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

Cancer Registry of Norway

Status: Enrolling

Conditions: Breast Cancer Patients; Health, Subjective

Treatments: Other: Stressproffen cognitive based stress management; Other: Stressproffen mindfulness based intervention; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT04480203

CABC - Kreftfor project - SEB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 390 estimated patients

Sex: Female

Ages: 20 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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390 participants in 3 patient groups, including a placebo group

Cognitive based stress management (CBSM)

Active Comparator group

Description:

Cognitive based digital intervention.

Treatment:

Other: Stressproffen cognitive based stress management

Mindfulness based intervention (MBI)

Active Comparator group

Description:

Mindfulness based digital intervention.

Treatment:

Other: Stressproffen mindfulness based intervention

Control

Placebo Comparator group

Description:

Control arm. No intervention.

Treatment:

Other: Control