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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: ePRO application and proactive clinical care with nurses.

Detailed Description

An unblinded, parallel-arm, randomized, controlled clinical trial will be conducted. This phase 2 clinical trial focuses on exploring the effect of the intervention on the study variables.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. 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. All participants will continue to receive the usual health care provided by the hospital. Study intervention wil last 6 months with additional passive folow-up till 9 months to allow post-intervention monitoring.

The participants will be randomly allocated to the intervention or control groups. The minimization technique with MS-DOS Minim program will be used for randomization. It will be conducted by a research assistant who will use a pre-prepared list of random numbers to randomize the first six participants. Starting with the seventh participant, randomization will be carried out using MS-DOS Minim program. The minimization technique is recommended as a standard to ensure that clinical trial groups are similar in terms of participant characteristics, such as age, schooling, breast cancer stage and treatment modality.

Intervention implementation: The lead researcher will weekly obtain the list of breast cancer patients who have started or will start neoadjuvant or adjuvant treatment with chemotherapy or radiotherapy within two weeks in the oncology hospital. The previously trained nurses will use this list to invite all eligible breast cancer patients to participate in the study. Initially, patients will be invited by telephone calls to attend the hospital or the research unit (located at the same medical center as the oncology hospital) to receive the study-related information and to confirm eligibility. Those who meet the inclusion criteria will be provided with the option to participate and invited to provide informed consent prior to participation. Participants will be provided with a username, password, and access to the intervention or control interface of the responsive ePRO App, and training on its use. All participants will be asked to answer the baseline record of sociodemographic and clinical characteristics and questionnaires to assess study outcomes. Intervention arm participants will be asked to complete the weekly register and will receive weekly WhatsApp reminders. Study nurses will contact patients without two weekly records to encourage adherence to the intervention. Study nurses will be supported by the study oncologist/ oncology resident to ensure adherence to the intervention activities. Additionally, the nurses will be in regular contact with the study team and will record their activities in the corresponding interface of the responsive ePRO App.

• Study Type: Interventional
• Enrollment (Estimated): 410
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Svetlana V. Doubova, MD. DSc.; Phone Number: 21072 +525556276900; Email: svetlana.doubova@gmail.com
• Study Contact Backup: Name: Saúl Eduardo Contreras Sánchez, MD. MSc.; Phone Number: 21074 +525556276900; Email: saul.contreras@imss.gob.mx

Study Locations

• Mexico
  • Mexico City, Mexico, 02990
    • Recruiting
    • UMAE Hospital de Gineco-Obstetricia No.3 "Dr. Víctor Manuel Espinoza de los Reyes Sánchez" CMN La Raza.
    • Contact: Enrique Isay Talamantes Gómez, MD; Phone Number: 2378 55-57-24-59-00; Email: tago23@gmail.com
  • Puebla, Mexico, 72089
    • Recruiting
    • UMAE Hospital de Especialidades CMN "Gral. de Div. Manuel Ávila Camacho"
    • Contact: Álvaro José Montiel Jarquín, MD; Phone Number: 22-21-94-53-60; Email: arturo.garciaga@imss.gob.mx
  • Ciudad De México
    • Mexico, Ciudad De México, Mexico, 06720
      • Recruiting
      • Hospital de Oncología del Centro Médico Nacional Siglo XXI
      • Contact: Rocío Grajales Álvarez, MD.; Phone Number: 5555-39331299; Email: chiograjales@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: ePRO application and proactive clinical care with nurses.; 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global quality of life	Change from baseline in Global quality of life at 1, 3, 6 and 9 months after the intervention commencement, which will be measured with the EORTC (European Organization for Research and Treatment of Cancer) QLQ-C30 questionnaire validated in Mexico	At 1, 3, 6 and 9 months after intervention commencement
Breast symptoms	Change from baseline in breast symptoms at 1, 3, 6 and 9 months after the intervention commencement, which will be measured with the breast symptoms scale of the EORTC QLQ-BR23 questionnaire validated in Mexico.	At 1, 3, 6 and 9 months after intervention commencement

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of emergency services	Change from baseline in the emergency room visits, which will be measured by the number of the emergency room visits during the previous month	At 1, 3, 6 and 9 months after intervention commencement
Use of the responsive ePRO App in the intervention group	Frequency of the responsive ePRO App use (site visits by IP address) and completion of a weekly report of symptoms and supportive care needs on the responsive digital App.	At 1, 3 and 6 months after intervention commencement
Unscheduled hospitalizations	Change from baseline in the unscheduled hospitalizations, which will be measured by the number of unscheduled hospitalizations in the previous month	At 1, 3, 6 and 9 months after intervention commencement
Perceived usability of the responsive ePRO App in the intervention group	Perceived usability will be measured by mHealth Application Usability Questionnaire [ ] translated into Spanish with content validation completed by the study expert group.	At 1, 3 and 6 months after intervention commencement

Collaborators and Investigators

• Sponsor: Coordinación de Investigación en Salud, Mexico
• Investigators: Principal Investigator: Svetlana V. Doubova, MD. DSc., Instituto Mexicano del Seguro Social

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2024
• Primary Completion (Estimated): December 29, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: June 28, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: R-2021-785-059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified study variables will be available.
• IPD Sharing Time Frame: De-identified data will be available once a trial is completed and their primary results are published and for 5 years thereafter.
• IPD Sharing Access Criteria: De-identified study variables will be available to secondary researchers whose proposed research has received IRB approval.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No