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

NCT ID: NCT03651570

Last Updated: 2020-03-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-25
• Study Completion Date: 2020-06-30

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

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Game application

Intervention Type: 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

Usually Care Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

PTSD Coach

Intervention Type: 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.

Interventions

PTSD Coach

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.

Intervention Type: DEVICE

Game application

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Jewish General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Melissa Henry

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melissa Henry, PH.D.

Role: PRINCIPAL_INVESTIGATOR

Jewish General Hospital

Locations

Jewish General Hospital

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 39709459 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

MM-CODIM-FLP-17-085

Identifier Type: -

Identifier Source: org_study_id