Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Physicians and clinic staff provide and patients recieve CRC screening usual care throughout the trial.

Physicians and clinic staff receive ongoing training, education, and feedback on CRC screening, and utilize point-of-care clinical decision support tool throughout the trial. Patients receive CRC screening recommendations from provider, a FIT kit with culturally tailored instructions, consultation with clinic staff, and text message reminders throughout the trial.

Best Practice

Consultation

Recieve education and training on CRC screening

Educational Intervention

Electronic Health Record Review

Recieve FIT kit with culturally tailored instructions

Fecal Immunochemical Test

Feedback

Health Education

Support Education Activity

Text Message-Based Navigation Intervention

Roshan Bastani

This clinical trial implements research strategies to increase colorectal cancer (CRC) screening rates among low income and ethnic minority groups. CRC is the second most common cause of cancer mortality in the United States and disproportionately burdens low income and ethnic minority groups. Fecal immunochemical testing (FIT) is a test to check for blood in the stool. A brush is used to collect water drops from around the surface of a stool while it is still in the toilet bowl. The samples are then sent to a laboratory, where they are checked for a human blood protein. Blood in the stool may be a sign of colorectal cancer. Despite its potential for reducing CRC incidence and mortality, screening remains woefully underutilized. There is an unmet need for practical and effective programs to improve CRC screening rates. By implementing a culturally-tailored screening CRC program that supports providers and clinic staff to encourage eligible patients to complete FIT, researchers hope to reduce cancer disparities among low-income and ethnic groups and increase the CRC screening rate, which will help providers find CRC sooner, when it may be easier to treat.

PRIMARY OBJECTIVE:

I. To increase CRC screening rates within Northeast Valley Health Corporation (NEVHC).

OUTLINE: Clinic sites are randomized to 1 of 2 groups.

GROUP I CLINICS: Physicians and clinic staff receive ongoing training, education, and feedback on CRC screening, and utilize point-of-care clinical decision support tool throughout the trial. Patients receive CRC screening recommendations from provider, a FIT kit with culturally tailored instructions, consultation with clinic staff, and text message reminders throughout the trial.

GROUP II CLINICS: Physicians and clinic staff provide and patients recieve CRC screening usual care throughout the trial.

Implementation Research to Increase Colorectal Cancer Screening Rates Among Low Income and Ethnic Minority Groups

Implementation Research to Reduce Colorectal Cancer Disparities

Patient-level study data on the primary outcome of CRC screening receipt will be assessed through electronic health record data systems. Fecal immunochemical test (FIT) is the screening method most commonly utilized in NEVHC. Patients who have completed a FIT within the past 12 months will be considered screened. Consistent with current CRC screening guidelines, patients screened via a flexible sigmoidoscopy in the past five years (very rare) or colonoscopy (very small numbers) in the past ten years will also be considered screened. The data will be analyzed using generalized linear mixed models that account for clustering within clinic and provider and multiple observations within patients.

Missed opportunity rates will be calculated at baseline, end of study, and intermediate time points by determining the number of eligible patients who made a clinic visit but did not receive a FIT kit. The data will be analyzed using generalized linear mixed models that account for clustering within clinic and provider and multiple observations within patients.

The data will be analyzed using generalized linear mixed models that account for clustering within clinic and provider and multiple observations within patients.

Tobacco Related Disease Research Program

Jonsson Comprehensive Cancer Center

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Behaviors and Mental Disorders

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Fatigue

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Quality of Life

Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light (mild) physical activity program that begins approximately within one week after discharge from the hospital with the physical activity program starting approximately within the first week post-discharge from the hospital.

Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light (mild) physical activity program that begins approximately within one week after discharge from the hospital with the physical activity program starting approximately 7 weeks post-discharge from the hospital.

Conventional treatment for cancer as prescribed by the participant's health care providers and will participate in a supportive cancer-related education activity each week for 6-weeks after returning home from the hospital.

Light (mild) physical activity program that corresponds with normal every day activities of daily living (\< 3.0 metabolic equivalents, METs), with a time commitment starting at 5 minutes a day 5 days a week gradually increasing to 30 minutes a day 5 days a week as you are able by week 6 as guided by your Registered Nurse researcher.

The program begins approximately within one week after discharge from the hospital with the physical activity program starting approximately within the first week post-discharge from the hospital.

Light Physical Activity 1

Light (mild) physical activity program that corresponds with normal every day activities of daily living (\< 3.0 metabolic equivalents, METs), with a time commitment starting at 5 minutes a day 5 days a week gradually increasing to 30 minutes a day 5 days a week as you are able by week 6 as guided by your Registered Nurse researcher.

The program begins approximately within one week after discharge from the hospital with the physical activity program starting approximately 7 weeks post-discharge from the hospital.

Light Physical Activity 2

Participate in a supportive cancer-related education activity including a direct 10 - 15 minute phone conversation with a Registered Nurse researcher each week for 6-weeks after returning home from the hospital. Wear a pedometer each day of the study.

Recording pedometer steps in the daily diary each day.

Amy J Hoffman, PhD, RN

Karin Trujillo, MD

Amy J Hoffman, PhD

Among 13 core symptoms across 3,106 breast, colorectal, prostate, and lung cancer patients, persons with lung cancer were the most symptomatic, with moderate to severe fatigue being reported with the greatest prevalence. This is a proposed randomized controlled trial of a novel rehabilitative intervention for persons with non-small cell lung cancer after surgery that promotes self-management of cancer-related fatigue (CRF) and is practical, portable, low cost, and safe. The results of the study will provide a novel exercise intervention, and its optimal timing, that helps a vulnerable population by reducing CRF severity and fatigability and is applicable to nearly all post-thoracotomy lung cancer patients.

Persons with non-small cell lung cancer (NSCLC) report significantly more unmet supportive care needs than other cancer populations, yet they are among the most vulnerable and least studied. Two of the most prevalent unmet supportive care needs include overcoming fatigue and attaining adequate exercise to meet physical demands of daily living. Cancer-related fatigue (CRF) is a prevalent, persistent, and distressing symptom in the NSCLC population. Cancer-related fatigue correlates with greater severity of 15 other symptoms, leading to lower physical function for persons with NSCLC. Among 13 core symptoms across 3,106 breast, colorectal, prostate, and lung cancer patients, persons with lung cancer were the most symptomatic, with moderate to severe fatigue being reported with the greatest prevalence. While surgery is the standard curative treatment for NSCLC, no formal guidelines exist for post-surgical rehabilitation. This is a proposed randomized controlled trial (RCT) of a novel rehabilitative intervention for persons with NSCLC after surgery. The intervention promotes self-management of CRF and tests the intervention's impact on CRF severity and fatigability with analysis by age. Preliminary data included a two-arm RCT (R21 CA164515) incorporating the proposed intervention, where study goals were exceeded for recruitment (66%), retention (97%), adherence (93%), and acceptability. The 6-wk exercise intervention demonstrated preliminary efficacy in significantly reducing CRF severity and fatigability as compared to usual care, with mean CRF levels restored to levels lower than pre-surgery. The exercise group's functional performance exceeded usual care. No adverse events were reported; participants had a mean age of 67 with a mean of 8 comorbid conditions. The investigator's long-term goal is to develop interventions to increase perceived self-efficacy for CRF self-management in order to improve CRF, symptom status, functional status, and quality of life (QOL) for persons with NSCLC. The objective in this application is to determine the efficacy, optimal timing, and sustainability of this innovative home-based exercise intervention. This study has the potential to transform the current standard by providing a rehabilitative exercise intervention after surgery. The intervention is home-based, self-paced, and builds in duration upon discharge from the hospital after surgery. Aim 1: Determine efficacy by comparing the immediate intervention group with wait-list control (usual care) and attention control by age. Aim 2: Determine efficacy of initiating the exercise intervention 6 wks post-discharge and compare results with the immediate intervention group for all ages. Aim 3: Determine the immediate intervention's sustainability by analyzing 3a) rates of extension, adherence, and retention; 3b) acceptability; and 3c) efficacy of primary and secondary outcomes. IMPACT: The results of this study will provide a novel exercise intervention, and its optimal timing, and fill the gap for a vulnerable population by providing a practical, portable, and low-cost means of reducing CRF severity and fatigability that is enjoyable and applicable to nearly all post-thoracotomy lung cancer patients.

Understanding the Post-Surgical Non-Small Cell Lung Cancer Patient's Symptom Experience

We will disseminate the results from this study at national/international meetings. We also expect that the findings of this study will be disseminated through scientific journals with multiple manuscripts prepared by the investigators from this study for publication in peer-reviewed journals. The investigators agree to continue to abide by the NIH Public Access Policy by submitting final peer-reviewed journal manuscripts to the digital archive, PubMed Central, upon acceptance for publication.

Degree of cancer-related fatigue severity on an 11-point scale (0-10, 10 = most severe)

Average fatigue level while performing the 6 minute walk test on an 11-point scale (0-10, 10 = most severe)

Severity of multiple symptoms and symptoms interference on daily life on an 11-point scale (0-10, 10 = most severe and most interference)

A persons's perception of ability to manage fatigue on an 11-point scale (0-10, 10 = very certain)

A person's perception to complete incremental 5-minute periods of walking using an 11-point scale (0-100%, 100% = very confident)

A person's perception of balance during every day activities using an 11-point scale (0-100%, 100% = very confident

Performance in average number of walking steps taken per day per week

Performance of daily mental and physical activities that people do in the normal course of their lives measured with eight subscales that focus on the physical and mental health components producing normative scores (0-100, 100 = higher functional status)

Satisfaction with various aspects of life and the importance of each aspect of life to the person using a 6 point-rating scale (1-6, 6 = very satisfied and very important)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Implementation Research to Increase Colorectal Cancer Screening Rates Among Low Income and Ethnic Minority Groups	NCT06090643	Colorectal Carc...	Best Practice Consultation Educational Int... Electronic Heal... Fecal Immunoche... Feedback Health Educatio... Support Educati... Text Message-Ba...	50 Years - 75 Years	Jonsson Comprehensive Cancer Center
Understanding the Post-Surgical Non-Small Cell Lung Cancer Patient's Symptom Experience	NCT03724331	Fatigue Self Efficacy Quality of Life Physical Activi... Lung Cancer Non-Small Cell ...	Light Physical ... Light Physical ... Support Educati...	18 Years -	University of Nebraska
Implementation Research to Increase Colorectal Cancer Screening Rates Among Low Income and Ethnic Minority Groups	NCT06090643	Colorectal Carc...	Best Practice Consultation Educational Int... Electronic Heal... Fecal Immunoche... Feedback Health Educatio... Support Educati... Text Message-Ba...	50 Years - 75 Years	Jonsson Comprehensive Cancer Center

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