- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03087422
Text Message (SMS) to Help Cancer Patients in Chemotherapy Treatment
An Intervention Based on Text Message (SMS) to Help Cancer Patients in Chemotherapy Treatment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Samanta Madruga, Dr.
- Phone Number: 55533284-4900
- Email: ensino@heufpel.com.br
Study Contact Backup
- Name: Timoteo Rico
- Phone Number: 555332739073
- Email: timoteomr@gmail.com
Study Locations
-
-
RS
-
Pelotas, RS, Brazil, 96020-360
- Recruiting
- Federal University of Pelotas
-
Contact:
- Timoteo Rico
- Phone Number: 555332739073
- Email: timoteomr@gmail.com
-
Contact:
- Samanta Madruga
- Phone Number: 55533284-4900
- Email: ensino@heufpel.com.br
-
Principal Investigator:
- Timoteo Rico
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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. |
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
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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