Ignite Creation Date:
2024-05-06 @ 9:25 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02970344
Status:
COMPLETED
Last Update Posted:
2022-03-15
First Post:
2016-10-21
Brief Title:
I HEAL for Breast Cancer Survivors With Diabetes
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Improving Health Engagement and Lifestyle Management for Breast Cancer Survivors With Diabetes
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
I HEAL
Brief 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 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 ie 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 31 million breast cancer survivors in the US 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 N230 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None