NCT02939612

Stress Management Intervention in Early Stage Cancer: Randomized Controlled Trial

Testing a Computerized Interactive Stress Management Intervention in Early Stage Cancer: a Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Stress, Psychological

Interventions

Type	Name	Description
BEHAVIORAL	App for stress management	An app consisting of 10 modules that teaches stress management, cognitive behavioral coping skills and relaxation training.

Timeline

• Start date: 2016-10-01
• Primary completion: 2020-08-01
• Completion: 2025-12-31
• First posted: 2016-10-20
• Last updated: 2025-03-20

Locations

1 site across 1 country: Norway