Skip to main content
OpenTrials
Completed

NCT Number: NCT05355987

Impact of 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Henri Becquerel

Rouen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early oncological supportive care

Other

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.

Delayed oncological supportive care

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Qualitative evaluation of quality of life

    Time frame: 6 months

    Semi-structured individual interviews

  2. 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. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Registry information

Official study title

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

Acronym: SOSAM

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 2, 2022
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.