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| ID | Type | Description | Link |
|---|---|---|---|
| K22CA225705-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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In this study, the investigators will deliver self-sampling human papillomavirus (HPV) tests and fecal immunochemical test (FIT) kits, as well as adapted cancer screening educational materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated counties of Pennsylvania.
The hypothesis is that delivering self-sampling HPV tests and FIT, as well as adapted educational materials, to women in rural, segregated areas could help increase cancer screening, reduce geographic cancer disparities, and improve public health.
In this study, the investigators will deliver self-sampling human papillomavirus (HPV) tests and fecal immunochemical test (FIT) kits, as well as adapted cancer screening educational materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated counties of Pennsylvania. A control group of 110 women, also recruited through FQHCs in rural, segregated counties of Pennsylvania, will be used for comparison; these women will receive standard-of-care reminders for cancer screening and complete the baseline and follow-up surveys.
The hypothesis is that delivering self-sampling HPV tests and FIT, as well as adapted educational materials, to women in rural, segregated areas could help increase cancer screening, reduce geographic cancer disparities, and improve public health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-Sampling Intervention | Experimental | Participants in this group will receive cervical and colorectal cancer self-sampling kits, instructions for completing the self-sampling kits, and educational materials about cervical and colorectal cancer. |
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| Control | No Intervention | Participants in this group will receive a standardized letter informing them that they are out-of-date for both cervical and colorectal cancer screenings and should schedule an appointment with their provider to receive these screenings. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-sampling HPV test | Diagnostic Test | Tests for human papillomavirus from cervical cell sample |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Percentage of Participants Who Completed Any Cervical PLUS Colorectal Cancer Screening Tests | Difference in percentage of participants who self-report having had cervical cancer screening PLUS having had colorectal cancer screening (all modalities) by the end of the study period between the two arms. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Percentage of Participants Who Completed At-home Cervical PLUS Colorectal Cancer Screening Tests | Difference in percentage of participants who completed at-home cervical cancer screening test PLUS completed at-home colorectal cancer screening test by the end of the study period between the two arms. | 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Moss, PhD | Penn State College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State College of Medicine | Hershey | Pennsylvania | 17033 | United States |
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The research team sent 3436 patients invitations to participate in the study. 200 patients responded. Of the 200 respondents that were contacted for follow-up: 62 were unreachable, 90 were ineligible to participate due to having a hysterectomy, and 48 were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Self-Sampling Intervention | Participants in this group will receive cervical and colorectal cancer self-sampling kits, instructions for completing the self-sampling kits, and educational materials about cervical and colorectal cancer. Self-sampling HPV test: Tests for human papillomavirus from cervical cell sample Fecal occult blood test: Tests for human hemoglobin from blood in fecal samples |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2021 |
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| Fecal occult blood test | Diagnostic Test | Tests for human hemoglobin from blood in fecal samples |
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| FG001 | Control | Participants in this group will receive a standardized letter informing them that they are out-of-date for both cervical and colorectal cancer screenings and should schedule an appointment with their provider to receive these screenings. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Self-Sampling Intervention | Participants in this group will receive cervical and colorectal cancer self-sampling kits, instructions for completing the self-sampling kits, and educational materials about cervical and colorectal cancer. Self-sampling HPV test: Tests for human papillomavirus from cervical cell sample Fecal occult blood test: Tests for human hemoglobin from blood in fecal samples |
| BG001 | Control | Participants in this group will receive a standardized letter informing them that they are out-of-date for both cervical and colorectal cancer screenings and should schedule an appointment with their provider to receive these screenings. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| household income | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in Percentage of Participants Who Completed Any Cervical PLUS Colorectal Cancer Screening Tests | Difference in percentage of participants who self-report having had cervical cancer screening PLUS having had colorectal cancer screening (all modalities) by the end of the study period between the two arms. | Posted | Count of Participants | Participants | 10 weeks |
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| Secondary | Difference in Percentage of Participants Who Completed At-home Cervical PLUS Colorectal Cancer Screening Tests | Difference in percentage of participants who completed at-home cervical cancer screening test PLUS completed at-home colorectal cancer screening test by the end of the study period between the two arms. | Posted | Count of Participants | Participants | 10 weeks |
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10 weeks (from the time of consent until the completion of the follow-up survey)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Self-Sampling Intervention | Participants in this group will receive cervical and colorectal cancer self-sampling kits, instructions for completing the self-sampling kits, and educational materials about cervical and colorectal cancer. Self-sampling HPV test: Tests for human papillomavirus from cervical cell sample Fecal occult blood test: Tests for human hemoglobin from blood in fecal samples | 0 | 24 | 0 | 24 | 0 | 24 |
| EG001 | Control | Participants in this group will receive a standardized letter informing them that they are out-of-date for both cervical and colorectal cancer screenings and should schedule an appointment with their provider to receive these screenings. | 0 | 24 | 0 | 24 | 0 | 24 |
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Low recruitment of minorities; Lack of sufficient power in statistical analyses; Use of cervical cancer screening methods unapproved by the FDA, Use of self-report for primary outcome.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer L. Moss, PhD | Pennsylvania State University College of Medicine | 717-531-0003 | 323429 | jmoss1@pennstatehealth.psu.edu |
| Nov 7, 2022 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 13, 2021 | Aug 18, 2022 | ICF_001.pdf |
| ID | Term |
|---|---|
| D009780 | Occult Blood |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| $50,000+ |
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