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

Multiple Myeloma Clinical Trial

— SOSAM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05355987
• Other study ID #: CHB21.01
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2022
• Est. completion date: March 29, 2025

Study information

• Verified date: April 2022
• Source: Centre Henri Becquerel
• Contact: Amel Benchemam
• Phone: +332 32 08 29 20
• Email: amel.benchemam[@]chb.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 29, 2025
• Est. primary completion date: October 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Centre Henri Becquerel	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Henri Becquerel

Country where clinical trial is conducted

France, 

Outcome

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