- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03296566
The SAFE Study: Satisfaction and Adherence to Follow-Up With Colposcopy Exams
April 10, 2020 updated by: Marette Lee, University of British Columbia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Cervical cancer is the second most commonly diagnosed cancer and third leading cause of cancer death in women worldwide.
Pre-cancerous cells can be detected with regular Pap smear screening and diagnosed and treated with colposcopy.
This process is limited by patient adherence to the follow-up and treatment recommendations.
Currently at Vancouver General Hospital (VGH), the largest colposcopy clinic in the province, results are forwarded from the colposcopy clinic to the family or referring physician who informs patients of results and recommendations.
Inefficiencies or errors in this step may cause patient dissatisfaction, missed appointments, increased costs, and compromise patient outcomes.
The primary objective of this study is to examine whether having a trained colposcopy nurse directly contact patients with their results and follow-up recommendations while providing education and support will improve patient satisfaction and reduce anxiety, with the secondary aim being to assess the clinical effectiveness of this intervention in improving rates of adherence to follow-up and treatment appointments and potentially long-term clinical outcomes.
The first phase of the study involves patient focus groups that will be interviewed about what elements of a patient liaison interaction are most important (separate Ethics submission).
This information will inform the development of the patient liaison role and approaches to patient interaction to be utilized in the intervention in the second phase.
The second phase will entail a randomized controlled trial comparing patient anxiety, satisfaction and adherence to follow-up between a control group (current practice) versus the intervention group exposed to the patient liaison at the VGH Colposcopy Clinic.
For the primary aim, a questionnaire containing items pertaining to patient anxiety and satisfaction with their experience of receiving their colposcopy results will be administered both to the intervention and control groups and the mean scores pertaining to anxiety and satisfaction will be compared using two-tailed t-tests.
For the secondary aim, a chart review at 6-12 months following the initial colposcopy visit will examine the rates of compliance with the recommended follow-up or treatment visits and histologic diagnoses, and comparisons will be sought between the intervention and control groups using z-score test.
Study Type
Interventional
Enrollment (Actual)
297
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver General Hospital - Gordon and Leslie Diamond Health Care Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patient Liaison Intervention
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.
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An experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report.
The colposcopy report will inform the referring provider that these patients will be informed of the results.
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.
She will forward any patient questions beyond her scope to the patient's colposcopist who may then provide answers to the patient liaison or to the patient directly depending on the complexity and nature of the question.
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No Intervention: Control
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety
Time Frame: To be collected by questionnaire in 4-6 weeks following colposcopy visit
|
Mean state anxiety scores as measured by the State Trait Anxiety Inventory (STAI) State Subscale.
The STAI has 40 items with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales.
Responses for the State Anxiety scale assess intensity of current feelings from 1-4 "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so.
Item scores are added to obtain subtest total scores and for anxiety-present items, a higher score suggests higher anxiety.
Scoring is reversed for anxiety-absent items (items in which a higher score suggests lower anxiety).
Range of scores for the subscale is 20-80 with a higher score indicating greater anxiety.
A cut point of 39-40 has been suggested to detect clinically significant symptoms for the State Anxiety scale.
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To be collected by questionnaire in 4-6 weeks following colposcopy visit
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Quantitative Satisfaction With Colposcopy Visit Experience Including Interactions With Colposcopy Professionals
Time Frame: To be collected by questionnaire in 4-6 weeks following colposcopy visit
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Patient satisfaction scores as measured by items in the questionnaire drawn from the Visit Specific Satisfaction Instrument (VSQ-9) Inventory.
The VSQ-9 is a 9 item survey that measures patient satisfaction with access to primary care, with the direct interaction with the physician, and with the visit overall on a scale ranging from 1 (poor) to 5 (excellent).
To score the VSQ-9, responses from each individual are transformed linearly to a 0 to 100 scale, with 100 corresponding to "excellent" and 0 corresponding to "poor" (0= Poor, 25= Fair, 50= Good, 75= Very Good, 100= Excellent).
The 9 responses are then averaged together to create a VSQ-9 overall score for each person, again with 100 being the best evaluation and 0 the poorest.
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To be collected by questionnaire in 4-6 weeks following colposcopy visit
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Satisfaction With Colposcopy Information and Diagnosis Education
Time Frame: To be collected by questionnaire in 4-6 weeks following colposcopy visit
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Satisfaction with information and education received regarding colposcopy, patient diagnosis and follow-up recommendations measured by questionnaire items that measure these factors (PSQ-18 Inventory).
This inventory contains 18 items assessing each of the 7 dimensions of satisfaction with medical care (general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, accessibility and convenience).
Each item is scored from 1-5.
Some PSQ-18 items are worded so that agreement reflects satisfaction with medical care, whereas other items are worded so that agreement reflects dissatisfaction with medical care.
All items all scored so that high scores reflect satisfaction with medical care.
All items are then summed; sum score of all items may range from 18 to 90 points, where 18 points is the poorest evaluation and 90 points the best.
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To be collected by questionnaire in 4-6 weeks following colposcopy visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Knowledge of Own Colposcopy Diagnosis
Time Frame: To be collected by questionnaire in 4-6 weeks following colposcopy visit
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The percent of patients who correctly report their colposcopy pathologic diagnosis
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To be collected by questionnaire in 4-6 weeks following colposcopy visit
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Adherence to Colposcopy Treatment and Follow-up Instructions
Time Frame: 6 months
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Percentage of patients who attended follow-up at the colposcopy clinic
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marette Lee, MD/MPH/FRCSC, University of British Columbia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Dietrich 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.
- Balasubramani 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.
- Boone 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.
- Bredart 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.
- Byrom 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.
- Lerman 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.
- Litchfield 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.
- Nugent LS, Tamlyn-Leaman K, Isa N, Reardon E, Crumley J. Anxiety and the colposcopy experience. Clin Nurs Res. 1993 Aug;2(3):267-77. doi: 10.1177/105477389300200304.
- O'Connor M, Gallagher P, Waller J, Martin CM, O'Leary JJ, Sharp L; Irish Cervical Screening Research Consortium (CERVIVA). Adverse psychological outcomes following colposcopy and related procedures: a systematic review. BJOG. 2016 Jan;123(1):24-38. doi: 10.1111/1471-0528.13462. Epub 2015 Jun 22.
- Percac-Lima S, Ashburner JM, Zai AH, Chang Y, Oo SA, Guimaraes E, Atlas SJ. Patient Navigation for Comprehensive Cancer Screening in High-Risk Patients Using a Population-Based Health Information Technology System: A Randomized Clinical Trial. JAMA Intern Med. 2016 Jul 1;176(7):930-7. doi: 10.1001/jamainternmed.2016.0841.
- Towler BP, Irwig LM, Shelley JM. The adequacy of management of women with CIN 2 and CIN 3 Pap smear abnormalities. Med J Aust. 1993 Oct 18;159(8):523, 526-8.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 13, 2017
Primary Completion (Actual)
June 30, 2018
Study Completion (Actual)
June 30, 2018
Study Registration Dates
First Submitted
July 20, 2017
First Submitted That Met QC Criteria
September 25, 2017
First Posted (Actual)
September 28, 2017
Study Record Updates
Last Update Posted (Actual)
April 24, 2020
Last Update Submitted That Met QC Criteria
April 10, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Precancerous Conditions
- Carcinoma in Situ
- Uterine Cervical Neoplasms
- Cervical Intraepithelial Neoplasia
- Uterine Cervical Dysplasia
Other Study ID Numbers
- H16-03194
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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