Design and Evaluation of the Effectiveness of a Digital Health Intervention to Improve Health Care and Outcomes for Cancer Patients

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Background: Nearly 30,000 Mexican women develop breast cancer annually. These patients frequently present multiple unmet supportive care needs. In high-income settings, incorporating electronic patient-reported outcomes (ePROs) into cancer care has demonstrated potential for increasing patient-centred care and reducing unmet needs. No such ePRO interventions have been implemented in Mexico. The objectives of this study are (I) to design a two-component intervention for monitoring ePROs among breast cancer patients using a responsive digital application and proactive follow-up by nurses, (II) to perform intervention pilot testing of the study materials, and (III) to conduct the clinical trial to assess usability and effectiveness of the intervention. Methods. The investigators designed a two-component intervention for women receiving breast cancer treatment: a responsive web application for monitoring ePROs and clinical algorithms guiding proactive follow-up by nurses. The investigators will conduct a pilot test of the intervention with 50 breast cancer patients for six weeks to assess the feasibility and inform intervention adaptations. After that, the investigators will conduct a parallel arm randomized controlled trial assigning 205 patients each to intervention and control in one of Mexico's largest public oncology hospitals. The intervention will be provided for six months, with additional three months of post-intervention observation. The control group will receive usual healthcare and a list of information sources on relevant breast cancer topics. Women diagnosed with stages I, II, or III breast cancer who initiate chemo and/or radiotherapy will be invited to participate. The study outcomes will include supportive care needs, quality of life, use of emergency services and unscheduled hospitalizations, the usability of the ePRO App, and adherence to the intervention. Information on the outcomes will be obtained through web-based self-administered questionnaires collected at baseline, 1, 3, 6, and 9 months.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 75
Healthy Volunteers: f
View:

• Women

• Age between 20 and 75 years

• Breast cancer stages I, II, or III

• Neoadjuvant or adjuvant treatment with chemotherapy that started within two to six weeks before enrollment

• Access to the internet on mobile phone, computer or tablet

• Written informed consent

Locations
Other Locations
Mexico
Hospital de Oncología del Centro Médico Nacional Siglo XXI
RECRUITING
Mexico City
UMAE Hospital de Gineco-Obstetricia No.3 Dr. Víctor Manuel Espinoza de los Reyes Sánchez CMN La Raza.
RECRUITING
Mexico City
UMAE Hospital de Especialidades CMN Gral. de Div. Manuel Ávila Camacho
RECRUITING
Puebla City
Contact Information
Primary
Svetlana V. Doubova, MD. DSc.
svetlana.doubova@gmail.com
+525556276900
Backup
Saúl Eduardo Contreras Sánchez, MD. MSc.
saul.contreras@imss.gob.mx
+525556276900
Time Frame
Start Date: 2024-03-05
Estimated Completion Date: 2025-03-31
Participants
Target number of participants: 410
Treatments
Experimental: Intervention group
The intervention group will be given access to the ePRO application and proactive clinical care, including study nurses responding to ePROs and weekly health information videos for six months.
No_intervention: Control group
Participants of the control group will be provided with a list of electronic links to videos on breast cancer-relevant topics on the websites of recognised cancer associations and health institutions.
Related Therapeutic Areas
Sponsors
Leads: Coordinación de Investigación en Salud, Mexico

This content was sourced from clinicaltrials.gov