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

Centre Henri Becquerel

Status: Completed

Conditions: Multiple Myeloma

Treatments: Other: Early oncological supportive care; Other: Delayed oncological supportive care

Study type: Interventional

Funder types: Other

Identifiers

NCT05355987

CHB21.01

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Early oncological supportive care

Experimental group

Description:

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

Treatment:

Other: Early oncological supportive care

Delayed oncological supportive care

Other group

Description:

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

Treatment:

Other: Delayed oncological supportive care