CancerNCT02939612
Stress Management Intervention in Early Stage Cancer: Randomized Controlled Trial
A study testing App for stress management in people with Cancer and Stress, Psychological, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Stress, Psychological
- What is being tested?
- App for stress management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2016to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing a Computerized Interactive Stress Management Intervention in Early Stage Cancer: a Randomized Controlled Trial
The purpose with this study is to test the effect of an app for stress management among patients with a variety of cancer diagnoses.
Read the 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.
- Conditions
- Cancer, Stress, Psychological
- Being tested
- App for stress management
- Keywords
- Stress management, App
- Medical subject headings
- Neoplasms, Stress, Psychological, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App for stress managementBehavioural
Also called Stress management
An app consisting of 10 modules that teaches stress management, cognitive behavioral coping skills and relaxation training.
| Study group | Role | What they receive |
|---|---|---|
| App for Stress management | Experimental | 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. Receives: Behavioral: App for stress management |
| Waitlist control group | No intervention | Participants will get treatment as usual during the study. After the one year study follow up they will receive the stress management app. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Perceived Stress Scale (PSS-14)
14 item scale measuring perceived stress. Scale range: 0-56. Higher scores indicate higher perceived stress.
Measured: Baseline, post intervention follow up at 3, 6, and 12 months
Secondary outcomes (7)
SF-36 Item Short Form Health Survey (RAND-36 version)
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.
Measured: Baseline, post intervention follow up at 3, 6, and 12 months
The Self-Regulatory Fatigue-18 (SRF-18)
18 item scale measuring self-regulation. Scale range: 18 to 90. A higher score indicates higher self regulatory fatigue
Measured: Baseline, post intervention follow up at 3 and 12 months
The Brief Coping Orientation to Problems (Brief COPE)
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
Measured: Baseline
Health, well-being and sleep
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
Measured: Baseline, post intervention follow up at 3, 6, and 12 months
Intervention commentary
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?
Measured: Post intervention (immediately post intervention)
The Hospital Anxiety and Depression Scale (HADS)
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
Measured: Baseline, post intervention follow up at 3, 6, and 12 months
The Distress Thermometer
One item scale measuring distress on a scale from 0 to 10. Higer scores indicate higher distress
Measured: Baseline, post intervention follow up at 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionAug 2020
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Cancer Society
- Responsible party
- Principal investigator, Lise Solberg Nes, Oslo University Hospital
- Investigators
- Lise Solberg Nes, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939612
- Sponsor's protocol ID
- 2016/1436
- Status last verified
- Mar 2025
- First submitted
- 17 Oct 2016
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30684438
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Computerized Interactive Stress Management Intervention in Early Stage Cancer: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02939612
- Acronym / sponsor ID
- 2016/1436
- Conditions
- Cancer, Stress, Psychological
- Keywords
- Stress management, App
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Cancer Society
- Study start
- Oct 2016 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App for Stress management | Experimental | Behavioral: App for stress managementParticipants 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. |
| Waitlist control group | No intervention | –Participants will get treatment as usual during the study. After the one year study follow up they will receive the stress management app. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App for stress managementAlso: Stress managementAn app consisting of 10 modules that teaches stress management, cognitive behavioral coping skills and relaxation training. | Behavioural | App for Stress management |
Primary outcome
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.
7 secondary outcomes
SF-36 Item Short Form Health Survey (RAND-36 version)
Time frame: Baseline, post intervention follow up at 3, 6, and 12 months
The Self-Regulatory Fatigue-18 (SRF-18)
Time frame: Baseline, post intervention follow up at 3 and 12 months
The Brief Coping Orientation to Problems (Brief COPE)
Time frame: Baseline
Health, well-being and sleep
Time frame: Baseline, post intervention follow up at 3, 6, and 12 months
Intervention commentary
Time frame: Post intervention (immediately post intervention)
The Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, post intervention follow up at 3, 6, and 12 months
The Distress Thermometer
Time frame: Baseline, post intervention follow up at 3, 6, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Derived from this study: PubMed 30684438Borosund 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lise Solberg Nes, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App for stress management in people with Cancer and Stress, Psychological, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Perceived Stress Scale (PSS-14) (time frame: Baseline, post intervention follow up at 3, 6, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02939612, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.