Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Stratifying by sex, 30 participants will be randomized to receive the CRC DA pamphlet.

Stratifying by sex, 30 will be randomized to receive the home safety information at the visit.

A newly developed 8-10 page decision aid pamphlet that discusses:1. Information on CRC; 2. Information about risk and benefits including the 10-year lag-time to benefitting from CRC screening; 3. Information to help patients evaluate CRC screening options (colonoscopy or stool testing); 4. Possible outcomes relevant to LE and health status. In addition, there will be a values clarification exercise

CRC decision aid pamphlet

The home safety information pamphlet is a 2-page fact sheet on home safety tips for older adults, and was designed by the AGS Health in Aging Foundation. It includes information in seven areas to help older adults stay safe in their homes. Areas include but are not limited to fall prevention and safety proofing homes. It has been used successfully in prior studies of DAs as a control intervention

Home Safety Pamphlet

Tamara Cadet, PhD, LICSW, MPH

Conduct a feasibility pilot RCT of a newly developed colorectal cancer screening (CRC) decision aid (DA) including 66 LHL adults 76-85 years recruited from community health centers. Hypotheses: Patients in the intervention group will be more likely to change their intentions to be screened with fewer patients with \<10 year LE and/or those with \>10 year LE and no risk factors intending to be screened and more with \>10 year LE and risk factors for CRC and/or those who have never been screened intending to be screened (primary outcome). The secondary outcomes are that the patients in the intervention group will have 1. increased knowledge of CRC screening options and the benefits and risks of these options; 2. increased SDM engagement; and 3. find the DA acceptable. Investigators also anticipate that at least 50% of eligible participants will choose to participate in the study.

Investigators will recruit and survey 66 adults (to reach a goal of 60 with complete data), 75-85 years with low health literacy LHL (30 per arm) over 24 months to learn the effects of the newly developed CRC DA pamphlet on older adult's screening intentions, knowledge of options and the benefits and harms, and SDM from community health centers. Investigators collect baseline data over the phone prior to the visit. Patients who are eligible and willing to participate will come to a regularly scheduled visit with their primary care physician (PCP) early to answer the pretest questions. Stratifying by sex, 30 participants will be randomized to receive the CRC DA pamphlet and 30 will be randomized to receive the home safety information at the visit in case they cancel their appointment and reschedule. The home safety information is 2 pages, and was designed by AGS Health in Aging Foundation. It has been used successfully in prior studies of DAs as a control intervention. Investigators chose this pamphlet for the control arm because it is written at \<7th grade reading level and reading about home safety should not affect screening decisions. Providing the control group the home safety pamphlet to read reduces response bias since it helps keep participants blinded to the intervention of interest and compensates for the time and attention required by the intervention group to read the DA. At the visit, participants will review the DA or the home safety pamphlet. The revised CRC DA pamphlet is expected to take 5-10 minutes to read as well as the home safety pamphlet. After completing the pre-survey questionnaire before the visit the patient will have their PCP visit. The post-test will be asked after the PCP visit in person or over the phone (depending on the participant's preference, access to a phone, and ability to stay after their appointment for enough time to complete the post-visit questionnaire). Investigators will conduct a chart review at 6 months to see if a CRC screening discussion occurred and the outcome (i.e., qualitative trends in use of CRC screening). Investigators will also call each patient at 6 months to ask about their CRC screening intentions.

Stratifying by sex, 30 participants will be randomized to receive the CRC DA pamphlet and 30 will be randomized to receive the home safety information at the visit in case they cancel their appointment and reschedule.

Shared Decision-making and Colorectal Cancer Screening

Shared Decision-making and Colorectal Cancer Screening Behaviors Among Older Adults With Low Health Literacy

There is not a plan to make individual participant data available to other researchers.

Number of participants who indicate their intentions to be screened or not be screened for CRC, Change from baseline to immediately after the intervention

Number of participants who correctly answer 15 true/false knowledge questions developed the investigators, about the harms and benefits of CRC screening, Change from baseline to immediately after the intervention

Number of participants who answer the question that participants want to make a CRC screening decision with their physician, from 5 decision-making role questions developed the investigators

Number of participants who indicate the decision aid is the right length, from a likert-scale question

Number of participants who indicate the decision aid is clear in the information presented, from a likert-scale question

Number of participants who indicate the decision aid present information that is not slanted towards CRC screening or slanted away from CRC screening, from a likert-scale question

Number of participants who felt anxious after reading the decision aid, from a likert-scale question

Number of participants who indicate recommending the decision aid to a friend, from a likert-scale question

Abramson Cancer Center at Penn Medicine

Associate Professor

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Pancreatic Neoplasms

Stomach Neoplasms

Lung Neoplasms

Pancreatic Cancer

Stomach Cancer

New lung, gastric and pancreatic cancer patients presenting to the University of Chicago outpatient oncology clinics, a large research institution located on Chicago's Southside, were identified for study accrual, using the electronic scheduling system.

Enrollment in therapeutic cancer trials remains low, and is especially challenging for patients with low health literacy. We tested an interactive technology designed for patients with diverse health literacy skills aimed at improving patient receptiveness, willingness, knowledge, self-efficacy and positive attitudes regarding clinical trials.

Testing an interactive technology in a diverse health literary population

Blase Polite, MD

The purpose of this research study is to test a touchscreen computer program, which allows patients to see information on a computer screen regarding cancer care, and specifically clinical trials. The purpose of this research is to help the investigators learn more about how to use technology in the medical setting to improve health outcomes.

Enrollment in therapeutic cancer trials remains low, and is especially challenging for patients with low health literacy. The purpose of this project is to pilot a multi-media technology intervention designed for patients with diverse health literacy skills with the aim of improving patient receptiveness, willingness, knowledge, self-efficacy, and positive attitudes regarding clinical trials. The intervention is comprised of multi-media touchscreen computer program components for clinical trial education and assessment of patient-reported outcomes. Patients presenting for their first oncology appointment were eligible. Patients viewed an interactive teaching video concerning clinical trials that was adapted from the National Institutes of Health. Validated surveys assessing receptiveness, willingness, knowledge, self-efficacy, and positive attitudes regarding clinical trials were administered before and after the test.

Effect of Multi-Media Tool on Enrollment in Oncology Clinical Trials

A Pilot Investigation to Examine the Effect of a Multi-Media, Computer Based Tool (Talking Touchscreen) on Enrollment in Adult Oncology-Specific Clinical Trials at an Academic Medical Center

We hypothesized that our interactive educational tool would improve patient receptivity, willingness, knowledge, self-efficacy and positive attitudes regarding therapeutic cancer clinical trials through the use of patient-friendly technology in the immediate pre-visit period. Patients used the TT to self-administer 24 items from the Clinical Trial questionnaire developed by Jacobsen and colleagues measuring Receptivity (range: 1-5), Willingness (range: 1-5), Knowledge about cancer clinical trials (range: 0-6), Positive Attitudes toward clinical trials (range: 1-5), and Self-Efficacy (range: 1-5). A high score for each subscale represents a more favorable outcome.

Secondary objectives of the study were to evaluate the feasibility and acceptability of multi-media technology for patient-reported outcomes (PRO) assessment and patient education in an oncology clinic. This was evaluated with a semi-structured interview with participants.

We used medical record abstraction to determine how many participants discussed clinical trials with their providers, how many were offered a clinical trial and how many were enrolled in a clinical trial.

Northwestern University

Merck Sharp & Dohme LLC

University of Chicago

Death and other serious and non-serious events were not collected.

New lung, gastric and pancreatic cancer patients presenting to the University of Chicago outpatient oncology clinics, a large research institution located on Chicago's Southside, were identified for study accrual, using the electronic scheduling system.

Testing an interactive technology in a diverse health literary population: Enrollment in therapeutic cancer trials remains low, and is especially challenging for patients with low health literacy. We tested an interactive technology designed for patients with diverse health literacy skills aimed at improving patient receptiveness, willingness, knowledge, self-efficacy and positive attitudes regarding clinical trials.

Touchscreen Participants

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Receptivity

Willingness

Knowledge

Positive Attitudes

Self-efficacy

Patients used the TT to self-administer 24 items from the Clinical Trial questionnaire developed by Jacobsen and colleagues measuring Receptivity (range: 1-5), Willingness (range: 1-5), Knowledge about cancer clinical trials (range:0-6), Positive Attitudes toward clinical trials (range:1-5), and Self-Efficacy (range: 1-5). A high score for each subscale represents a more favorable outcome.

Clinical Trials Attitudes, Knowledge, and Interest

Companionship

Instrumental Support

Physical Health

Mental Health

PROMIS Companionship Short Form, v2.0 - 6 items. PROMIS Instrumental Support Short Form, v2.0 - 6 items. PROMIS Global Health, v1.1 - 10 items assess overall health status (2 subscales: physical and mental health).

All PROMIS measures are standardized so that a score of 50 (standard deviation of 10) represents the mean (and standard deviation) of the general U.S. population. A higher score denotes more support or better health.

PROMIS

Health LiTT - The Health Literacy Assessment Using Talking Touchscreen Technology (Health LiTT) is a novel, self-administered multi-media test that meets psychometric standards (reliability of 0.90 or higher) for measurement of individual respondents, especially in the low to middle range of health literacy. Scores are standardized so that 50 (10) represents the mean (standard deviation) of the validation sample. A high score indicates better/high health literacy.

Health Literacy

Toni M Cipriano

Positive Attitude

Self-Efficacy

New lung, gastric and pancreatic cancer patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Shared Decision-making and Colorectal Cancer Screening	NCT04748380	Colorectal Canc...	CRC decision ai... Home Safety Pam...	75 Years - 85 Years	Abramson Cancer Center at Penn Medicine
Shared Decision-making and Colorectal Cancer Screening	NCT04748380	Colorectal Canc...	CRC decision ai... Home Safety Pam...	75 Years - 85 Years	Abramson Cancer Center at Penn Medicine
Effect of Multi-Media Tool on Enrollment in Oncology Clinical Trials	NCT02020252	Lung Cancer Gastric Cancer Pancreatic Canc...	Testing an inte...	18 Years -	University of Chicago

Spots Global Cancer Trial Database for low health literacy