Quality of Life Assessment of Caregivers of Patients With Multiple Myeloma (ENTRAIDANT)

Quality of Life Assessment of Caregivers of Patients With Multiple Myeloma Participating in a Therapeutic Education Program and Receiving a Supportive Care Needs Evaluation

The diagnosis and treatment of multiple myeloma affect not only the patient but also their family and caregivers. Advances in therapy have transformed the follow-up of patients treated for multiple myeloma. The involvement of informal caregivers has become increasingly essential to ensure adequate home-based care, as most treatments are now delivered on an outpatient basis. Literature reviews suggest that caregivers of cancer patients often face unmet supportive care needs, which in turn negatively impact their quality of life.

Study Overview

• Status: Not yet recruiting
• Conditions: Caregivers of Patients With Multiple Myeloma
• Intervention / Treatment: Other: Therapeutic Education and Needs Assessment Program for Caregivers

Detailed Description

By improving the quality of life of caregivers, the intervention can help prevent cascading effects such as a deterioration in the quality of life of the care recipient, thereby reducing the overall burden on healthcare systems. In addition, therapeutic education is an ongoing process aimed at helping patients and/or caregivers acquire or maintain the skills they need to best manage their lives with a chronic condition.

Study procedures :

1. During the hematology consultation, the study will be presented to the caregiver identified by the patient (between Day -7 and Day 0). After receiving full oral and written information, the caregiver's free, written, and informed consent will be obtained prior to participation.

2. After providing written informed consent to participate in the study, the caregiver will attend an individual interview at Day 0 with a nurse to complete a Shared Educational Assessment .The caregiver will then independently complete a self-administered questionnaire assessing quality of life using the CarGOQoL (CareGiver Oncology Quality of Life).

   The Shared Educational Assessment is a discussion between the healthcare professional and the caregiver focusing on the skills to be acquired or strengthened in order to improve health and quality of life. It enables exploration and assessment of the caregiver's needs and resources in terms of :

   • Acquisition of knowledge;
   • Acquisition or reinforcement of self-care and coping skills, while recognizing and valuing the caregiver's own self learning efforts.

3. The group of caregivers thus constituted will attend four therapeutic education workshops. Each workshop will last approximately 1 hour and 30 minutes. Caregivers will attend two half-day sessions, participating in two workshops per session (Week 1: Workshops 1 & 2; Week 2: Workshops 3 & 4).

   The topics addressed in the workshops are as follows:

   • Workshop 1: Understanding the disease
   • Workshop 2: Identifying abnormalities in biological tests and adapting the appropriate response
   • Workshop 3: Understanding treatments and their adverse effects
   • Workshop 4: Expressing personal experiences and feelings caregivers' satisfaction with each workshop will be assessed at the end of every session
4. At the end of the program (three months after inclusion), the caregiver will attend a follow-up consultation with the nurse to evaluate skill acquisition and will independently complete the same quality of life questionnaire (CarGOQoL) that was administered prior to the program
5. At six months, a new assessment of quality of life will be conducted using the CarGOQoL questionnaire during a telephone interview with a member of the investigative team

The questionnaire will be available in paper format, and the responses will be entered into an electronic case report form (e-CRF) using the CleanWeb system. The data will be analyzed by the Clinical Research Unit (URC).

• Study Type: Interventional
• Enrollment (Estimated): 27
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne LE BORGNE, Mrs; Phone Number: + 33 01 84 82 83 15; Email: anne.le-borgne@aphp.fr
• Study Contact Backup: Name: Laurent Dr GARDERET, MD; Phone Number: + 33 01 42 16 27 94; Email: laurent.garderet@aphp.fr

Study Locations

• France
  • Paris, France, 75013
    • Hématologie clinique - Pitié-Salpêtrière Hospital (APHP)
    • Contact: Anne LE BORGNE, Mrs; Phone Number: + 33 01 84 82 83 15; Email: anne.le-borgne@aphp.fr
    • Contact: Laurent Dr GARDERET, MD; Phone Number: + 33 01 42 16 27 94; Email: laurent.garderet@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Caregiver :

• Designated by a patient followed for multiple myeloma during first-line treatment
• Providing weekly assistance to the patient (e.g., shopping, housekeeping, management of daily living activities, healthcare or hygiene support, etc.)
• Aged 18 years or older
• Fluent in French
• Affiliated with or benefiting from a social security system (excluding state medical aid - AME)
• Able to provide free, written, and informed consent

Exclusion Criteria:

Caregiver :

• Not designated by the patient as the primary caregiver
• Currently being treated for an acute medical condition
• Refusal of the caregiver to participate in the study
• Under legal protection (guardianship or curatorship)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Caregivers; Therapeutic Education and Needs Assessment Program for Caregivers of Patients with Multiple Myeloma	Other: Therapeutic Education and Needs Assessment Program for Caregivers; Participation in a weekly therapeutic education group for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of a needs assessment approach through participation in a therapeutic education program on improving the quality of life of caregivers of patients with multiple myeloma.	Change in caregivers' CarGOQoL (CareGiver Oncology Quality of Life) scores between baseline and 3 months. The higher the score, the better the quality of life.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregivers' adherence to the therapeutic education program for caregivers of patients with multiple myeloma	Proportion of caregivers who completed the entire therapeutic education program	3 months
Changes in caregivers' specific skills after participation in the program (self-care and coping skills)	Assessment of self-care and coping skills using a four-level competency acquisition scale: acquired, not acquired, introduced, and reinforcement session required	6 months
Caregivers' satisfaction with participation in the workshops	Caregivers' satisfaction measured using a Visual Analogue Scale (VAS) ranging from 1 to 10. The higher the score, the greater the satisfaction.	2 weeks
The long-term effectiveness of this approach on caregivers' quality of life.	Change in caregivers' CarGOQoL (CareGiver Oncology Quality of Life) scores between baseline and 6 months. The higher the score, the better the quality of life.	6 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Anne LE BORGNE, Mrs, Hospital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: November 28, 2025
• First Posted (Estimated): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: caregivers; multiple myeloma
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Health Care Facilities Workforce and Services; Health Personnel; Caregivers
• Other Study ID Numbers: APHP250083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

• IPD Sharing Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No