 months
Secondary outcomes (8)
Accessing change in Diabetes self-management behaviors via self reported medication adherence
Participants who receive DCST will exhibit greater improvements in medication adherence compare to the education group.
Measured: Baseline to 12 months
Accessing change in Diabetes self-management behavior via Barriers to taking medication
Participants who receive DCST will exhibit greater improvements in medication adherence compare to the education group.
Measured: Baseline to 12 months
Accessing change in Diabetes self-management behavior via Adherence to diabetes self-management behaviors
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.
Measured: Baseline to 12 months
Accessing change in Diabetes self-management behavior via Use of home blood glucose monitoring
Participants who receive DCST will exhibit greater improvements in adherence to blood glucose monitoring compare to the education group.
Measured: Baseline, 6 months and 12 months
Improved glycemic control
Participants who receive DCST will show greater improvements in HbA1c compared to the diabetes education alone.
Measured: Baseline, 6 months and 12 months
Change in self-efficacy
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.
Measured: Baseline, 6 months and 12 months
Change in Physical Activity
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.
Measured: Baseline, 6 months and 12 months
Assessing change in Physical Activity
Wireless activity tracking devices 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.
Measured: Baseline, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study start20 Apr 2017
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca A Shelby, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970344
- Sponsor's protocol ID
- Pro00073234
- Acronym
- I HEAL
- Status last verified
- Feb 2022
- First submitted
- 21 Oct 2016
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shelby RA, Dorfman CS, Arthur SS, Bosworth HB, Corsino L, Sutton L, Owen L, Erkanli A, Keefe F, Corbett C, Kimmick G. Improving health engagement and lifestyle management for breast cancer survivors with diabetes. Contemp Clin Trials. 2020 May;92:105998. doi: 10.1016/j.cct.2020.105998. Epub 2020 Apr 11.
PubMed 32289471
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Health Engagement and Lifestyle Management for Breast Cancer Survivors With Diabetes
- ClinicalTrials.gov ID
- NCT02970344
- Acronym / sponsor ID
- I HEAL / Pro00073234
- Conditions
- Diabetes
- Keywords
- Coping Skills Training, Diabetes Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 22 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 and data will be obtained from home blood glucose monitoring devices. Glycosylated hemoglobin (HbA1c) will be assessed at baseline, 6, and 12 months.
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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes Coping Skills training (DCST) | Experimental | Behavioral: 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. |
| Diabetes Education | No intervention | –one 60 minute diabetes education session. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- <21 years of age,
- severe 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Behavioural | Diabetes Coping Skills training (DCST) |
Primary outcome
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.
8 secondary outcomes
Accessing change in Diabetes self-management behaviors via self reported medication adherence
Time frame: Baseline to 12 months
Accessing change in Diabetes self-management behavior via Barriers to taking medication
Time frame: Baseline to 12 months
Accessing change in Diabetes self-management behavior via Adherence to diabetes self-management behaviors
Time frame: Baseline to 12 months
Accessing change in Diabetes self-management behavior via Use of home blood glucose monitoring
Time frame: Baseline, 6 months and 12 months
Improved glycemic control
Time frame: Baseline, 6 months and 12 months
Change in self-efficacy
Time frame: Baseline, 6 months and 12 months
Change in Physical Activity
Time frame: Baseline, 6 months and 12 months
Assessing change in Physical Activity
Time frame: Baseline, 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Derived from this study: PubMed 32289471Shelby RA, Dorfman CS, Arthur SS, Bosworth HB, Corsino L, Sutton L, Owen L, Erkanli A, Keefe F, Corbett C, Kimmick G. Improving health engagement and lifestyle management for breast cancer survivors with diabetes. Contemp Clin Trials. 2020 May;92:105998. doi: 10.1016/j.cct.2020.105998. Epub 2020 Apr 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca A Shelby, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Coping Skills Training (DCST) in people with Diabetes, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical symptoms (time frame: baseline, 3 months, 6 months and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02970344, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.