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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03651570
• Other study ID #: MM-CODIM-FLP-17-085
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 25, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: March 2020
• Source: Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Description:

See above

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Device:
• 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.

Behavioral:
• 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

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Jewish General Hospital	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of recruitment for a full trial study	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; 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?	2 months post-randomization
Primary	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
Secondary	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
Secondary	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