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

• Sponsor: Rigshospitalet, Denmark (Other)
• Overall Status: Completed
• CT.gov ID: NCT02996201
• Collaborator: Danish Cancer Society (Other)
• Enrollment: 700
• Arms: 2
• Actual Duration (Months): 14

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Adverse Event; Cancer, Breast; Chemotherapeutic Toxicity; Patient Outcomes Assessments	Other: Completion of PRO-CTCAE items before consultation	N/A

Study Design

• Study Type: Interventional
• 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: Nov 1, 2015
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

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

Primary Outcome Measures

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 Outcome Measures

1. 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]

2. 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]

3. 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]

4. 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]

5. 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]

6. Patient and staff compliance as registerede by the software used [up to 18 weeks (November 1, 2015 - January 31, 2017)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• Rigshospitalet, Denmark
• Danish Cancer Society

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Helle Pappot, Chief physician, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT02996201
• Other Study ID Numbers: R113-A7084-14-S34
• First Posted: Dec 19, 2016
• Last Update Posted: Oct 18, 2017
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Oct 18, 2017