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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05355987
Acronym
SOSAM
Enrollment
20
Registered
2022-05-02
Start date
2022-06-03
Completion date
2025-06-26
Last updated
2026-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

supportive care, multiple myeloma

Brief 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.

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.

Sponsors

Centre Henri Becquerel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of quality of life evolution in outpatients with multiple myeloma between the two groups6 monthsComparison of the score obtained with Functional Assessment of Cancer Therapy- Multiple Myeloma questionnary

Secondary

MeasureTime frameDescription
Qualitative evaluation of quality of life6 monthsSemi-structured individual interviews
Comparison of quality of life in outpatients with multiple myeloma between the two groups3 monthsComparison of the score obtained with Functional Assessment of Cancer Therapy- Multiple Myeloma questionnary
Comparison of autonomy evolution in outpatients with multiple myeloma between the two groups6 monthsComparison of the score of Instrument Activities of daily Living questionnary

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026