Coping After Breast Cancer - a Randomized Clinical Trial With Two Digital Interventions
- Conditions
- Breast Cancer PatientsHealth, Subjective
- Interventions
- Other: Stressproffen mindfulness based interventionOther: Stressproffen cognitive based stress managementOther: Control
- Registration Number
- NCT04480203
- Lead Sponsor
- Norwegian Institute of Public Health
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 390
- 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)
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mindfulness based intervention (MBI) Stressproffen mindfulness based intervention Mindfulness based digital intervention. Cognitive based stress management (CBSM) Stressproffen cognitive based stress management Cognitive based digital intervention. Control Control Control arm. No intervention.
- Primary Outcome Measures
Name Time Method Stress change from CABC baseline (week 0) to f-up week 21 Cohens perceived stress scale. Unit is summary score.
- Secondary Outcome Measures
Name Time Method Anxiety and depression change from CABC baseline (week 0) to f-up month 27 PHQ-4 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.
Coping change from CABC baseline (week 0) to f-up month 27 TOMCATS 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.
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
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.
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.
Trial Locations
- Locations (1)
Cancer Registry of Norway
🇳🇴Oslo, Norway