Colorectal Cancer Screening, Cervical Cancer Screening
Conditions
Keywords
Environmental barriers to cancer screening, Person-level barriers to cancer screening
Brief summary
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immunochemical test (FIT) kits, as well as adapted cancer screening educational materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated counties of Pennsylvania.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.
Detailed description
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immunochemical test (FIT) kits, as well as adapted cancer screening educational materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated counties of Pennsylvania.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.
Interventions
DIAGNOSTIC_TESTSelf-sampling HPV test
Tests for human papillomavirus from cervical cell sample
DIAGNOSTIC_TESTFecal occult blood test
Tests for human hemoglobin from blood in fecal samples
Sponsors
National Cancer Institute (NCI)
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* lives in rural, segregated county of Pennsylvania * able to speak, read, and communicate well in English * out of date for both cervical and colorectal cancer screening
Exclusion criteria
* has had a partial or complete hysterectomy * has a family history of colorectal cancer * has a personal history of cervical or colorectal cancer * persons who are cognitively impaired * persons who are incarcerated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Percentage of Participants Who Completed Any Cervical PLUS Colorectal Cancer Screening Tests | 10 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Percentage of Participants Who Completed At-home Cervical PLUS Colorectal Cancer Screening Tests | 10 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 24 |
| 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. | 24 |
| Total | 48 |
Baseline characteristics
| Characteristic | Control | Self-Sampling Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 23 Participants | 47 Participants |
| Age, Continuous | 56 years STANDARD_DEVIATION 4.3 | 56 years STANDARD_DEVIATION 4.4 | 56 years STANDARD_DEVIATION 4.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 24 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| household income < $50,000 | 15 Participants | 17 Participants | 32 Participants |
| household income $50,000+ | 9 Participants | 7 Participants | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 20 Participants | 40 Participants |
| Region of Enrollment United States | 24 participants | 24 participants | 48 participants |
| Sex: Female, Male Female | 24 Participants | 24 Participants | 48 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 |
Outcome results
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.
Time frame: 10 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-Sampling Intervention | Difference in Percentage of Participants Who Completed Any Cervical PLUS Colorectal Cancer Screening Tests | 18 Participants |
| Control | Difference in Percentage of Participants Who Completed Any Cervical PLUS Colorectal Cancer Screening Tests | 1 Participants |
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.
Time frame: 10 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-Sampling Intervention | Difference in Percentage of Participants Who Completed At-home Cervical PLUS Colorectal Cancer Screening Tests | 17 Participants |
| Control | Difference in Percentage of Participants Who Completed At-home Cervical PLUS Colorectal Cancer Screening Tests | 0 Participants |