Health-Related Quality of Life Coupled With Therapeutic Information on Compliance to Endocrine Therapy in Breast Cancer

NCT04176809 | Unknown

• 1 other identifier: 2019-A01323-54
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer

Keywords

Health Related Quality of Life; Compliance; Endocrine Therapy; Therapeutic Information

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of anxious and depress participants as assessed by Hospital Anxiety and Depression Scale (HADS)

  at baseline and 12 months after the onset of endocrine therapy

• social support as assessed by Sarason's Social Support Questionnaire 6-item (SSQ6)

  at baseline and 12 months after the onset of endocrine therapy

• HRQoL data using Functional Assessment Cancer Therapy-General questionnaire (FACT-G)

  at baseline and 12 months after the onset of endocrine therapy

• 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)

  at baseline and 12 months after the onset of endocrine therapy

• Physician perception regarding the utility of systematic HRQoL evaluation as assessed by an ad-hoc questionnaire

  through study completion, an average of 3 years

Study Arms (2)

Interventional arm

EXPERIMENTAL

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.

Other: Routine Assessment of HRQoL coupled with Therapeutic Information

Control arm

NO INTERVENTION

Participants in the control arm will receive standard care. They will not undergo digital HRQoL collection, and therapeutic information workshops will not be proposed.

Interventions

Routine Assessment of HRQoL coupled with Therapeutic Information OTHER

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.

Interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (1)

Centre Georges François Leclerc

Dijon, France

RECRUITING

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  PMID: 32546198 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Patient Compliance

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Isabelle DESMOULINS, MD

  Georges François Leclerc Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandrine DABAKUYO, PhD, HDR

CONTACT

0345348067; sdabakuyo@cgfl.fr

Ariane MAMGUEM KAMGA, PhD

CONTACT

0345348069; amamguem@cgfl.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible patients who agree to participate will be randomized into two parallel arms (ratio 1:1) by the minimization technique with stratification by age, stage, presence or absence of comorbidities and type of endocrine therapy prescribed

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 25, 2019
• Study Start: May 14, 2021
• Primary Completion: April 1, 2025
• Study Completion: October 1, 2025
• Last Updated: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)