Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

No Intervention-"Standard Care"

UCLA Health has a mailed FIT outreach program. This group will receive standard FIT mailer protocol. They will receive a tailored MyChart message indicating the importance of CRC screening and not be presented with a choice for screening modalities.

This group will receive a tailored message via MyChart with information about CRC screening and using the FIT kit for noninvasive screening. They will then have to actively choose if they want CRC screening with a FIT kit vs no screening. If they opt for screening, the investigators will mail them a FIT kit.

This group will receive a tailored message via MyChart with information about CRC screening and colonoscopy for CRC screening. They will then have to actively choose if they want CRC screening with a colonoscopy vs no screening. If they opt for screening, the investigators will direct them to our patient navigators to get scheduled for a colonoscopy.

This group will receive a tailored message via MyChart with information about CRC screening and using either the FIT kit or colonoscopy for CRC screening. They will then have to actively choose if they want CRC screening with a FIT kit, a colonoscopy, or no screening. If they opt for screening, the investigators will either mail them a FIT kit or direct them to our patient navigators to schedule a colonoscopy, depending on their choice.

The investigators will send randomized participants a message via MyChart indicating the benefits of CRC screening, along with tailored information about FIT as a screening strategy. At the end of the message, participants will complete a survey asking them to indicate if they would like to be screened for CRC with a FIT, or if they prefer no screening whatsoever. The investigators will then ask follow-up questions to better understand the reason patients made their respective choices.

Active FIT Choice

The investigators will send randomized participants a message via MyChart indicating the benefits of CRC screening, along with tailored information about colonoscopy as a screening strategy. At the end of the message, participants will complete a survey asking them to indicate if they would like to be screened for CRC with a colonoscopy, or if they prefer no screening whatsoever. The investigators will then ask follow-up questions to better understand the reason patients made their respective choices.

Active Colonoscopy Choice

The investigators will send randomized participants a message via MyChart indicating the benefits of CRC screening, along with tailored information about FIT Kit and Colonoscopy screening. At the end of the message, participants will complete a survey asking them to indicate if they would like to be screened for CRC with either a FIT or Colonoscopy, or if they prefer no screening whatsoever. The investigators will then ask follow-up questions to better understand the reason patients made their respective choices.

Active Dual Choice

In May of 2021, the United States Preventive Service Task Force (USPSTF) updated their colorectal cancer (CRC) screening guidelines by recommending screening at an earlier age for average-risk adults starting at the age of 45 years old (Grade B recommendation). This is in addition to their Grade A recommendations of continuing to screen average-risk adults ages 50-75 years old. UCLA Health previously implemented a fecal immunochemical test (FIT) outreach program wherein FIT kits are mailed to average-risk patients overdue for CRC screening twice annually to promote screening uptake. As the investigators health system aims to screen the newly eligible population of average-risk patients between the ages of 45-49, the investigators proposed randomized controlled trial is aimed to determine the most effective patient outreach approach to maximize screening uptake within this age-group.

Colorectal cancer (CRC) is the second leading cause of cancer-related death for both men and women in the United States. One in 17 Americans will suffer from CRC during their lifetime and early detection of cancers and polyps by screening is shown to reduce CRC mortality. In 2021, the USPSTF updated its CRC screening guidelines to start screening average-risk individuals at the age of 45 years due in part to a rising incidence of CRC and premalignant polyps in younger patients.

Conventional screening options include both invasive (or direct-visualization) and non-invasive (or stool-based) options. Invasive screening tests include flexible sigmoidoscopy, CT colonography, and colonoscopy. Non-invasive screening tests include the fecal immunochemical test (FIT), the high sensitivity guaiac fecal occult blood test, and stool DNA testing. All of these screening tests are recommended by the USPSTF for CRC screening.

Nationally (and at UCLA Health), the two most common CRC screening modalities are the colonoscopy and the FIT. UCLA Health has previously implemented a FIT mailer outreach program wherein FIT kits are mailed to average-risk patients overdue for CRC screening twice annually to promote screening uptake. The program has been extremely effective in increasing CRC screening adherence rates, with an increase in the health system's screening rate over the past several years.

The investigators current study aims to determine the most effective patient outreach approach to maximize CRC screening utilization in average-risk individuals ages 45-49 years. In addition, the investigators aim to understand the impact of screening modality choice on uptake of CRC screening, patients' preference for screening modality, and sociodemographic differences in screening utilization among individuals ages 45-49 years.

There are approximately 18,000 patients eligible for inclusion. The investigators will randomly assign approximately 17,000 average-risk patients aged 45-49 to one of four arms. 1,000 of the patients will be reserved for an internal pilot project. In all arms, all patients will receive a text message encouraging them to access their patient communication portal via Epic electronic health record (EHR) (referred to as "MyChart"). In all arms, once a patient visits MyChart, a message on MyChart will state that they are due for CRC screening and the importance of CRC screening. In the control (standard care) arm, patients will treated as part of our "FIT-kit mailer program." These patients will receive a mailed FIT kit, and the message on MyChart will encourage them to complete the FIT kit. In the "FIT Kit Choice" arm, patients will be presented with the choice to complete screening with a FIT kit or opt out of screening. In the "Colonoscopy Choice" arm, patients will be presented with the choice to complete screening with a colonoscopy or opt out of screening. In the "Dual Choice" arm, patients will be presented with the choice to complete screening with a FIT kit, complete screening with a colonoscopy, or opt out of screening. After patients make the choice in MyChart, the patient will be asked why they made that choice.

We will resend the message on MyChart (as a reminder) two weeks after they receive the initial MyChart message. The reminder message content will be very similar to the content of initial MyChart message, and differ by arm.

The investigators have competing predictions based on the literature about whether giving people the option of choosing between two screening modalities (vs. neither) is better than giving people the option of deciding whether to take one modality (vs. not). On the one hand, offering people two modalities should increase flexibility and thus enhance participation; on the other hand, choosing between two modalities could tax mental resources and create choice avoidance, thus decreasing participation. Specifically:

In addition, the investigators have competing predictions based on the literature about whether active choice is better than assigning people a screening modality. On one side, active choice can make patients feel more empowered, thus enhancing participation in screening. On the other side, active choice takes more of patients' cognitive and time resources than following the assigned option, thus decreasing participation in screening.

Analysis Plan:

* Patient-level linear regression models with robust standard errors
* The primary model term will be indicator variables for arms that patients are assigned to.
* Covariates will include age, sex, race/ethnicity, social vulnerability index (ZIP code level), and baseline HM focus measure completion rate
* Treatment effects will be summarized using rate differences and 95% confidence intervals
* Exploratory analyses will investigate heterogeneous treatment effects by splitting the sample into demographic subgroups and by testing for demographic x choice arm interactions
* Sensitivity analyses will be performed without covariates, and using logistic regression models in place of linear regression models
* Missing covariate values will be handled by including 'unknown' indicators, along with mean imputation for quantitative covariates
* To analyze the effect of offering a choice between modalities (vs. single choice), we will compare the single choice arms (arms 1 and 2) with the dual choice arm (arm 3).
* To analyze the effect of active choice, we will compare the control arm (arm 0) with (1) active FIT choice arm (arm 1) and (2) the dual choice arm (arm 3).
* To assess both the effect of offering the dual choice (vs. single choice) and the effect of active choice, we will analyze two samples: (1) patients who open their initial MyChart message within 1 week of the date sent and (2) intention-to-treat regardless of whether patients open the MyChart message. In addition, when assessing the effect of offering the dual choice (vs. single choice), we will also examine patients who open either the initial or the reminder MyChart message within 1 week.

* Parallel-arm randomized controlled trial
* Patient-level randomization
* Four arms

  * Arm 0: Standard of care control
  * Arm 1: Active FIT choice
  * Arm 2: Active colonoscopy choice
  * Arm 3: Active FIT v. colonoscopy choice

The Impact of Choice on Colorectal Cancer Screening

The Impact of Choice on Colorectal Cancer (CRC) Screening Uptake Among Average-risk Individuals 45-49 Years of Age

We do not plan to make any individual participant data available.

Rate of completion of any CRC screening (FIT Kit or Colonoscopy) throughout the observation window.

Frequency of CRC screening choice indicated in the MyChart survey per arm

The frequency of ordering FIT Kit or Colonoscopy in the "FIT Kit Choice", "Colonoscopy Choice" and "Dual Choice" arms

Rate of completion of CRC screening by specific modality (FIT Kit or Colonoscopy) throughout the observation window.

UCLA Vatche and Tamar Manoukian Division of Digestive Diseases

UCLA Department of Medicine

University of California, Los Angeles

Medical Director, DOM Quality

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Women assigned to this arm were invited to get a Pap testing at the Basic Health Unit

Women assigned to this arm were provided with a kit to engage in self-collection for HPV testing

Women assigned to this arm were given a choice between a Pap testing at the local Basic Health Unit or self-collection for HPV testing

Un/underscreened women received a home visit by a Community Health Worker and were scheduled an appointment for a Pap testing at the Basic Health Unit

Pap testing

Un/underscreened women received a home visit by a Community Health Worker and were given a kit to self-collect their own sampling for HPV testing at home

Self-collection for HPV testing

Un/underscreened women received a home visit by a Community Health Worker and were given a choice between scheduling an appointment for a Pap testing at the Basic Health Unit or self-collect their own sampling for HPV testing at home

Choice

Isabel C Scarinci, PhD

Our long-term goal is to decrease cervical cancer incidence and mortality among women in low- and middle-income countries (LMICs) by using the most efficacious and acceptable screening method, particularly among women who do not come to the clinic for their regular Pap testing. The purpose of this feasibility study is to compare three cervical cancer screening modalities (self-collection and HPV testing, Pap testing at the public health clinic, and choice between self-collection and HPV testing and Pap testing) among women who have not undergone cervical cancer screening within the past four years using a theory-based, culturally relevant intervention implemented by Community Health Workers (CHWs) via door-to-door visits. Three Basic Health Units (BHUs) within the public health system will be randomly assigned to one of the three screening modalities/conditions (self-collection and HPV testing, Pap testing at the local public health clinic, and choice between self-collection and HPV testing and Pap testing). CHWs will invite women who report not having been screened for cervical cancer in the past four years to participate in the study, and deliver a brief educational/behavioral session on cervical cancer and screening using a door-to-door approach under of one of the three conditions. The primary outcome will be adherence to cervical cancer screening. We hypothesize that (1) Women in the "choice" and "self-collection" groups will be more likely to engage in cervical cancer screening and display higher satisfaction with their screening than women assigned to the "Pap" with women assigned to the "choice" group having the highest adherence of the three groups; and (2) Within the "choice" group, more women will choose and complete self-collection than Pap test.

Self-Collection and Human Papillomavirus (HPV) Testing in Unscreened Women: a Feasibility Study in Brazil

Self-Collection and HPV Testing in Unscreened Women: a Feasibility Study in Brazil

Adherence to cervical cancer screening by completing either the Pap testing or self-collection for HPV testing)

National Cancer Institute (NCI)

University of Alabama at Birmingham

Primary Investigator

Herbal and Botanical

All Drugs and Chemicals

Cola

Participants in this arm will receive a letter from their provider informing them they are overdue for colon cancer screening and requesting their participation in colonoscopy, and including a referral for the procedure at a local endoscopy center. Participants will be provided a phone number if interested in navigated colonoscopy scheduling.

Participants in this arm will receive a letter from their provider informing them they are overdue for colon cancer screening and requesting their participation in their choice of either colonoscopy or mailed fecal immunochemical testing (FIT). The letter will include both a referral for the colonoscopy at a local endoscopy enter and a FIT kit with a lab requisition and instructions for completion.

Participants in this arm will receive a letter from their provider informing them they are overdue for colon cancer screening and requesting their participation in FIT testing. The letter will include a FIT kit with lab requisition and instructions for completion.

Mailed letter asking participants to complete CRC screening by colonoscopy

Colonoscopy Only

Mailed letter and FIT test asking participants to complete CRC screening by their choice of either colonoscopy or mailed FIT

Mailed letter and FIT test asking participants to complete CRC screening by mailed FIT

FIT Only

Shivan Mehta, MD

This is a 3-arm randomized trial aimed at increasing rates of participation in colorectal cancer (CRC) screening by outreach to patients' homes using choice architecture informed by behavioral science principles.

The investigators will evaluate the effectiveness of mailed outreach with choice between colonoscopy and FIT, and FIT alone, as compared to colonoscopy alone in increasing CRC screening rates.

Choice Architecture and Mailed Colorectal Cancer Screening Outreach in a Community Health Setting

Screening completion rate in arm 2 (Choice) to arm 1 (Colonoscopy only) and arm 3 (FIT only) separately.

The proportion of patients choosing either FIT or Colonoscopy in study arm 2 (Choice)

National Comprehensive Cancer Network

Abramson Cancer Center at Penn Medicine

Principal Investigator

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Lymphosarcoma

Use of Choice intervention to support consultations

Use of Choice support system as preparation for patient consultations

CHOICE

This interdisciplinary international research collaboration will test effects of Choice, a computer-assisted, interactive support system designed to help cancer patients communicate their symptoms and preferences, and clinicians in incorporating this information into patient care. In this pretest-post test clinical trial with 200 leukemia and lymphoma patients we will: 1) Test effects of Choice when integrated into routine clinical practice on: patient-provider communication, documented patient care, anxiety and patient satisfaction; 2) analyze relationships among the above variables and explore differences in these relationships between groups; 3) analyze group differences in communication style in terms of instrumental and affective behavior, content, participation, initiative and person addressed; and 4) investigate the extent of the time requirements when using Choice in clinical practice, perceived usefulness and ease of use.

Improving shared decision making (SDM), patient-provider communication and incorporating patients' illness experiences and preferences into patient care are high priority health policy goals. However, this is difficult to accomplish without methods and systems that assist patients in sharing their illness experiences and clinicians in integrating this information into patient care. Choice is a computer-assisted, interactive communication and support system for cancer patients designed for this purpose. This interdisciplinary, international research collaboration will test effects of Choice in a pretest-post test clinical trial with 200 leukemia and lymphoma patients. We hypothesize that when patients use Choice for symptom and preference assessments and this information is provided to their clinicians to support consultations in routine practice, (1) patient-provider communication will be more patient-centered; (2) documented care will be more congruent with patients' reported symptoms and preferences; (3) patients will experience lower levels of anxiety and stress during consultations; and (4) they will be more satisfied with the consultation than the "usual care" control group. To better understand the mechanisms by which these effects occur, we will investigate relationships between communication style, documented patient care, anxiety and satisfaction; and explore time requirements, perceived usefulness and ease of use of Choice by patients and clinicians. Controlling for gender, age, diagnosis and type/stage of treatment, analyses of covariance and repeated measurement models will be primarily used for hypotheses testing, correlations and descriptive statistics to answer research questions. This study will contribute to new technologies to support SDM and patient-provider partnerships in health care that can significantly improve patient-provider communication, patient-centered care and physical, emotional and psycho-social well-being of cancer patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Impact of Choice on Colorectal Cancer Screening	NCT05275530	Colorectal Canc... Colorectal Neop... Health Screenin...	Active FIT Choi... Active Colonosc... Active Dual Cho...	45 Years - 49 Years	University of California, Los Angeles
Self-Collection and Human Papillomavirus (HPV) Testing in Unscreened Women: a Feasibility Study in Brazil	NCT03713697	Cervical Cancer	Pap testing Self-collection... Choice	25 Years - 64 Years	University of Alabama at Birmingham
Choice Architecture and Mailed Colorectal Cancer Screening Outreach in a Community Health Setting	NCT04711473	Colorectal Canc...	Colonoscopy Onl... Choice FIT Only	50 Years - 74 Years	Abramson Cancer Center at Penn Medicine
The Impact of Choice on Colorectal Cancer Screening	NCT05275530	Colorectal Canc... Colorectal Neop... Health Screenin...	Active FIT Choi... Active Colonosc... Active Dual Cho...	45 Years - 49 Years	University of California, Los Angeles
Choice Architecture and Mailed Colorectal Cancer Screening Outreach in a Community Health Setting	NCT04711473	Colorectal Canc...	Colonoscopy Onl... Choice FIT Only	50 Years - 74 Years	Abramson Cancer Center at Penn Medicine
The Impact of Choice on Colorectal Cancer Screening	NCT05275530	Colorectal Canc... Colorectal Neop... Health Screenin...	Active FIT Choi... Active Colonosc... Active Dual Cho...	45 Years - 49 Years	University of California, Los Angeles
Effect of Interactive Tailored Assessment on Patient-provider Communication	NCT00857103	Lymphoma	CHOICE	18 Years -	Oslo University Hospital

Spots Global Cancer Trial Database for choice

Every month we try and update this database with for choice cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for choice

Every month we try and update this database with for choice cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for choice cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.