Uterine Cervical NeoplasmsTC3NCT01561326
Facilitating Follow-Up Adherence for Abnormal Pap Smears
A study testing Cognitive-affective barriers counseling and Cognitive-affective barriers counseling via brochure in people with Uterine Cervical Neoplasms, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
Objective: Previous studies have suggested that psycho-educational interventions delivered by telephone improve adherence to initial colposcopy after an abnormal Pap smear. To further explore strategies for enhanced follow-up to medical care recommendations, we studied the impact of a theory-guided cognitive-affective… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cervical Neoplasms
- What is being tested?
- Cognitive-affective barriers counseling and Cognitive-affective barriers counseling via brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women 18 years old or older
- have recently received an abnormal Pap smear indicative of oncogenic HPV
- have been referred for initial colposcopic evaluation at the Women's Care Center at Temple University Hospital
- able to communicate with ease in English
Who cannot join
- unable to communicate readily in English
- do not have access to a telephone
- have a history of any malignancy
- display current evidence of positive invasive carcinoma of the cervix
- display presence of another life-threatening medical condition
- show evidence of dementia
- prior participation in research study
- HIV
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Objective: Previous studies have suggested that psycho-educational interventions delivered by telephone improve adherence to initial colposcopy after an abnormal Pap smear. To further explore strategies for enhanced follow-up to medical care recommendations, we studied the impact of a theory-guided cognitive-affective barriers counseling intervention, delivered at 2-4 weeks before the colposcopy appointment, for inner city women. The comprehensive telephone barriers intervention was compared to an enhanced comparison group and a group that received tailored print materials.
Methods: Participants (N = 211) were recruited through a colposcopy clinic and randomly assigned to: 1) telephone assessment of barriers to follow up adherence recommendations combined with tailored telephone barriers counseling; 2) telephone assessment combined with tailored barriers print brochure; or 3) telephone assessment with no barriers counseling. Participants were assessed at baseline, 1-week, 9 and 15 months post-colposcopy.
Read the detailed description
Objective: Previous studies have shown that theory-based, tailored telephone barriers counseling significantly improves adherence to a colposcopy appointment after an abnormal pap smear result among low-income, minority women. This study built on these research findings and explored the efficacy of a state-of-the-science telephone counseling intervention utilizing a more rigorous study design. This enhanced counseling intervention was tailored to individual's distinctive cognitive-affective barriers profile, as assessed by the Cognitive-Social Health Information Processing (C-SHIP) model-guided barriers assessment tool, and with counseling messages targeted to all five domains of individual's barriers to adherence. In addition, the current study design was improved in two ways. First, the comparison group in this current study was an enhanced one that received a notification letter, assessment of cognitive-affective barriers by telephone, and a telephone appointment reminder. Second, this study had a longer follow-up period to allow testing of the intervention effect beyond initial colposcopy adherence. The participants were followed for 15 months post-colposcopy so that participants' adherence to medical follow-up recommendations (if any) within the 12 months after initial colposcopy can be collected and studied. Adherence to medical follow-up at 6 months and 12 months was measured at 9 months and 15 months, respectively, to allow 3 months for rescheduling, attending, and recording of the appointment. Overall, this study tested whether an enhanced tailored telephone barriers counseling intervention improve adherence to medical follow-up after abnormal pap smear among low-income, minority women.
Methods:
METHODS Participants (211) were randomized to the following baseline conditions: a) standard care (SC), i.e., a cognitive-affective barriers (CAB) assessment delivered via phone, receipt of a notification letter from physician regarding abnormal Pap test result and need to undergo colposcopy, and also including appointment date and clinic contact numbers, plus telephone confirmation and post-card appointment reminder; b) SC plus CAB counseling delivered by phone (CAB-C -T), i.e., culturally-relevant/sensitive barrier-specific messages drawn from a pre-developed library designed to counsel individuals regarding their specific barriers to adherence, e.g., by increasing risk-related knowledge, providing accurate outcome and self-efficacy expectancies, addressing health-related values and goals, moderating risk-related affect, or offering active plans and strategies to assist with self-regulation; c) SC plus CAB counseling delivered via Mail-Home Print Material (CAB-C-P), which included exactly the same applicable messages as were delivered by phone, but in print form. The tailoring of messages to a participant's cognitive-affective barriers profile was based on the two barriers in each of the five Cognitive-Social Health Information Processing (C-SHIP) categories (a total of 10 messages) that she rated most important on a five-point scale. There were 23 cognitive-affective adherence barriers grouped into the following C-SHIP categories: 1) risk-related encodings/perceptions (i.e., purpose of colposcopy, presence and progression of HPV-related disease); 2) risk-related expectancies and beliefs (i.e., confidence in ability to keep appointment, fatalistic beliefs about cancer); 3) risk-related values and goals (i.e., maintaining modesty, importance of having children); 4) risk-related affect (i.e., worries about necessary procedures and/or progression of disease, concerns regarding fertility); and 5) risk-related self-regulation (i.e., remembering appointment, overcoming child-care or work-related conflicts, transportation difficulties, ability to manage any negative risk-related affect). With regard to assessments, they were conducted at the following time points: baseline, and 1-week, 9-month, and 15-month post-colposcopy and included the following: the CAB assessment; background variables, including demographic (e.g., gender, age, ethnicity, education, marital and employment status, household income, number of children); medical and screening history (e.g., cancer diagnosis, previous Pap smears and frequency; breast exams (self and clinical); mammograms and abnormal results; results of the index colposcopy and physician recommendations from medical records; a potential moderating dispositional variable, attentional style (Monitoring-Blunting Style Scale); potential mediating variables, including affective variables (Spielberger State-Trait Anxiety Inventory, the Center for Epidemiological Studies-Depression Scale), and cognitive-affective process variables (knowledge, risk perceptions, expectancies and beliefs, affect, values and goals, regulatory skills); outcome variables, including adherence to initial diagnostic colposcopy and to 6- and 12-months colposcopically-based follow-up diagnostic and medical management recommendations, and an intervention evaluation. All assessments used scales developed in previous research, except the Powe Fatalism Inventory used to assess fatalism and the Revised Impact of Events Scale used to assess affect (i.e., stress-related intrusive and avoidant thoughts). Assessed at baseline were background variables (except medical recommendations), the moderating variable, and all mediating variables. The cognitive-affective barriers were assessed only at baseline. Assessed at 1-week post-colposcopy and at the 9-month and 15 month follow-ups were all mediating variables (except the cognitive-affect barriers) and outcome variables. The medical recommendations were assessed only at the 1-week post-colposcopy. Medical history was also re-assessed at the 15-month follow-up relating to the interim period from baseline.
- Conditions
- Uterine Cervical Neoplasms
- Being tested
- Cognitive-affective barriers counseling, Cognitive-affective barriers counseling via brochure, standard care
- Keywords
- cervical cancer, follow-up, Pap test, Medical management, Colposcopy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-affective barriers counselingBehavioural
Culturally-relevant/sensitive barrier-specific messages drawn from a pre-developed library designed to counsel individuals regarding their specific barriers to adherence, e.g., by increasing risk-related knowledge, providing accurate outcome and self-efficacy expectancies, addressing health-related values and goals, moderating risk-related affect, or offering active plans and strategies to assist with self-regulation
Cognitive-affective barriers counseling via brochureBehavioural
Culturally-relevant/sensitive barrier-specific messages drawn from a pre-developed library designed to counsel individuals regarding their specific barriers to adherence via brochure, e.g., by increasing risk-related knowledge, providing accurate outcome and self-efficacy expectancies, addressing health-related values and goals, moderating risk-related affect, or offering active plans and strategies to assist with self-regulation
standard careBehavioural
Cognitive-affective barriers (CAB) assessment delivered via phone; receipt of a notification letter from physician regarding abnormal Pap test result, need to undergo colposcopy, appointment date and clinic contact numbers; telephone confirmation and post-card appointment reminder
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-affective barriers counseling delivered by phone | Experimental | Standard care plus cognitive-affective barriers counseling delivered by phone , i.e., culturally-relevant/sensitive barrier-specific messages drawn from a pre-developed library designed to counsel individuals regarding their specific barriers to adherence Receives: Behavioral: Cognitive-affective barriers counseling |
| cognitive-affective barriers counseling via brochure | Experimental | Standard care plus cognitive-affective barriers counseling delivered via mail-home print material Receives: Behavioral: Cognitive-affective barriers counseling via brochure |
| standard care | Active comparator | Cognitive-affective barriers (CAB) assessment delivered via phone; receipt of a notification letter from physician regarding abnormal Pap test result, need to undergo colposcopy, appointment date and clinic contact numbers; telephone confirmation and post-card appointment reminder Receives: Behavioral: standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to diagnostic colposcopy appointment
Adherence to initial diagnostic colposcopy will be assessed for each participant through tracking of clinic reports/patient medical records immediately post-colposcopy. Adherence will be measured dichotomously with patients who attend their initial appointment or who cancel their initial colposcopy appointment but reschedule within one month of their original date deemed adherent and eligible for follow-up assessments.
Measured: 1-week Post-Colposcopy
Secondary outcomes (1)
Adherence to long-term follow-up medical recommendations
Adherence to 6- and 12-months colposcopically-directed recommendations and medical management over time will be assessed through medical chart review, as well as self-report, at 9- and 15-months post-index appointment. A 3-month grace period was selected to accommodate any clinic-based rescheduling and/or cancellation of appointments for procedures.
Measured: 9- and 15-months post-index appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startMay 2005
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Suzanne M. Miller-Halegoua, Ph.D., Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561326
- Sponsor's protocol ID
- IRB04802
- Other IDs
- R01CA104979
- Acronym
- TC3
- Status last verified
- Mar 2012
- First submitted
- 20 Mar 2012
- Last updated
- 23 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Follow-Up Adherence for Abnormal Pap Smears
- ClinicalTrials.gov ID
- NCT01561326
- Acronym / sponsor ID
- TC3 / IRB04802
- Conditions
- Uterine Cervical Neoplasms
- Keywords
- cervical cancer, follow-up, Pap test, Medical management, Colposcopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- Temple University, National Cancer Institute (NCI)
- Study start
- May 2005
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: Previous studies have suggested that psycho-educational interventions delivered by telephone improve adherence to initial colposcopy after an abnormal Pap smear. To further explore strategies for enhanced follow-up to medical care recommendations, we studied the impact of a theory-guided cognitive-affective barriers counseling intervention, delivered at 2-4 weeks before the colposcopy appointment, for inner city women. The comprehensive telephone barriers intervention was compared to an enhanced comparison group and a group that received tailored print materials.
Methods: Participants (N = 211) were recruited through a colposcopy clinic and randomly assigned to: 1) telephone assessment of barriers to follow up adherence recommendations combined with tailored telephone barriers counseling; 2) telephone assessment combined with tailored barriers print brochure; or 3) telephone assessment with no barriers counseling. Participants were assessed at baseline, 1-week, 9 and 15 months post-colposcopy.
Detailed description
Objective: Previous studies have shown that theory-based, tailored telephone barriers counseling significantly improves adherence to a colposcopy appointment after an abnormal pap smear result among low-income, minority women. This study built on these research findings and explored the efficacy of a state-of-the-science telephone counseling intervention utilizing a more rigorous study design. This enhanced counseling intervention was tailored to individual's distinctive cognitive-affective barriers profile, as assessed by the Cognitive-Social Health Information Processing (C-SHIP) model-guided barriers assessment tool, and with counseling messages targeted to all five domains of individual's barriers to adherence. In addition, the current study design was improved in two ways. First, the comparison group in this current study was an enhanced one that received a notification letter, assessment of cognitive-affective barriers by telephone, and a telephone appointment reminder. Second, this study had a longer follow-up period to allow testing of the intervention effect beyond initial colposcopy adherence. The participants were followed for 15 months post-colposcopy so that participants' adherence to medical follow-up recommendations (if any) within the 12 months after initial colposcopy can be collected and studied. Adherence to medical follow-up at 6 months and 12 months was measured at 9 months and 15 months, respectively, to allow 3 months for rescheduling, attending, and recording of the appointment. Overall, this study tested whether an enhanced tailored telephone barriers counseling intervention improve adherence to medical follow-up after abnormal pap smear among low-income, minority women.
Methods:
METHODS Participants (211) were randomized to the following baseline conditions: a) standard care (SC), i.e., a cognitive-affective barriers (CAB) assessment delivered via phone, receipt of a notification letter from physician regarding abnormal Pap test result and need to undergo colposcopy, and also including appointment date and clinic contact numbers, plus telephone confirmation and post-card appointment reminder; b) SC plus CAB counseling delivered by phone (CAB-C -T), i.e., culturally-relevant/sensitive barrier-specific messages drawn from a pre-developed library designed to counsel individuals regarding their specific barriers to adherence, e.g., by increasing risk-related knowledge, providing accurate outcome and self-efficacy expectancies, addressing health-related values and goals, moderating risk-related affect, or offering active plans and strategies to assist with self-regulation; c) SC plus CAB counseling delivered via Mail-Home Print Material (CAB-C-P), which included exactly the same applicable messages as were delivered by phone, but in print form. The tailoring of messages to a participant's cognitive-affective barriers profile was based on the two barriers in each of the five Cognitive-Social Health Information Processing (C-SHIP) categories (a total of 10 messages) that she rated most important on a five-point scale. There were 23 cognitive-affective adherence barriers grouped into the following C-SHIP categories: 1) risk-related encodings/perceptions (i.e., purpose of colposcopy, presence and progression of HPV-related disease); 2) risk-related expectancies and beliefs (i.e., confidence in ability to keep appointment, fatalistic beliefs about cancer); 3) risk-related values and goals (i.e., maintaining modesty, importance of having children); 4) risk-related affect (i.e., worries about necessary procedures and/or progression of disease, concerns regarding fertility); and 5) risk-related self-regulation (i.e., remembering appointment, overcoming child-care or work-related conflicts, transportation difficulties, ability to manage any negative risk-related affect). With regard to assessments, they were conducted at the following time points: baseline, and 1-week, 9-month, and 15-month post-colposcopy and included the following: the CAB assessment; background variables, including demographic (e.g., gender, age, ethnicity, education, marital and employment status, household income, number of children); medical and screening history (e.g., cancer diagnosis, previous Pap smears and frequency; breast exams (self and clinical); mammograms and abnormal results; results of the index colposcopy and physician recommendations from medical records; a potential moderating dispositional variable, attentional style (Monitoring-Blunting Style Scale); potential mediating variables, including affective variables (Spielberger State-Trait Anxiety Inventory, the Center for Epidemiological Studies-Depression Scale), and cognitive-affective process variables (knowledge, risk perceptions, expectancies and beliefs, affect, values and goals, regulatory skills); outcome variables, including adherence to initial diagnostic colposcopy and to 6- and 12-months colposcopically-based follow-up diagnostic and medical management recommendations, and an intervention evaluation. All assessments used scales developed in previous research, except the Powe Fatalism Inventory used to assess fatalism and the Revised Impact of Events Scale used to assess affect (i.e., stress-related intrusive and avoidant thoughts). Assessed at baseline were background variables (except medical recommendations), the moderating variable, and all mediating variables. The cognitive-affective barriers were assessed only at baseline. Assessed at 1-week post-colposcopy and at the 9-month and 15 month follow-ups were all mediating variables (except the cognitive-affect barriers) and outcome variables. The medical recommendations were assessed only at the 1-week post-colposcopy. Medical history was also re-assessed at the 15-month follow-up relating to the interim period from baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive-affective barriers counseling delivered by phone | Experimental | Behavioral: Cognitive-affective barriers counselingStandard care plus cognitive-affective barriers counseling delivered by phone , i.e., culturally-relevant/sensitive barrier-specific messages drawn from a pre-developed library designed to counsel individuals regarding their specific barriers to adherence |
| cognitive-affective barriers counseling via brochure | Experimental | Behavioral: Cognitive-affective barriers counseling via brochureStandard care plus cognitive-affective barriers counseling delivered via mail-home print material |
| standard care | Active comparator | Behavioral: standard careCognitive-affective barriers (CAB) assessment delivered via phone; receipt of a notification letter from physician regarding abnormal Pap test result, need to undergo colposcopy, appointment date and clinic contact numbers; telephone confirmation and post-card appointment reminder |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- women 18 years old or older
- have recently received an abnormal Pap smear indicative of oncogenic HPV
- have been referred for initial colposcopic evaluation at the Women's Care Center at Temple University Hospital
- able to communicate with ease in English
Key exclusion criteria (8 listed)
- unable to communicate readily in English
- do not have access to a telephone
- have a history of any malignancy
- display current evidence of positive invasive carcinoma of the cervix
- display presence of another life-threatening medical condition
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 |
|---|---|---|
| Cognitive-affective barriers counselingCulturally-relevant/sensitive barrier-specific messages drawn from a pre-developed library designed to counsel individuals regarding their specific barriers to adherence, e.g., by increasing risk-related knowledge, providing accurate outcome and self-efficacy expectancies, addressing health-related values and goals, moderating risk-related affect, or offering active plans and strategies to assist with self-regulation | Behavioural | Cognitive-affective barriers counseling delivered by phone |
| Cognitive-affective barriers counseling via brochureCulturally-relevant/sensitive barrier-specific messages drawn from a pre-developed library designed to counsel individuals regarding their specific barriers to adherence via brochure, e.g., by increasing risk-related knowledge, providing accurate outcome and self-efficacy expectancies, addressing health-related values and goals, moderating risk-related affect, or offering active plans and strategies to assist with self-regulation | Behavioural | cognitive-affective barriers counseling via brochure |
| standard careCognitive-affective barriers (CAB) assessment delivered via phone; receipt of a notification letter from physician regarding abnormal Pap test result, need to undergo colposcopy, appointment date and clinic contact numbers; telephone confirmation and post-card appointment reminder | Behavioural | standard care |
Primary outcome
Adherence to diagnostic colposcopy appointment
Time frame: 1-week Post-Colposcopy
Adherence to initial diagnostic colposcopy will be assessed for each participant through tracking of clinic reports/patient medical records immediately post-colposcopy. Adherence will be measured dichotomously with patients who attend their initial appointment or who cancel their initial colposcopy appointment but reschedule within one month of their original date deemed adherent and eligible for follow-up assessments.
1 secondary outcome
Adherence to long-term follow-up medical recommendations
Time frame: 9- and 15-months post-index appointment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2012.
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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.
Suzanne M. Miller-Halegoua, Ph.D. principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-affective barriers counseling and Cognitive-affective barriers counseling via brochure in people with Uterine Cervical Neoplasms, run by Fox Chase Cancer Center at 1 site 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 4 inclusion and 8 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 23 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adherence to diagnostic colposcopy appointment (time frame: 1-week Post-Colposcopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2012.