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

February 11, 2022 updated by: Cancer Registry of Norway

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
390

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stress
Time Frame: change from CABC baseline (week 0) to f-up week 21
Cohens perceived stress scale. Unit is summary score.
change from CABC baseline (week 0) to f-up week 21

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subjective health (HRQoL)
Time Frame: change from CABC baseline (week 0) to f-up week 21
RAND-36 questionnaire. Unit is summary score and module-specific scores
change from CABC baseline (week 0) to f-up week 21
Coping
Time Frame: change from CABC baseline (week 0) to f-up week 21
TOMCATS questionnaire. Unit is summary score.
change from CABC baseline (week 0) to f-up week 21
Anxiety and depression
Time Frame: change from CABC baseline (week 0) to f-up week 21
PHQ-4 questionnaire. Unit is summary score.
change from CABC baseline (week 0) to f-up week 21
Fatigue
Time Frame: change from CABC baseline (week 0) to f-up week 21
Chalders' fatigue questionnaire. Unit is summary score.
change from CABC baseline (week 0) to f-up week 21
Mindfulness
Time Frame: change from CABC baseline (week 0) to f-up week 21
Baer 2006 mindfulness questionnaire. Unit is summary score.
change from CABC baseline (week 0) to f-up week 21
Sleep
Time Frame: change from CABC baseline (week 0) to f-up week 21
selected questions fro SUSSH questionnaire. Unit is summary score.
change from CABC baseline (week 0) to f-up week 21
EORTC QLQ-C30
Time Frame: From NBCR baseline to f-up week 20
EORTC health related quality of life (HRQoL) general questionnaire. Unit is summary score.
From NBCR baseline to f-up week 20
EORTC QLQ-BR23
Time Frame: From NBCR baseline to f-up week 20
EORTC breast cancer questionnaire. Unit is summary score.
From NBCR baseline to f-up week 20
Neuropathy (FACT GOG-NTX and -ES)
Time Frame: From NBCR baseline to f-up week 20
neuropathy questionnaire. Unit is summary score.
From NBCR baseline to f-up week 20
Stress
Time Frame: change from CABC baseline (week 0) to f-up month 15
Cohens perceived stress scale. Unit is summary score.
change from CABC baseline (week 0) to f-up month 15
Subjective health (HRQoL)
Time Frame: change from CABC baseline (week 0) to f-up month 15
RAND-36 questionnaire. Unit is summary score and module-specific scores
change from CABC baseline (week 0) to f-up month 15
Coping
Time Frame: change from CABC baseline (week 0) to f-up month 15
TOMCATS questionnaire. Unit is summary score.
change from CABC baseline (week 0) to f-up month 15
Fatigue
Time Frame: change from CABC baseline (week 0) to f-up month 15
Chalders' fatigue questionnaire. Unit is summary score.
change from CABC baseline (week 0) to f-up month 15
Mindfulness
Time Frame: change from CABC baseline (week 0) to f-up month 15
Baer 2006 mindfulness questionnaire. Unit is summary score.
change from CABC baseline (week 0) to f-up month 15
Anxiety and depression
Time Frame: change from CABC baseline (week 0) to f-up month 15
PHQ-4 questionnaire. Unit is summary score.
change from CABC baseline (week 0) to f-up month 15
Sleep
Time Frame: change from CABC baseline (week 0) to f-up month 15
selected questions fro SUSSH questionnaire. Unit is summary score.
change from CABC baseline (week 0) to f-up month 15
Work
Time Frame: status at f-up month 15
questions on employment. Whether employed and percentage
status at f-up month 15
Stress
Time Frame: change from CABC baseline (week 0) to f-up month 27
Cohens perceived stress scale. Unit is summary score.
change from CABC baseline (week 0) to f-up month 27
Subjective health (HRQoL)
Time Frame: change from CABC baseline (week 0) to f-up month 27
RAND-36 questionnaire. Unit is summary score and module-specific scores
change from CABC baseline (week 0) to f-up month 27
Coping
Time Frame: change from CABC baseline (week 0) to f-up month 27
TOMCATS questionnaire. Unit is summary score.
change from CABC baseline (week 0) to f-up month 27
Anxiety and depression
Time Frame: change from CABC baseline (week 0) to f-up month 27
PHQ-4 questionnaire. Unit is summary score.
change from CABC baseline (week 0) to f-up month 27
Fatigue
Time Frame: change from CABC baseline (week 0) to f-up month 27
Chalders' fatigue questionnaire. Unit is summary score.
change from CABC baseline (week 0) to f-up month 27
Mindfulness
Time Frame: change from CABC baseline (week 0) to f-up month 27
Baer 2006 mindfulness questionnaire. Unit is summary score.
change from CABC baseline (week 0) to f-up month 27
Sleep
Time Frame: change from CABC baseline (week 0) to f-up month 27
selected questions fro SUSSH questionnaire. Unit is summary score.
change from CABC baseline (week 0) to f-up month 27
EORTC QLQ-C30
Time Frame: change from NBCR baseline to f-up month 27
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
Time Frame: change from NBCR baseline to f-up month 27
EORTC breast cancer questionnaire. Unit is summary score.
change from NBCR baseline to f-up month 27
Neuropathy (FACT GOG-NTX and -ES)
Time Frame: From NBCR baseline to f-up month 27
neuropathy questionnaire. Unit is summary score.
From NBCR baseline to f-up month 27

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cancer Registry of Norway

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Giske Ursin, MD, PhD, Cancer Registry of Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2035

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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