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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Health, Subjective; Breast Cancer Patients
• Intervention / Treatment: Other: Stressproffen cognitive based stress management; Other: Stressproffen mindfulness based intervention; Other: Control

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 Type: Interventional
• Enrollment (Anticipated): 390
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giske Ursin, MD, PhD; Phone Number: +4722451300; Email: giske.ursin@kreftregisteret.no
• Study Contact Backup: Name: Ine M Larsson; Phone Number: +4722928985; Email: ine.marie.larsson@kreftregisteret.no

Study Locations

• Norway
  • Oslo, Norway, 0379
    • Recruiting
    • Cancer Registry of Norway
    • Contact: Giske Ursin; Phone Number: +47 22928701; Email: giske.ursin@kreftregisteret.no
    • Contact: Ine Marie Larsson; Phone Number: +4722928985; Email: ine.marie.larsson@kreftregisteret.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: CBSM
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: MBI
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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cancer Registry of Norway
• Investigators: Principal Investigator: Giske Ursin, MD, PhD, Cancer Registry of Norway

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): December 31, 2035

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (Actual): July 21, 2020

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Health Related Quality of Life; Stress management intervention
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CABC - Kreftfor project - SEB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No