Ignite Creation Date:
2024-05-06 @ 3:57 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02410564
Status:
TERMINATED
Last Update Posted:
2016-02-10
First Post:
2015-03-11
Brief Title:
CBT-I Intervention for Insomnia in Newly Diagnosed Cancer Patients
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Testing an Accessible Cognitive Behavioral Therapy for Insomnia CBT-I Intervention in Newly Diagnosed Cancer Patients
Status:
TERMINATED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
insufficient staff
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the efficacy of a CBT-I intervention in improving sleep and other quality of life outcomes during cancer treatment To assess the feasibility and acceptability of a CBT-I intervention among newly diagnosed cancer patients
Detailed Description:
The proposed study will be a randomized controlled trial design Participants will be randomized to either a CBTI treatment or a wait list control condition The intervention is SHUTi a validated web based version of CBTI which will take place over seven weeks and will include a combination of face to face and telephone sessions and email updates All participants will have a face to face meeting with the doctoral student at enrollment During the intervention period all participants will be contacted by telephone at week 1 3 and 6 to check in and to encourage participant engagement However during phone calls with control participants no advice regarding sleep will be given and if participants ask they will be informed that such advice can be provided in a few weeks if they choose to crossover to the treatment condition at the end of the study Participants in SHUTi will additionally be provided the the doctoral students phone number and will be encouraged to contact her if they have any questions during the intervention They will also have the option of setting up appointments for face to face meetings during a clinic appointment if they desire additional therapist guidance Pretreatment all participants will complete a two week sleep diary and multiple self report measures At the end of the intervention all participants will complete a two week sleep diary and multiple self report measures again
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HM20002827 | None | None | None |