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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
390
The participants will download an app (Stressproffen 2A) with cognitive based stress management.
The participants will download an app (Stressproffen 2B) with mindfulness based intervention.
The participants will receive no app. (They will be able to download it after the end of the 3 year study).
Cancer Registry of Norway
Oslo, Norway
RECRUITINGStress
Cohens perceived stress scale. Unit is summary score.
Time frame: change from CABC baseline (week 0) to f-up week 21
Subjective health (HRQoL)
RAND-36 questionnaire. Unit is summary score and module-specific scores
Time frame: change from CABC baseline (week 0) to f-up week 21
Coping
TOMCATS questionnaire. Unit is summary score.
Time frame: change from CABC baseline (week 0) to f-up week 21
Anxiety and depression
PHQ-4 questionnaire. Unit is summary score.
Time frame: change from CABC baseline (week 0) to f-up week 21
Fatigue
Chalders' fatigue questionnaire. Unit is summary score.
Time frame: change from CABC baseline (week 0) to f-up week 21
Mindfulness
Baer 2006 mindfulness questionnaire. Unit is summary score.
Time frame: change from CABC baseline (week 0) to f-up week 21
Sleep
selected questions fro SUSSH questionnaire. Unit is summary score.
Time frame: 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.
Time frame: From NBCR baseline to f-up week 20
EORTC QLQ-BR23
EORTC breast cancer questionnaire. Unit is summary score.
Time frame: From NBCR baseline to f-up week 20
Neuropathy (FACT GOG-NTX and -ES)
neuropathy questionnaire. Unit is summary score.
Time frame: From NBCR baseline to f-up week 20
Stress
Cohens perceived stress scale. Unit is summary score.
Time frame: 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
Time frame: change from CABC baseline (week 0) to f-up month 15
Coping
TOMCATS questionnaire. Unit is summary score.
Time frame: change from CABC baseline (week 0) to f-up month 15
Fatigue
Chalders' fatigue questionnaire. Unit is summary score.
Time frame: change from CABC baseline (week 0) to f-up month 15
Mindfulness
Baer 2006 mindfulness questionnaire. Unit is summary score.
Time frame: change from CABC baseline (week 0) to f-up month 15
Anxiety and depression
PHQ-4 questionnaire. Unit is summary score.
Time frame: change from CABC baseline (week 0) to f-up month 15
Sleep
selected questions fro SUSSH questionnaire. Unit is summary score.
Time frame: change from CABC baseline (week 0) to f-up month 15
Work
questions on employment. Whether employed and percentage
Time frame: status at f-up month 15
Stress
Cohens perceived stress scale. Unit is summary score.
Time frame: 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
Time frame: change from CABC baseline (week 0) to f-up month 27
Coping
TOMCATS questionnaire. Unit is summary score.
Time frame: change from CABC baseline (week 0) to f-up month 27
Anxiety and depression
PHQ-4 questionnaire. Unit is summary score.
Time frame: change from CABC baseline (week 0) to f-up month 27
Fatigue
Chalders' fatigue questionnaire. Unit is summary score.
Time frame: change from CABC baseline (week 0) to f-up month 27
Mindfulness
Baer 2006 mindfulness questionnaire. Unit is summary score.
Time frame: change from CABC baseline (week 0) to f-up month 27
Sleep
selected questions fro SUSSH questionnaire. Unit is summary score.
Time frame: 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.
Time frame: change from NBCR baseline to f-up month 27
EORTC QLQ-BR23
EORTC breast cancer questionnaire. Unit is summary score.
Time frame: change from NBCR baseline to f-up month 27
Neuropathy (FACT GOG-NTX and -ES)
neuropathy questionnaire. Unit is summary score.
Time frame: From NBCR baseline to f-up month 27
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