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Trial record 91 of 661 for:    SMS

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

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ClinicalTrials.gov Identifier: NCT03087422
Recruitment Status : Unknown
Verified March 2017 by Samanta Winck Madruga, Federal University of Pelotas.
Recruitment status was:  Recruiting
First Posted : March 22, 2017
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Samanta Winck Madruga, Federal University of Pelotas

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

Condition or disease Intervention/treatment Phase
Cancer Side Effect Behavioral: Text message intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: An Intervention Based on Text Message (SMS) to Help Cancer Patients in Chemotherapy Treatment
Actual Study Start Date : August 1, 2016
Estimated Primary Completion Date : September 1, 2017
Estimated Study Completion Date : December 15, 2017

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03087422


Contacts
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Contact: Samanta Madruga, Dr. 55533284-4900 ensino@heufpel.com.br
Contact: Timoteo Rico 555332739073 timoteomr@gmail.com

Locations
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Brazil
Federal University of Pelotas Recruiting
Pelotas, RS, Brazil, 96020-360
Contact: Samanta Madruga    55533284-4900    ensino@heufpel.com.br   
Contact: Timoteo Rico    555332739073    timoteomr@gmail.com   
Principal Investigator: Timoteo Rico         
Sponsors and Collaborators
Samanta Winck Madruga

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Responsible Party: Samanta Winck Madruga, Hospital Escola, Federal University of Pelotas
ClinicalTrials.gov Identifier: NCT03087422     History of Changes
Other Study ID Numbers: HospitalEscolaUFPel
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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