Breast Cancer Clinical Trial
— REaCT-TEMPOOfficial title:
A Pragmatic Randomised, Trial Evaluating an Endocrine Therapy Dose-frequency Escalation Strategy and Its Effects on Tolerability and Compliance (REaCT-TEMPO)
The goal of this randomized, pragmatic clinical trial is to evaluate an endocrine therapy dose-frequency escalation strategy and its effects on tolerability and compliance. Participants will be randomized to standard daily dosing of endocrine therapy or endocrine therapy dose-frequency escalation defined as, taking endocrine therapy every other day for 1 month and then daily.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | July 2029 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with an early stage or locally advanced hormonal receptor positive breast cancer - Plan to receive endocrine therapy - Able to provide oral consent - Willing and able to complete questionnaires as per study protocol Exclusion Criteria: - Metastatic cancer - Adjuvant abemaciclib |
Country | Name | City | State |
---|---|---|---|
Canada | The Ottawa Hospital Cancer Centre | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 1-year adherence with prescribed endocrine therapy | 1-year adherence with prescribed endocrine therapy measured by the validated Five-item Medication Adherence Report Scale (MARS-5 score). The MARS-5 score can range from 5 to 25 indicating greater level of adherence. A participant will be considered adherent if they have a MARS-5 score of 23 and more (specificity and sensitivity maximized at this value). The adherence rate at 1-year will be calculated as the number of patients who are initially enrolled in the study. Participants who do not complete the 1-year MARS-5 questionnaire will be considered as non-adherent for the primary analysis of adherence rate. | 1 year after start of endocrine therapy | |
Secondary | Adherence rates with prescribed endocrine therapy | adherence with prescribed endocrine therapy measured by the validated Five-item Medication Adherence Report Scale (MARS-5 score). The MARS-5 score can range from 5 to 25 indicating greater level of adherence. A participant will be considered adherent if they have a MARS-5 score of 23 and more (specificity and sensitivity maximized at this value). | Through study completion, 5 years | |
Secondary | Persistence with prescribed endocrine therapy | Rates of persistence with prescribed endocrine therapy measured by a non-validated endocrine therapy adherence questionnaire. | Through study completion, 5 years | |
Secondary | Endocrine toxicity and tolerability | Endocrine toxicity and tolerability measured by the change in total score and individual items of the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) score, a validated subscale of the FACIT measurement system from baseline to 6 months, 1 year and 5 years following the beginning of endocrine therapy. The FACT-ES is a 46 item, 5 point Likert-type scale questionnaire that asks questions relating to physical well-being, social/family well-being, emotional well-being, functional well-being and the endocrine symptom subscale. | Through study completion, 5 years | |
Secondary | Patient health-related quality of life | Patient Health-Related Quality of Life (HR-QoL) measured by the change in the total score and individual subscales of the validated Functional Assessment of Cancer Therapy for patients with a Breast cancer (FACT-B) questionnaire from baseline to 6 months, 1 year and 5 years following the beginning of endocrine therapy. The FACT-B is a 37 item, 5 point Likert-type scale questionnaire that asks questions relating to physical well-being, social/family well-being, emotional well-being, functional well-being and the breast cancer subscale. | Through study completion, 5 years | |
Secondary | Endocrine therapy interruptions | Endocrine therapy interruption periods will be collected throughout study. An interruption is being defined as a pause in treatment for more than 7 days in a row. | Through study completion, 5 years | |
Secondary | Endocrine therapy discontinuations | Endocrine therapy discontinuation rates will be collected throughout study. Discontinuation means stopping of endocrine therapy and not continuing, even on a different type. | Through study completion, 5 years | |
Secondary | Endocrine therapy changes | Alterations made to endocrine therapy for toxicity. Meaning was there a change with the type of endocrine therapy used. | Through study completion, 5 years |
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