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

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Early oncological supportive care
Delayed oncological supportive care
Sponsored by
Centre Henri Becquerel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Myeloma focused on measuring supportive care, multiple myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre Henri BecquerelRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Early oncological supportive care

Delayed oncological supportive care

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Qualitative evaluation of quality of life
Semi-structured individual interviews
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
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
Comparison of autonomy evolution in outpatients with multiple myeloma between the two groups
Comparison of the score of Instrument Activities of daily Living questionnary

Full Information

First Posted
April 26, 2022
Last Updated
December 22, 2022
Sponsor
Centre Henri Becquerel
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1. Study Identification

Unique Protocol Identification Number
NCT05355987
Brief Title
Impact of Paramedical Consultations in Oncological Supportive Care in Outpatients With Multiple Myeloma
Acronym
SOSAM
Official Title
Impact of Point in Time of Introducing Paramedical Consultations in Oncological Supportive Care in Outpatients With Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2022 (Actual)
Primary Completion Date
October 29, 2024 (Anticipated)
Study Completion Date
March 29, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Henri Becquerel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
supportive care, multiple myeloma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early oncological supportive care
Arm Type
Experimental
Arm 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
Arm Title
Delayed oncological supportive care
Arm Type
Other
Arm 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
Intervention Type
Other
Intervention Name(s)
Early oncological supportive care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Delayed oncological supportive care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of quality of life evolution in outpatients with multiple myeloma between the two groups
Description
Comparison of the score obtained with Functional Assessment of Cancer Therapy- Multiple Myeloma questionnary
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Qualitative evaluation of quality of life
Description
Semi-structured individual interviews
Time Frame
6 months
Title
Comparison of quality of life in outpatients with multiple myeloma between the two groups
Description
Comparison of the score obtained with Functional Assessment of Cancer Therapy- Multiple Myeloma questionnary
Time Frame
3 months
Title
Comparison of quality of life in outpatients with multiple myeloma between the two groups
Description
Comparison of the score obtained with Functional Assessment of Cancer Therapy- Multiple Myeloma questionnary
Time Frame
9 months
Title
Comparison of autonomy evolution in outpatients with multiple myeloma between the two groups
Description
Comparison of the score of Instrument Activities of daily Living questionnary
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amel Benchemam
Phone
+332 32 08 29 20
Email
amel.benchemam@chb.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Doriane Richard, PhD
Phone
+33232082985
Email
doriane.richard@chb.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amel Benchemam
Organizational Affiliation
Centre Henri Becquerel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amel Benchemam
Phone
+33232082920
Email
amel.benchemam@chb.unicancer.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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