Clinical trial NCT02939612: Stress Management Intervention in Early Stage Cancer: Randomized Controlled Trial
Official title: Testing a Computerized Interactive Stress Management Intervention in Early Stage Cancer: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Stress, Psychological
Keywords: Stress management
App
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Cancer Society
First posted: 2016-10-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Perceived Stress Scale (PSS-14)
timeFrame: Baseline, post intervention follow up at 3, 6, and 12 months
Secondary outcomes:
measure: SF-36 Item Short Form Health Survey (RAND-36 version)
timeFrame: Baseline, post intervention follow up at 3, 6, and 12 months
measure: The Self-Regulatory Fatigue-18 (SRF-18)
timeFrame: Baseline, post intervention follow up at 3 and 12 months
measure: The Brief Coping Orientation to Problems (Brief COPE)
timeFrame: Baseline
measure: Health, well-being and sleep
timeFrame: Baseline, post intervention follow up at 3, 6, and 12 months
measure: Intervention commentary
timeFrame: Post intervention (immediately post intervention)
measure: The Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, post intervention follow up at 3, 6, and 12 months
measure: The Distress Thermometer
timeFrame: Baseline, post intervention follow up at 3, 6, and 12 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University hospital
Study officials:
affiliation: Oslo University Hospital
name: Lise Solberg Nes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.