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

ConditionsBreast Cancer Patients Health, Subjective

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age20-69

SponsorNorwegian Institute of Public Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

first occurrence breast cancer diagnosed from Jan 1, 2020

non-metastatic cancer stage 0-III

HER2 positive (regardless of ER, PR) or

ER negative

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Stressproffen cognitive based stress management
Other intervention
The participants will download an app (Stressproffen 2A) with cognitive based stress management.
Stressproffen mindfulness based intervention
Other intervention
The participants will download an app (Stressproffen 2B) with mindfulness based intervention.
Control
Other intervention
The participants will receive no app. (They will be able to download it after the end of the 3 year study).

Treatment groups

390 Participants

are divided into 3 treatment groups

Group A: Cognitive based stress management (CBSM)Active comparator 1 intervention

Group B: Mindfulness based intervention (MBI)Active comparator 1 intervention

Group C: ControlPlacebo comparator 1 intervention

Trial outcomes