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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

322 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-25

Study Completion Date

2024-10-13

Brief Summary

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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)

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Detailed Description

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Conditions

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Cancer Insomnia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Coaching arm

Group Type OTHER

Self screening

Intervention Type OTHER

Score ISI (Index de Sévérité de l'Insomnie)

Phone call

Intervention Type OTHER

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

Online questionnaires

Intervention Type OTHER

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

Interventions

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Self screening

Score ISI (Index de Sévérité de l'Insomnie)

Intervention Type OTHER

Phone call

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

Intervention Type OTHER

Online questionnaires

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No