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

The purpose with this study is to test the effect of an app for stress management among patients with a variety of cancer diagnoses.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer; Stress, Psychological
• Intervention / Treatment: Behavioral: App for stress management

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: App for stress management; An app consisting of 10 modules that teaches stress management, cognitive behavioral coping skills and relaxation training.; Other Names: Stress management
No Intervention: Waitlist control group; 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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Norwegian Cancer Society
• Investigators: Principal Investigator: Lise Solberg Nes, PhD, Oslo University Hospital

Publications and helpful links

General Publications

• Borosund E, Mirkovic J, Clark MM, Ehlers SL, Andrykowski MA, Bergland A, Westeng M, Solberg Nes L. A Stress Management App Intervention for Cancer Survivors: Design, Development, and Usability Testing. JMIR Form Res. 2018 Sep 6;2(2):e19. doi: 10.2196/formative.9954.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): August 1, 2020
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 17, 2016
• First Submitted That Met QC Criteria: October 19, 2016
• First Posted (Estimated): October 20, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: App; Stress management
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: 2016/1436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No