NCT02939612

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

3.8 years

First QC Date

October 17, 2016

Last Update Submit

March 18, 2025

Conditions

CancerStress, Psychological

Keywords

Stress managementApp

Outcome Measures

Primary Outcomes (1)

  • The Perceived Stress Scale (PSS-14)

    14 item scale measuring perceived stress. Scale range: 0-56. Higher scores indicate higher perceived stress.

    Baseline, post intervention follow up at 3, 6, and 12 months

Secondary Outcomes (7)

  • SF-36 Item Short Form Health Survey (RAND-36 version)

    Baseline, post intervention follow up at 3, 6, and 12 months

  • The Self-Regulatory Fatigue-18 (SRF-18)

    Baseline, post intervention follow up at 3 and 12 months

  • The Brief Coping Orientation to Problems (Brief COPE)

    Baseline

  • Health, well-being and sleep

    Baseline, post intervention follow up at 3, 6, and 12 months

  • Intervention commentary

    Post intervention (immediately post intervention)

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

App for stress managementBEHAVIORAL

An app consisting of 10 modules that teaches stress management, cognitive behavioral coping skills and relaxation training.

Also known as: Stress management
App for Stress management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University hospital

Oslo, Norway

Location

Related Publications (1)

  • 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.

    PMID: 30684438DERIVED

MeSH Terms

Conditions

NeoplasmsStress, PsychologicalAlzheimer Disease

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Multiprotein ComplexesMacromolecular SubstancesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Lise Solberg Nes, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 20, 2016

Study Start

October 1, 2016

Primary Completion

August 1, 2020

Study Completion

December 31, 2025

Last Updated

March 20, 2025

Record last verified: 2025-03

Locations

NO(1)