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Stress Management Intervention in Early Stage Cancer: Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT02939612
Recruitment Status : Recruiting
First Posted : October 20, 2016
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
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 different cancer diagnosis.

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 will first be tested in a pilot study among 20 patients with different cancer diagnosis and eventually in a randomized controlled trial with a sample of 260 patients with different cancer diagnosis. The participants will be randomly assigned to use the 10 module app or to a control group that receive treatment as usual, and followed with repeated measures over 12 months.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 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 (measuring changes over time) [ Time Frame: Baseline, immediately post intervention (immediately post intervention, approximately 5 weeks), follow up at 3, 6, and 12 months ]
    14 item scale measuring perceived stress

  2. The Distress Thermometer (measuring changes over time) [ Time Frame: Baseline, immediately post intervention (immediately post intervention, approximately 5 weeks), follow up at 3, 6, and 12 months ]
    One item scale measuring distress

  3. The Hospital Anxiety and Depression Scale (measuring changes over time) [ Time Frame: Baseline, immediately post intervention (immediately post intervention, approximately 5 weeks), follow up at 3, 6, and 12 months ]
    14 item scale measuring anxiety and depression


Secondary Outcome Measures :
  1. RAND Health Related Quality of Life (measuring changes over time) [ Time Frame: Baseline, post intervention (immediately post intervention, approximately at 5 weeks), follow up 3, 6, and 12 months ]
    36 item scale measuring health related quality of life

  2. SRF-18 Self-Regulation (measuring changes over time) [ Time Frame: Baseline, follow up 3 and 12 months ]
    18 item scale measuring self-regulation

  3. The Brief COPE [ Time Frame: Baseline ]
    28 item scale measuring coping

  4. Health, well-being and sleep (measuring changes over time) [ Time Frame: Baseline, post intervention (immediately post intervention, approximately at 5 weeks), follow up 3, 6, and 12 months ]
    One 5 item scale measuring health, well-being and sleep

  5. Intervention commentary (measuring changes over time) [ Time Frame: Post intervention (immediately post intervention, approximately at 5 weeks) ]
    Questionnaire: A brief measure of participant's intervention reactions



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Elevated stress: Score ≥2 on the distress thermometer before inclusion

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 ClinicalTrials.gov identifier (NCT number): NCT02939612


Contacts
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Contact: Elin Børøsund, PhD +47 23066010 elin.borosund@rr-research.no
Contact: Lise Solberg Nes, PhD +47 23066004 lise.solberg.nes@rr-research.no

Locations
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Norway
Oslo University hospital Recruiting
Oslo, Norway
Contact: Elin Borosund, PhD    +47 23066010      
Sponsors and Collaborators
Oslo University Hospital
Norwegian Cancer Society
Investigators
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Principal Investigator: Lise Solberg Nes, PhD Oslo University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lise Solberg Nes, Center Director & Head of Reserach, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02939612     History of Changes
Other Study ID Numbers: 2016/1436
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Lise Solberg Nes, Oslo University Hospital:
Stress management
App
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms