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Video-Based Cognitive Behavioral Therapy for Insomnia in Adults Cancer Patients and Survivors (SLEEP-4-ALL)

G

Gustave Roussy

Status

Completed

Conditions

Insomnia

Treatments

Other: Questionnaires

Study type

Interventional

Funder types

Other

Identifiers

NCT03981666
2018-A00260-55
2017/2659 (Other Identifier)

Details and patient eligibility

About

SLEEP-4-ALL-1 is a pilot and ecological study corresponding to the developpement phase of a randomized controlled multicentric trial SLEEP-4-ALL-2. The main objective of this second study will be the validation of a stepped-care model in the treatment of persistant insomnia in cancer patients.

The primary objective of SLEEP-4-ALL-1 is to determine the acceptability of a self-screening for insomnia in cancer outpatients at Gustave Roussy.

Enrollment

177 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Adults outpatients at Gustave Roussy,
  2. with a breast, colorectal, pulmonary or urological,
  3. localized or metastatic cancer,
  4. during or after their treatment,
  5. able to readily read and understand French,
  6. able to use informatic tools confidently and with Internet access at home,
  7. who have signed a written informed consent form prior to any study specific procedures,
  8. affiliated to a social security system or beneficiary of the same.

Exclusion criteria

  1. Age > 85 years old,
  2. patient receiving a cancer diagnostic during a consultation of announcement
  3. with a WHO index of 3 or 4
  4. severe cognitive impairements or psychiatric disorders which are incompatible with the conditions and the conduct of the study (understanding of the objectives, completion of the questionnaires)
  5. simultaneous participation in another study of the same type
  6. patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

177 participants in 1 patient group

Patients with insomnia
Experimental group
Description:
adult outpatients with a localized or metastatic breast, colorectal, pulmonary or urological cancer
Treatment:
Other: Questionnaires

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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