Text Message (SMS) to Help Cancer Patients in Chemotherapy Treatment

March 16, 2017 updated by: Samanta Winck Madruga

An Intervention Based on Text Message (SMS) to Help Cancer Patients in Chemotherapy Treatment

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Pelotas, RS, Brazil, 96020-360
        • Recruiting
        • Federal University of Pelotas
        • Contact:
        • Contact:
        • Principal Investigator:
          • Timoteo Rico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention

The patients in this group will receive daily a text message (SMS) with some orientation about Homecare as an attempt to minimize the side effects of chemotherapy.

The text messages are based on oncology guidelines.The text messages contain information about water intake, emotional support, hygiene, immunity, nutrition, and physical activity. In addition, text messages about prevention and management of symptoms were also developed: nausea and vomiting, diarrhea, constipation, gas, changes in the skin and taste.

Also, the patients allocated in this group will receive the standard care.
Behavioral: Text message intervention
The intervention consists in sending text messages with orientation that helps in homecare, specifically attempting to minimize chemotherapy side effects.
No Intervention: control
The patients allocated in this group will receive the standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Chemotherapy Side Effects - QLQ-C30 EORTC questionnaire
Time Frame: Up to 4 month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Anxiety and Depression - HADS (Hospital Anxiety and Depression Scale) questionnaire
Time Frame: Up to 4 month
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from ECOG (The Eastern Cooperative Oncology Group) scale - performance status - well-being
Time Frame: Up to 4 month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samanta Winck Madruga

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

December 15, 2017

Study Registration Dates

First Submitted

March 3, 2017

First Submitted That Met QC Criteria

March 16, 2017

First Posted (Actual)

March 22, 2017

Study Record Updates

Last Update Posted (Actual)

March 22, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • HospitalEscolaUFPel

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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