CABC: Coping After Breast Cancer - a Randomized Clinical Trial With Two Digital Interventions
Study Details
Study Description
Brief Summary
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Breast cancer patients and age-matched controls are first invited to answer questions on HRQoL.
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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.
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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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Cognitive based stress management (CBSM) Cognitive based digital intervention. |
Other: Stressproffen cognitive based stress management
The participants will download an app (Stressproffen 2A) with cognitive based stress management.
Other Names:
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Active Comparator: Mindfulness based intervention (MBI) Mindfulness based digital intervention. |
Other: Stressproffen mindfulness based intervention
The participants will download an app (Stressproffen 2B) with mindfulness based intervention.
Other Names:
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Placebo Comparator: Control Control arm. No intervention. |
Other: Control
The participants will receive no app. (They will be able to download it after the end of the 3 year study).
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Outcome Measures
Primary Outcome Measures
- Stress [change from CABC baseline (week 0) to f-up week 21]
Cohens perceived stress scale. Unit is summary score.
Secondary Outcome Measures
- Subjective health (HRQoL) [change from CABC baseline (week 0) to f-up week 21]
RAND-36 questionnaire. Unit is summary score and module-specific scores
- Coping [change from CABC baseline (week 0) to f-up week 21]
TOMCATS questionnaire. Unit is summary score.
- Anxiety and depression [change from CABC baseline (week 0) to f-up week 21]
PHQ-4 questionnaire. Unit is summary score.
- Fatigue [change from CABC baseline (week 0) to f-up week 21]
Chalders' fatigue questionnaire. Unit is summary score.
- Mindfulness [change from CABC baseline (week 0) to f-up week 21]
Baer 2006 mindfulness questionnaire. Unit is summary score.
- Sleep [change from CABC baseline (week 0) to f-up week 21]
selected questions fro SUSSH questionnaire. Unit is summary score.
- EORTC QLQ-C30 [From NBCR baseline to f-up week 20]
EORTC health related quality of life (HRQoL) general questionnaire. Unit is summary score.
- EORTC QLQ-BR23 [From NBCR baseline to f-up week 20]
EORTC breast cancer questionnaire. Unit is summary score.
- Neuropathy (FACT GOG-NTX and -ES) [From NBCR baseline to f-up week 20]
neuropathy questionnaire. Unit is summary score.
- Stress [change from CABC baseline (week 0) to f-up month 15]
Cohens perceived stress scale. Unit is summary score.
- Subjective health (HRQoL) [change from CABC baseline (week 0) to f-up month 15]
RAND-36 questionnaire. Unit is summary score and module-specific scores
- Coping [change from CABC baseline (week 0) to f-up month 15]
TOMCATS questionnaire. Unit is summary score.
- Fatigue [change from CABC baseline (week 0) to f-up month 15]
Chalders' fatigue questionnaire. Unit is summary score.
- Mindfulness [change from CABC baseline (week 0) to f-up month 15]
Baer 2006 mindfulness questionnaire. Unit is summary score.
- Anxiety and depression [change from CABC baseline (week 0) to f-up month 15]
PHQ-4 questionnaire. Unit is summary score.
- Sleep [change from CABC baseline (week 0) to f-up month 15]
selected questions fro SUSSH questionnaire. Unit is summary score.
- Work [status at f-up month 15]
questions on employment. Whether employed and percentage
- Stress [change from CABC baseline (week 0) to f-up month 27]
Cohens perceived stress scale. Unit is summary score.
- Subjective health (HRQoL) [change from CABC baseline (week 0) to f-up month 27]
RAND-36 questionnaire. Unit is summary score and module-specific scores
- Coping [change from CABC baseline (week 0) to f-up month 27]
TOMCATS questionnaire. Unit is summary score.
- Anxiety and depression [change from CABC baseline (week 0) to f-up month 27]
PHQ-4 questionnaire. Unit is summary score.
- Fatigue [change from CABC baseline (week 0) to f-up month 27]
Chalders' fatigue questionnaire. Unit is summary score.
- Mindfulness [change from CABC baseline (week 0) to f-up month 27]
Baer 2006 mindfulness questionnaire. Unit is summary score.
- Sleep [change from CABC baseline (week 0) to f-up month 27]
selected questions fro SUSSH questionnaire. Unit is summary score.
- EORTC QLQ-C30 [change from NBCR baseline to f-up month 27]
EORTC health related quality of life (HRQoL) general questionnaire. Unit is summary score.
- EORTC QLQ-BR23 [change from NBCR baseline to f-up month 27]
EORTC breast cancer questionnaire. Unit is summary score.
- Neuropathy (FACT GOG-NTX and -ES) [From NBCR baseline to f-up month 27]
neuropathy questionnaire. Unit is summary score.
Eligibility Criteria
Criteria
Inclusion Criteria:
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first occurrence breast cancer diagnosed from Jan 1, 2020
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non-metastatic cancer stage 0-III
Invasive tumors must be:
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HER2 positive (regardless of ER, PR) or
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ER negative
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(may later include other ER+ if not conflict with recruitment for EMIT/OPTIMA)
Exclusion Criteria:
- None
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Cancer Registry of Norway | Oslo | Norway | 0379 |
Sponsors and Collaborators
- Cancer Registry of Norway
Investigators
- Principal Investigator: Giske Ursin, MD, PhD, Cancer Registry of Norway
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CABC - Kreftfor project - SEB