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

December 29, 2025 updated by: Centre Henri Becquerel

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France
        • Centre Henri Becquerel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of quality of life evolution in outpatients with multiple myeloma between the two groups
Time Frame: 6 months
Comparison of the score obtained with Functional Assessment of Cancer Therapy- Multiple Myeloma questionnary
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative evaluation of quality of life
Time Frame: 6 months
Semi-structured individual interviews
6 months
Comparison of quality of life in outpatients with multiple myeloma between the two groups
Time Frame: 3 months
Comparison of the score obtained with Functional Assessment of Cancer Therapy- Multiple Myeloma questionnary
3 months
Comparison of quality of life in outpatients with multiple myeloma between the two groups
Time Frame: 9 months
Comparison of the score obtained with Functional Assessment of Cancer Therapy- Multiple Myeloma questionnary
9 months
Comparison of autonomy evolution in outpatients with multiple myeloma between the two groups
Time Frame: 6 months
Comparison of the score of Instrument Activities of daily Living questionnary
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Henri Becquerel

Investigators

  • Principal Investigator: Amel Benchemam, Centre Henri Becquerel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2022

Primary Completion (Actual)

June 2, 2025

Study Completion (Actual)

June 26, 2025

Study Registration Dates

First Submitted

April 26, 2022

First Submitted That Met QC Criteria

April 29, 2022

First Posted (Actual)

May 2, 2022

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHB21.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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