N/A
N=297
The SAFE Study: Satisfaction and Adherence to Follow-Up With Colposcopy Exams
Uterine Cervical Dysplasia · Uterine Cervix Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03296566 ↗Enrolled (actual)
297
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Anxiety — 37.3; 40.7 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Patient Liaison (Behavioral)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- Female
- Sponsor
- University of British Columbia
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anxiety |
37.3; 40.7 | — |
| PRIMARY Quantitative Satisfaction With Colposcopy Visit Experience Including Interactions With Colposcopy Professionals |
68.3; 66.6 | — |
| PRIMARY Satisfaction With Colposcopy Information and Diagnosis Education |
65.6; 65.1 | — |
| SECONDARY Patient Knowledge of Own Colposcopy Diagnosis |
66.3; 84 | — |
| SECONDARY Adherence to Colposcopy Treatment and Follow-up Instructions |
61.4; 52.3 | — |
Summary
This study is intended to improve the patient experience of communication of colposcopy results and follow-up recommendations to patients. Current practice involves results being forwarded from the colposcopy clinic to the family or referring physician who then informs the patient. We are testing an intervention informed by focus groups in which a trained colposcopy nurse (patient liaison) directly contacts patients with their results and follow-up recommendations while providing education and support. We will examine whether this intervention improves patient satisfaction, reduces anxiety, and improves rates of adherence to follow-up and treatment appointments compared to the current practice.
Eligibility Criteria
Inclusion Criteria
- Must be 19 years of age or older
- Must be patients presenting for an initial visit at the VGH Colposcopy Clinic
Exclusion Criteria
- Inability to speak conversational English- required to complete the questionnaire as well as provide informed consent to participate
- Inability or refusal to provide consent
- Pregnant - pregnant women do not usually have biopsies and their subsequent care may be much different than non-pregnant patients
- Do not have a family physician or referring physician who will provide continuity of care following colposcopy - these patients do not have the option of getting results from a family or referring physician, so they would bias results.
Data sourced from ClinicalTrials.gov (NCT03296566). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.