Quality of Life Assessment of Caregivers of Patients With Multiple Myeloma

NCT ID: NCT07276230

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2027-11-01

Brief Summary

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.

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).

Conditions

Caregivers of Patients With Multiple Myeloma

Keywords

caregivers; multiple myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Caregivers

Therapeutic Education and Needs Assessment Program for Caregivers of Patients with Multiple Myeloma

Group Type: EXPERIMENTAL

Therapeutic Education and Needs Assessment Program for Caregivers

Intervention Type: OTHER

Participation in a weekly therapeutic education group for 4 weeks.

Interventions

Therapeutic Education and Needs Assessment Program for Caregivers

Participation in a weekly therapeutic education group for 4 weeks.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne LE BORGNE, Mrs

Role: PRINCIPAL_INVESTIGATOR

Hospital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris

Locations

Hématologie clinique - Pitié-Salpêtrière Hospital (APHP)

Paris, , France

Countries

France

Central Contacts

Anne LE BORGNE, Mrs

Role: CONTACT

Phone: 01 84 82 83 15

Email: anne.le-borgne@aphp.fr

Laurent Dr GARDERET, MD

Role: CONTACT

Phone: 01 42 16 27 94

Email: laurent.garderet@aphp.fr

Facility Contacts

Anne LE BORGNE, Mrs

Role: primary

Laurent Dr GARDERET, MD

Role: backup

Other Identifiers

APHP250083

Identifier Type: -

Identifier Source: org_study_id