Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02996201
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02996201
Recruitment Status : Completed
First Posted : December 19, 2016
Last Update Posted : October 18, 2017
Sponsor:
Collaborator:
Danish Cancer Society
Information provided by (Responsible Party):
Helle Pappot, Rigshospitalet, Denmark

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Adverse Event Cancer, Breast Chemotherapeutic Toxicity Patient Outcomes Assessments Other: Completion of PRO-CTCAE items before consultation Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : November 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Electronic reporting of PRO-CTCAE items
Patients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy
 Other: Completion of PRO-CTCAE items before consultation
Patients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy
No Intervention: Standard practice


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. Patient and staff compliance as registerede by the software used [ Time Frame: up to 18 weeks (November 1, 2015 - January 31, 2017) ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Helle Pappot, Chief physician, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02996201     History of Changes
Other Study ID Numbers: R113-A7084-14-S34
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases