The purpose with this study is to test the effect of an app for stress management among patients with a variety of cancer diagnoses.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
200
An app consisting of 10 modules that teaches stress management, cognitive behavioral coping skills and relaxation training.
Oslo University hospital
Oslo, Norway
The Perceived Stress Scale (PSS-14)
14 item scale measuring perceived stress. Scale range: 0-56. Higher scores indicate higher perceived stress.
Time frame: Baseline, post intervention follow up at 3, 6, and 12 months
SF-36 Item Short Form Health Survey (RAND-36 version)
36 item scale measuring health related quality of life (HRQoL). The scale has 8 subscales and 1 single item score. Scale and single item range: 0 to 100. Higher scores indicate higher HRQoL.
Time frame: Baseline, post intervention follow up at 3, 6, and 12 months
The Self-Regulatory Fatigue-18 (SRF-18)
18 item scale measuring self-regulation. Scale range: 18 to 90. A higher score indicates higher self regulatory fatigue
Time frame: Baseline, post intervention follow up at 3 and 12 months
The Brief Coping Orientation to Problems (Brief COPE)
The outcome measure consists of 14 different scales of different coping strategies with two items per scale, for a total of 28 items. Scale range 2 to 8. Higher scores indicate higer use of the different coping strategies
Time frame: Baseline
Health, well-being and sleep
A 5 item measure, measuring health, well-being and sleep on a scale from 0 to 10. Higher scores indicate better health, well-being and sleep
Time frame: Baseline, post intervention follow up at 3, 6, and 12 months
Intervention commentary
A six item brief measure of participant's intervention reactions. The first 3 items gauged participants' program perception on a scale from 1 to 5, with 5 indicating better perception. The next 3 items were open ended questions: \* What did you like best? \* What did you like the least? \* Suggestions for improvement?
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Time frame: Post intervention (immediately post intervention)
The Hospital Anxiety and Depression Scale (HADS)
14 item scale measuring anxiety and depression. The Scale has a total score with a scale range of 0 to 42 and an anxiety (HADS-A) and a depression (HADS-D) subscale, both with scale range of 0 to 21. Higer scores indicate higher level of anxiety and depression
Time frame: Baseline, post intervention follow up at 3, 6, and 12 months
The Distress Thermometer
One item scale measuring distress on a scale from 0 to 10. Higer scores indicate higher distress
Time frame: Baseline, post intervention follow up at 3, 6, and 12 months