Caregivers of Patients With Multiple MyelomaENTRAIDANTNCT07276230
Quality of Life Assessment of Caregivers of Patients With Multiple Myeloma
A study testing Therapeutic Education and Needs Assessment Program for Caregivers in people with Caregivers of Patients With Multiple Myeloma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregivers of Patients With Multiple Myeloma
- What is being tested?
- Therapeutic Education and Needs Assessment Program for Caregivers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2026to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hématologie clinique - Pitié-Salpêtrière Hospital (APHP)
Paris, 75013
Anne LE BORGNE, Mrs, 01 84 82 83 15 ext. + 33, anne.le-borgne@aphp.fr
Laurent Dr GARDERET, MD, 01 42 16 27 94 ext. + 33, laurent.garderet@aphp.fr
About this study
Official title: 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.
Read the 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 :
- 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 :
- Acquisition of knowledge;
- Acquisition or reinforcement of self-care and coping skills, while recognizing and valuing the caregiver's own self learning efforts.
- 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
- 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).
- Being tested
- Therapeutic Education and Needs Assessment Program for Caregivers
- Keywords
- caregivers, multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Education and Needs Assessment Program for CaregiversOther
Participation in a weekly therapeutic education group for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Caregivers | Experimental | Therapeutic Education and Needs Assessment Program for Caregivers of Patients with Multiple Myeloma Receives: Other: Therapeutic Education and Needs Assessment Program for Caregivers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (4)
Caregivers' adherence to the therapeutic education program for caregivers of patients with multiple myeloma
Proportion of caregivers who completed the entire therapeutic education program
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Feb 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregivers of Patients With Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Caregivers of patients followed for multiple myeloma during first-line therapy
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne LE BORGNE, Mrs, Principal investigator, Hospital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276230
- Sponsor's protocol ID
- APHP250083
- Acronym
- ENTRAIDANT
- Status last verified
- Nov 2025
- First submitted
- 28 Nov 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Assessment of Caregivers of Patients With Multiple Myeloma Participating in a Therapeutic Education Program and Receiving a Supportive Care Needs Evaluation
- ClinicalTrials.gov ID
- NCT07276230
- Acronym / sponsor ID
- ENTRAIDANT / APHP250083
- Keywords
- caregivers, multiple myeloma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- 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 :
- Acquisition of knowledge;
- Acquisition or reinforcement of self-care and coping skills, while recognizing and valuing the caregiver's own self learning efforts.
- 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
- 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Caregivers of patients followed for multiple myeloma during first-line therapy
| Arm | Type | Receives |
|---|---|---|
| Caregivers | Experimental | Other: Therapeutic Education and Needs Assessment Program for CaregiversTherapeutic Education and Needs Assessment Program for Caregivers of Patients with Multiple Myeloma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Education and Needs Assessment Program for CaregiversParticipation in a weekly therapeutic education group for 4 weeks. | Other | Caregivers |
Primary outcome
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.
Time frame: 3 months
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.
4 secondary outcomes
Caregivers' adherence to the therapeutic education program for caregivers of patients with multiple myeloma
Time frame: 3 months
Changes in caregivers' specific skills after participation in the program (self-care and coping skills)
Time frame: 6 months
Caregivers' satisfaction with participation in the workshops
Time frame: 2 weeks
The long-term effectiveness of this approach on caregivers' quality of life.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Caregivers of Patients With Multiple Myeloma
RecruitingObservational study
Factors Associated With Health-related Quality of Life and Social Participation of Patients With Multiple Myeloma and Their Caregivers
Multiple Myeloma (MM), Hematologic Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne LE BORGNE, Mrs principal investigator
Hospital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Education and Needs Assessment Program for Caregivers in people with Caregivers of Patients With Multiple Myeloma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne LE BORGNE, Mrs (01 84 82 83 15 ext. + 33, anne.le-borgne@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.