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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & 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:

  • -

    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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05355987
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centre Henri Becquerel
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Amel Benchemam
Principal Investigator Affiliation Centre Henri Becquerel
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Arms & Interventions

Arms

Experimental: Early oncological supportive care

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: Delayed oncological supportive care

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

Interventions

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.

Other: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Centre Henri Becquerel, Rouen, France

Status

Recruiting

Address

Centre Henri Becquerel

Rouen, ,

Site Contact

Amel Benchemam

amel.benchemam@chb.unicancer.fr

+33232082920