NCT03087422

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2017

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

1.1 years

First QC Date

March 3, 2017

Last Update Submit

March 16, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change from Anxiety and Depression - HADS (Hospital Anxiety and Depression Scale) questionnaire

    Up to 4 month

Other Outcomes (1)

  • Change from ECOG (The Eastern Cooperative Oncology Group) scale - performance status - well-being

    Up to 4 month

Study Arms (2)

intervention

EXPERIMENTAL

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

control

NO INTERVENTION

The patients allocated in this group will receive the standard care.

Interventions

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

intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Pelotas

Pelotas, Rio Grande do Sul, 96020-360, Brazil

RECRUITING

Related Publications (1)

  • Rico TM, Dos Santos Machado K, Fernandes VP, Madruga SW, Santin MM, Petrarca CR, Dumith SC. Use of Text Messaging (SMS) for the Management of Side Effects in Cancer Patients Undergoing Chemotherapy Treatment: a Randomized Controlled Trial. J Med Syst. 2020 Sep 30;44(11):193. doi: 10.1007/s10916-020-01663-x.

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Samanta Madruga, Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Hospital Escola

Study Record Dates

First Submitted

March 3, 2017

First Posted

March 22, 2017

Study Start

August 1, 2016

Primary Completion

September 1, 2017

Study Completion

December 15, 2017

Last Updated

March 22, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations