Clinical trial NCT02707471: Improving Well-Being for Breast Cancer Patients
Official title: Improving Well-Being for Breast Cancer Patients Taking Adjuvant Endocrine Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self-management Intervention (SM-AET)
General Health Education
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-03-14
Enrollment: 312
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Percent daily adherence assessed over 18 months
timeFrame: 18 month
Secondary outcomes:
measure: Change in medication taking behaviors
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months
measure: Change in Menopausal Symptoms and Symptom Interference
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months
measure: Change in Pain and Joint Stiffness/Aching and Symptom Interference
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months
measure: Change in Sleep Problems
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months
measure: Change in Fatigue
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months
measure: Change in psychological distress
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months
measure: Change in Physical Functioning and Symptom Interference: 6-minute walk test
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months
measure: Change in Physical Functioning and Symptom Interference: Get Up and Go test
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months
measure: Change in Physical Functioning and Symptom Interference: Grip strength
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months
measure: Change in perceived barriers to taking AET medication
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months
measure: Change in treatment interference
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months
measure: Change in beliefs about medication
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months
measure: Change in self-efficacy for managing symptoms and taking AET
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months
measure: Estimate of cost-effectiveness of the CST-AET intervention
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months
Other outcomes:
measure: Treatment Credibility and Satisfaction
timeFrame: 3 months, 6 months
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Rebecca Shelby, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.