Colorectal Cancer
Conditions
Keywords
health literacy, screening
Brief summary
This study, led by the American Samoa Community Cancer Coalition's INdigenous Samoan Partnership to Initiate Research Excellence (INSPIRE) and the UH Cancer Center's project team including Dr. Cassel, will utilize a community-based and culturally relevant process to assess the uptake of fecal occult blood testing (FOBT) using tailored colorectal cancer patient education materials for those with inadequate health literacy. Our primary outcomes include: 1) process to develop suitable and comprehensible health promotion materials for populations in English and Samoan with various health literacy levels, 2) commitment to use the FOBT Colocare home kit, and 3) use of a FOBT Colocare home kit.
Detailed description
Utilizing the Behavioral Model of Health Services Use as a conceptual framework and the evidence-based program Against Colorectal Cancer in Our Neighborhoods (ACCION) for the Latino population in Texas as a guide, the proposed study will conduct a randomized controlled trial of Indigenous Samoan participants (N=312), age≥ 50 recruited using Respondent-Driven Sampling (RDS). This design will compare use of non-tailored instruction for completing ColoCare FOBT home-kits (N=156) versus the experimental condition, using a ColoCare FOBT home-kit with instructions tailored to low health literacy and to enhance CRC-Knowledge Attitudes and Behavior (KAB) - (N=156). Our goal is to test the influence of tailored materials on timely completion of CRC screening using the ColoCARE FOBT.
Interventions
BEHAVIORALColocare Instruction Video: Modified SAM + CAM -Superior rating
Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
BEHAVIORALColocare Instruction Sheet: SAM + CAM Cloze Procedure
Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
BEHAVIORALColocare Instruction Sheet: SAM + CAM SMOG
Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
BEHAVIORALCDC Colorectal cancer screening for life brochure: SAM + CAM SMOG
Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
BEHAVIORALColocare Instruction Sheet: SAM + CAM - Superior rating SMOG - 5th Grade Level
Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
BEHAVIORALCDC Colorectal Cancer Screening for Life Brochure: SAM + CAM - Superior rating SMOG - 5th Grade Level
Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
BEHAVIORALCDC Colorectal cancer screening for life brochure: SAM + CAM Cloze Procedure
Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
BEHAVIORALColocare Instruction Sheet: SAM + CAM - Superior rating Cloze Procedure
Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
BEHAVIORALCDC Colorectal Cancer Screening for Life Brochure: SAM + CAM - Superior rating Cloze Procedure
Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
Sponsors
University of Hawaii
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
The health belief model and social cognitive theory were used as foundational principles to develop an intervention that builds awareness to initiate a CRC screening behavior modification. This research project will be the first to test the efficacy of the ColoCare FOBT home kit as a CRC screening intervention using a classical experimental (randomized clinical trial) in American Samoa. Second, the ColoCare kits can be identified as a cost-effective and culturally appropriate alternative to traditional FOBT home test kits. Lastly, results will be used to develop recommendations in healthcare delivery systems to improve information, communication, informed decision-making, and access to care in American Samoa.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Resident of America Samoa 2. Over age 50 3. Have not been diagnosed or treated for colon cancer 4. Is not high risk for CRC by having family history or diagnosed with irritable bowel syndrome 5. Can read and speak English and Samoan (can provide written informed consent) 6. Have a home address and working phone 7. Is willing to provide information on their health behaviors
Exclusion criteria
* persons who indicate they speak or read and write Samoan or English less than well
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use of FOBT ColoCARE Home Kit | 3 months | Number of participants reporting results for the FOBT ColoCARE Home kit |
| Increase Uptake of FOBT ColoCARE Home Kit | 2 months | Change in CRC-Knowledge Attitudes and Behavior (KAB) among subjects who viewed the tailored ColoCARE video. This measure is a 7 question assessment given before and after participants viewed the ColoCARE video. Participants were scored based on their pre and post assessment responses. |
| Modified Patient Education Materials | 1 Month | Use a combination of inadequate health literacy recommendations, suitable, and comprehensible assessment methods to develop modified culturally appropriate patient education materials for Colorectal Cancer (CRC). Each of the 22 items within the 6 identified categories are given a score of 0 - 2 based upon certain criteria. Total scores are calculated into percentages and 100% to 70% is adequate, 69% to 40% is marginal, while 39% - 0% is inadequate. |
Countries
American Samoa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| English Original Assessment Tools Short-Test of Functional Health Literacy in Adults ColoCARE Instruction Sheet CDC Colorectal Cancer Screening for Life Brochure ColoCARE Reply Card
Colocare Instruction Sheet: SAM + CAM SMOG: Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
CDC Colorectal cancer screening for life brochure: SAM + CAM SMOG: Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words | 58 |
| Samoan Original Assessment Tools Samoan Short-Test of Functional Health Literacy in Adults ColoCARE Instruction sheet CDC Colorectal Cancer Screening for Life Brochure ColoCARE Reply Card
Colocare Instruction Sheet: SAM + CAM Cloze Procedure: Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
CDC Colorectal cancer screening for life brochure: SAM + CAM Cloze Procedure: Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words | 90 |
| English Modified Assessment Tools Short-Test of Functional Health Literacy in Adults Modified ColoCARE Instruction Sheet Modified Colorectal Cancer Screening Brochure ColoCARE Reply Card
Colocare Instruction Sheet: SAM + CAM - Superior rating SMOG - 5th Grade Level: Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
CDC Colorectal Cancer Screening for Life Brochure: SAM + CAM - Superior rating SMOG - 5th Grade Level: Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
Colocare Instruction Video: Modified SAM + CAM -Superior rating: Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words | 40 |
| Samoan Modified Assessment Tools Samoan Short Test of Functional Health Literacy in Adults Modified ColoCARE Instruction Sheet Modified Colorectal Cancer Screening Brochure ColoCARE Reply Card
Colocare Instruction Video: Modified SAM + CAM -Superior rating: Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
Colocare Instruction Sheet: SAM + CAM - Superior rating Cloze Procedure: Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
CDC Colorectal Cancer Screening for Life Brochure: SAM + CAM - Superior rating Cloze Procedure: Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words | 76 |
| Total | 264 |
Baseline characteristics
| Characteristic | English Original Assessment Tools | Samoan Original Assessment Tools | English Modified Assessment Tools | Samoan Modified Assessment Tools | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 7 Participants | 5 Participants | 7 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants | 80 Participants | 32 Participants | 66 Participants | 230 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 58 Participants | 90 Participants | 40 Participants | 76 Participants | 264 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 57 Participants | 90 Participants | 38 Participants | 76 Participants | 261 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment American Samoa | 58 participants | 90 participants | 40 participants | 76 participants | 264 participants |
| Sex: Female, Male Female | 44 Participants | 67 Participants | 30 Participants | 16 Participants | 157 Participants |
| Sex: Female, Male Male | 14 Participants | 23 Participants | 10 Participants | 60 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 90 | 0 / 40 | 0 / 76 |
| other Total, other adverse events | 0 / 58 | 0 / 90 | 0 / 40 | 0 / 76 |
| serious Total, serious adverse events | 0 / 58 | 0 / 90 | 0 / 40 | 0 / 76 |
Outcome results
Primary
Increase Uptake of FOBT ColoCARE Home Kit
Change in CRC-Knowledge Attitudes and Behavior (KAB) among subjects who viewed the tailored ColoCARE video. This measure is a 7 question assessment given before and after participants viewed the ColoCARE video. Participants were scored based on their pre and post assessment responses.
Time frame: 2 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| English Original Assessment Tools | Increase Uptake of FOBT ColoCARE Home Kit | Positive Change | 48 Participants |
| English Original Assessment Tools | Increase Uptake of FOBT ColoCARE Home Kit | Negative Change | 10 Participants |
| Samoan Original Assessment Tools | Increase Uptake of FOBT ColoCARE Home Kit | Positive Change | 84 Participants |
| Samoan Original Assessment Tools | Increase Uptake of FOBT ColoCARE Home Kit | Negative Change | 6 Participants |
| English Modified Assessment Tools | Increase Uptake of FOBT ColoCARE Home Kit | Negative Change | 17 Participants |
| English Modified Assessment Tools | Increase Uptake of FOBT ColoCARE Home Kit | Positive Change | 23 Participants |
| Samoan Modified Assessment Tools | Increase Uptake of FOBT ColoCARE Home Kit | Positive Change | 67 Participants |
| Samoan Modified Assessment Tools | Increase Uptake of FOBT ColoCARE Home Kit | Negative Change | 6 Participants |
Primary
Modified Patient Education Materials
Use a combination of inadequate health literacy recommendations, suitable, and comprehensible assessment methods to develop modified culturally appropriate patient education materials for Colorectal Cancer (CRC). Each of the 22 items within the 6 identified categories are given a score of 0 - 2 based upon certain criteria. Total scores are calculated into percentages and 100% to 70% is adequate, 69% to 40% is marginal, while 39% - 0% is inadequate.
Time frame: 1 Month
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| English Original Assessment Tools | Modified Patient Education Materials | Adequate STOFHLA Score | 41 Participants |
| English Original Assessment Tools | Modified Patient Education Materials | Marginal STOFHLA Score | 13 Participants |
| English Original Assessment Tools | Modified Patient Education Materials | Inadequate STOFHLA Score | 4 Participants |
| Samoan Original Assessment Tools | Modified Patient Education Materials | Adequate STOFHLA Score | 18 Participants |
| Samoan Original Assessment Tools | Modified Patient Education Materials | Marginal STOFHLA Score | 25 Participants |
| Samoan Original Assessment Tools | Modified Patient Education Materials | Inadequate STOFHLA Score | 47 Participants |
| English Modified Assessment Tools | Modified Patient Education Materials | Inadequate STOFHLA Score | 4 Participants |
| English Modified Assessment Tools | Modified Patient Education Materials | Adequate STOFHLA Score | 27 Participants |
| English Modified Assessment Tools | Modified Patient Education Materials | Marginal STOFHLA Score | 9 Participants |
| Samoan Modified Assessment Tools | Modified Patient Education Materials | Marginal STOFHLA Score | 26 Participants |
| Samoan Modified Assessment Tools | Modified Patient Education Materials | Inadequate STOFHLA Score | 37 Participants |
| Samoan Modified Assessment Tools | Modified Patient Education Materials | Adequate STOFHLA Score | 10 Participants |
Primary
Use of FOBT ColoCARE Home Kit
Number of participants reporting results for the FOBT ColoCARE Home kit
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| English Original Assessment Tools | Use of FOBT ColoCARE Home Kit | 14 participants |
| Samoan Original Assessment Tools | Use of FOBT ColoCARE Home Kit | 2 participants |
| English Modified Assessment Tools | Use of FOBT ColoCARE Home Kit | 14 participants |
| Samoan Modified Assessment Tools | Use of FOBT ColoCARE Home Kit | 0 participants |