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CompletedNCT05355987SOSAMUpdated Jan 2, 2026

Impact of Paramedical Consultations in Oncological Supportive Care in Outpatients With Multiple Myeloma

An interventional study of Early oncological supportive care and Delayed oncological supportive care in Multiple Myeloma, sponsored by Centre Henri Becquerel. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-02.

Sponsored by Centre Henri Becquerel · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Multiple myeloma is the second most frequent hematologic malignancy, which incidence augmented between 1995 and 2018, with an annual mean variation of +0.6% to 1.1%. Although treatment improved in the last years, the patients' prognostic is associated with cytogenetic abnormalities.

Oncological supportive care provides patients with a global perspective, in addition to specific medical treatment adapted to pathology and patient profile. It contributes to the improvement of quality of life of patients, throughout their care pathway regarding physical, psychological and social aspects, according to their specific needs as well as their caregivers'.

The aim of this study is to evaluate the quality of life at 6 months after multiple myeloma diagnosis in outpatients receiving paramedical consultations in oncological supportive care from the diagnosis versus outpatients receiving paramedical consultations in oncological supportive care after 6 months after diagnosis.

02

Conditions studied

  • Multiple Myeloma

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Keywords

  • supportive care
  • multiple myeloma
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 20 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Centre Henri Becquerel is the lead sponsor of 57 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Age superior to 18 years old
  • Patient recently diagnosed with multiple myeloma not eligible to autologous blood stem-cell transplantation, before starting therapy in day hospital
  • Patient coming regularly to Centre Henri Becquerel for treatment and follow up for multiple myeloma
  • Informed consent form signed

Exclusion Criteria:

  • Inclusion Criteria:
  • Age superior to 18 years old
  • Patient recently diagnosed with multiple myeloma not eligible to autologous blood stem-cell transplantation, before starting therapy in day hospital
  • Patient coming regularly to Centre Henri Becquerel for treatment and follow up for multiple myeloma
  • Informed consent form signed

Exclusion Criteria:

  • Patient with urgent need of treatment after multiple myeloma diagnosis with urgent and absolute need of oncological supportive care immediately after diagnosis
  • Patient deprived of liberty, under judicial supervision, under guardianship or trusteeship
  • History of psychological or sensorial disorder or anomaly that can prevent the patient from understanding the conditions for study participation
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Early oncological supportive care

    Evaluation of needs in oncological supportive care by a nursing coordinator from diagnosis and recommendation to plan appointments with different specialists in supportive care regarding to patient's needs

    Other: Early oncological supportive care

  • Other
    Delayed oncological supportive care

    Evaluation of needs in oncological supportive care by a nursing coordinator at 6 months after diagnosis and recommendation to plan appointments with different specialists in supportive care regarding to patient's needs

    Other: Delayed oncological supportive care

Interventions

  • OtherEarly oncological supportive care

    Several appointments (at diagnosis, 3 months, 6 months and 9 months) with nursing coordinator to define the needs in oncological supportive care. Different appointments will be planned according to patient's needs, with several possibilities: oncological supportive care nurse, social worker, psychologist, physiotherapist, adapted physical activity, medication reconciliation, oncologic geriatric medicine, dietician, nutritionist, smoking cessation advisor, sexologist, sophrologist, pain management nursing and palliative care, socio-aesthetician and religious cult coordinator.

  • OtherDelayed oncological supportive care

    Two appointments (6 months and 9 months) with nursing coordinator to define the needs in oncological supportive care. Different appointments will be planned according to patient's needs, with several possibilities: oncological supportive care nurse, social worker, psychologist, physiotherapist, adapted physical activity, medication reconciliation, oncologic geriatric medicine, dietician, nutritionist, smoking cessation advisor, sexologist, sophrologist, pain management nursing and palliative care, socio-aesthetician and religious cult coordinator.

06

What researchers measure

Primary outcomes

  1. Comparison of quality of life evolution in outpatients with multiple myeloma between the two groups

    Comparison of the score obtained with Functional Assessment of Cancer Therapy- Multiple Myeloma questionnary

    Time frame: 6 months

Secondary outcomes

  1. Qualitative evaluation of quality of life

    Semi-structured individual interviews

    Time frame: 6 months

  2. Comparison of quality of life in outpatients with multiple myeloma between the two groups

    Comparison of the score obtained with Functional Assessment of Cancer Therapy- Multiple Myeloma questionnary

    Time frame: 3 months

  3. Comparison of quality of life in outpatients with multiple myeloma between the two groups

    Comparison of the score obtained with Functional Assessment of Cancer Therapy- Multiple Myeloma questionnary

    Time frame: 9 months

  4. Comparison of autonomy evolution in outpatients with multiple myeloma between the two groups

    Comparison of the score of Instrument Activities of daily Living questionnary

    Time frame: 6 months

07

Study locations

1 site
  • Centre Henri Becquerel
    Rouen, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05355987
Lead sponsor
Centre Henri Becquerel
Responsible party
Sponsor
First posted
May 2, 2022
Start date
Jun 3, 2022
Primary completion
Jun 2, 2025
Completion
Jun 26, 2025
Last update
Jan 2, 2026

Study contacts

Amel Benchemam
principal investigator · Centre Henri Becquerel

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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