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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03087422
Other study ID # HospitalEscolaUFPel
Secondary ID
Status Recruiting
Phase N/A
First received March 3, 2017
Last updated March 16, 2017
Start date August 1, 2016
Est. completion date December 15, 2017

Study information

Verified date March 2017
Source Federal University of Pelotas
Contact Samanta Madruga, Dr.
Phone 55533284-4900
Email ensino@heufpel.com.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the text message (SMS) with orientation to help the management of chemotherapy treatment.


Description:

The investigators developed an app (called ChemotherApp) for Android that automatically sends text messages with homecare orientation to cancer patients in intervention group. The main features of this app are: to register information such as name, number of cellphone, gender, and chemotherapy schedule of the patient. Other feature is to register the orientation that will be sent to patients by text messages. Daily, the app send a registered orientation to each patient.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 15, 2017
Est. primary completion date September 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Cancer patients who will start chemotherapy treatment in Hospital Escola of Federal University of Pelotas.

Exclusion Criteria:

- Illiterate patients; Patients who do not have their own cell phone

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Text message intervention
The intervention consists in sending text messages with orientation that helps in homecare, specifically attempting to minimize chemotherapy side effects.

Locations

Country Name City State
Brazil Federal University of Pelotas Pelotas RS

Sponsors (1)

Lead Sponsor Collaborator
Samanta Winck Madruga

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Other Change from ECOG (The Eastern Cooperative Oncology Group) scale - performance status - well-being ECOG (The Eastern Cooperative Oncology Group) scale will be used to evaluate the performance status,to measure the well-being. It will be investigated if patients who will receive the text message will have better performance status than patients who will not receive text messages. A performance status will be evaluated at the beginning of treatment and at the beginning of the second cycle of chemotherapy. Up to 4 month
Primary Change from Chemotherapy Side Effects - QLQ-C30 EORTC questionnaire To measure the side effects, the QLQ-C30 EORTC questionnaire is going to be used. This questionnaire aims to identify if the patient had nausea and vomit, diarrhea, pain, fever, constipation, diarrhea, gas, among other symptoms. It will be investigated if patients who will receive the text message will have less side effects than patients who will not receive text messages. The questionnaire will be applied to each patient in the study at the beginning of the second,third and fourth cycles of chemotherapy. Up to 4 month
Secondary Change from Anxiety and Depression - HADS (Hospital Anxiety and Depression Scale) questionnaire To measure anxiety and depression, the HADS (Hospital Anxiety and Depression Scale) questionnaire is going to be used. It will be investigated if patients who will receive the text message will have less score of depression and anxiety than patients who will not receive text messages. The HADS questionnaire is going to be applied to each patient on the first day of treatment and at the beginning of the fourth cycle of chemotherapy. Up to 4 month
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