CancerNCT03087422
Text Message (SMS) to Help Cancer Patients in Chemotherapy Treatment
A study testing Text message intervention in people with Cancer and Side Effect, run by Samanta Winck Madruga at 1 site in Brazil.
Trial summary
This study evaluates the text message (SMS) with orientation to help the management of chemotherapy treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cancer, Side Effect
- What is being tested?
- Text message intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2016to 15 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer patients who will start chemotherapy treatment in Hospital Escola of Federal University of Pelotas.
Who cannot join
- Illiterate patients; Patients who do not have their own cell phone
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Pelotas
Pelotas, Rio Grande do Sul, 96020-360
Samanta Madruga, 55533284-4900, ensino@heufpel.com.br
Timoteo Rico, 555332739073, timoteomr@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer, Side Effect
- Being tested
- Text message intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text message interventionBehavioural
The intervention consists in sending text messages with orientation that helps in homecare, specifically attempting to minimize chemotherapy side effects.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Text message intervention |
| control | No intervention | The patients allocated in this group will receive the standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 month
Secondary outcomes (1)
Change from Anxiety and Depression - HADS (Hospital Anxiety and Depression Scale) questionnaire
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.
Measured: Up to 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start1 Aug 2016
- Primary completion1 Sep 2017 (estimated)
- Study completion15 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samanta Winck Madruga
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Samanta Winck Madruga, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087422
- Sponsor's protocol ID
- HospitalEscolaUFPel
- Status last verified
- Mar 2017
- First submitted
- 3 Mar 2017
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32996027
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention Based on Text Message (SMS) to Help Cancer Patients in Chemotherapy Treatment
- ClinicalTrials.gov ID
- NCT03087422
- Acronym / sponsor ID
- HospitalEscolaUFPel
- Conditions
- Cancer, Side Effect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Samanta Winck MadrugaUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Sep 2017 (estimated)
- Study completion
- 15 Dec 2017 (estimated)
- First posted
- 22 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the text message (SMS) with orientation to help the management of chemotherapy 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Behavioral: Text message interventionThe 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. |
| control | No intervention | –The patients allocated in this group will receive the standard care. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cancer patients who will start chemotherapy treatment in Hospital Escola of Federal University of Pelotas.
Key exclusion criteria (1 listed)
- Illiterate patients; Patients who do not have their own cell phone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text message interventionThe intervention consists in sending text messages with orientation that helps in homecare, specifically attempting to minimize chemotherapy side effects. | Behavioural | intervention |
Primary outcome
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.
1 secondary outcome
Change from Anxiety and Depression - HADS (Hospital Anxiety and Depression Scale) questionnaire
Time frame: Up to 4 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- Derived from this study: PubMed 32996027Rico 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text message intervention in people with Cancer and Side Effect, run by Samanta Winck Madruga at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samanta Madruga, Dr. (55533284-4900, ensino@heufpel.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Chemotherapy Side Effects - QLQ-C30 EORTC questionnaire (time frame: Up to 4 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03087422, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017.