Improving Well-Being for Breast Cancer Patients

NCT02707471 | Completed

• 1 other identifier: Pro00068595
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percent daily adherence assessed over 18 months

  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).

  18 month

Secondary Outcomes (14)

• Change in medication taking behaviors

  Baseline, 3 months, 6 months, 12 months, 18 months

• Change in Menopausal Symptoms and Symptom Interference

  Baseline, 3 months, 6 months, 12 months, 18 months

• Change in Pain and Joint Stiffness/Aching and Symptom Interference

  Baseline, 3 months, 6 months, 12 months, 18 months

• Change in Sleep Problems

  Baseline, 3 months, 6 months, 12 months, 18 months

• Change in Fatigue

  Baseline, 3 months, 6 months, 12 months, 18 months

Other Outcomes (1)

• Treatment Credibility and Satisfaction

  3 months, 6 months

Study Arms (2)

SM-AET

EXPERIMENTAL

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

Behavioral: SM-AET

general health education Intervention

OTHER

general health education Intervention (control group)

Behavioral: general health education

Interventions

SM-AET BEHAVIORAL

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

SM-AET

general health education BEHAVIORAL

general health education intervention that focuses on improving overall health.

general health education Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<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).

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• 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.

  PMID: 30472215 DERIVED

Study Officials

• Rebecca Shelby, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 14, 2016
• Study Start: March 14, 2017
• Primary Completion: November 9, 2023
• Study Completion: November 9, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Locations

US (1)