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出境医 / 临床实验 / Video-Based Cognitive Behavioral Therapy for Insomnia in Adults Cancer Patients and Survivors (SLEEP-4-ALL)

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

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Insomnia Other: Questionnaires Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 177 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Systematic Self-screening of Insomnia and Proposition of a Video-Based Cognitive Behavioral Therapy for Insomnia in Adults Cancer Patients and Survivors: A Pilot Study
Actual Study Start Date : May 4, 2018
Actual Primary Completion Date : June 29, 2018
Actual Study Completion Date : February 10, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Patients with insomnia
adult outpatients with a localized or metastatic breast, colorectal, pulmonary or urological cancer
 Other: Questionnaires

To patients who have given their consent for the self-screening, the research assistant will propose 3 questionnaires, which will be completed in the waiting room and returned the same day:

  • Ad hoc questionnaire for demographics and medical data;
  • Insomnia Severity Index (ISI, 7 items, Savard et al., 2005);
  • Edmonton Symptom Assessment System (ESAS, 10 items, Visual Analogue Scale, Bruera et al. 1991) assessing comorbidities as pain, dyspnea, anxiety or depression...

The ISI scoring will be realized by the research assistant (in the research office) immediately after its completion.
Outcome Measures
Primary Outcome Measures :
  1. Acceptance rate of self-screening for insomnia [ Time Frame: Up to 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Locations
Layout table for location information
France
Gustave Roussy
Villejuif, Val De Marne, France, 94805
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Tracking Information
First Submitted Date  ICMJE June 7, 2019
First Posted Date  ICMJE June 11, 2019
Last Update Posted Date June 11, 2019
Actual Study Start Date  ICMJE May 4, 2018
Actual Primary Completion Date June 29, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2019) 		Acceptance rate of self-screening for insomnia [ Time Frame: Up to 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Video-Based Cognitive Behavioral Therapy for Insomnia in Adults Cancer Patients and Survivors
Official Title  ICMJE Systematic Self-screening of Insomnia and Proposition of a Video-Based Cognitive Behavioral Therapy for Insomnia in Adults Cancer Patients and Survivors: A Pilot Study
Brief Summary

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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Insomnia
Intervention  ICMJE Other: Questionnaires

To patients who have given their consent for the self-screening, the research assistant will propose 3 questionnaires, which will be completed in the waiting room and returned the same day:

  • Ad hoc questionnaire for demographics and medical data;
  • Insomnia Severity Index (ISI, 7 items, Savard et al., 2005);
  • Edmonton Symptom Assessment System (ESAS, 10 items, Visual Analogue Scale, Bruera et al. 1991) assessing comorbidities as pain, dyspnea, anxiety or depression...

The ISI scoring will be realized by the research assistant (in the research office) immediately after its completion.
Study Arms  ICMJE Experimental: Patients with insomnia
adult outpatients with a localized or metastatic breast, colorectal, pulmonary or urological cancer
Intervention: Other: Questionnaires
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 7, 2019) 		177
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 10, 2019
Actual Primary Completion Date June 29, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03981666
Other Study ID Numbers  ICMJE 2018-A00260-55
2017/2659 ( Other Identifier: CSET number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Gustave Roussy, Cancer Campus, Grand Paris
Study Sponsor  ICMJE Gustave Roussy, Cancer Campus, Grand Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Gustave Roussy, Cancer Campus, Grand Paris
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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