Stress Management Intervention in Early Stage Cancer: Randomized Controlled Trial

Not Applicable

Active, not recruiting

• Conditions: Cancer; Stress, Psychological
• Interventions: Behavioral: App for stress management

• Registration Number: NCT02939612
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-19
• Study First Posted: 2016-10-20
• Primary Completion: 2020-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-20
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
App for Stress management	App for stress management	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.

Primary Outcome Measures

Name	Time	Method
The Perceived Stress Scale (PSS-14)	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 Outcome Measures

Name	Time	Method
SF-36 Item Short Form Health Survey (RAND-36 version)	Baseline, post intervention follow up at 3, 6, and 12 months	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.
The Brief Coping Orientation to Problems (Brief COPE)	Baseline	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
The Distress Thermometer	Baseline, post intervention follow up at 3, 6, and 12 months	One item scale measuring distress on a scale from 0 to 10. Higer scores indicate higher distress
Health, well-being and sleep	Baseline, post intervention follow up at 3, 6, and 12 months	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
The Self-Regulatory Fatigue-18 (SRF-18)	Baseline, post intervention follow up at 3 and 12 months	18 item scale measuring self-regulation. Scale range: 18 to 90. A higher score indicates higher self regulatory fatigue
The Hospital Anxiety and Depression Scale (HADS)	Baseline, post intervention follow up at 3, 6, and 12 months	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
Intervention commentary	Post intervention (immediately post intervention)	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?

Trial Locations

Locations (1)

Oslo University hospital; 🇳🇴 Oslo, Norway