Clinical trial NCT04480203: Coping After Breast Cancer - a Randomized Clinical Trial With Two Digital Interventions
Official title: Coping After Breast Cancer - CABC - Stressmestring Etter Brystkreft - SEB
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Patients
Health, Subjective
Keywords: Health Related Quality of Life
Stress management intervention
Lead sponsor: Norwegian Institute of Public Health
Sponsor class: OTHER_GOV
First posted: 2020-07-21
Enrollment: 390
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An intervention study of breast cancer patients with two digital intervention arms and one control group.
Primary purpose: PREVENTION

Brief 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.

Detailed description: After completing the baseline HRQoL assessment, eligible breast cancer patients will be invited to participate in a randomized clinical trial.

Those who are willing will be randomly allocated to one of the following arms: a) Digital cognitive based stress management, b) Digital mindfulness based intervention or c) Control group.

The intervention is based on a revised version of the Stressproffen app, which was developed by the Oslo University Hospital (Lise Solberg Nes, Elin Børøsund and others).

Outcome measures include measures of perceived stress and HRQoL.

Eligibility criteria: Inclusion Criteria:

* first occurrence breast cancer diagnosed from Jan 1, 2020
* non-metastatic cancer stage 0-III

Invasive tumors must be:

* HER2 positive (regardless of ER, PR) or
* ER negative
* (may later include other ER+ if not conflict with recruitment for EMIT/OPTIMA)

Exclusion Criteria:

* None

Primary outcomes:
measure: Stress
timeFrame: change from CABC baseline (week 0) to f-up week 21
Secondary outcomes:
measure: Subjective health (HRQoL)
timeFrame: change from CABC baseline (week 0) to f-up week 21
measure: Coping
timeFrame: change from CABC baseline (week 0) to f-up week 21
measure: Anxiety and depression
timeFrame: change from CABC baseline (week 0) to f-up week 21
measure: Fatigue
timeFrame: change from CABC baseline (week 0) to f-up week 21
measure: Mindfulness
timeFrame: change from CABC baseline (week 0) to f-up week 21
measure: Sleep
timeFrame: change from CABC baseline (week 0) to f-up week 21
measure: EORTC QLQ-C30
timeFrame: From NBCR baseline to f-up week 20
measure: EORTC QLQ-BR23
timeFrame: From NBCR baseline to f-up week 20
measure: Neuropathy (FACT GOG-NTX and -ES)
timeFrame: From NBCR baseline to f-up week 20
measure: Stress
timeFrame: change from CABC baseline (week 0) to f-up month 15
measure: Subjective health (HRQoL)
timeFrame: change from CABC baseline (week 0) to f-up month 15
measure: Coping
timeFrame: change from CABC baseline (week 0) to f-up month 15
measure: Fatigue
timeFrame: change from CABC baseline (week 0) to f-up month 15
measure: Mindfulness
timeFrame: change from CABC baseline (week 0) to f-up month 15
measure: Anxiety and depression
timeFrame: change from CABC baseline (week 0) to f-up month 15
measure: Sleep
timeFrame: change from CABC baseline (week 0) to f-up month 15
measure: Work
timeFrame: status at f-up month 15
measure: Stress
timeFrame: change from CABC baseline (week 0) to f-up month 27
measure: Subjective health (HRQoL)
timeFrame: change from CABC baseline (week 0) to f-up month 27
measure: Coping
timeFrame: change from CABC baseline (week 0) to f-up month 27
measure: Anxiety and depression
timeFrame: change from CABC baseline (week 0) to f-up month 27
measure: Fatigue
timeFrame: change from CABC baseline (week 0) to f-up month 27
measure: Mindfulness
timeFrame: change from CABC baseline (week 0) to f-up month 27
measure: Sleep
timeFrame: change from CABC baseline (week 0) to f-up month 27
measure: EORTC QLQ-C30
timeFrame: change from NBCR baseline to f-up month 27
measure: EORTC QLQ-BR23
timeFrame: change from NBCR baseline to f-up month 27
measure: Neuropathy (FACT GOG-NTX and -ES)
timeFrame: From NBCR baseline to f-up month 27
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Cancer Registry of Norway
Study officials:
affiliation: Norwegian Institute of Public Health
name: Giske Ursin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: