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

Primary Purpose

Breast Cancer Patients, Health, Subjective

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Stressproffen cognitive based stress management
Stressproffen mindfulness based intervention
Control
Sponsored by
Cancer Registry of Norway
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer Patients focused on measuring Health Related Quality of Life, Stress management intervention

Eligibility Criteria

20 Years - 69 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Registry of NorwayRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Cognitive based stress management (CBSM)

Mindfulness based intervention (MBI)

Control

Arm Description

Cognitive based digital intervention.

Mindfulness based digital intervention.

Control arm. No intervention.

Outcomes

Primary Outcome Measures

Stress
Cohens perceived stress scale. Unit is summary score.

Secondary Outcome Measures

Subjective health (HRQoL)
RAND-36 questionnaire. Unit is summary score and module-specific scores
Coping
TOMCATS questionnaire. Unit is summary score.
Anxiety and depression
PHQ-4 questionnaire. Unit is summary score.
Fatigue
Chalders' fatigue questionnaire. Unit is summary score.
Mindfulness
Baer 2006 mindfulness questionnaire. Unit is summary score.
Sleep
selected questions fro SUSSH questionnaire. Unit is summary score.
EORTC QLQ-C30
EORTC health related quality of life (HRQoL) general questionnaire. Unit is summary score.
EORTC QLQ-BR23
EORTC breast cancer questionnaire. Unit is summary score.
Neuropathy (FACT GOG-NTX and -ES)
neuropathy questionnaire. Unit is summary score.
Stress
Cohens perceived stress scale. Unit is summary score.
Subjective health (HRQoL)
RAND-36 questionnaire. Unit is summary score and module-specific scores
Coping
TOMCATS questionnaire. Unit is summary score.
Fatigue
Chalders' fatigue questionnaire. Unit is summary score.
Mindfulness
Baer 2006 mindfulness questionnaire. Unit is summary score.
Anxiety and depression
PHQ-4 questionnaire. Unit is summary score.
Sleep
selected questions fro SUSSH questionnaire. Unit is summary score.
Work
questions on employment. Whether employed and percentage
Stress
Cohens perceived stress scale. Unit is summary score.
Subjective health (HRQoL)
RAND-36 questionnaire. Unit is summary score and module-specific scores
Coping
TOMCATS questionnaire. Unit is summary score.
Anxiety and depression
PHQ-4 questionnaire. Unit is summary score.
Fatigue
Chalders' fatigue questionnaire. Unit is summary score.
Mindfulness
Baer 2006 mindfulness questionnaire. Unit is summary score.
Sleep
selected questions fro SUSSH questionnaire. Unit is summary score.
EORTC QLQ-C30
EORTC health related quality of life (HRQoL) general questionnaire. Unit is summary score.
EORTC QLQ-BR23
EORTC breast cancer questionnaire. Unit is summary score.
Neuropathy (FACT GOG-NTX and -ES)
neuropathy questionnaire. Unit is summary score.

Full Information

First Posted
July 9, 2020
Last Updated
February 11, 2022
Sponsor
Cancer Registry of Norway
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1. Study Identification

Unique Protocol Identification Number
NCT04480203
Brief Title
Coping After Breast Cancer - a Randomized Clinical Trial With Two Digital Interventions
Acronym
CABC
Official Title
Coping After Breast Cancer - CABC - Stressmestring Etter Brystkreft - SEB
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
December 31, 2035 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Registry of Norway

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Breast cancer patients and age-matched controls are first invited to answer questions on HRQoL. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Patients, Health, Subjective
Keywords
Health Related Quality of Life, Stress management intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
An intervention study of breast cancer patients with two digital intervention arms and one control group.
Masking
InvestigatorOutcomes Assessor
Masking Description
Only the staff that have contact with the participants will know who receives which intervention. The statistician and investigators will be masked.
Allocation
Randomized
Enrollment
390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive based stress management (CBSM)
Arm Type
Active Comparator
Arm Description
Cognitive based digital intervention.
Arm Title
Mindfulness based intervention (MBI)
Arm Type
Active Comparator
Arm Description
Mindfulness based digital intervention.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control arm. No intervention.
Intervention Type
Other
Intervention Name(s)
Stressproffen cognitive based stress management
Other Intervention Name(s)
CBSM
Intervention Description
The participants will download an app (Stressproffen 2A) with cognitive based stress management.
Intervention Type
Other
Intervention Name(s)
Stressproffen mindfulness based intervention
Other Intervention Name(s)
MBI
Intervention Description
The participants will download an app (Stressproffen 2B) with mindfulness based intervention.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
The participants will receive no app. (They will be able to download it after the end of the 3 year study).
Primary Outcome Measure Information:
Title
Stress
Description
Cohens perceived stress scale. Unit is summary score.
Time Frame
change from CABC baseline (week 0) to f-up week 21
Secondary Outcome Measure Information:
Title
Subjective health (HRQoL)
Description
RAND-36 questionnaire. Unit is summary score and module-specific scores
Time Frame
change from CABC baseline (week 0) to f-up week 21
Title
Coping
Description
TOMCATS questionnaire. Unit is summary score.
Time Frame
change from CABC baseline (week 0) to f-up week 21
Title
Anxiety and depression
Description
PHQ-4 questionnaire. Unit is summary score.
Time Frame
change from CABC baseline (week 0) to f-up week 21
Title
Fatigue
Description
Chalders' fatigue questionnaire. Unit is summary score.
Time Frame
change from CABC baseline (week 0) to f-up week 21
Title
Mindfulness
Description
Baer 2006 mindfulness questionnaire. Unit is summary score.
Time Frame
change from CABC baseline (week 0) to f-up week 21
Title
Sleep
Description
selected questions fro SUSSH questionnaire. Unit is summary score.
Time Frame
change from CABC baseline (week 0) to f-up week 21
Title
EORTC QLQ-C30
Description
EORTC health related quality of life (HRQoL) general questionnaire. Unit is summary score.
Time Frame
From NBCR baseline to f-up week 20
Title
EORTC QLQ-BR23
Description
EORTC breast cancer questionnaire. Unit is summary score.
Time Frame
From NBCR baseline to f-up week 20
Title
Neuropathy (FACT GOG-NTX and -ES)
Description
neuropathy questionnaire. Unit is summary score.
Time Frame
From NBCR baseline to f-up week 20
Title
Stress
Description
Cohens perceived stress scale. Unit is summary score.
Time Frame
change from CABC baseline (week 0) to f-up month 15
Title
Subjective health (HRQoL)
Description
RAND-36 questionnaire. Unit is summary score and module-specific scores
Time Frame
change from CABC baseline (week 0) to f-up month 15
Title
Coping
Description
TOMCATS questionnaire. Unit is summary score.
Time Frame
change from CABC baseline (week 0) to f-up month 15
Title
Fatigue
Description
Chalders' fatigue questionnaire. Unit is summary score.
Time Frame
change from CABC baseline (week 0) to f-up month 15
Title
Mindfulness
Description
Baer 2006 mindfulness questionnaire. Unit is summary score.
Time Frame
change from CABC baseline (week 0) to f-up month 15
Title
Anxiety and depression
Description
PHQ-4 questionnaire. Unit is summary score.
Time Frame
change from CABC baseline (week 0) to f-up month 15
Title
Sleep
Description
selected questions fro SUSSH questionnaire. Unit is summary score.
Time Frame
change from CABC baseline (week 0) to f-up month 15
Title
Work
Description
questions on employment. Whether employed and percentage
Time Frame
status at f-up month 15
Title
Stress
Description
Cohens perceived stress scale. Unit is summary score.
Time Frame
change from CABC baseline (week 0) to f-up month 27
Title
Subjective health (HRQoL)
Description
RAND-36 questionnaire. Unit is summary score and module-specific scores
Time Frame
change from CABC baseline (week 0) to f-up month 27
Title
Coping
Description
TOMCATS questionnaire. Unit is summary score.
Time Frame
change from CABC baseline (week 0) to f-up month 27
Title
Anxiety and depression
Description
PHQ-4 questionnaire. Unit is summary score.
Time Frame
change from CABC baseline (week 0) to f-up month 27
Title
Fatigue
Description
Chalders' fatigue questionnaire. Unit is summary score.
Time Frame
change from CABC baseline (week 0) to f-up month 27
Title
Mindfulness
Description
Baer 2006 mindfulness questionnaire. Unit is summary score.
Time Frame
change from CABC baseline (week 0) to f-up month 27
Title
Sleep
Description
selected questions fro SUSSH questionnaire. Unit is summary score.
Time Frame
change from CABC baseline (week 0) to f-up month 27
Title
EORTC QLQ-C30
Description
EORTC health related quality of life (HRQoL) general questionnaire. Unit is summary score.
Time Frame
change from NBCR baseline to f-up month 27
Title
EORTC QLQ-BR23
Description
EORTC breast cancer questionnaire. Unit is summary score.
Time Frame
change from NBCR baseline to f-up month 27
Title
Neuropathy (FACT GOG-NTX and -ES)
Description
neuropathy questionnaire. Unit is summary score.
Time Frame
From NBCR baseline to f-up month 27

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female breast cancer patients
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giske Ursin, MD, PhD
Phone
+4722451300
Email
giske.ursin@kreftregisteret.no
First Name & Middle Initial & Last Name or Official Title & Degree
Ine M Larsson
Phone
+4722928985
Email
ine.marie.larsson@kreftregisteret.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giske Ursin, MD, PhD
Organizational Affiliation
Cancer Registry of Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Registry of Norway
City
Oslo
ZIP/Postal Code
0379
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giske Ursin
Phone
+47 22928701
Email
giske.ursin@kreftregisteret.no
First Name & Middle Initial & Last Name & Degree
Ine Marie Larsson
Phone
+4722928985
Email
ine.marie.larsson@kreftregisteret.no

12. IPD Sharing Statement

Plan to Share IPD
No

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

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