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Active, Not Recruiting

NCT Number: NCT02939612

Stress Management Intervention in Early Stage Cancer: 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cancer Alzheimer Disease Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Neoplasms Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Stress, Psychological Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University hospital

Oslo, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

App for stress management

Behavioral

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

Other names: Stress management

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Norwegian Cancer Society

Registry information

Official study title

Testing a Computerized Interactive Stress Management Intervention in Early Stage Cancer: a Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2020
Study completion
2025
First posted
Oct 20, 2016
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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