Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Well-Being for Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02707471
Recruitment Status : Recruiting
First Posted : March 14, 2016
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 (e.g., skipped dose, forgot, adjusted dose) in the past month. Symptoms (e.g., 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 (e.g., 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 (e.g., 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.

Condition or disease Intervention/treatment Phase
Self-management Intervention (SM-AET) General Health Education Behavioral: SM-AET Behavioral: general health education Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Well-Being for Breast Cancer Patients Taking Adjuvant Endocrine Therapy
Actual Study Start Date : March 14, 2017
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: SM-AET
a self-management intervention for enhancing skills to improve adherence and reduce symptom interference (SM-AET) (active intervention group)
 Behavioral: SM-AET
self-management for improving adherence and reducing symptom interference (SM-AET)
general health education Intervention
general health education Intervention (control group)
 Behavioral: general health education
general health education intervention that focuses on improving overall health.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Percent daily adherence assessed over 18 months [ Time Frame: 18 month ]
    The SM-AET protocol includes eight sessions and two maintenance calls administered by a nurse via the phone. The intervention also includes interactive voice messaging that is tailored based on participants' medication taking behavior. Adherence to AET will be assessed using smart pill bottles (i.e., bottle opening and percent of pills remaining).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of Stage I to III breast cancer
  • hormone receptor positive tumor defined as any positivity of estrogen or progesterone receptor
  • completed local definitive treatment (i.e., surgery, chemotherapy, radiation),
  • within 12 months of beginning AET
  • at least 18 months of AET recommended

Exclusion Criteria:

  • <21 years of age,
  • severe cognitive or hearing impairment that is documented in the medical record
  • unable to provide meaningful consent (e.g., severe cognitive impairment).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02707471


Contacts
Layout table for location contacts
Contact: Rebecca Shelby, PhD 919-416-3410 rebecca.shebly@duke.edu

Locations
Layout table for location information
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Layout table for investigator information
Principal Investigator: Rebecca Shelby, PhD Duke University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02707471    
Other Study ID Numbers: Pro00068595
First Posted: March 14, 2016    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No