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

NCT05977062 | Unknown

• 2 other identifiers: 2021-A01891-402021/3317
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 3

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)

Conditions

Cancer; Insomnia

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Coaching arm

OTHER

Other: Self screening; Other: Phone call; Other: Online questionnaires

Interventions

Self screening OTHER

Score ISI (Index de Sévérité de l'Insomnie)

Coaching arm

Phone call OTHER

Phone call at the beginning of the program and at the middle and at the end.

Coaching arm

Online questionnaires OTHER

To be completed at week 1, 6, 12 and 24.

Coaching arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (3)

Centre Léon Bérard

Lyon, 69008, France

Location

Institut de Cancérologie de Montpellier

Montpellier, 34090, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Neoplasms; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Diane BOINON, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: August 4, 2023
• Study Start: February 25, 2022
• Primary Completion: October 13, 2023
• Study Completion: October 13, 2024
• Last Updated: August 4, 2023

Record last verified: 2023-07

Locations

FR (3)