Stress Management Intervention in Early Stage Cancer: Randomized Controlled Trial

University of Oslo (UIO)

Status: Active, not recruiting

Conditions: Cancer; Stress, Psychological

Treatments: Behavioral: App for stress management

Study type: Interventional

Funder types: Other

Identifiers

NCT02939612

2016/1436

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

App for Stress management

Experimental group

Description:

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.

Treatment:

Behavioral: App for stress management

Waitlist control group

No Intervention group

Description:

Participants will get treatment as usual during the study. After the one year study follow up they will receive the stress management app.