Improving Well-Being for Breast Cancer Patients

NCT ID: NCT02707471

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 312 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-14
• Study Completion Date: 2023-11-09

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.

Conditions

Self-management Intervention (SM-AET); General Health Education

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SM-AET

a self-management intervention for enhancing skills to improve adherence and reduce symptom interference (SM-AET) (active intervention group)

Group Type: EXPERIMENTAL

SM-AET

Intervention Type: BEHAVIORAL

self-management for improving adherence and reducing symptom interference (SM-AET)

general health education Intervention

general health education Intervention (control group)

Group Type: OTHER

general health education

Intervention Type: BEHAVIORAL

general health education intervention that focuses on improving overall health.

Interventions

SM-AET

self-management for improving adherence and reducing symptom interference (SM-AET)

Intervention Type: BEHAVIORAL

general health education

general health education intervention that focuses on improving overall health.

Intervention Type: BEHAVIORAL

Eligibility 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).

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca Shelby, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

Shelby RA, Dorfman CS, Bosworth HB, Keefe F, Sutton L, Owen L, Corsino L, Erkanli A, Reed SD, Arthur SS, Somers T, Barrett N, Huettel S, Gonzalez JM, Kimmick G. Testing a behavioral intervention to improve adherence to adjuvant endocrine therapy (AET). Contemp Clin Trials. 2019 Jan;76:120-131. doi: 10.1016/j.cct.2018.11.010. Epub 2018 Nov 22.

Reference Type: DERIVED

PMID: 30472215 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00068595

Identifier Type: -

Identifier Source: org_study_id