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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTSD Coach | Experimental | 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. |
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| Game application | Placebo Comparator | 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. |
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| Usually Care Control Group | No Intervention | The 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTSD Coach | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of recruitment for a full trial study |
| 2 months post-randomization |
| 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) | 2 months post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 2 months post-randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Henry, PH.D. | Jewish General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jewish General Hospital | Montreal | Quebec | H3T 1E8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39709459 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 6, 2018 | Aug 5, 2019 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Game application | Behavioral | 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 |
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| 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. | 2 months post-randomization |