Stress Management Intervention in Early Stage Cancer: Randomized Controlled Trial
|ClinicalTrials.gov Identifier: NCT02939612|
Recruitment Status : Active, not recruiting
First Posted : October 20, 2016
Last Update Posted : December 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cancer Stress, Psychological||Behavioral: App for stress management||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Testing a Computerized Interactive Stress Management Intervention in Early Stage Cancer: A Randomized Controlled Trial|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
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 Name: 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.
- The Perceived Stress Scale (PSS-14) [ Time Frame: 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.
- SF-36 Item Short Form Health Survey (RAND-36 version) [ Time Frame: 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 Self-Regulatory Fatigue-18 (SRF-18) [ Time Frame: 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 Brief Coping Orientation to Problems (Brief COPE) [ Time Frame: 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
- Health, well-being and sleep [ Time Frame: 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
- Intervention commentary [ Time Frame: 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?
- The Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 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
- The Distress Thermometer [ Time Frame: 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939612
|Oslo University hospital|
|Principal Investigator:||Lise Solberg Nes, PhD||Oslo University Hospital|