search
Back to results

Electronic Patient Reporting of Side Effects to Chemotherapy: A Cluster Randomized Controlled Trial

Primary Purpose

Adverse Event, Cancer, Breast, Chemotherapeutic Toxicity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Completion of PRO-CTCAE items before consultation
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Adverse Event

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Gender •Female: only female participants are being studied

Minimum age

•18 years

Maximum age •N/A

Accepts Healthy Volunteers

•No

Eligibility Criteria

Inclusion criteria

  • Breast cancer patients starting adjuvant chemotherapy in the period November 1, 2015 - September 1, 2016 in Danish oncology clinics

Exclusion Criteria:

  • More than six scheduled cycles of chemotherapy
  • Not able to read and understand Danish language

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Electronic reporting of PRO-CTCAE items

    Standard practice

    Arm Description

    Patients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy

    Outcomes

    Primary Outcome Measures

    Dose adjustments reported in the medication treatment sheet before each cycle of chemotherapy (5 time points with three weeks interval)

    Secondary Outcome Measures

    Number of hospitalizations reported in the medical record after each of the six cycles of chemotherapy
    Febrile neutropenia reported in the medical record after each of the six cycles of chemotherapy
    Detailed description of side effects in the medical record before start of chemotherapy and after each six cycles of chemotherapy
    Handling of side effects documented in the medical record
    Patients' experience of communication and handling of side effects measured in questionnaire survey and qualitative interviews
    Patient and staff compliance as registerede by the software used

    Full Information

    First Posted
    November 4, 2016
    Last Updated
    October 17, 2017
    Sponsor
    Rigshospitalet, Denmark
    Collaborators
    Danish Cancer Society
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02996201
    Brief Title
    Electronic Patient Reporting of Side Effects to Chemotherapy: A Cluster Randomized Controlled Trial
    Official Title
    Electronic Patient Reporting of Side Effects to Chemotherapy Among Breast Cancer Patients Using the Patient-Reported Outcomes Version of Common Terminology Criteria for Adverse Events (PRO-CTCAE): A Cluster Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (Actual)
    Primary Completion Date
    January 2017 (Actual)
    Study Completion Date
    January 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rigshospitalet, Denmark
    Collaborators
    Danish Cancer Society

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to determine whether the use of breast cancer patients' own electronic reporting of side effects to chemotherapy in a treatment setting has an impact on the handling of side effects and on the number of hospitalizations, febrile neutropenia and dose adjustments. We are using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for the patients' reporting of side effects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adverse Event, Cancer, Breast, Chemotherapeutic Toxicity, Patient Outcomes Assessments

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    700 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Electronic reporting of PRO-CTCAE items
    Arm Type
    Experimental
    Arm Description
    Patients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy
    Arm Title
    Standard practice
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    Completion of PRO-CTCAE items before consultation
    Intervention Description
    Patients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy
    Primary Outcome Measure Information:
    Title
    Dose adjustments reported in the medication treatment sheet before each cycle of chemotherapy (5 time points with three weeks interval)
    Time Frame
    up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
    Secondary Outcome Measure Information:
    Title
    Number of hospitalizations reported in the medical record after each of the six cycles of chemotherapy
    Time Frame
    up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
    Title
    Febrile neutropenia reported in the medical record after each of the six cycles of chemotherapy
    Time Frame
    up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
    Title
    Detailed description of side effects in the medical record before start of chemotherapy and after each six cycles of chemotherapy
    Time Frame
    up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
    Title
    Handling of side effects documented in the medical record
    Time Frame
    up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
    Title
    Patients' experience of communication and handling of side effects measured in questionnaire survey and qualitative interviews
    Time Frame
    up to18 weeks of chemotherapy in the period November 1, 2015 - January 31, 2017
    Title
    Patient and staff compliance as registerede by the software used
    Time Frame
    up to 18 weeks (November 1, 2015 - January 31, 2017)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Gender •Female: only female participants are being studied Minimum age •18 years Maximum age •N/A Accepts Healthy Volunteers •No Eligibility Criteria Inclusion criteria Breast cancer patients starting adjuvant chemotherapy in the period November 1, 2015 - September 1, 2016 in Danish oncology clinics Exclusion Criteria: More than six scheduled cycles of chemotherapy Not able to read and understand Danish language

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33837509
    Citation
    Pappot H, Baeksted CW, Nissen A, Knoop A, Mitchell SA, Christensen J, Hjollund NH, Johansen C. Clinical effects of assessing electronic patient-reported outcomes monitoring symptomatic toxicities during breast cancer therapy: a nationwide and population-based study. Breast Cancer. 2021 Sep;28(5):1096-1099. doi: 10.1007/s12282-021-01244-x. Epub 2021 Apr 9.
    Results Reference
    derived
    PubMed Identifier
    31832240
    Citation
    Baeksted CW, Nissen A, Knoop AS, Pappot H. Patients' experience of communication and handling of symptomatic adverse events in breast cancer patients receiving adjuvant chemotherapy. Res Involv Engagem. 2019 Nov 20;5:36. doi: 10.1186/s40900-019-0171-1. eCollection 2019.
    Results Reference
    derived

    Learn more about this trial

    Electronic Patient Reporting of Side Effects to Chemotherapy: A Cluster Randomized Controlled Trial

    We'll reach out to this number within 24 hrs