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NCT04948983
The Effect of a Patient Decision Aids for Breast Cancer Screening
NA trial testing Decision aid (DA) for breast cancer screening in Breast Cancer in 3,269 participants. Status unknown.
31 October 2022
Quick facts
| Lead sponsor | Pontificia Universidad Catolica de Chile |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 3,269 |
| Start date | 1 July 2021 |
| Primary completion | 31 October 2022 |
| Estimated completion | 31 October 2022 |
| Sites | 1 location across Chile |
Drugs / interventions tested
- Decision aid (DA) for breast cancer screening
- Standarised information for breast cancer screening
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Mammary Cancer — all drugs for Mammary Cancer →
- Breast Tumor — all drugs for Breast Tumor →
- Mammary Tumor — all drugs for Mammary Tumor →
Sponsor
Pontificia Universidad Catolica de Chile — full company profile →
Who can join
Adults 50 to 69, female only, with Breast Cancer or Mammary Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Breast cancer is one of the most common cancers in Chile. National efforts focus on early detection, offering universal access to breast cancer screening through mammography to women at risk age. However, 30% of women do not undertake the exam due to a lack of knowledge and anxiety when facing the decision. The aim of this study is to develop and evaluate the effectiveness of a decision aid (DA) for women facing breast cancer screening decision in the country. Methods: following the Medical Research Council guidelines for the development and implementation of a complex intervention in public health, the investigators have: 1) culturally adapted the German DA for mammography; 2) conducted focus groups with experts to further develop the DA; 3) pilot-tested the online DA with 20 women in primary care centres. A total of 3,269 women aged 50 to 69 years old are invited to join the study. The intervention group accesses a webpage, answers a set of questionnaires at baseline, and then the DA (developed according to the IPDAS recommendations). The Control group accesses a webpage, answers a set of questionnaires at baseline, and then receives standardised information given by the healthcare system. Both groups complete the questionnaires two weeks later. The primary outcome measure is an adapted and validated version of Informed Choice. Additionally, decisional conflict, anxiety, and screening undertake rate are measured. Multiple lineal regression analysis will be conducted.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Decision aids for people facing health treatment or screening decisions.
Stacey D, Lewis KB, Smith M, Carley M, et al · · 2024 · cited 203× · PMID 38284415 · DOI 10.1002/14651858.cd001431.pub6 -
Shared decision-making for supporting women's decisions about breast cancer screening.
Riganti P, Ruiz Yanzi MV, Escobar Liquitay CM, Sgarbossa NJ, et al · · 2024 · cited 13× · PMID 38726892 · DOI 10.1002/14651858.cd013822.pub2
Verify or expand the search:
- PubMed search for NCT04948983
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Pontificia Universidad Catolica de Chile trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04948983 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pontificia Universidad Catolica de Chile
- Last refreshed: 5 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04948983.
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