Stress Management Intervention in Early Stage Cancer: Randomized Controlled Trial

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02939612
• Other study ID #: 2016/1436
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Stress, Psychological

Intervention

Behavioral:
• App for stress management
An app consisting of 10 modules that teaches stress management, cognitive behavioral coping skills and relaxation training.

Locations

Country	Name	City	State
Norway	Oslo University hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Norwegian Cancer Society

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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