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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.
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 :
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.
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 :
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:
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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caregivers | Experimental | Therapeutic Education and Needs Assessment Program for Caregivers of Patients with Multiple Myeloma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic Education and Needs Assessment Program for Caregivers | Other | Participation in a weekly therapeutic education group for 4 weeks. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Caregiver :
Exclusion Criteria:
Caregiver :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne LE BORGNE, Mrs | Contact | 01 84 82 83 15 | + 33 | anne.le-borgne@aphp.fr |
| Laurent Dr GARDERET, MD | Contact | 01 42 16 27 94 | + 33 | laurent.garderet@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Anne LE BORGNE, Mrs | Hospital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hématologie clinique - Pitié-Salpêtrière Hospital (APHP) | Paris | 75013 | France |
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.
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D017028 | Caregivers |
| ID | Term |
|---|---|
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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Caregivers of patients followed for multiple myeloma during first-line therapy
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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 |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |