Text Message (SMS) to Help Cancer Patients in Chemotherapy Treatment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Cancer Side Effect||Behavioral: Text message intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|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|
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.
- 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.
- 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.
- 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.
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
|Contact: Samanta Madruga, Dr.||firstname.lastname@example.org|
|Contact: Timoteo Ricoemail@example.com|
|Federal University of Pelotas||Recruiting|
|Pelotas, RS, Brazil, 96020-360|
|Contact: Samanta Madruga 55533284-4900 firstname.lastname@example.org|
|Contact: Timoteo Rico 555332739073 email@example.com|
|Principal Investigator: Timoteo Rico|