Evaluation of an mHealth Intervention to Promote Participation in Breast Cancer Screening in Argentina

NCT06500936 | Completed

• 1 other identifier: INC927
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief Summary

We carried out with a mixed-method study including a pragmatic randomized controlled trial to evaluate effectiveness of the intervention and quantitative and qualitative evaluation of the implementation from women and stakeholders' perspective. In this report, we present results of the pragmatic randomized control trial and implementation evaluation from women´s perspective guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework, specifically developed to assess interventions beyond efficacy across multiple public health criteria. RE-AIM framework was integrated in all stages of the research process, including conceptualization (e.g., selecting implementation processes that would be evaluated), data collection and analysis. Following Proctor´s Taxonomy of Implementation Outcomes \[34\], we also measured acceptability and appropriateness, which are essential to understand the success (or failure) of the implementation of an intervention from users' perspective. This approach is the same as we used to evaluate implementation in our previous study (The ATICA study).

Conditions

Breast Cancer Screening

Keywords

Breast cancer screening; mHealth; Argentina; Implementation

Outcome Measures

Primary Outcomes (2)

• Effectiveness outcome

  Percentage of women with a mammography recorded in SITAM within105 days from recruitment.

  105 days from recruitment.

• Effectivenes outcome

  Percentage of women with a mammography recorded in SITAM within 45 days from

  45 days from recruitment.

Study Arms (2)

Intervention (SMS)

EXPERIMENTAL

The intervention included two series of SMS messages. First, women of IG received one weekly SMS messages for 2 weeks. Those women that did not register a mammography in SITAM 45 days after the 2nd message, received the second series, consisting of one weekly SMS message over two weeks. The intervention assumed an average of 30 days to obtain appointments and perform the mammography, plus 15 days until the report was uploaded in SITAM and available for delivery. Messages stopped if a mammography was registered in SITAM.

Other: SMS

Usual care

NO INTERVENTION

The women in the control group received standard care, which in this context is opportunistic screening. Women in the control group had the possibility of asking for an appointment for mammography, if they wanted to do so. To ask for the appointment, women must complete different steps: 1) women have to ask for an appointment with a health professional in a primary health center; 2) a health professional has to prescribe a mammography, 3) then women ask for the appointment at the administrative office in the health center.

Interventions

SMS OTHER

The intervention included two series of SMS messages. First, women of IG received one weekly SMS messages for 2 weeks. Those women that did not register a mammography in SITAM 45 days after the 2nd message, received the second series, consisting of one weekly SMS message over two weeks.

Also known as: ATICA strategy

Intervention (SMS)

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A woman was eligible if she was 50+years, had not performed a mammography in the last two years, had not a breast cancer diagnosis and was able to provide a mobile phone number

You may not qualify if:

• Women under 50 years
• Women who had performed a mammography in the last two years,
• Women who had breast cancer diagnosis

Sponsors & Collaborators

• Centro de Estudio de Estado y Sociedad: lead
• Instituto Nacional del Cáncer, Argentina: collaborator

Study Sites (1)

Agencia del Control del Cáncer Santa Fe

Santa Fe, Argentina

Location

Related Publications (8)

• Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, Bray F (2024). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available from: https://gco.iarc.fr/today, accessed [05 July 2024].

  BACKGROUND

• IARC Working Group on the Evaluation of Cancer-Preventive Interventions. Breast cancer screening. Lyon (FR): International Agency for Research on Cancer; 2016. Available from http://www.ncbi.nlm.nih.gov/books/NBK546556/

  PMID: 31553546 BACKGROUND

• Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.

  PMID: 10474547 BACKGROUND

• Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.

  PMID: 20957426 BACKGROUND

• Arrossi S, Paolino M, Antelo VS, Thouyaret L, Kohler RE, Cuberli M, Flores L, Serra V, Viswanath K, Orellana L; ATICA Study team. Effectiveness of an mHealth intervention to increase adherence to triage of HPV DNA positive women who have performed self-collection (the ATICA study): A hybrid type I cluster randomised effectiveness-implementation trial. Lancet Reg Health Am. 2022 May;9:100199. doi: 10.1016/j.lana.2022.100199. Epub 2022 Feb 13.

  PMID: 35655914 BACKGROUND

• Arrossi S, Paolino M, Orellana L, Thouyaret L, Kohler RE, Viswanath K. Mixed-methods approach to evaluate an mHealth intervention to increase adherence to triage of human papillomavirus-positive women who have performed self-collection (the ATICA study): study protocol for a hybrid type I cluster randomized effectiveness-implementation trial. Trials. 2019 Feb 26;20(1):148. doi: 10.1186/s13063-019-3229-3.

  PMID: 30808379 BACKGROUND

• Paolino M, Sanchez Antelo V, Kohler RE, Viswanath K, Arrossi S. Implementation of an mHealth intervention to increase adherence to triage among HPV positive women with HPV-self-collection (ATICA study): post-implementation evaluation from the women's perspective. BMC Womens Health. 2023 Jun 23;23(1):332. doi: 10.1186/s12905-023-02475-0.

  PMID: 37353835 BACKGROUND

• 10. Censo 2022 Instituto Nacional de Estadisticas y Censos (INDEC). Uso tecnología Acceso y uso de tecnologías de la información y la comunicación. EPH Cuarto trimestre de 2021. Informes Técnicos. Vol. 6, no 89. Ciencia y tecnología. Vol. 6, no 1, Buenos Aires. https://www.indec.gob.ar/uploads/informesdeprensa/mautic_05_22843D61C141.pdf

  BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Women were randomly allocated either to the intervention or to the control group (1:1 ratio) using a computer-generated random number list generated by the study statistician. Blinding allocation was guaranteed, because neither the recruiters nor the field coordination knew the group to which women would be assigned. The local field coordinator sent the list of recruited women to the study coordinator on a weekly basis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We carried out with a mixed-method study including a pragmatic randomized controlled trial to evaluate effectiveness of the intervention and quantitative and qualitative evaluation of the implementation from women and stakeholders' perspective

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: December 5, 2021
• Primary Completion: December 31, 2022
• Study Completion: August 1, 2023
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)