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

Study Overview
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Brief Summary
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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.

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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Other: Early oncological supportive care
* Other: Delayed oncological supportive care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early oncological supportive care<br>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<br>* 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.<br>|
| Other: Delayed oncological supportive care<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative evaluation of quality of life | Semi-structured individual interviews | 6 months | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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supportive care, multiple myeloma