Ignite Creation Date:
2024-05-06 @ 8:17 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02707471
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2016-03-03
Brief Title:
Improving Well-Being for Breast Cancer Patients
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Improving Well-Being for Breast Cancer Patients Taking Adjuvant Endocrine Therapy
Status:
COMPLETED
Status Verified Date:
2023-11
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:
None
Brief Summary:
Adjuvant endocrine therapy AET is a crucial component of treatment used to prevent recurrence and reduce breast cancer-related mortality for breast cancer patients with hormone receptor positive disease Studies report low rates of adherence to AET 38 to 86 and in our preliminary work 65 of breast cancer patients taking AET reported one or more non-adherent medication taking behaviors eg skipped dose forgot adjusted dose in the past month Symptoms eg arthralgia vasomotor symptoms associated with AET are strongly related to non-adherence and early discontinuation of treatment Poor adherence to AET due to symptoms may compromise the effectiveness of AET Prior to conducting a clinical trial we will conduct user testing of the self-management intervention protocol with 20 women In the proposed randomized clinical trial 400 women who are taking AET for breast cancer will be randomly assigned to one of two conditions 1 a self-management intervention for improving adherence and symptom management or 2 a general health education control condition The self-management intervention integrates three key theory-based strategies for improving adherence to AET coping skills training for managing symptoms eg arthralgia vasomotor symptoms behavioral strategies for improving medication adherence and symptom and medication education The intervention addresses the specific symptoms a woman is experiencing and is designed to meet the needs of women who are at high risk for non-adherence to AET eg low socioeconomic status low literacy The self-management intervention is administered by a nurse via the telephone and combines the use of phone calls and tailored interactive voice messaging based on information exchanged during phone sessions and real-time adherence data obtained from smart medication bottles Women randomly assigned to the control condition will receive a general health education intervention that is delivered by a nurse via the telephone This study will take place in the Duke Cancer Institute breast clinic and in community hospitals that are members of the Duke Cancer Network which will allow access to women receiving care outside the medical center setting and increase generalizability of findings to a variety of settings Adherence to AET will be assessed over the 18 month period following study enrollment using wireless smart medication bottles that provide real-time adherence data and pill counts completed by study staff during in-person study assessments Patient-reported outcome measures assessing symptoms perceived necessity of AET concerns about AET and self-efficacy will be obtained at baseline and 3 6 12 and 18 months To increase the likelihood of later implementation of the self-management intervention the cost effectiveness of the intervention will be evaluated
Detailed Description:
None
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