Stress Management Intervention in Early Stage Cancer: Randomized Controlled Trial

Study 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.

Official Title
-----------------
Testing a Computerized Interactive Stress Management Intervention in Early Stage Cancer: A Randomized Controlled Trial

Conditions
-----------------
Cancer, Stress, Psychological

Intervention / Treatment
-----------------
* Behavioral: App for stress management


Participation Criteria
=================
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: • None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: App for Stress management<br>Participants will get access to two modules per week for five weeks (total 10 modules). The app consists of stress management education, cognitive behavioral interventions and relaxation training exercises. | Behavioral: App for stress management<br>* An app consisting of 10 modules that teaches stress management, cognitive behavioral coping skills and relaxation training.<br>* Other names: Stress management;|
| No Intervention: Waitlist control group<br>Participants will get treatment as usual during the study. After the one year study follow up they will receive the stress management app. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Perceived Stress Scale (PSS-14) | 14 item scale measuring perceived stress. Scale range: 0-56. Higher scores indicate higher perceived stress. | Baseline, post intervention follow up at 3, 6, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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 | 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? | 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 | 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 | Baseline, post intervention follow up at 3, 6, and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
App, Stress management