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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05977062
Other study ID # 2021-A01891-40
Secondary ID 2021/3317
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 25, 2022
Est. completion date October 13, 2024

Study information

Verified date July 2023
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Determine who can benefit from additional follow-up by a professional and what type of help is most appropriate (need and expectation of patients in terms of support by a health professional)


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 322
Est. completion date October 13, 2024
Est. primary completion date October 13, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults patients, - With a diagnosis of localized or metastatic cancer, - During or after their treatment, - In one of the following three cancer centres: Gustave Roussy (Villejuif), Montpellier Cancer Institute (Montpellier), and Léon Bérard Center (Lyon) - With a significative score on the self-screening Insomnia Severity Index score (ISI = 8) - Able to readily read and understand French, - Able to use informatic tools confidently and with Internet access, - Who have signed the online consent form, - Affiliated to a social security system or beneficiary of the same. Exclusion Criteria: - Patient with a visual, hearing or cognitive disability that is incompatible with the study, - Simultaneous participation in another study evaluating a treatment of insomnia, - Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Self screening
Score ISI (Index de Sévérité de l'Insomnie)
Phone call
Phone call at the beginning of the program and at the middle and at the end.
Online questionnaires
To be completed at week 1, 6, 12 and 24.

Locations

Country Name City State
France Centre Léon Bérard Lyon
France Institut de Cancérologie de Montpellier Montpellier
France Gustave Roussy Villejuif

Sponsors (1)

Lead Sponsor Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evolution of the ISI score The primary outcome is to evaluate the evolution of the ISI score of patients with score > 8.
ISI = Index de Sévérité de l'Insomnie. Score > 8 means the patient has insomnia issue.
until 24 weeks after enrolment
Primary Patient insomnia perception Two ad-hoc items will be proposed to the participants to determine if insomnia is considered as a problem for them (outcome perception), and as a problem important to solve (outcome expectancy). until 24 weeks after enrolment
Primary Adherence to the intervention The frequency and the evolution of connections (A/globally, namely total number of connections per week and during all the intervention; B/potential differences in the frequency of connections throughout the weeks);
the type and proportion of components effectively consulted (videos, modules, and tools);
the duration of the use of the study web platform (total number of weeks).
until 24 weeks after enrolment
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