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Stress Management Intervention in Early Stage Cancer: Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02939612
Recruitment Status : Active, not recruiting
First Posted : October 20, 2016
Last Update Posted : December 24, 2019
Norwegian Cancer Society
Information provided by (Responsible Party):
Lise Solberg Nes, Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Cancer Stress, Psychological Behavioral: App for stress management Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
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

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 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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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?

  6. 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

  7. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02939612

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Oslo University hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Norwegian Cancer Society
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Principal Investigator: Lise Solberg Nes, PhD Oslo University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lise Solberg Nes, Head of Department, Oslo University Hospital Identifier: NCT02939612    
Other Study ID Numbers: 2016/1436
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Lise Solberg Nes, Oslo University Hospital:
Stress management
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms