Ignite Creation Date:
2024-05-06 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03651570
Status:
UNKNOWN
Last Update Posted:
2020-03-06
First Post:
2018-06-26
Brief Title:
Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better Pilot Study
Sponsor:
Jewish General Hospital
Organization:
Jewish General Hospital
Study Overview
Official Title:
Implementing an e-Intervention to Reduce Anxiety Symptoms and Improve Psychosocial Oncology Uptake in Patients Newly Diagnosed With Head and Neck Cancer Pilot Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Informed by a previous trial in general cancer patients the investigators aim to conduct a multi-centre Phase III explanatory RCT to demonstrate a significant impact of PTSD Coach on levels of anxiety in head and neck cancer HNC patients including saliva and hair cortisol as bio-immunological indicators for stress However prior to proposing a larger trial requiring 267 patients the investigators aim to demonstrate feasibility of recruitment and compliance with protocol procedures in a Phase II Pilot of 60 newly diagnosed HNC patients The EG will receive PTSD Coach usual care compared to two control groups UC and AC AC will be comprised of a game app eg Tetris Candy Crush or Solitaire and will be structurally equivalent to the EG to control for distraction attention on something pleasant or a task and the human factor involved in usage prompting ie same exposure time contacts with personnel since either distraction or the human contact with staff may alone lower anxiety From a resource allocation perspective it is important to know if the positive effects of PTSD Coach are due to the intervention itself or to the use of an app and its usage prompting The investigators believe that PTSD Coach will be even more effective at reducing anxiety in HNC patients as it teaches specific CBT techniques and uses psychoeducation already found to be more effective than distraction alone
Detailed Description:
See above
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None