Clinical trial · Interventional
Health-Related Quality of Life Coupled With Therapeutic Information on Compliance to Endocrine Therapy in Breast Cancer
Impact of Routine Assessment of Health-Related Quality of Life Coupled With Therapeutic Information on Compliance With Endocrine Therapy in Patients With Non-metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Only 59% of women with breast cancer (BC) treated with Endocrine Therapy (ET) remain compliant one year upon initial prescription, despite its proven effectiveness in reducing recurrence and improving survival. Health-related quality of life (HRQoL) in BC has been widely studied and the positive effects of its routine evaluation on the improvement of communication between patients and medical staff and survival have been highlighted. Recently, a link between HRQoL and compliance with ET has been suggested, which would suggest a potential role for HRQoL assessment in improving compliance with ET. With the advent of digital technologies, electronic collection of HRQoL on a tablet is now possible. Since compliance is a multidimensional phenomenon, a multifaceted intervention is necessary to improve it. Thus, the investigators hypothesize that systematic HRQoL assessment (using a tablet, prior to each consultation, with delivery of scores to clinicians) coupled with therapeutic information could have an impact on 12-month compliance with ET in patients with non-metastatic BC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Routine Assessment of HRQoL coupled with Therapeutic Information | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interventional arm
- description
- 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.
- interventionNames
- Other: Routine Assessment of HRQoL coupled with Therapeutic Information
- type
- NO_INTERVENTION
- label
- Control arm
- description
- Participants in the control arm will receive standard care. They will not undergo digital HRQoL collection, and therapeutic information workshops will not be proposed.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 18 and over * 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: * Participants who participate in another clinical trial where HRQoL is assessed * Women for whom HRQoL evaluation is not possible (cognitive disorders, psychiatric disorders, people who do not speak French, etc.). * Vulnerable participants (pregnant women, etc.)
References
Publications (38)
- BACKGROUNDHuiart L, Bardou VJ, Giorgi R. [The importance of adherence to oral therapies in the field of oncology: the example of breast cancer]. Bull Cancer. 2013 Oct;100(10):1007-15. doi: 10.1684/bdc.2013.1830. French. PMID 24113516
- BACKGROUNDAyres LR, Baldoni Ade O, Borges AP, Pereira LR. Adherence and discontinuation of oral hormonal therapy in patients with hormone receptor positive breast cancer. Int J Clin Pharm. 2014 Feb;36(1):45-54. doi: 10.1007/s11096-013-9833-5. Epub 2013 Aug 11. PMID 23934310
- BACKGROUNDHugtenburg JG, Timmers L, Elders PJ, Vervloet M, van Dijk L. Definitions, variants, and causes of nonadherence with medication: a challenge for tailored interventions. Patient Prefer Adherence. 2013 Jul 10;7:675-82. doi: 10.2147/PPA.S29549. Print 2013. PMID 23874088
- BACKGROUNDEgede LE, Gebregziabher M, Dismuke CE, Lynch CP, Axon RN, Zhao Y, Mauldin PD. Medication nonadherence in diabetes: longitudinal effects on costs and potential cost savings from improvement. Diabetes Care. 2012 Dec;35(12):2533-9. doi: 10.2337/dc12-0572. Epub 2012 Aug 21. PMID 22912429
- BACKGROUNDCheung WY, Lai EC, Ruan JY, Chang JT, Setoguchi S. Comparative adherence to oral hormonal agents in older women with breast cancer. Breast Cancer Res Treat. 2015 Jul;152(2):419-27. doi: 10.1007/s10549-015-3455-7. Epub 2015 Jun 13. PMID 26070268
- BACKGROUNDMurphy CC, Bartholomew LK, Carpentier MY, Bluethmann SM, Vernon SW. Adherence to adjuvant hormonal therapy among breast cancer survivors in clinical practice: a systematic review. Breast Cancer Res Treat. 2012 Jul;134(2):459-78. doi: 10.1007/s10549-012-2114-5. Epub 2012 Jun 12. PMID 22689091
- BACKGROUNDWeaver KE, Camacho F, Hwang W, Anderson R, Kimmick G. Adherence to adjuvant hormonal therapy and its relationship to breast cancer recurrence and survival among low-income women. Am J Clin Oncol. 2013 Apr;36(2):181-7. doi: 10.1097/COC.0b013e3182436ec1.