NCT03651570

Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study

Status unknown NA Last updated 6 March 2020

What this trial tests

NA trial testing PTSD Coach in Head and Neck Cancer in 60 participants. Status unknown.

Timeline

25 September 2018

Primary endpoint
30 December 2019

30 June 2020

Quick facts

Lead sponsor	Jewish General Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	60
Start date	25 September 2018
Primary completion	30 December 2019
Estimated completion	30 June 2020
Sites	1 location across Canada

Drugs / interventions tested

• PTSD Coach
• Game application

Conditions studied

• Head and Neck Cancer — all drugs for Head and Neck Cancer →

Sponsor

Jewish General Hospital

Who can join

18 and older, any sex, with Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 (e.g., 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 (i.e., 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. PTSD Coach as an early mobile intervention to improve cancer-related anxiety and psychosocial oncology uptake in patients newly diagnosed with head and neck cancer: pilot randomized controlled trial.
   Ducharme L, Lo C, Hier M, Zeitouni A, et al · · 2024 · PMID 39709459 · DOI 10.1186/s40814-024-01556-7