Telephone Support for Breast Cancer Treatment Adherence
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ohio State University Comprehensive Cancer Center
Stay on your current meds
No Placebo Group
Approved in 5 jurisdictions
Trial Summary
What is the purpose of this trial?This pilot trial studies a telephone-based intervention to see if it increases adherence to adjuvant hormonal therapy in patients with breast cancer. Increasing communication between doctors and patients with breast cancer may help patients to better follow recommendations on taking adjuvant hormonal treatment medication. A telephone-based intervention may help to increase doctor-patient communication and patients' adherence to their prescribed medication.
Is telephone support for breast cancer treatment adherence safe?
The research indicates that while adjuvant hormone therapy (a type of treatment for breast cancer) can have side effects, these are generally related to adherence issues rather than safety concerns. No specific safety issues related to telephone support interventions were identified in the studies.
247911How is adjuvant hormonal therapy for breast cancer different from other treatments?
Adjuvant hormonal therapy for breast cancer is unique because it specifically targets hormone receptor-positive tumors, which are common in breast cancer, by blocking or lowering estrogen levels to prevent cancer growth. Unlike chemotherapy, which attacks all rapidly dividing cells, this therapy is more targeted and is taken orally over a long period to reduce recurrence and improve survival rates.
23568Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it focuses on helping you stick to your prescribed adjuvant hormonal therapy for breast cancer.
What data supports the effectiveness of the treatment Telephone Support for Breast Cancer Treatment Adherence?
Research shows that adherence to adjuvant endocrine therapy (AET) is crucial for reducing breast cancer recurrence and mortality, but many patients struggle to stick with the treatment. Strategies like improving patient-provider communication and providing frequent feedback have been suggested to enhance adherence, which could be supported by telephone-based interventions.
123610Eligibility Criteria
This trial is for post-menopausal women with stages I-III breast cancer who've finished primary treatment and are starting adjuvant hormonal therapy (AHT) like tamoxifen or aromatase inhibitors. Participants must own a smartphone, agree to text communication, consent to medical record review, and plan to stay in the study area for at least 3 months.Inclusion Criteria
I am post-menopausal, confirmed by surgery, lack of periods for a year, or hormone levels.
I have been diagnosed with early-stage breast cancer (stages I-III).
I am eligible to start hormone therapy (tamoxifen or an AI) for the first time.
I have finished all my initial cancer treatments.
Participant Groups
The study tests if regular phone calls can help patients stick to their hormone therapy schedule after breast cancer treatment. It involves surveys, lab biomarker analysis, and a telephone-based program designed to improve doctor-patient communication about medication adherence.
1Treatment groups
Experimental Treatment
Group I: Supportive (text messages and interactive exchanges)Experimental Treatment3 Interventions
Patients receive daily text messages reminding them to take AHT and weekly interactive surveys delivered by a smart phone app for 3 months.
Adjuvant Hormonal Therapy is already approved in European Union, United States, Canada, Japan, Australia for the following indications:
🇪🇺 Approved in European Union as Hormone Therapy for:
- Breast cancer
- Prostate cancer
- Endometrial cancer
🇺🇸 Approved in United States as Hormone Therapy for:
- Breast cancer
- Prostate cancer
- Endometrial cancer
- Uterine cancer
🇨🇦 Approved in Canada as Hormone Therapy for:
- Breast cancer
- Prostate cancer
- Endometrial cancer
🇯🇵 Approved in Japan as Hormone Therapy for:
- Breast cancer
- Prostate cancer
🇦🇺 Approved in Australia as Hormone Therapy for:
- Breast cancer
- Prostate cancer
- Endometrial cancer
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Comprehensive Cancer Center of Wake Forest UniversityWinston-Salem, NC
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Wexner Medical CenterColumbus, OH
Fletcher Allen Health Care-Medical CenterBurlington, VT
Ohio State University Comprehensive Cancer CenterColumbus, OH
More Trial Locations
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Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
Alliance for Clinical Trials in OncologyCollaborator
References
Improving compliance and persistence to adjuvant tamoxifen and aromatase inhibitor therapy. [2022]Better compliance and persistence with therapy are associated with improved patient outcomes. As more and more patients survive breast cancer, compliance with adjuvant therapy becomes increasingly important. In clinical trials, compliance with adjuvant endocrine therapy among women with breast cancer is usually high. Retrospective analyses of databases and medical records from clinical practice, insurance databases of prescription refills, and survey data show a significant decrease in persistence after 12 months of therapy. With ongoing therapy, a further decline in persistence of up to 50% has been reported. A consistent methodology is needed to measure patient behavior and identify patients who are not adhering to therapy. Promising strategies for enhancing adherence to treatment in clinical practice include improving access to health care, increasing patient satisfaction, managing side effects, patient education, and better communication between the patient and health care provider. Positive relationships between patients and their health care providers, and frequent monitoring and feedback, may be most effective. While the lack of conformity across studies in measuring makes cross-study comparisons difficult, this review evaluates the available data regarding compliance and persistence with adjuvant endocrine therapies for breast cancer (tamoxifen and aromatase inhibitors) and presents strategies for improving adherence.
Identification of subgroups of early breast cancer patients at high risk of nonadherence to adjuvant hormone therapy: results of an Italian survey. [2015]Adherence to adjuvant endocrine therapy (HT) is suboptimal among breast cancer patients. A high rate of nonadherence might explain differences in survival between clinical trial and clinical practice. Tailored interventions aimed at improving adherence can only be implemented if subgroups of patients at higher risk of poor adherence are identified. Because no data are available for Italy, we undertook a large survey on adherence among women taking adjuvant HT for breast cancer.
Interventions to improve endocrine therapy adherence in breast cancer survivors: what is the evidence? [2019]Endocrine therapy reduces the risk of breast cancer recurrences and mortality in hormone receptor-positive (HR+) breast cancer survivors. However, non-adherence to treatment remains a significant problem. The aim of this study was to review current literature and ongoing trials to identify interventions employed to improve adherence to adjuvant endocrine therapy (AET) in breast cancer survivors.
Good adherence to adjuvant endocrine therapy in early breast cancer - a population-based study based on the Swedish Prescribed Drug Register. [2018]Adjuvant endocrine therapy improves recurrence-free and overall survival in primary breast cancer. However, not all patients complete their planned treatment, mostly because of side-effects. The aim of this study was to examine the adherence to adjuvant endocrine therapy in a cohort of primary breast cancer patients in Region Jönköping County, Sweden, after 3 and 5 years.
Improving adherence to endocrine hormonal therapy among breast cancer patients: Study protocol for a randomized controlled trial. [2020]Adjuvant endocrine hormonal therapy (EHT) is highly effective and appropriate for nearly all breast cancer patients with hormone receptor-positive tumors, which represent 75% of all breast cancer diagnoses. Long-term use of EHT reduces recurrence rates and nearly halves the risk of death during the second decade after diagnosis. Despite the proven benefits, about 33% of women receiving EHT do not take their medication as prescribed. This causes an increase in the risk for recurrence and death. To promote adherence to EHT among breast cancer patients, this study will develop and pilot-test an intervention consisting of 1) a bilingual, culturally tailored, personalized, interactive smartphone application (app); and 2) support from a patient navigator. The control group will receive usual care. This 2-group randomized control trial will recruit 120 breast cancer patients receiving EHT at the Mays Cancer Center at UT Health San Antonio. The two-year study will have 3-time assessments (baseline, 3 and 6 months). This theory-based intervention will empower patients' self-monitoring and management. It will facilitate patient education, identification/reporting of side effects, delivery of self-care advice, and simplify communication between the patient and the oncology team. The ultimate goal of this innovative multi-communication intervention is to improve overall survival and life expectancy, enhance quality of life, reduce recurrence, and decrease healthcare cost. The anticipated outcome is a scalable, evidence-based, and easily disseminated intervention with potentially broad use to patients using EHT and other oral anticancer agents.
Study protocol for a randomised controlled feasibility trial of a virtual intervention (STRIDE) for symptom management, distress and adherence to adjuvant endocrine therapy after breast cancer. [2021]Patient adherence to adjuvant endocrine therapy (AET) after a diagnosis of hormone-sensitive breast cancer is poor. Previous interventions have failed to produce changes in adherence, address patient preferences or include theoretically informed and evidence-based components. Therefore, we iteratively developed a patient-centred, evidence-based, small-group, videoconference intervention to improve adherence and symptom management as well as reduce distress for patients taking AET after breast cancer (Symptom-Targeted Randomised Intervention for Distress and Adherence to Adjuvant Endocrine Therapy, STRIDE).
Traditional Korean medicine treatment for tamoxifen associated adverse events of breast cancer patient: A CARE - Compliant case report. [2021]Adverse events of endocrine therapy reduce the breast cancer patient's quality of life and adversely affect treatment compliance.
A telehealth intervention for symptom management, distress, and adherence to adjuvant endocrine therapy: A randomized controlled trial. [2023]Patients taking adjuvant endocrine therapy (AET) after breast cancer face adherence challenges and symptom-related distress. We conducted a randomized trial to evaluate the feasibility, acceptability, and preliminary efficacy of a telehealth intervention (Symptom-Targeted Randomized Intervention for Distress and Adherence to Adjuvant Endocrine Therapy [STRIDE]) for patients taking AET.
Adherence to Adjuvant Endocrine Therapy in Breast Cancer Patients. [2023]Adjuvant endocrine therapy (AET) reduces breast cancer recurrence and mortality of women with hormone-receptor-positive tumors, but poor adherence remains a significant problem. The aim of this study was to analyze AET side effects and their impact on adherence to treatment.
Optimization of an Information Leaflet to Influence Medication Beliefs in Women With Breast Cancer: A Randomized Factorial Experiment. [2023]Adherence to adjuvant endocrine therapy (AET) is low in women with breast cancer. Negative beliefs about the necessity of AET and high concerns are barriers to adherence.
Assessing Adherence to Adjuvant Hormone Therapy in Breast Cancer Patients in Routine Clinical Practice. [2023]Adjuvant hormone therapy (HT) in patients with hormone receptor-positive breast cancer (BC) increases overall survival (OS). A lack of adherence to adjuvant endocrine therapy is common, 31.0-73.0% of women discontinue endocrine treatment before 5 years. The aim of the study was to assess adherence to HT in routine clinical practice in patients assisted at the Clinical Oncology Department of the Hospital de Clinicas - Universidad de la Republica, Uruguay.