Breast Cancer Clinical Trial
— COMPLIANCEOfficial title:
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
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.
Status | Recruiting |
Enrollment | 342 |
Est. completion date | October 2025 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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.) |
Country | Name | City | State |
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France | Centre Georges François Leclerc | Dijon |
Lead Sponsor | Collaborator |
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Centre Georges Francois Leclerc |
France,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants compliant with endocrine therapy as assessed by Morisky Green Levine (MGL) scale | Compliance with endocrine therapy, will be evaluated using the Morisky Green Levine scale (MGL). It has a range of 0 to 4, where 0 is very low and 4 is highest. Patients are categorized according to three levels of adherence: high (score equal to 4), moderate (score equal to 2 or 3) and low (score equal to 0 or 1). Participants will be considered as compliant if they have a high adherence score in MGL scale. | 12 months after the onset of endocrine therapy | |
Secondary | Number of anxious and depress participants as assessed by Hospital Anxiety and Depression Scale (HADS) | HADS has 14 items rated from 0 to 3 and covers 2 dimensions. Seven questions related to the anxiety dimension and seven other related to the depressive dimension, yielding 2 scores, A (Anxiety) and D (Depression). The maximum score for each dimension is 21. A score of 11 or higher indicates the probable presence of the disorder. | at baseline and 12 months after the onset of endocrine therapy | |
Secondary | social support as assessed by Sarason's Social Support Questionnaire 6-item (SSQ6) | Social support is measured across 2 dimensions: support availability, through the number of contacts that the patient can count on (0 to 9 people) and quality of support, through patient satisfaction with support received. Each item represents a situation in which the patient may need support. Patient is asked to cite the number of people that she could count on in that particular situation. Concerning the second item, the patient is asked to assess satisfaction with the support provided. The scores are generated according to Sarason's recommendations. A score is calculated for each dimension. Support availability score is calculated as the sum of the number of people available for the 6 items, this score ranges from 0 to 54, with 54 representing the highest availability. The social support satisfaction score is calculated by the sum of the satisfaction of the 6 items. This score ranges from 6 to 36, with 36 representing the highest level of satisfaction |
at baseline and 12 months after the onset of endocrine therapy | |
Secondary | HRQoL data using Functional Assessment Cancer Therapy-General questionnaire (FACT-G) | HRQoL data using the Functional Assessment Cancer Therapy General (FACT-G) questionnaire will be assessed at inclusion in both arms to ensure comparability between groups and at 12 months, to assess the predictive value of HRQoL on compliance to endocrine therapy. The FACT-G instrument assesses 4 HRQoL domains: physical well-being (7 items); social and/or family well-being (7 items); emotional well-being (6 items); and functional well-being (7 items). Respondents use a 5-point Likert-type scale which rates the relevant domain from 0 (not at all) to 4 (very much). From these subscales a global score is obtained. The FACT-G total score vary from 0 to 108. The higher the score, the better the HRQoL. | at baseline and 12 months after the onset of endocrine therapy | |
Secondary | Patient satisfaction with care as assessed by European Organization Research and Treatment Cancer 33-item Satisfaction with cancer care core questionnaire (EORTC PATSAT-C33) and its module 7-item Outpatient Satisfaction with care (EORTC OUT-PATSAT-7) | The European Organization Research and Treatment Cancer 33-item Satisfaction with cancer care core (EORTC PATSAT-C33) questionnaire and its module 7-item Outpatient Satisfaction with care (EORTC OUT-PATSAT-7) assess perceptions of cancer patients regarding the quality of care received. The EORTC PATSAT-C33 includes 3 sections on the perceived quality of care provided by physicians, radiotherapy nurses/technicians and services/care organization. The first one includes 3 dimensions that address technical skills, quality and quantity of information exchanged and behavior. The second one has 2 dimensions: information provision and reactivity and affective behavior. The third one has 3 dimensions: coordination, interaction with the healthcare team and 5 single items. The module EORTC-OUT-PATSAT7 includes 2 dimensions dealing with convenience of care and transition and a single item on continuity of care. The score vary from 0 to 100. A higher score indicates higher level of satisfaction. | at baseline and 12 months after the onset of endocrine therapy | |
Secondary | Physician perception regarding the utility of systematic HRQoL evaluation as assessed by an ad-hoc questionnaire | Physician perception regarding the utility of systematic HRQoL evaluation will be assessed using an ad hoc questionnaire derived from the work of Velikova, including the perceived utility and satisfaction of routine assessment HRQoL, reasons for use/non-use and the intention to adopt this assessment in routine care. This questionnaire does not generate a score but give us information on the points mention above. | through study completion, an average of 3 years |
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