Digital Health Intervention to Improve Health Care and Outcomes for Breast Cancer Patients

NCT05925257 | Recruiting Phase 2

• 1 other identifier: R-2021-785-059
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Health systems and information supportive care needs

  Change from baseline in health systems and information supportive care needs at 1, 3, 6 and 9 months after the intervention commencement, which will be measured with the Supportive Care Needs Survey Short Form-34 (SCNS SF-34) questionnaire validated in Mexico.

  At 1, 3, 6 and 9 months after intervention commencement

Secondary Outcomes (2)

• Global quality of life

  At 1, 3, 6 and 9 months after intervention commencement

• Breast symptoms

  At 1, 3, 6 and 9 months after intervention commencement

Other Outcomes (4)

• Use of emergency services

  At 1, 3, 6 and 9 months after intervention commencement

• Use of the responsive ePRO App in the intervention group

  At 1, 3 and 6 months after intervention commencement

• Unscheduled hospitalizations

  At 1, 3, 6 and 9 months after intervention commencement

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Other: ePRO application and proactive clinical care with nurses.

Control group

NO INTERVENTION

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.

Interventions

ePRO application and proactive clinical care with nurses. OTHER

The investigators defined ePRO intervention as a weekly register of breast cancer patients' symptoms and supportive care needs using the study ePRO App combined with proactive follow-up by nurses guided by predefined clinical algorithms and a weekly cellphone message providing an educational video from a recognised cancer association or health institution. The intervention will be provided for six months with additional three months of post-intervention observation.

Intervention group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Illiterate
• Stage IV breast cancer
• Cognitive dysfunction
• Blindness or low vision not corrected with glasses
• Severe depression (≥12 points on the Hospital Anxiety and Depression Scale)

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (3)

Hospital de Oncología del Centro Médico Nacional Siglo XXI

Mexico City, Mexico City, 06720, Mexico

RECRUITING

UMAE Hospital de Gineco-Obstetricia No.3 "Dr. Víctor Manuel Espinoza de los Reyes Sánchez" CMN La Raza.

Mexico City, 02990, Mexico

RECRUITING

UMAE Hospital de Especialidades CMN "Gral. de Div. Manuel Ávila Camacho"

Puebla City, 72089, Mexico

RECRUITING

Related Publications (2)

• Contreras Sanchez SE, Doubova SV, Martinez Vega IP, Grajales Alvarez R, Villalobos Valencia R, Dip Borunda AK, Lio Mondragon L, Martinez Pineda WJ, Nunez Cerrillo JG, Huerta Lopez AD, Zalapa Velazquez R, Mendoza Ortiz V, Vazquez Zamora VJ, Montiel Jarquin AJ, Garcia Galicia A, Talamantes Gomez EI, Sanchez Reyes R, Aguirre Gomez J, Ayala Anzures ME, Zapata Tarres M, Monroy A, Leslie HH. Addressing the unmet needs of women with breast cancer in Mexico: a non-randomised pilot study of the digital ePRO intervention. BMJ Open. 2024 Jun 21;14(6):e087240. doi: 10.1136/bmjopen-2024-087240.

  PMID: 38908841 DERIVED

• Contreras Sanchez SE, Doubova SV, Grajales Alvarez R, Dip Borunda AK, Martinez Pineda WJ, Nunez Cerrillo JG, Silva Bravo F, Zalapa Velazquez R, Gutierrez De la Barrera M, Leslie HH. Design and evaluation of a digital health intervention with proactive follow-up by nurses to improve healthcare and outcomes for patients with breast cancer in Mexico: protocol for a randomised clinical trial. BMJ Open. 2023 Nov 6;13(11):e077322. doi: 10.1136/bmjopen-2023-077322.

  PMID: 37931967 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Nurses

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Svetlana V. Doubova, MD. DSc.

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Svetlana V. Doubova, MD. DSc.

CONTACT

+525556276900; svetlana.doubova@gmail.com

Saúl Eduardo Contreras Sánchez, MD. MSc.

CONTACT

+525556276900; saul.contreras@imss.gob.mx

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Epidemiology and Health Services Research Unit National Medical Center Century XXI of the Mexican Institute of Social Security and Principal Investigator of the present study

Model Details: unblinded, parallel-arm randomized controlled clinical trial

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: June 29, 2023
• Study Start: March 5, 2024
• Primary Completion: December 29, 2024
• Study Completion: March 31, 2025
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: De-identified data will be available once a trial is completed and their primary results are published and for 5 years thereafter.
• Access Criteria: De-identified study variables will be available to secondary researchers whose proposed research has received IRB approval.

Locations

ME (3)