Clinical trial NCT05355987: Impact of Paramedical Consultations in Oncological Supportive Care in Outpatients With Multiple Myeloma
Official title: Impact of Point in Time of Introducing Paramedical Consultations in Oncological Supportive Care in Outpatients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Myeloma
Keywords: supportive care
multiple myeloma
Lead sponsor: Centre Henri Becquerel
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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:

* 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

Primary outcomes:
measure: Comparison of quality of life evolution in outpatients with multiple myeloma between the two groups
timeFrame: 6 months
Secondary outcomes:
measure: Qualitative evaluation of quality of life
timeFrame: 6 months
measure: Comparison of quality of life in outpatients with multiple myeloma between the two groups
timeFrame: 3 months
measure: Comparison of quality of life in outpatients with multiple myeloma between the two groups
timeFrame: 9 months
measure: Comparison of autonomy evolution in outpatients with multiple myeloma between the two groups
timeFrame: 6 months
Other outcomes:
Locations:
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
affiliation: Centre Henri Becquerel
name: Amel Benchemam
role: PRINCIPAL_INVESTIGATOR
References: