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

NCT04480203 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2022-03-02

No results posted yet for this study

Summary

1. Breast cancer patients and age-matched controls are first invited to answer questions on HRQoL.
2. Among responding breast cancer patients, a subset are invited in a randomized clinical trial with two digital interventions for cancer stress management, cognitive based stress management (CBSM) and mindfulness based intervention (MBI), as well as a control group.
3. The goal is to determine whether digital CBSM or MBI can effectively reduce stress levels as compared to a control group. Second, whether these interventions can improve HRQoL (or avoid onset of HRQoL problems) for patients with breast cancer, compared to a control group.

Conditions

  • Breast Cancer Patients
  • Health, Subjective

Interventions

OTHER

Stressproffen cognitive based stress management

The participants will download an app (Stressproffen 2A) with cognitive based stress management.

OTHER

Stressproffen mindfulness based intervention

The participants will download an app (Stressproffen 2B) with mindfulness based intervention.

OTHER

Control

The participants will receive no app. (They will be able to download it after the end of the 3 year study).

Sponsors & Collaborators

  • Norwegian Institute of Public Health

    lead OTHER_GOV

Principal Investigators

  • Giske Ursin, MD, PhD · Norwegian Institute of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
69 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2023-08-31
Completion
2035-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04480203 on ClinicalTrials.gov