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

Health, Subjective Clinical Trial

— CABC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04480203
• Other study ID #: CABC - Kreftfor project - SEB
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: December 31, 2035

Study information

• Verified date: February 2022
• Source: Cancer Registry of Norway
• Contact: Giske Ursin, MD, PhD
• Phone: +4722451300
• Email: giske.ursin[@]kreftregisteret.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: December 31, 2035
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Patients
• Breast Neoplasms
• Health, Subjective

Intervention

Other:
• Stressproffen cognitive based stress management
The participants will download an app (Stressproffen 2A) with cognitive based stress management.
• Stressproffen mindfulness based intervention
The participants will download an app (Stressproffen 2B) with mindfulness based intervention.
• Control
The participants will receive no app. (They will be able to download it after the end of the 3 year study).

Locations

Country	Name	City	State
Norway	Cancer Registry of Norway	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Registry of Norway

Country where clinical trial is conducted

Norway, 

Outcome

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