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Trial record 1 of 1 for:    NCT02996201
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Electronic Patient Reporting of Side Effects to Chemotherapy: A Cluster Randomized Controlled Trial

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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

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

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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


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



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) ]


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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

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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:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases