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Completed

NCT Number: NCT02996201

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

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.

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Key information

Conditions

Adverse Event Breast Diseases Breast Neoplasms Cancer, Breast Chemotherapeutic Toxicity Neoplasms Neoplasms by Site Patient Outcomes Assessments Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Completion of PRO-CTCAE items before consultation

Other

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Danish Cancer Society

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 19, 2016
Registry last updated
Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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