Ignite Creation Date:
2024-05-06 @ 9:14 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02939612
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2016-10-17
Brief Title:
Stress Management Intervention in Early Stage Cancer Randomized Controlled Trial
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Testing a Computerized Interactive Stress Management Intervention in Early Stage Cancer A Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None