Stress Management Intervention in Early Stage Cancer: Randomized Controlled Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose with this study is to test the effect of an app for stress management among patients with a variety of cancer diagnoses.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Stress Management in Breast Cancer Patients

NCT01555645

Breast Cancer Stress

COMPLETED NA

Influence of Psychosocial Distress and Lifetime Trauma Exposure on Traumatic Stress Among Oncology Patients on Clinical Trials

NCT02948413

Lymphoma Mesothelioma Prostate Cancer +1 more

COMPLETED

Early Rehabilitation of Cancer Patients

NCT01588262

Breast Cancer Colorectal Cancer Lymphoma +2 more

COMPLETED NA

Hospital Based Group Intervention for Breast Cancer Patients.

NCT00289432

Breast Cancer Anxiety Depression +2 more

COMPLETED NA

Coping After Breast Cancer - a Randomized Clinical Trial With Two Digital Interventions

NCT04480203

Breast Cancer Patients Health, Subjective

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Stress, Psychological

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

App for stress management

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

App for stress management

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Stress management

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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