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

Sponsor
Cancer Registry of Norway (Other)
Overall Status
Recruiting
CT.gov ID
NCT04480203
Collaborator
(none)
390
1
3
179.5
2.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Stressproffen cognitive based stress management
  • Other: Stressproffen mindfulness based intervention
  • Other: Control
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
390 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
An intervention study of breast cancer patients with two digital intervention arms and one control group.An intervention study of breast cancer patients with two digital intervention arms and one control group.
Masking:
Double (Investigator, Outcomes 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.
Primary Purpose:
Prevention
Official Title:
Coping After Breast Cancer - CABC - Stressmestring Etter Brystkreft - SEB
Actual Study Start Date :
Jan 15, 2021
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Dec 31, 2035

Arms and Interventions

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).

    Outcome Measures

    Primary Outcome Measures

    1. Stress [change from CABC baseline (week 0) to f-up week 21]

      Cohens perceived stress scale. Unit is summary score.

    Secondary Outcome Measures

    1. Subjective health (HRQoL) [change from CABC baseline (week 0) to f-up week 21]

      RAND-36 questionnaire. Unit is summary score and module-specific scores

    2. Coping [change from CABC baseline (week 0) to f-up week 21]

      TOMCATS questionnaire. Unit is summary score.

    3. Anxiety and depression [change from CABC baseline (week 0) to f-up week 21]

      PHQ-4 questionnaire. Unit is summary score.

    4. Fatigue [change from CABC baseline (week 0) to f-up week 21]

      Chalders' fatigue questionnaire. Unit is summary score.

    5. Mindfulness [change from CABC baseline (week 0) to f-up week 21]

      Baer 2006 mindfulness questionnaire. Unit is summary score.

    6. Sleep [change from CABC baseline (week 0) to f-up week 21]

      selected questions fro SUSSH questionnaire. Unit is summary score.

    7. EORTC QLQ-C30 [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 [From NBCR baseline to f-up week 20]

      EORTC breast cancer questionnaire. Unit is summary score.

    9. Neuropathy (FACT GOG-NTX and -ES) [From NBCR baseline to f-up week 20]

      neuropathy questionnaire. Unit is summary score.

    10. Stress [change from CABC baseline (week 0) to f-up month 15]

      Cohens perceived stress scale. Unit is summary score.

    11. Subjective health (HRQoL) [change from CABC baseline (week 0) to f-up month 15]

      RAND-36 questionnaire. Unit is summary score and module-specific scores

    12. Coping [change from CABC baseline (week 0) to f-up month 15]

      TOMCATS questionnaire. Unit is summary score.

    13. Fatigue [change from CABC baseline (week 0) to f-up month 15]

      Chalders' fatigue questionnaire. Unit is summary score.

    14. Mindfulness [change from CABC baseline (week 0) to f-up month 15]

      Baer 2006 mindfulness questionnaire. Unit is summary score.

    15. Anxiety and depression [change from CABC baseline (week 0) to f-up month 15]

      PHQ-4 questionnaire. Unit is summary score.

    16. Sleep [change from CABC baseline (week 0) to f-up month 15]

      selected questions fro SUSSH questionnaire. Unit is summary score.

    17. Work [status at f-up month 15]

      questions on employment. Whether employed and percentage

    18. Stress [change from CABC baseline (week 0) to f-up month 27]

      Cohens perceived stress scale. Unit is summary score.

    19. Subjective health (HRQoL) [change from CABC baseline (week 0) to f-up month 27]

      RAND-36 questionnaire. Unit is summary score and module-specific scores

    20. Coping [change from CABC baseline (week 0) to f-up month 27]

      TOMCATS questionnaire. Unit is summary score.

    21. Anxiety and depression [change from CABC baseline (week 0) to f-up month 27]

      PHQ-4 questionnaire. Unit is summary score.

    22. Fatigue [change from CABC baseline (week 0) to f-up month 27]

      Chalders' fatigue questionnaire. Unit is summary score.

    23. Mindfulness [change from CABC baseline (week 0) to f-up month 27]

      Baer 2006 mindfulness questionnaire. Unit is summary score.

    24. Sleep [change from CABC baseline (week 0) to f-up month 27]

      selected questions fro SUSSH questionnaire. Unit is summary score.

    25. EORTC QLQ-C30 [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 [change from NBCR baseline to f-up month 27]

      EORTC breast cancer questionnaire. Unit is summary score.

    27. Neuropathy (FACT GOG-NTX and -ES) [From NBCR baseline to f-up month 27]

      neuropathy questionnaire. Unit is summary score.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 69 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cancer Registry of Norway Oslo Norway 0379

    Sponsors and Collaborators

    • Cancer Registry of Norway

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cancer Registry of Norway
    ClinicalTrials.gov Identifier:
    NCT04480203
    Other Study ID Numbers:
    • CABC - Kreftfor project - SEB
    First Posted:
    Jul 21, 2020
    Last Update Posted:
    Mar 2, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Cancer Registry of Norway
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 2, 2022