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

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Caregivers of Patients With Multiple Myeloma

Treatments: Other: Therapeutic Education and Needs Assessment Program for Caregivers

Study type: Interventional

Funder types: Other

Identifiers

NCT07276230

APHP250083

Details and patient eligibility

About

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.

Full 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).

Enrollment: 27 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Caregivers

Experimental group

Description:

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

Treatment:

Other: Therapeutic Education and Needs Assessment Program for Caregivers