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

Study Overview
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Brief Summary
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Breast cancer patients and age-matched controls are first invited to answer questions on HRQoL. 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. 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
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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.

Official Title
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Coping After Breast Cancer - CABC - Stressmestring Etter Brystkreft - SEB

Conditions
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Breast Cancer Patients, Health, Subjective

Intervention / Treatment
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* Other: Stressproffen cognitive based stress management
* Other: Stressproffen mindfulness based intervention
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: An intervention study of breast cancer patients with two digital intervention arms and one control group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive based stress management (CBSM)<br>Cognitive based digital intervention. | Other: Stressproffen cognitive based stress management<br>* The participants will download an app (Stressproffen 2A) with cognitive based stress management.<br>* Other names: CBSM;|
| Active Comparator: Mindfulness based intervention (MBI)<br>Mindfulness based digital intervention. | Other: Stressproffen mindfulness based intervention<br>* The participants will download an app (Stressproffen 2B) with mindfulness based intervention.<br>* Other names: MBI;|
| Placebo Comparator: Control<br>Control arm. No intervention. | Other: Control<br>* The participants will receive no app. (They will be able to download it after the end of the 3 year study).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress | Cohens perceived stress scale. Unit is summary score. | change from CABC baseline (week 0) to f-up week 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective health (HRQoL) | RAND-36 questionnaire. Unit is summary score and module-specific scores | change from CABC baseline (week 0) to f-up week 21 | 
| Coping | TOMCATS questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up week 21 | 
| Anxiety and depression | PHQ-4 questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up week 21 | 
| Fatigue | Chalders' fatigue questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up week 21 | 
| Mindfulness | Baer 2006 mindfulness questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up week 21 | 
| Sleep | selected questions fro SUSSH questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up week 21 | 
| EORTC QLQ-C30 | EORTC health related quality of life (HRQoL) general questionnaire. Unit is summary score. | From NBCR baseline to f-up week 20 | 
| EORTC QLQ-BR23 | EORTC breast cancer questionnaire. Unit is summary score. | From NBCR baseline to f-up week 20 | 
| Neuropathy (FACT GOG-NTX and -ES) | neuropathy questionnaire. Unit is summary score. | From NBCR baseline to f-up week 20 | 
| Stress | Cohens perceived stress scale. Unit is summary score. | change from CABC baseline (week 0) to f-up month 15 | 
| Subjective health (HRQoL) | RAND-36 questionnaire. Unit is summary score and module-specific scores | change from CABC baseline (week 0) to f-up month 15 | 
| Coping | TOMCATS questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up month 15 | 
| Fatigue | Chalders' fatigue questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up month 15 | 
| Mindfulness | Baer 2006 mindfulness questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up month 15 | 
| Anxiety and depression | PHQ-4 questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up month 15 | 
| Sleep | selected questions fro SUSSH questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up month 15 | 
| Work | questions on employment. Whether employed and percentage | status at f-up month 15 | 
| Stress | Cohens perceived stress scale. Unit is summary score. | change from CABC baseline (week 0) to f-up month 27 | 
| Subjective health (HRQoL) | RAND-36 questionnaire. Unit is summary score and module-specific scores | change from CABC baseline (week 0) to f-up month 27 | 
| Coping | TOMCATS questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up month 27 | 
| Anxiety and depression | PHQ-4 questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up month 27 | 
| Fatigue | Chalders' fatigue questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up month 27 | 
| Mindfulness | Baer 2006 mindfulness questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up month 27 | 
| Sleep | selected questions fro SUSSH questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up month 27 | 
| EORTC QLQ-C30 | EORTC health related quality of life (HRQoL) general questionnaire. Unit is summary score. | change from NBCR baseline to f-up month 27 | 
| EORTC QLQ-BR23 | EORTC breast cancer questionnaire. Unit is summary score. | change from NBCR baseline to f-up month 27 | 
| Neuropathy (FACT GOG-NTX and -ES) | neuropathy questionnaire. Unit is summary score. | From NBCR baseline to f-up month 27 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health Related Quality of Life, Stress management intervention