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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)

G

Gustave Roussy

Status

Active, not recruiting

Conditions

Insomnia
Cancer

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05977062
2021/3317 (Other Identifier)
2021-A01891-40

Details and patient eligibility

About

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)

Enrollment

322 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

322 participants in 1 patient group

Coaching arm
Other group
Treatment:
Other: Phone call
Other: Self screening
Other: Online questionnaires

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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