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
Introduction Nearly 30 000 Mexican women develop breast cancer annually, frequently presenting unmet supportive care needs. In high-income countries, incorporating electronic patient-reported outcomes (ePROs) into cancer care has demonstrated potential for increasing patient-centred care and reducin...
| Main Authors: | , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2023-11-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/11/e077322.full |
| _version_ | 1797435550245847040 |
|---|---|
| author | Hannah H Leslie Svetlana V Doubova Saúl Eduardo Contreras Sánchez Rocío Grajales Álvarez Abdel Krim Dip Borunda Wendy Jazmín Martínez Pineda Jose Gustavo Nuñez Cerrillo Fernando Silva Bravo Rita Zalapa Velázquez Marcos Gutiérrez De la Barrera |
| author_facet | Hannah H Leslie Svetlana V Doubova Saúl Eduardo Contreras Sánchez Rocío Grajales Álvarez Abdel Krim Dip Borunda Wendy Jazmín Martínez Pineda Jose Gustavo Nuñez Cerrillo Fernando Silva Bravo Rita Zalapa Velázquez Marcos Gutiérrez De la Barrera |
| author_sort | Hannah H Leslie |
| collection | DOAJ |
| description | Introduction Nearly 30 000 Mexican women develop breast cancer annually, frequently presenting unmet supportive care needs. In high-income countries, 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. This paper presents the study protocol for designing and evaluating an ePRO digital health application combined with proactive follow-up by nurses.Methods and analysis We 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. We will conduct a pilot test of the intervention with 50 patients with breast cancer for 6 weeks to assess feasibility and adjust the application. We will conduct a parallel arm randomised 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 6 months, with additional 3 months of post-intervention observation. The control group will receive usual healthcare and a list of breast cancer information sources. Women diagnosed with stages I, II or III breast cancer who initiate chemotherapy and/or radiotherapy will be invited to participate. The primary study outcome will be supportive care needs; secondary outcomes include global quality of life and breast symptoms. Information on the outcomes will be obtained through web-based self-administered questionnaires collected at baseline, 1, 3, 6 and 9 months.Ethics and dissemination The National Research and Ethics Committees of the Mexican Institute of Social Security approved the study (R-2021-785-059). Participants will sign an informed consent form prior to their inclusion. Findings will be disseminated through a policy brief to the local authorities, a webinar for patients, publications in peer-reviewed journals and presentations at national and international conferences.Trial registration number NCT05925257. |
| first_indexed | 2024-03-09T10:49:22Z |
| format | Article |
| id | doaj.art-d5f275d1f5f941fea5b9ed13f1f52b7e |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-09T10:49:22Z |
| publishDate | 2023-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-d5f275d1f5f941fea5b9ed13f1f52b7e2023-12-01T09:30:08ZengBMJ Publishing GroupBMJ Open2044-60552023-11-01131110.1136/bmjopen-2023-077322Design 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 trialHannah H Leslie0Svetlana V Doubova1Saúl Eduardo Contreras Sánchez2Rocío Grajales Álvarez3Abdel Krim Dip Borunda4Wendy Jazmín Martínez Pineda5Jose Gustavo Nuñez Cerrillo6Fernando Silva Bravo7Rita Zalapa Velázquez8Marcos Gutiérrez De la Barrera9Division of Prevention Science, University of California San Francisco, San Francisco, California, USAEpidemiology and Health Services Research Unit CMN Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de Mexico, MexicoEpidemiology and Health Services Research Unit CMN Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de Mexico, MexicoOncology Department, Oncology Hospital CMN Siglo XXI, IMSS, Ciudad de Mexico, MexicoOncology Department, Oncology Hospital CMN Siglo XXI, IMSS, Ciudad de Mexico, MexicoRadiation Oncology Department, Oncology Hospital CMN Siglo XXI, IMSS, Ciudad de Mexico, MexicoOncology Department, Speciality Hospital CMN Manuel Ávila Camacho, IMSS, Puebla, Puebla, MexicoOncology Department, Speciality Hospital CMN Manuel Ávila Camacho, IMSS, Puebla, Puebla, MexicoOncology Department, Speciality Hospital CMN Manuel Ávila Camacho, IMSS, Puebla, Puebla, MexicoResearch Division. Oncology Hospital CMN Siglo XXI, Mexican Institute of Social Security, Ciudad de Mexico, MexicoIntroduction Nearly 30 000 Mexican women develop breast cancer annually, frequently presenting unmet supportive care needs. In high-income countries, 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. This paper presents the study protocol for designing and evaluating an ePRO digital health application combined with proactive follow-up by nurses.Methods and analysis We 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. We will conduct a pilot test of the intervention with 50 patients with breast cancer for 6 weeks to assess feasibility and adjust the application. We will conduct a parallel arm randomised 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 6 months, with additional 3 months of post-intervention observation. The control group will receive usual healthcare and a list of breast cancer information sources. Women diagnosed with stages I, II or III breast cancer who initiate chemotherapy and/or radiotherapy will be invited to participate. The primary study outcome will be supportive care needs; secondary outcomes include global quality of life and breast symptoms. Information on the outcomes will be obtained through web-based self-administered questionnaires collected at baseline, 1, 3, 6 and 9 months.Ethics and dissemination The National Research and Ethics Committees of the Mexican Institute of Social Security approved the study (R-2021-785-059). Participants will sign an informed consent form prior to their inclusion. Findings will be disseminated through a policy brief to the local authorities, a webinar for patients, publications in peer-reviewed journals and presentations at national and international conferences.Trial registration number NCT05925257.https://bmjopen.bmj.com/content/13/11/e077322.full |
| spellingShingle | Hannah H Leslie Svetlana V Doubova Saúl Eduardo Contreras Sánchez Rocío Grajales Álvarez Abdel Krim Dip Borunda Wendy Jazmín Martínez Pineda Jose Gustavo Nuñez Cerrillo Fernando Silva Bravo Rita Zalapa Velázquez Marcos Gutiérrez De la Barrera 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/13/11/e077322.full |
| work_keys_str_mv | AT hannahhleslie designandevaluationofadigitalhealthinterventionwithproactivefollowupbynursestoimprovehealthcareandoutcomesforpatientswithbreastcancerinmexicoprotocolforarandomisedclinicaltrial AT svetlanavdoubova designandevaluationofadigitalhealthinterventionwithproactivefollowupbynursestoimprovehealthcareandoutcomesforpatientswithbreastcancerinmexicoprotocolforarandomisedclinicaltrial AT sauleduardocontrerassanchez designandevaluationofadigitalhealthinterventionwithproactivefollowupbynursestoimprovehealthcareandoutcomesforpatientswithbreastcancerinmexicoprotocolforarandomisedclinicaltrial AT rociograjalesalvarez designandevaluationofadigitalhealthinterventionwithproactivefollowupbynursestoimprovehealthcareandoutcomesforpatientswithbreastcancerinmexicoprotocolforarandomisedclinicaltrial AT abdelkrimdipborunda designandevaluationofadigitalhealthinterventionwithproactivefollowupbynursestoimprovehealthcareandoutcomesforpatientswithbreastcancerinmexicoprotocolforarandomisedclinicaltrial AT wendyjazminmartinezpineda designandevaluationofadigitalhealthinterventionwithproactivefollowupbynursestoimprovehealthcareandoutcomesforpatientswithbreastcancerinmexicoprotocolforarandomisedclinicaltrial AT josegustavonunezcerrillo designandevaluationofadigitalhealthinterventionwithproactivefollowupbynursestoimprovehealthcareandoutcomesforpatientswithbreastcancerinmexicoprotocolforarandomisedclinicaltrial AT fernandosilvabravo designandevaluationofadigitalhealthinterventionwithproactivefollowupbynursestoimprovehealthcareandoutcomesforpatientswithbreastcancerinmexicoprotocolforarandomisedclinicaltrial AT ritazalapavelazquez designandevaluationofadigitalhealthinterventionwithproactivefollowupbynursestoimprovehealthcareandoutcomesforpatientswithbreastcancerinmexicoprotocolforarandomisedclinicaltrial AT marcosgutierrezdelabarrera designandevaluationofadigitalhealthinterventionwithproactivefollowupbynursestoimprovehealthcareandoutcomesforpatientswithbreastcancerinmexicoprotocolforarandomisedclinicaltrial |