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

NCT05355987 | Completed

• 1 other identifier: CHB21.01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

supportive care; multiple myeloma

Outcome Measures

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

  6 months

Secondary Outcomes (4)

• Qualitative evaluation of quality of life

  6 months

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

  3 months

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

  9 months

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

  6 months

Study Arms (2)

Early oncological supportive care

EXPERIMENTAL

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

Delayed oncological supportive care

OTHER

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

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.

Delayed oncological supportive care

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.

Early oncological supportive care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Centre Henri Becquerel: lead

Study Sites (1)

Centre Henri Becquerel

Rouen, France

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

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

Study Officials

• Amel Benchemam

  Centre Henri Becquerel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 2, 2022
• Study Start: June 3, 2022
• Primary Completion: June 2, 2025
• Study Completion: June 26, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)