Testing a Computerized Interactive Stress Management Intervention in Early Stage Cancer: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Oslo University Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- The Perceived Stress Scale (PSS-14)
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
The purpose with this study is to test the effect of an app for stress management among patients with a variety of cancer diagnoses.
Detailed Description
A cancer diagnosis and subsequent treatment can be disruptive and traumatic, often accompanied by a multitude of stressors for the patients and their support network. Uncertainty of outcome and invasive medical procedures with aversive side effects are not uncommon, and while people differ widely in how they experience and cope with such challenges, cancer related distress including anxiety, depression, worry and rumination is prevalent. With multiple domains of function impacted it is also not surprising that quality of life (QoL) often is diminished. Stress management interventions can facilitate adjustment to cancer, including reduced distress and improved quality of life. Unfortunately, many people with cancer do not have the strength or opportunity to attend groups or in-person interventions. This study will therefore test the effect of an app for stress management among patients with different cancer diagnosis. The app contains 10 modules distributed over five weeks, focusing on education of different techniques for reduction of stress and stress reduction exercises. The app was tested in a feasibility pilot study among 25 patients with a variety of cancer diagnoses and is now being tested in a randomized controlled trial with a sample of 175 cancer survivors. The participants were randomly assigned to use the 10 module app or to a control group that receive treatment as usual, and will be followed with repeated measures over 12 months.
Investigators
Lise Solberg Nes
Head of Department
Oslo University Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients diagnosed with cancer (all diagnosis).
- •Maximum time since completed treatment at hospital: 12 months
- •Patients are \> 18 years of age, able to write/read/speak Norwegian and have their own smart phone or tablet
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The Perceived Stress Scale (PSS-14)
Time Frame: Baseline, post intervention follow up at 3, 6, and 12 months
14 item scale measuring perceived stress. Scale range: 0-56. Higher scores indicate higher perceived stress.
Secondary Outcomes
- SF-36 Item Short Form Health Survey (RAND-36 version)(Baseline, post intervention follow up at 3, 6, and 12 months)
- The Brief Coping Orientation to Problems (Brief COPE)(Baseline)
- The Distress Thermometer(Baseline, post intervention follow up at 3, 6, and 12 months)
- Health, well-being and sleep(Baseline, post intervention follow up at 3, 6, and 12 months)
- The Self-Regulatory Fatigue-18 (SRF-18)(Baseline, post intervention follow up at 3 and 12 months)
- The Hospital Anxiety and Depression Scale (HADS)(Baseline, post intervention follow up at 3, 6, and 12 months)
- Intervention commentary(Post intervention (immediately post intervention))