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

Not Applicable

• Conditions: Head and Neck Cancer
• Interventions: Behavioral: Game application; Device: PTSD Coach

• Registration Number: NCT03651570
• Lead Sponsor: Jewish General Hospital

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 (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.

Detailed Description

See above

Study Timeline

• Study First Submitted: 2018-06-26
• Study First Submitted QC: 2018-08-27
• Study First Posted: 2018-08-29
• Study Start: 2018-09-25
• Primary Completion: 2019-12-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-05
• Last Update Posted: 2020-03-06
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Newly diagnosed with HNC (all HNC sites; TNM classification system); first occurrence, progression or recurrence <4 weeks at referral.
2. Willing to complete PTSD Coach or game app within 3 weeks as they await treatment onset.
3. >18 years old
4. Alert and capable of giving free and informed consent according to referring clinician.

Exclusion Criteria

1. Karnofsky Performance Status (KPS) score < 60 (rated by referring oncologists/nurses or Research Coordinator) or expected survival <6 months according to clinical judgment of physicians and/or nurses.
2. Suicidal. Present a score of ≥2 on the Beck Depression Inventory (BDI) suicide item.
3. Known diagnosis of schizophrenia or schizoaffective disorder.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Game application	Game application	Patients will be assigned to three apps involving playing a game (i.e., Candy Crush, Tetris, or Solitaire), during the waiting time before and between medical treatments in the hospital, on the same weekly schedule as the experimental group. The game apps contain no element of intervention and were selected based on popularity and capacity to interests.
PTSD Coach	PTSD Coach	PTSD Coach is a mobile mental health app developed by US Veterans Affairs translated into French by Veterans Affairs Canada in partnership with the Department of National Defence and the Canadian Mental Health Association. It was developed for a male population (92% of veterans are men), as is predominantly found in HNC, and addresses the issue of mental health and stigma as found in our HNC patients. PTSD Coach can be used as a stand-alone education and symptom management and contains 4 modules: 1) Learn- Module, 2) Self-Assessment-Module, 3) Manage Symptoms-Module and 4) Find Support-Module. The content of the first and last modules were adapted to the oncological population.

Primary Outcome Measures

Name	Time	Method
Feasibility of recruitment for a full trial study	2 months post-randomization	1. Can we recruit a sufficient number (i.e., n=60 over 8 months or 8/month) of newly diagnosed head and neck cancer patients? AND; 2. Can we retain a sufficient proportion (i.e., ≥85% at three months post-randomization, having completed the primary outcome) of head and neck patients in all trial arms to allow completion of a full study (n=267) in a timely fashion?
PTSD Coach app Acceptability	2 months post-randomization	Is the PTSD Coach app acceptable to at least 80% of newly diagnosed head and neck cancer patients, as indicated by 80% positive responses on the Pilot-Study Questionnaire (PSQ; adapted from the CSQ-8; Attkisson \& Zwick, 1982)

Secondary Outcome Measures

Name	Time	Method
Completion of intervention in a timely manner	2 months post-randomization	At least 90% of experimental group complete PTSD Coach within 3 weeks from randomization.; At least 85% of the content for each module of PTSD Coach be completed.; At least 90% of the attention control complete their assigned condition as planned (i.e., 45 min/week over 3 weeks).
Sample size calculation for full trial study	2 months post-randomization	Identify the 80% upper confidence interval for pooled standard deviation at baseline for use of full trial sample calculation.

Trial Locations

Locations (1)

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada