AzTrials
AzTrials

Head and Neck CancerNCT03651570

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

A study testing PTSD Coach and Game application in people with Head and Neck Cancer, run by Jewish General Hospital at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
PTSD Coach and Game application
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteCanada
Study dates
25 Sep 2018to 30 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
  • Suicidal. Present a score of ≥2 on the Beck Depression Inventory (BDI) suicide item.
  • Known diagnosis of schizophrenia or schizoaffective disorder.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E8

Other trials in Canada

About this study

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

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.

Read the detailed description

See above

Being tested
PTSD Coach, Game application
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PTSD CoachDevice

    PTSD Coach is a mobile mental health app that addresses the issue of mental health and stigma which 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.

  • Game applicationBehavioural

    This control condition is important 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

Study groups in NCT03651570
Study groupRoleWhat they receive
PTSD CoachExperimentalPTSD 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.
Receives: Device: PTSD Coach
Game applicationPlacebo comparatorPatients 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.
Receives: Behavioral: Game application
Usually Care Control GroupNo interventionThe Otolaryngology - Head and Neck Surgery (OHNS) Departments do not offer systematic interventions on anxiety and self-management, neither does any intervention address stigma. However, participating recruitment centres are already offering a best-of-care approach with well-established psychosocial oncology services, including psychiatrists, psychologists, social workers, nurses, and volunteers. All participants will be free to use hospital- or community-based support throughout the study, which will be tracked in all groups via questionnaire and chart review.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of recruitment for a full trial study

    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?

    Measured: 2 months post-randomization

  2. PTSD Coach app Acceptability

    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)

    Measured: 2 months post-randomization

Secondary outcomes (2)

  1. Completion of intervention in a timely manner

    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).

    Measured: 2 months post-randomization

  2. Sample size calculation for full trial study

    Identify the 80% upper confidence interval for pooled standard deviation at baseline for use of full trial sample calculation.

    Measured: 2 months post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2018
  2. Study start25 Sep 2018
  3. Primary completion30 Dec 2019
  4. Study completion30 Jun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03651570
Sponsor's protocol ID
MM-CODIM-FLP-17-085
Status last verified
Mar 2020
First submitted
26 Jun 2018
Last updated
6 Mar 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ducharme L, Lo C, Hier M, Zeitouni A, Kost K, Mlynarek A, Antoni M, Kuhn E, Owen JE, Heyland D, Platt R, Fuehrmann F, Sadeghi N, Rosberger Z, Frenkiel S, Sultanem K, Shenouda G, Cury F, Henry M. 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. Pilot Feasibility Stud. 2024 Dec 21;10(1):153. doi: 10.1186/s40814-024-01556-7.

    PubMed 39709459

Questions about this trial

What is this clinical trial studying?

A study testing PTSD Coach and Game application in people with Head and Neck Cancer, run by Jewish General Hospital at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of recruitment for a full trial study (time frame: 2 months post-randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03651570, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in