Clinical trial · Interventional
The SAFE Study: Satisfaction and Adherence to Follow-Up With Colposcopy Exams
NCT03296566CI-TRIAL-00044800completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
| Uterine Cervix Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient Liaison | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patient Liaison Intervention
- description
- The participants randomized to the intervention group will be exposed to the patient liaison in receiving their colposcopy report results and recommendations. Rather than receive results from their referring/family physician, an experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report. The colposcopy nurse will provide an explanation of the colposcopy results and subsequent follow-up or treatment recommendations, be available to answer patient questions (within her scope), offer educational or support resources to patients.
- interventionNames
- Behavioral: Patient Liaison
- type
- NO_INTERVENTION
- label
- Control
- description
- The control group will receive the standard of care for colposcopy results reporting via their referring physician. Following their colposcopy visit, control patients are given a slip of paper reminding them to call their family/referring physician for their colposcopy results in three weeks if they have not yet been contacted. Upon receipt of the final pathology, colposcopy reports are prepared by the colposcopists and forwarded to family/referring physicians typically within 2-3 weeks of the visit. Patients then receive the results of their colposcopy report from their family/referring physician by whatever method of communication preferred by that provider.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Must be 19 years of age or older 2. Must be patients presenting for an initial visit at the VGH Colposcopy Clinic Exclusion Criteria: 1. Inability to speak conversational English- required to complete the questionnaire as well as provide informed consent to participate 2. Inability or refusal to provide consent 3. Pregnant - pregnant women do not usually have biopsies and their subsequent care may be much different than non-pregnant patients 4. 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.
References
Publications (11)
- BACKGROUNDBalasubramani L, Orbell S, Hagger M, Brown V, Tidy J. Can default rates in colposcopy really be reduced? BJOG. 2008 Feb;115(3):403-8. doi: 10.1111/j.1471-0528.2007.01594.x. PMID 18190379
- BACKGROUNDBoone JD, Erickson BK, Huh WK. New insights into cervical cancer screening. J Gynecol Oncol. 2012 Oct;23(4):282-7. doi: 10.3802/jgo.2012.23.4.282. Epub 2012 Sep 19. PMID 23094132
- BACKGROUNDBredart A, Kop JL, Efficace F, Beaudeau A, Brito T, Dolbeault S, Aaronson N; EORTC Quality of Life Group. Quality of care in the oncology outpatient setting from patients' perspective: a systematic review of questionnaires' content and psychometric performance. Psychooncology. 2015 Apr;24(4):382-94. doi: 10.1002/pon.3661. Epub 2014 Sep 5. PMID 25196048
- BACKGROUNDByrom J, Clarke T, Neale J, Dunn PD, Hughes GM, Redman CW, Pitts M. Can pre-colposcopy sessions reduce anxiety at the time of colposcopy? A prospective randomised study. J Obstet Gynaecol. 2002 Jul;22(4):415-20. doi: 10.1080/01443610220141407. PMID 12521468
- BACKGROUNDDietrich AJ, Tobin JN, Cassells A, Robinson CM, Greene MA, Sox CH, Beach ML, DuHamel KN, Younge RG. Telephone care management to improve cancer screening among low-income women: a randomized, controlled trial. Ann Intern Med. 2006 Apr 18;144(8):563-71. doi: 10.7326/0003-4819-144-8-200604180-00006. PMID 16618953
- BACKGROUNDLerman C, Hanjani P, Caputo C, Miller S, Delmoor E, Nolte S, Engstrom P. Telephone counseling improves adherence to colposcopy among lower-income minority women. J Clin Oncol. 1992 Feb;10(2):330-3. doi: 10.1200/JCO.1992.10.2.330. PMID 1732434
- BACKGROUNDLitchfield IJ, Bentham LM, Lilford RJ, McManus RJ, Greenfield SM. Patient perspectives on test result communication in primary care: a qualitative study. Br J Gen Pract. 2015 Mar;65(632):e133-40. doi: 10.3399/bjgp15X683929.