Precancerous ConditionNCT00873288
Activating Collaborative CIS Support Via Targeted Provider Mailing
A study testing CIS support mailing intervention in people with Precancerous Condition, run by Northwestern University at 2 sites in United States.
Trial summary
RATIONALE: Receiving a reminder letter from their doctor with questions to ask the Cancer Information Service may be more effective than a standard reminder letter in helping patients who have had an abnormal Pap test keep their follow-up colposcopy appointment. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Precancerous Condition
- What is being tested?
- CIS support mailing intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2006to Nov 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DISEASE CHARACTERISTICS:
- Received an abnormal Pap test result
- Scheduled for a colposcopy within 6 months of their Pap test at either the Erie Family Health Center or the Prentice Ambulatory Clinic
- PATIENT CHARACTERISTICS:
- Female
- Able to communicate in either English or Spanish
Show all 9Show fewer
- Clinic staff will review patient charts to determine eligibility
- PRIOR CONCURRENT THERAPY:
- Not specified
Who cannot join
- <18 years
- unable to communicate in English or Spanish
- no address to which a letter can be mailed
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
Erie Family Health Center
Chicago, Illinois, 60622
About this study
RATIONALE: Receiving a reminder letter from their doctor with questions to ask the Cancer Information Service may be more effective than a standard reminder letter in helping patients who have had an abnormal Pap test keep their follow-up colposcopy appointment.
PURPOSE: This randomized clinical trial is studying a personalized letter with Cancer Information Service support to see how well it works compared with a standard reminder letter in women scheduled for colposcopy after an abnormal Pap test.
Read the detailed description
OBJECTIVES:
- Compare the effect of a usual care mailing intervention vs a Cancer Information Service (CIS) support mailing intervention on the likelihood that women with an abnormal Pap test will keep their medical follow-up appointments and be satisfied with how they talk to their provider.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 intervention arms.
- Arm I (Usual-care mailing intervention): Patients receive a generic letter reminding them of their follow-up colposcopy appointment.
- Arm II (Cancer Information Service [CIS] support mailing intervention): Patients receive a targeted letter reminding them of their follow-up colposcopy appointment, asking them or someone they designate to call the CIS, and suggesting some questions to ask the CIS about colposcopies and Pap tests.
At their follow-up appointments, all patients undergo an exit interview to compare patient satisfaction between the 2 interventions. Patients in arm II also answer questions about their CIS experience, and if the intervention made their follow-up visit less difficult.
- Conditions
- Precancerous Condition
- Being tested
- Usual care mailing intervention, CIS support mailing intervention
- Keywords
- cervical intraepithelial neoplasia, atypical squamous cells of undetermined significance, high-grade squamous intraepithelial lesion, low-grade squamous intraepithelial lesion
- Medical subject headings
- Precancerous Conditions, Uterine Cervical Dysplasia, Atypical Squamous Cells of the Cervix, Squamous Intraepithelial Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual care mailing interventionOther
routine colposcopy reminder letter
CIS support mailing interventionOther
Mailed reminder plus provider recommendation to call CIS and sample questions to ask
| Study group | Role | What they receive |
|---|---|---|
| Usual Care mailing intervention | Active comparator | routine colposcopy reminder letter mailed Receives: Other: Usual care mailing intervention |
| CIS support mailing intervention | Experimental | Mailed reminder plus provider recommendation to call CIS and sample questions to ask Receives: Other: CIS support mailing intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction in the 2 Interventions
Patient satisfaction with provider-patient communication was assessed via administration of the Consumer Assessment of Health Plans Study (CAHPS) satisfaction questionnaire which rates satisfaction on a 1 to 3 scale. Scores are added together, with minimum score being 4 and the maximum score being 12, with a higher score indicating greater satisfaction.
Measured: within 6 months of PAP
CIS Experience of Patients in Arm II and the Effect of the Intervention on Their Follow-up Colposcopy
Measured: within 6 months of PAP
Secondary outcomes (3)
Attendance at a Follow-up Colposcopy Appointment Within 6 Months of Their Pap Test
Measured: within 6 months of PAP
Latency Between the Pap Test and the Colposcopy Appointment
Measured: within 6 months of PAP
Number of CIS Callers Who Provided the Specific Codes Listed in the Intervention Letter
Measured: WITHIN 6 MONTHS OF PAP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study startOct 2006
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Precancerous ConditionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Bonnie Spring, Northwestern University
- Investigators
- Bonnie Spring, PhD, Principal investigator, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873288
- Sponsor's protocol ID
- CDR0000626557
- Other IDs
- P30CA060553, NU-1719-007, R21CA126450
- Status last verified
- Mar 2023
- First submitted
- 31 Mar 2009
- Last updated
- 21 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cofta-Woerpel L, Randhawa V, McFadden HG, Fought A, Bullard E, Spring B. ACCISS study rationale and design: activating collaborative cancer information service support for cervical cancer screening. BMC Public Health. 2009 Dec 2;9:444. doi: 10.1186/1471-2458-9-444.
PubMed 19951443Simon MA, Cofta-Woerpel L, Randhawa V, John P, Makoul G, Spring B. Using the word 'cancer' in communication about an abnormal Pap test: finding common ground with patient-provider communication. Patient Educ Couns. 2010 Oct;81(1):106-12. doi: 10.1016/j.pec.2009.11.022. Epub 2010 Jan 8.
PubMed 20060255
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activating Collaborative CIS Support Via Targeted Provider Mailing
- ClinicalTrials.gov ID
- NCT00873288
- Acronym / sponsor ID
- CDR0000626557
- Conditions
- Precancerous Condition
- Keywords
- cervical intraepithelial neoplasia, atypical squamous cells of undetermined significance, high-grade squamous intraepithelial lesion, low-grade squamous intraepithelial lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 1 Apr 2009 (estimated)
- Results
- Posted 20 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Receiving a reminder letter from their doctor with questions to ask the Cancer Information Service may be more effective than a standard reminder letter in helping patients who have had an abnormal Pap test keep their follow-up colposcopy appointment.
PURPOSE: This randomized clinical trial is studying a personalized letter with Cancer Information Service support to see how well it works compared with a standard reminder letter in women scheduled for colposcopy after an abnormal Pap test.
Detailed description
OBJECTIVES:
- Compare the effect of a usual care mailing intervention vs a Cancer Information Service (CIS) support mailing intervention on the likelihood that women with an abnormal Pap test will keep their medical follow-up appointments and be satisfied with how they talk to their provider.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 intervention arms.
- Arm I (Usual-care mailing intervention): Patients receive a generic letter reminding them of their follow-up colposcopy appointment.
- Arm II (Cancer Information Service [CIS] support mailing intervention): Patients receive a targeted letter reminding them of their follow-up colposcopy appointment, asking them or someone they designate to call the CIS, and suggesting some questions to ask the CIS about colposcopies and Pap tests.
At their follow-up appointments, all patients undergo an exit interview to compare patient satisfaction between the 2 interventions. Patients in arm II also answer questions about their CIS experience, and if the intervention made their follow-up visit less difficult.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care mailing intervention | Active comparator | Other: Usual care mailing interventionroutine colposcopy reminder letter mailed |
| CIS support mailing intervention | Experimental | Other: CIS support mailing interventionMailed reminder plus provider recommendation to call CIS and sample questions to ask |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Received an abnormal Pap test result
- Scheduled for a colposcopy within 6 months of their Pap test at either the Erie Family Health Center or the Prentice Ambulatory Clinic
- Female
- Able to communicate in either English or Spanish
- Clinic staff will review patient charts to determine eligibility
Key exclusion criteria (3 listed)
- <18 years
- unable to communicate in English or Spanish
- no address to which a letter can be mailed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual care mailing interventionroutine colposcopy reminder letter | Other | Usual Care mailing intervention |
| CIS support mailing interventionMailed reminder plus provider recommendation to call CIS and sample questions to ask | Other | CIS support mailing intervention |
Primary outcome
Patient Satisfaction in the 2 Interventions
Time frame: within 6 months of PAP
Patient satisfaction with provider-patient communication was assessed via administration of the Consumer Assessment of Health Plans Study (CAHPS) satisfaction questionnaire which rates satisfaction on a 1 to 3 scale. Scores are added together, with minimum score being 4 and the maximum score being 12, with a higher score indicating greater satisfaction.
CIS Experience of Patients in Arm II and the Effect of the Intervention on Their Follow-up Colposcopy
Time frame: within 6 months of PAP
3 secondary outcomes
Attendance at a Follow-up Colposcopy Appointment Within 6 Months of Their Pap Test
Time frame: within 6 months of PAP
Latency Between the Pap Test and the Colposcopy Appointment
Time frame: within 6 months of PAP
Number of CIS Callers Who Provided the Specific Codes Listed in the Intervention Letter
Time frame: WITHIN 6 MONTHS OF PAP
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19951443Cofta-Woerpel L, Randhawa V, McFadden HG, Fought A, Bullard E, Spring B. ACCISS study rationale and design: activating collaborative cancer information service support for cervical cancer screening. BMC Public Health. 2009 Dec 2;9:444. doi: 10.1186/1471-2458-9-444.
- Background: PubMed 20060255Simon MA, Cofta-Woerpel L, Randhawa V, John P, Makoul G, Spring B. Using the word 'cancer' in communication about an abnormal Pap test: finding common ground with patient-provider communication. Patient Educ Couns. 2010 Oct;81(1):106-12. doi: 10.1016/j.pec.2009.11.022. Epub 2010 Jan 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bonnie Spring, PhD principal investigator
Robert H. Lurie Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CIS support mailing intervention in people with Precancerous Condition, run by Northwestern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction in the 2 Interventions (time frame: within 6 months of PAP). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00873288, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023; AzTrials last refreshed its copy on 27 Oct 2026.