NCT02996201

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 4, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 19, 2016

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 18, 2017

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

November 4, 2016

Last Update Submit

October 17, 2017

Conditions

Adverse EventCancer, BreastChemotherapeutic ToxicityPatient Outcomes Assessments

Outcome Measures

Primary Outcomes (1)

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

    up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017

Secondary Outcomes (6)

  • Number of hospitalizations reported in the medical record after each of the six cycles of chemotherapy

    up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017

  • Febrile neutropenia reported in the medical record after each of the six cycles of chemotherapy

    up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017

  • Detailed description of side effects in the medical record before start of chemotherapy and after each six cycles of chemotherapy

    up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017

  • Handling of side effects documented in the medical record

    up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017

  • Patients' experience of communication and handling of side effects measured in questionnaire survey and qualitative interviews

    up to18 weeks of chemotherapy in the period November 1, 2015 - January 31, 2017

  • +1 more secondary outcomes

Study Arms (2)

Electronic reporting of PRO-CTCAE items

EXPERIMENTAL

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

Other: Completion of PRO-CTCAE items before consultation

Standard practice

NO INTERVENTION

Interventions

Completion of PRO-CTCAE items before consultationOTHER

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

Electronic reporting of PRO-CTCAE items

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 33837509DERIVED

  • 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.

    PMID: 31832240DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

November 4, 2016

First Posted

December 19, 2016

Study Start

November 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

October 18, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share