Clinical trial NCT03651570: Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2018-08-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

Primary outcomes:
measure: Feasibility of recruitment for a full trial study
timeFrame: 2 months post-randomization
measure: PTSD Coach app Acceptability
timeFrame: 2 months post-randomization
Secondary outcomes:
measure: Completion of intervention in a timely manner
timeFrame: 2 months post-randomization
measure: Sample size calculation for full trial study
timeFrame: 2 months post-randomization
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Melissa Henry, PH.D.
role: PRINCIPAL_INVESTIGATOR
References: