Improving Well-Being for Breast Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Improving Well-Being for Breast Cancer Patients Taking Adjuvant Endocrine Therapy

Conditions
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Self-management Intervention (SM-AET), General Health Education

Intervention / Treatment
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* Behavioral: SM-AET
* Behavioral: general health education


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SM-AET<br>a self-management intervention for enhancing skills to improve adherence and reduce symptom interference (SM-AET) (active intervention group) | Behavioral: SM-AET<br>* self-management for improving adherence and reducing symptom interference (SM-AET)<br>|
| Other: general health education Intervention<br>general health education Intervention (control group) | Behavioral: general health education<br>* general health education intervention that focuses on improving overall health.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in medication taking behaviors | A revised 16-item measure based on the Medication Adherence Rating Scale and our prior studies is used to assess self-reported adherence. Items were revised to refer specifically to participants' AET medication, assess medication-taking behaviors related to adherence (e.g., forgetting), and capture intentional and unintentional nonadherence over the past month. | Baseline, 3 months, 6 months, 12 months, 18 months | 
| Change in Menopausal Symptoms and Symptom Interference | The 32-item Menopause Specific Quality of Life Questionnaire (MENQOL) assesses the degree of symptom interference in the past week related to four domains: physical symptoms, vasomotor symptoms, psychosocial symptoms, and sexual symptoms. | Baseline, 3 months, 6 months, 12 months, 18 months | 
| Change in Pain and Joint Stiffness/Aching and Symptom Interference | The Brief Pain Inventory - Short form (BPI-SF) is used to assess pain interference in the past week across 9 areas (e.g., general activity, mood, sleep, enjoyment of life). Five items adapted from the Arthritis Impact Measurement Scale-II (AIMS-II; e.g., How would you describe the joint aching that you usually had?; How often did joint aching make it difficult to sleep?) and four items modified from the BPI-SF pain severity scale (e.g., Please rate stiffness in your joints by selecting the one number that best describes your stiffness at its worst in the past week) are used to measure aching and joint stiffness. | Baseline, 3 months, 6 months, 12 months, 18 months | 
| Change in Sleep Problems | The 7-item Insomnia Severity Index (ISI) is a measure of participants' perceived severity of sleep difficulties and the interference of these difficulties with emotional distress, daily functioning, and quality of life in the last two weeks. | Baseline, 3 months, 6 months, 12 months, 18 months | 
| Change in Fatigue | The 8-item Patient Reported Outcomes Information System Fatigue Scale (PROMIS Fatigue) assesses fatigue over the past seven days. | Baseline, 3 months, 6 months, 12 months, 18 months | 
| Change in psychological distress | The eight-item Patient Reported Outcomes Information System Depression Scale (PROMIS Depression) assesses depressive symptoms. The eight-item Patient Reported Outcomes Information System Anxiety Scale (PROMIS Anxiety) is used to assess symptoms of anxiety. | Baseline, 3 months, 6 months, 12 months, 18 months | 
| Change in Physical Functioning and Symptom Interference: 6-minute walk test | The 6-minute walk test assesses women's abilities to exert effort in activity and the degree of pain experienced during activity. Women are asked to walk along an indoor hallway for 6-minutes with the goal being to walk as far as possible within the allotted time. Total distance in feet walked during the allotted time is recorded. | Baseline, 3 months, 6 months, 12 months, 18 months | 
| Change in Physical Functioning and Symptom Interference: Get Up and Go test | In the timed get up and go test participants are asked to stand up from a chair, walk 10 feet, turn, walk back to the chair, and sit down. Total time to complete the task is recorded in seconds. | Baseline, 3 months, 6 months, 12 months, 18 months | 
| Change in Physical Functioning and Symptom Interference: Grip strength | Grip strength is assessed using a latex free JAMAR hydraulic hand dynamometer. The participant sits with her forearm in a neutral position, and wrist between 0° and 30° dorsiflexion and between 0° and 15° ulnar deviation. She then squeezes the handle of the dynamometer as hard as she can. Data is recorded in pounds. Three trials are conducted with each hand. | Baseline, 3 months, 6 months, 12 months, 18 months | 
| Change in perceived barriers to taking AET medication | Eleven items assess barriers to taking medication over the past month. Specifically, women rate how often certain situations (e.g., forgetfulness, problematic side effects, being out of routine) make it difficult for them to take their medications every day. | Baseline, 3 months, 6 months, 12 months, 18 months | 
| Change in treatment interference | Five items from the Treatment Burden Questionnaire assess how often, time spent, frequency, or inconveniences associated with recommended health care present a problem for the participant. | Baseline, 3 months, 6 months, 12 months, 18 months | 
| Change in beliefs about medication | The 10-item Beliefs about Medicines Questionnaire (BMQ) assesses perceived necessity and concerns about AET (e.g., my health depends on my medicine, my medicine protects me from becoming ill). | Baseline, 3 months, 6 months, 12 months, 18 months | 
| Change in self-efficacy for managing symptoms and taking AET | An 8-item scale will measure self-efficacy for managing symptoms. Participants are asked to rate how confident they are that they can manage common symptoms (e.g., aches and plain, sexual side effects and hot flashes/sweating) related to AET. The 13-item Self-Efficacy for Appropriate Medication Use Scale assesses self-efficacy for taking medications across various situations (e.g., when no one reminds you to take the medicine, when you have a busy day planned, when you are away from home). | Baseline, 3 months, 6 months, 12 months, 18 months | 
| Estimate of cost-effectiveness of the CST-AET intervention | The 5-level EuroQol-5 Dimensions (EQ-5D-5L) health questionnaire assesses current health status across five domains that map to a 0 (dead) to 1 (perfect health) scale representing the relative utility (or desirability) of health-related quality of life. These utility weights are used to derive quality-adjusted life years (QALYs). | Baseline, 3 months, 6 months, 12 months, 18 months |