Health-Related Quality of Life Coupled With Therapeutic Information on Compliance to Endocrine Therapy in Breast Cancer
NCT ID: NCT04176809
Last Updated: 2021-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
342 participants
INTERVENTIONAL
2021-05-14
2025-10-31
Brief Summary
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Detailed Description
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An analysis of missing HRQoL data profiles will also be performed. If a Missing Not At Random (MNAR) profile is demonstrated / suspected, multiple imputation of missing data can be performed in sensitivity analysis, taking into account the variables associated with the occurrence of missing data. As a sensitivity analysis, the investigators will performed a contamination-based intent-to-treat analysis to account for potential cross-contamination between the arms.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Interventional arm
The intervention will consist in an electronic measurement of HRQoL before each consultation with delivery scores to clinicians, who can discuss it with patients and coupled with therapeutic information. Patients will complete the EORTC-Quality of Life Questionnaire (QLQ)-C30 and the EORTC-QLQ-Breast (BR) 23 questionnaires using the CHES software before their consultation, via a touch pad or from their home via a secure web portal. Therapeutic information will consist on workshops on various themes. Only attendance Workshop 1 will be required, other workshops will be optional. The aim of workshop 1 is to inform patients about their ET and treatment benefits. Two additional optional workshops on nutrition (Workshop 2) and fatigue (Workshop 3) will be offered. This workshops will be collective. Every month, a letter encouraging patients to regularly take their medication will be sent. This letter will also include some tips on how to deal with some particular side effects of ET.
Routine Assessment of HRQoL coupled with Therapeutic Information
Participants will complete the EORTC-QLQ-C30 and EORTC-QLQ-BR23 questionnaires before their consultation via the CHES software. The scores will then be generated and provided to clinicians in a graphic form, describing scores course. Access to CHES web portal will also be open to participants outside consultation time points, to enable them to monitor HRQoL if necessary. Workshop 1, will help patients to recognize and react to the occurrence of possible adverse effects, and anticipate their occurrence through appropriate preventive means. In workshop 2, participants will have the opportunity to express their representations and experiences related to their diet and the consequences of disease and treatments on diet. In workshop 3, participants can describe their experiences of fatigue and how their life is affected by it. Moreover, they can identify possible causes and finally discuss solutions to better this symptom. Every month, a reminder letter will also be sent to participants.
Control arm
Participants in the control arm will receive standard care. They will not undergo digital HRQoL collection, and therapeutic information workshops will not be proposed.
No interventions assigned to this group
Interventions
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Routine Assessment of HRQoL coupled with Therapeutic Information
Participants will complete the EORTC-QLQ-C30 and EORTC-QLQ-BR23 questionnaires before their consultation via the CHES software. The scores will then be generated and provided to clinicians in a graphic form, describing scores course. Access to CHES web portal will also be open to participants outside consultation time points, to enable them to monitor HRQoL if necessary. Workshop 1, will help patients to recognize and react to the occurrence of possible adverse effects, and anticipate their occurrence through appropriate preventive means. In workshop 2, participants will have the opportunity to express their representations and experiences related to their diet and the consequences of disease and treatments on diet. In workshop 3, participants can describe their experiences of fatigue and how their life is affected by it. Moreover, they can identify possible causes and finally discuss solutions to better this symptom. Every month, a reminder letter will also be sent to participants.
Eligibility Criteria
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Inclusion Criteria
* With non-metastatic hormone receptor positive breast cancer
* Women will have to be at the end of primary treatment
* An indication for endocrine therapy treatment during 5 to 10 years
* be affiliated to a French social security scheme or beneficiary of such a scheme
* agreed to participate by signing a written consent
Exclusion Criteria
* Women for whom HRQoL evaluation is not possible (cognitive disorders, psychiatric disorders, people who do not speak French, etc.).
* Vulnerable participants (pregnant women, etc.)
18 Years
FEMALE
No
Sponsors
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Centre Georges Francois Leclerc
OTHER
Responsible Party
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Principal Investigators
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Isabelle DESMOULINS, MD
Role: PRINCIPAL_INVESTIGATOR
Georges François Leclerc Centre
Locations
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Centre Georges François Leclerc
Dijon, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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2019-A01323-54
Identifier Type: -
Identifier Source: org_study_id
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