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CancerDETECTNCT06077123

Telemonitoring Platforms and Chemotherapy-Associated Toxicity

A study testing Contigo Application in people with Cancer and Chemotherapeutic Agent Toxicity, run by Universidad Nacional Andres Bello at 2 sites in Chile.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary objective of this trial is to evaluate the impact of a telemonitoring platform on patient satisfaction with care amongst adult cancer patients receiving chemotherapy. The key questions it seeks to address revolve around the potential improvements in both quality of life and satisfaction with healthcare. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Chemotherapeutic Agent Toxicity
What is being tested?
Contigo Application
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesChile
Study dates
1 Apr 2024to 30 Mar 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients (>18 years)
  • Histologically confirmed diagnosis of lung, gastric, gallbladder, colon, breast, or cervical carcinoma in any of its forms and stages
  • Initiating an outpatient curative intent chemotherapy regimen within the facilities of UC-Christus Health Network or Hospital Sotero del Río during the months of November 2023 to July 2024
  • Proficient in the Spanish language
  • Possess a smartphone, regardless of the native operating system (iOS® or Android®)

Who cannot join

  • Individuals undergoing concomitant radiotherapy
  • Those with any form of sensory impairment hindering the use of the application
  • Those with cognitive impairment or psychiatric pathology preventing the use of the application
  • Those who do not wish to participate in the study

Trial locations and contacts

2 sites in 1 country.

Felipe Martinez, MD, MSc contact

+56 9 99690953

felipe.martinez.l@unab.cl

Carla Taramasco, PhD contact

carla.taramasco@unab.cl

Chile2 sites, 2 recruiting

  • Centro del Cáncer, Pontificia Universidad Católica de Chile

    Santiago

    Bruno Nervi, MD, bnervi@uc.cl

    Recruiting

  • Complejo Asistencial Dr. Sotero del Río

    Santiago

    Bruno Nervi, MD, 25762300, bnervi@uc.cl

    Not yet recruiting

Other trials in Chile

About this study

Official title: Differential Effects of a Telemonitoring Platform in the Development of Chemotherapy-Associated Toxicity: A Randomised Trial

The primary objective of this trial is to evaluate the impact of a telemonitoring platform on patient satisfaction with care amongst adult cancer patients receiving chemotherapy. The key questions it seeks to address revolve around the potential improvements in both quality of life and satisfaction with healthcare. Participants in the trial will be provided with a specialized application developed by a team of experienced oncology professionals. Their quality of life and healthcare experience will be compared with that of the control group, who will only receive the standard in-person check-ups established by their healthcare team.

Read the detailed description

This protocol describes a randomized parallel-group clinical trial among recently diagnosed patients with solid carcinomas preparing for curative intent chemotherapy at Hospital Sótero del Río and UC-Christus Health Network centers. Eligible adult patients (>18 years) diagnosed with lung, gastric, gallbladder, colon, breast, or cervical carcinoma, scheduled for outpatient curative intent chemotherapy within UC-Christus Health Network or Hospital Sotero del Rio from November 2023 to July 2024, proficient in Spanish, and possessing a smartphone (iOS® or Android®) will be recruited. Exclusions include those undergoing concomitant radiotherapy, sensory impairments hindering app use, cognitive or psychiatric issues, and unwillingness to participate. Participants will be randomized 1:1 to receive either the Contigo smartphone application or standard care. Contigo aims to monitor chemotherapy toxicity symptoms and deliver cancer-related educational content. The application includes modules addressing cancer care, self-perception of health, patient experiences, frequently asked questions, community resources, and scheduling. Information collected by the app will be available to healthcare providers. Patients will receive the app for free and undergo training on its usage. Weekly toxicity assessments using Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) will be conducted. The control group will receive standard in-person care. The primary outcome is patient experience during chemotherapy, measured using the OUT-PATSAT-35 questionnaire three months after randomization. Secondary outcomes include severe chemotherapy-associated toxicity, quality of life, and user satisfaction with the application. A sample size of 80 participants (40 per group) was calculated. Descriptive analysis will utilize means, standard deviation, frequencies, and percentages. Inferential analysis will involve t-tests, Mann-Whitney U tests, Fisher's Exact Test, and Kaplan-Meier survival curves. All analyses will adhere to intention-to-treat principles and use Stata v.16.0® software. No subgroup analyses have been programmed.

Being tested
Contigo Application
Keywords
Telemonitoring, Internet, Smartphones, Quality of Life, User Satisfaction
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Contigo ApplicationDevice

    Contigo, a smartphone application, aims to achieve two main objectives: monitoring cancer patients for early detection of oncology drug toxicity signs and providing educational content to empower patients in handling clinical challenges tied to their diagnosis and treatment. Monitoring involves modules and sub-modules where patients input experiences through oncology-related questionnaires. Weekly checks for chemotherapy toxicity-associated symptoms use a validated questionnaire (PRO-CTCAE). Severe toxicity triggers immediate alerts, while milder cases receive educational guidance. Data collected is shared with healthcare providers. Educational health content has been created by professionals, encompassing cancer-specific topics, healthcare processes, administration, health coverage, self-awareness, and self-care practices. The content is based on scientific evidence, official reports, and group sessions involving healthcare professionals and cancer patients.

Study groups in NCT06077123
Study groupRoleWhat they receive
Telemonitoring PlatformExperimentalPatients allocated to the active intervention group will receive a smartphone application called Contigo. This tool aims to detect signs and symptoms of oncology drug toxicity and delivering educational content that enables the patient to have tools to address common clinical situations associated with the diagnosis and treatment of their disease.
Receives: Device: Contigo Application
Traditional Follow-UpNo interventionThose assigned to the traditional follow-up group will receive standard care and in-person check-ups as determined by their attending physician.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Experience Scores

    Patient Satisfaction with Healthcare Services Provided using the European Organisation for Research and Treatment of Cancer Satisfaction with Cancer Care for Outpatients questionnaire (EORTC OUTPATSAT-35). Scores can range from 0 to 100 points, with higher scores implying greater satisfaction with care.

    Measured: 3 months after randomization

Secondary outcomes (5)

  1. Quality of Life Scores

    Quality of Life scores as assessed by the EuroQol 5 Dimension (EQ-5D) questionnaire. The index score ranges from 0 to 1, with higher values indicating an overall better quality of life.

    Measured: 3 months after randomization

  2. Severe adverse event attributable to chemotherapy

    Proportion of patients who develop a severe adverse event attributable to cytotoxic chemotherapy. Severe events will be those of grade 3 to 5 of the Common Terminology Criteria for Adverse Events classification.

    Measured: 3 months after randomization

  3. Hospitalizations due to a chemotherapy adverse event

    Propotion of patients who require hospitalizations due to an adverse event attributable to cytotoxic chemotherapy

    Measured: 3 months after randomization

  4. Chemotherapy dose adjustment

    Proportion of patients who require a reduction in their chemotherapy dose in each group.

    Measured: 3 months after randomization

  5. Emergency department visits

    Median number of emergency department visits in each study group

    Measured: 3 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2023
  2. Study start1 Apr 2024
  3. Primary completion30 Dec 2024 (estimated)
  4. Study completion30 Mar 2025 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomized in a 1:1 ratio using a permuted block method to receive one of the two intervention strategies.
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06077123
Sponsor's protocol ID
UNAB-004
Acronym
DETECT
Status last verified
Apr 2024
First submitted
4 Oct 2023
Last updated
8 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Anonymized individual participant data including clinical characteristics and outcomes will be made available to other researchers on reasonable request, such as to inform the conduction a systematic review on telemonitoring platforms for providing care to patients with cancers.

Publications

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338

  • Arnold B, Mitchell SA, Lent L, Mendoza TR, Rogak LJ, Barragan NM, Willis G, Medina M, Lechner S, Penedo FJ, Harness JK, Basch EM; PRO-CTCAE Spanish Translation and Linguistic Validation Study Group. Linguistic validation of the Spanish version of the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Support Care Cancer. 2016 Jul;24(7):2843-51. doi: 10.1007/s00520-015-3062-5. Epub 2016 Feb 2.

    PubMed 26838022

  • Basch E, Stover AM, Schrag D, Chung A, Jansen J, Henson S, Carr P, Ginos B, Deal A, Spears PA, Jonsson M, Bennett AV, Mody G, Thanarajasingam G, Rogak LJ, Reeve BB, Snyder C, Kottschade LA, Charlot M, Weiss A, Bruner D, Dueck AC. Clinical Utility and User Perceptions of a Digital System for Electronic Patient-Reported Symptom Monitoring During Routine Cancer Care: Findings From the PRO-TECT Trial. JCO Clin Cancer Inform. 2020 Oct;4:947-957. doi: 10.1200/CCI.20.00081.

    PubMed 33112661

  • Zarate V, Kind P, Valenzuela P, Vignau A, Olivares-Tirado P, Munoz A. Social valuation of EQ-5D health states: the Chilean case. Value Health. 2011 Dec;14(8):1135-41. doi: 10.1016/j.jval.2011.09.002. Epub 2011 Nov 6.

    PubMed 22152184

  • Arraras JI, Illarramendi JJ, Viudez A, Lecumberri MJ, de la Cruz S, Hernandez B, Zarandona U, Bredart A, Martinez M, Salgado E, Lainez N, Vera R. The cancer outpatient satisfaction with care questionnaire for chemotherapy, OUT-PATSAT35 CT: a validation study for Spanish patients. Support Care Cancer. 2012 Dec;20(12):3269-78. doi: 10.1007/s00520-012-1467-y. Epub 2012 May 2.

    PubMed 22549507

  • Martinez F, Taramasco C, Espinoza M, Acevedo J, Goic C, Nervi B. Differential Effects of a Telemonitoring Platform in the Development of Chemotherapy-Associated Toxicity: A Randomized Trial Protocol. Diagnostics (Basel). 2024 Mar 14;14(6):619. doi: 10.3390/diagnostics14060619.

    PubMed 38535039

Questions about this trial

What is this clinical trial studying?

A study testing Contigo Application in people with Cancer and Chemotherapeutic Agent Toxicity, run by Universidad Nacional Andres Bello at 2 sites in Chile.

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 5 inclusion and 4 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 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Chile. 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 Felipe Martinez, MD, MSc (+56 9 99690953, felipe.martinez.l@unab.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Experience Scores (time frame: 3 months after randomization). 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 NCT06077123, which also lists 6 linked publications.

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 8 Apr 2024.

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DETECT Clinical Trial NCT06077123 | AzTrials