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NCT Number: NCT04480203

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

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.

Recruiting

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Key information

Conditions

Breast Cancer Patients Health, Subjective

Age range

20 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stressproffen cognitive based stress management

Other

The participants will download an app (Stressproffen 2A) with cognitive based stress management.

Other names: CBSM

Stressproffen mindfulness based intervention

Other

The participants will download an app (Stressproffen 2B) with mindfulness based intervention.

Other names: MBI

Control

Other

The participants will receive no app. (They will be able to download it after the end of the 3 year study).

Primary outcomes

  1. Stress

    Time frame: change from CABC baseline (week 0) to f-up week 21

    Cohens perceived stress scale. Unit is summary score.

Secondary outcomes

  1. 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

  2. Coping

    Time frame: change from CABC baseline (week 0) to f-up week 21

    TOMCATS questionnaire. Unit is summary score.

  3. Anxiety and depression

    Time frame: change from CABC baseline (week 0) to f-up week 21

    PHQ-4 questionnaire. Unit is summary score.

  4. Fatigue

    Time frame: change from CABC baseline (week 0) to f-up week 21

    Chalders' fatigue questionnaire. Unit is summary score.

  5. Mindfulness

    Time frame: change from CABC baseline (week 0) to f-up week 21

    Baer 2006 mindfulness questionnaire. Unit is summary score.

  6. Sleep

    Time frame: change from CABC baseline (week 0) to f-up week 21

    selected questions fro SUSSH questionnaire. Unit is summary score.

  7. 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.

  8. EORTC QLQ-BR23

    Time frame: From NBCR baseline to f-up week 20

    EORTC breast cancer questionnaire. Unit is summary score.

  9. Neuropathy (FACT GOG-NTX and -ES)

    Time frame: From NBCR baseline to f-up week 20

    neuropathy questionnaire. Unit is summary score.

  10. Stress

    Time frame: change from CABC baseline (week 0) to f-up month 15

    Cohens perceived stress scale. Unit is summary score.

  11. 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

  12. Coping

    Time frame: change from CABC baseline (week 0) to f-up month 15

    TOMCATS questionnaire. Unit is summary score.

  13. Fatigue

    Time frame: change from CABC baseline (week 0) to f-up month 15

    Chalders' fatigue questionnaire. Unit is summary score.

  14. Mindfulness

    Time frame: change from CABC baseline (week 0) to f-up month 15

    Baer 2006 mindfulness questionnaire. Unit is summary score.

  15. Anxiety and depression

    Time frame: change from CABC baseline (week 0) to f-up month 15

    PHQ-4 questionnaire. Unit is summary score.

  16. Sleep

    Time frame: change from CABC baseline (week 0) to f-up month 15

    selected questions fro SUSSH questionnaire. Unit is summary score.

  17. Work

    Time frame: status at f-up month 15

    questions on employment. Whether employed and percentage

  18. Stress

    Time frame: change from CABC baseline (week 0) to f-up month 27

    Cohens perceived stress scale. Unit is summary score.

  19. 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

  20. Coping

    Time frame: change from CABC baseline (week 0) to f-up month 27

    TOMCATS questionnaire. Unit is summary score.

  21. Anxiety and depression

    Time frame: change from CABC baseline (week 0) to f-up month 27

    PHQ-4 questionnaire. Unit is summary score.

  22. Fatigue

    Time frame: change from CABC baseline (week 0) to f-up month 27

    Chalders' fatigue questionnaire. Unit is summary score.

  23. Mindfulness

    Time frame: change from CABC baseline (week 0) to f-up month 27

    Baer 2006 mindfulness questionnaire. Unit is summary score.

  24. Sleep

    Time frame: change from CABC baseline (week 0) to f-up month 27

    selected questions fro SUSSH questionnaire. Unit is summary score.

  25. 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.

  26. EORTC QLQ-BR23

    Time frame: change from NBCR baseline to f-up month 27

    EORTC breast cancer questionnaire. Unit is summary score.

  27. Neuropathy (FACT GOG-NTX and -ES)

    Time frame: From NBCR baseline to f-up month 27

    neuropathy questionnaire. Unit is summary score.

Study contacts

Contact information is provided by the study sponsor or research team.

Giske Ursin, MD, PhD

CONTACT

[email protected]

+4722451300

Ine M Larsson

CONTACT

[email protected]

+4722928985

Sponsors and collaborators

Lead sponsor

Norwegian Institute of Public Health

Other Gov

Registry information

Official study title

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

Acronym: CABC

Important dates

Study start
2021
Primary completion
2023
Study completion
2035
First posted
Jul 21, 2020
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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