Evaluating the Dose Timing (Morning vs Evening) of Endocrine Therapy and Its Effects on Tolerability and Compliance
Study Details
Study Description
Brief Summary
Endocrine therapy is an established treatment for hormone receptor-positive breast cancer, but can cause significant side effects with deterioration in quality of life. The side effects of all forms of endocrine therapy are well recognized and can lead to treatment non-persistence or non-compliance. Chronotherapy, also called chronotherapeutics, is defined as the administration of a medication in coordination with circadian rhythm in order to minimize side effects and yield a greater efficacy. The investigators propose to perform a pragmatic, multi-centre, open-label, randomized clinical trial to establish the optimal timing (morning vs. evening) of administering endocrine therapy based on side effects and benefits in early stage breast cancer patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Endocrine therapy is an established treatment for hormone receptor-positive breast cancer, but can cause significant side effects with deterioration in quality of life. The side effects of all forms of endocrine therapy are well recognized and can lead to treatment non-persistence or non-compliance. Compliance is defined as the degree or extent of conformity to the recommended administration by the provider, whereas persistence refers to the act of continuing treatment for a certain prescribed duration. Treatment adherence is especially important in breast cancer, as early cessation or reduced compliance to hormonal therapy are associated with reduced disease-free survival and increased mortality. Chronotherapy, also called chronotherapeutics, is defined as the administration of a medication in coordination with circadian rhythm in order to minimize side effects and yield a greater efficacy. The investigators propose to perform a pragmatic, multi-centre, open-label, randomized clinical trial to establish the optimal timing (morning vs. evening) of administering endocrine therapy based on side effects and benefits in early stage breast cancer patients.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Morning administration of endocrine therapy Administration of endocrine therapy defined as, within one hour of the patient wake up time |
Other: Morning administration of endocrine therapy
Endocrine therapy administered within one hour of patient wake up time
|
| Active Comparator: Evening administration of endocrine therapy Administration of endocrine therapy defined as, within one hour of the patient bed time |
Other: Evening administration of endocrine therapy
Endocrine therapy administered within one hour of the patient bed time
|
Outcome Measures
Primary Outcome Measures
- Endocrine toxicity and tolerability at 12 weeks [12 weeks after treatment initiation]
Measured by the change in total Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) questionnaire from baseline to 12 weeks following the beginning of endocrine therapy. FACT-ES is a validated sub scale of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system. FACT-ES consists of 46 items on a 5 point Likert type scale ranging from 0 (not at all) to 4 (very much). It is designed to measure five domains of health related quality of life in breast cancer patients receiving endocrine therapy: physical, social, emotional, functional well-being as well as an endocrine symptom sub-scale (ESS).
Secondary Outcome Measures
- Endocrine toxicity and tolerability [Baseline, 4, 8, 12 and 52 weeks after treatment initiation]
Measured by the change in total score and individual Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) questionnaires from baseline to 4, 8, 12 and 52 weeks following the beginning of endocrine therapy. FACT-ES consists of 46 items on a 5 point Likert type scale ranging from 0 (not at all) to 4 (very much). It is designed to measure five domains of health related quality of life in breast cancer patients receiving endocrine therapy: physical, social, emotional, functional well-being as well as an endocrine symptom sub-scale (ESS).
- Health related quality of life scores [Baseline, 4, 8, 12 and 52 weeks after treatment initiation]
Measured by the change in the total score and individual sub scales of the validated Functional Assessment of Cancer Therapy for patients with Breast cancer (FACT-B) questionnaire from baseline to 4, 8, 12 and 52 weeks following the beginning of endocrine therapy. The FACT-B consists of 37 items on a 5 point Likert type scale ranging from 0 (not at all) to 4 (very much). It is designed to measure five domains of health related quality of life in breast cancer patients: physical, social, emotional, functional well-being as well as a breast-cancer sub-scale (BCS).
- Endocrine therapy rates of non-compliance [52 weeks after treatment initiation]
Rates of non-persistence or non-compliance with initially prescribed endocrine therapy
- Cost-effectiveness [52 weeks after treatment initiation]
Incremental cost-effectiveness rations (cost per one quality-adjusted life year (QALY) gained).
Other Outcome Measures
- Rates of non-compliance to endocrine therapy [52 weeks after treatment initiation]
Comparing rates of non-compliance and non-persistence to endocrine therapy with patient age, turmour stage, chemotherapy use and type of endocrine therapy. The rates of non-compliance and rates of non-persistence will be tracked throughout the duration of the study and then compared to patient age, tumour stage, chemotherapy use and the type of endocrine therapy used.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with an early stage or locally advanced hormonal receptor positive breast cancer
-
Plan to receive endocrine therapy
-
18 years of age or older
-
Able to provide oral consent
-
Willing and able to complete questionnaires as per study protocol
Exclusion Criteria:
-
Metastatic cancer
-
Previous endocrine therapy for breast cancer
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Ottawa Hospital Cancer Centre | Ottawa | Ontario | Canada | |
| 2 | Thunder Bay Regional Health Sciences Centre | Thunder Bay | Ontario | Canada | P7B 6V4 |
Sponsors and Collaborators
- Ottawa Hospital Research Institute
Investigators
- Principal Investigator: Marie-France Savard, MD, Ottawa Hospital Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- REaCT-CHRONO