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Optimization of an Online Stepwise Therapeutic Device Based on a Cognitive-behavioral Approach for Cancer Patients With Insomnia (Sleep-4-All-2)

Primary Purpose

Cancer, Insomnia

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Self screening
Phone call
Online questionnaires
Sponsored by
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer

Eligibility Criteria

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

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.

Sites / Locations

  • Centre Léon Bérard
  • Institut de Cancérologie de Montpellier
  • Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Coaching arm

Arm Description

Outcomes

Primary Outcome Measures

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.
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).
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).

Secondary Outcome Measures

Full Information

First Posted
May 24, 2023
Last Updated
July 27, 2023
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05977062
Brief Title
Optimization of an Online Stepwise Therapeutic Device Based on a Cognitive-behavioral Approach for Cancer Patients With Insomnia
Acronym
Sleep-4-All-2
Official Title
Sleep-4-all-2.0 Study: Optimization of an Online Stepwise Therapeutic Device Based on a Cognitive-behavioral Approach for Cancer Patients With Insomnia - A Prospective Real-life Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 25, 2022 (Actual)
Primary Completion Date
October 13, 2023 (Anticipated)
Study Completion Date
October 13, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris

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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Insomnia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
322 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coaching arm
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Self screening
Intervention Description
Score ISI (Index de Sévérité de l'Insomnie)
Intervention Type
Other
Intervention Name(s)
Phone call
Intervention Description
Phone call at the beginning of the program and at the middle and at the end.
Intervention Type
Other
Intervention Name(s)
Online questionnaires
Intervention Description
To be completed at week 1, 6, 12 and 24.
Primary Outcome Measure Information:
Title
Evolution of the ISI score
Description
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.
Time Frame
until 24 weeks after enrolment
Title
Patient insomnia perception
Description
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).
Time Frame
until 24 weeks after enrolment
Title
Adherence to the intervention
Description
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).
Time Frame
until 24 weeks after enrolment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane BOINON, MD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Institut de Cancérologie de Montpellier
City
Montpellier
ZIP/Postal Code
34090
Country
France
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

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Optimization of an Online Stepwise Therapeutic Device Based on a Cognitive-behavioral Approach for Cancer Patients With Insomnia

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