Impact of SMS Messaging on Participation in Colorectal Cancer Screening
Impact of SMS Notifications on the Colorectal Cancer Screening Program
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
This study is a pragmatic, randomized, parallel-group clinical trial with a 1:1 allocation ratio, conducted within the framework of the Colorectal Cancer Early Detection Program (PDPCCR) in the Vallès Occidental region. The trial is coordinated by the Cancer Screening Unit of the Consorci Corporació Sanitària Parc Taulí.
Operational Flow and Randomization: The study follows a sequential recruitment process. At Week 0, the entire target population receives a standard invitation letter according to the program's usual standard of care. For individuals who have not participated by Week 5, a computer-generated randomization sequence (Microsoft Excel) is applied weekly to assign them to either the intervention or control group. This weekly approach ensures the intervention is timely and integrated into the program's existing administrative workflow.
Intervention Logistics: The Intervention Group receives a one-way SMS reminder sent via the 'Alhora' platform, the secure institutional messaging system used by the screening program. The content of the SMS was previously optimized and validated through a qualitative pilot study involving semi-structured interviews to ensure high readability and cultural acceptability among the target population. Non-participants in both groups receive the standard postal reminder letter at Week 6.
Statistical Analysis Plan: The analysis will be conducted on both an intent-to-treat (ITT) and per-protocol basis. Descriptive statistics will report frequencies and medians with interquartile ranges (25th-75th percentiles). Bivariate analysis will utilize Chi-square tests for participation rates and the Mann-Whitney U test for response time differences. To estimate the effect size, Relative Risks (RR) with 95% confidence intervals will be calculated. Furthermore, a multivariate binary logistic regression will be performed using Jamovi software to adjust for potential confounders such as sex, age, geographic area, and history of previous participation
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Anna Selva Olid, PhD
- 전화번호: 82240 +34937231010
- 이메일: aselva@tauli.cat
연구 연락처 백업
- 이름: Marina Lleal Custey, PhD
- 전화번호: 82241 +34937231010
- 이메일: mlleal@tauli.cat
연구 장소
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Catalonia
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Sabadell, Catalonia, 스페인, 08208
- 모병
- Unitat de Cribratge de Cáncer, Consorci Corporació Sanitaria Parc Taulí
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연락하다:
- Anna Selva Olid, PhD
- 전화번호: 82240 +34937231010
- 이메일: aselva@tauli.cat
-
연락하다:
- Marina Lleal Custey, PhD
- 전화번호: 82239 +34937231010
- 이메일: mlleal@tauli.cat
-
수석 연구원:
- Anna Selva Olid, PhD
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수석 연구원:
- Marina Lleal Custey, PhD
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부수사관:
- Cessia Vilcahuamán Esteban, RN, Sp
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Women and men aged 50 to 69 years.
- Residents of the Vallès Occidental area.
- Individuals invited to the Colorectal Cancer Screening Program (PDPCCR) who have not participated within 5 weeks of the initial invitation.
Exclusion Criteria:
- Personal history of colorectal cancer.
- Inflammatory bowel disease (IBD)
- Colorectal polyps requiring specific clinical follow-up.
- Hereditary polyposis syndromes.
- High-risk family history of colorectal cancer: a first-degree relative diagnosed before age 50, or two or more first-degree relatives at any age.
- Severe morbidity that precludes the performance of a colonoscopy in the event of a positive test result.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: Control Group: Standard Care
Participants in this group follow the screening program's standard operating procedure.
This consists of an initial invitation letter sent at week 0 and, in the event of non-participation, a postal reminder letter sent at week 6.
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Control intervention based on the colorectal cancer screening program's usual standard of care. Components and Timing:
Duration: Participation follow-up for both components concludes 3 months after the initial invitation. This study arm receives no digital or telephone-based stimuli during the study period. |
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실험적: Intervention Group: SMS + Standard Care
Participants receive the initial invitation letter at week 0. If they have not participated by week 5, an SMS text message reminder is sent.
If they remain non-participants following the SMS, they receive the standard postal reminder letter at week 6.
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Control intervention based on the colorectal cancer screening program's usual standard of care. Components and Timing:
Duration: Participation follow-up for both components concludes 3 months after the initial invitation. This study arm receives no digital or telephone-based stimuli during the study period.
Behavioral intervention consisting of a one-way short message service (SMS) text message sent to the mobile phones of participants who have not completed the fecal immunochemical test (FIT) following the initial invitation.
A single SMS reminder is sent exactly 5 weeks after the issuance of the standard invitation letter, one week prior to the scheduled postal reminder.
Delivery is centrally managed through the secure 'Alhora' messaging platform.
The message format is validated through a qualitative pilot study to ensure readability and acceptability by the target population (aged 50-69 years).
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Participation rate
기간: 3 months after the initial invitation
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Proportion of individuals who complete a valid fecal immunochemical test (FIT) relative to the total number of individuals invited.
This variable will be objectively obtained through the screening program's information system
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3 months after the initial invitation
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time to participation
기간: 3 months after the initial invitation (at the conclusion of the study follow-up).
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Measurement of the number of days elapsed from the delivery of the initial invitation letter to the effective completion of the test (defined as the moment the participant's sample is analyzed in the laboratory ).
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3 months after the initial invitation (at the conclusion of the study follow-up).
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Number of reminder letters sent
기간: 3 months after the initial invitation.
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Total count of postal reminder letters sent by the program for participants in each group.
This measure evaluates whether the SMS in the intervention group reduces the need for paper-based reminders.
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3 months after the initial invitation.
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공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Anna Selva Olid, PhD, MPH, MD, Corporacion Parc Tauli
간행물 및 유용한 링크
일반 간행물
- Shaukat A, Mongin SJ, Geisser MS, Lederle FA, Bond JH, Mandel JS, Church TR. Long-term mortality after screening for colorectal cancer. N Engl J Med. 2013 Sep 19;369(12):1106-14. doi: 10.1056/NEJMoa1300720.
- Vives N, Vidal C, de Guzman EN, Farre A, Panera JA, Binefa G, Garcia M; M-TICS research group. The use of text messages as an alternative invitation method for breast cancer screening: A randomized controlled trial (M-TICS study). PLoS One. 2024 Aug 29;19(8):e0306720. doi: 10.1371/journal.pone.0306720. eCollection 2024.
- Vives N, Travier N, Farre A, Binefa G, Vidal C, Perez Lacasta MJ, Ibanez-Sanz G, Nino de Guzman EP, Panera JA, Garcia M; M-TICS Research Group. Effectiveness and Acceptability of Targeted Text Message Reminders in Colorectal Cancer Screening: Randomized Controlled Trial (M-TICS Study). JMIR Public Health Surveill. 2024 Jul 31;10:e57959. doi: 10.2196/57959.
- Vives N, Farre A, Ibanez-Sanz G, Vidal C, Binefa G, Mila N, Perez-Lacasta MJ, Travier N, Benito L, Espinas JA, Bagaria G, Garcia M. Text messaging as a tool to improve cancer screening programs (M-TICS Study): A randomized controlled trial protocol. PLoS One. 2021 Jan 22;16(1):e0245806. doi: 10.1371/journal.pone.0245806. eCollection 2021.
- Hewitson P, Glasziou P, Irwig L, Towler B, Watson E. Screening for colorectal cancer using the faecal occult blood test, Hemoccult. Cochrane Database Syst Rev. 2007 Jan 24;2007(1):CD001216. doi: 10.1002/14651858.CD001216.pub2.
- Mandel JS, Church TR, Bond JH, Ederer F, Geisser MS, Mongin SJ, Snover DC, Schuman LM. The effect of fecal occult-blood screening on the incidence of colorectal cancer. N Engl J Med. 2000 Nov 30;343(22):1603-7. doi: 10.1056/NEJM200011303432203.
- Schliemann D, Tan MM, Hoe WMK, Mohan D, Taib NA, Donnelly M, Su TT. mHealth Interventions to Improve Cancer Screening and Early Detection: Scoping Review of Reviews. J Med Internet Res. 2022 Aug 15;24(8):e36316. doi: 10.2196/36316.
- Uy C, Lopez J, Trinh-Shevrin C, Kwon SC, Sherman SE, Liang PS. Text Messaging Interventions on Cancer Screening Rates: A Systematic Review. J Med Internet Res. 2017 Aug 24;19(8):e296. doi: 10.2196/jmir.7893.
- Camilloni L, Ferroni E, Cendales BJ, Pezzarossi A, Furnari G, Borgia P, Guasticchi G, Giorgi Rossi P; Methods to increase participation Working Group. Methods to increase participation in organised screening programs: a systematic review. BMC Public Health. 2013 May 13;13:464. doi: 10.1186/1471-2458-13-464.
유용한 링크
- Programa de detecció precoç del càncer de còlon i recte del Vallès Occidental. Resultats ronda 4. Generalitat de Catalunya, Departament de Salut.
- European Comission. (March de 2024). Uncovering Inequalities. Obtenido de Colorrectal Cancer Screening in Europe.
- Plan Director de Oncología. (Junio de 2023). Estadísticas del cáncer en Cataluña durante el año 2022. Barcelona, España: Generalidad de Cataluña, Departamento de Salud.
- Lleal Custey, M., Selva Olid, A., Garró Gómez, A., & Ferrándiz Civil, A. (2025). Evaluación del impacto del envío de SMS en el programa de detección precoz de cáncer colorrectal. Gaceta Sanitaria, 39(S2), 205.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 2026.054-30
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Restricted Access and Security: The protocol stipulates that data will be stored on secure hospital servers with access strictly limited to authorized research staff through encryption systems and secure passwords.
Privacy and Confidentiality: The use of personal identifying data is strictly limited to the technical execution of the intervention (SMS delivery). The research team has implemented measures to ensure the anonymization of the analytical database.
Legal Compliance: The study is governed by Regulation (EU) 2016/679 (GDPR) and Organic Law 3/2018 on the Protection of Personal Data, which imposes legal restrictions on the transfer of individual data outside the consented framework for this specific research.
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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