Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

Patients randomized to this arm will receive automated prompts to complete and return the FIT kit.

Patients randomized to this arm will receive automated prompts plus linguistically and culturally tailored live prompts to complete and return the FIT kit.

Patients randomized to this arm will receive usual care screening opportunities per recommended colorectal cancer screening guidelines.

This intervention is an automated data-driven program, using automated phone calls, text messages, and/or emails, for delivering FIT kit prompts to patients due for colorectal cancer screening. The specific components of the intervention are forthcoming and will be determined using a community-based participatory research approach known as boot camp translation which seeks input from patients and providers.

Automated Prompts

This intervention is a higher-intensity program, using automated data-driven prompts plus linguistically and culturally tailored live prompts, for delivering FIT kit messages to patients due for colorectal cancer screening. The specific components of the intervention are forthcoming and will be determined using a community-based participatory research approach known as boot camp translation which seeks input from patients and providers.

Automated Plus Live Prompts

Gloria Coronado, PhD

The overall goal of this study is to test strategies to raise rates of colorectal cancer screening among the Latino population in a federally qualified health center that operates multiple clinics. This intervention study will test automated and live prompts to a direct-mail fecal testing program in two phases.

In Phase I (Years 01 - 02), the investigators will tailor and define intervention components using a community-based participatory research approach called boot camp translation (BCT). The ultimate design of the intervention will be defined by patient and provider feedback from BCT. The investigators will then conduct a three-arm patient-randomized comparative effectiveness trial in two pilot clinics to compare 1) automated prompts (i.e., automated phone calls, text messages) to alert and remind patients to complete screening, 2) live prompts (i.e., live phone calls), and 3) a combination approach of automated plus live prompts.

In Phase II (Years 03 - 05), the investigators will spread and test the spread of the adapted intervention to additional clinics within the partnering health center using a two-arm main trial.

Both phases will be guided by an advisory group of clinicians, researchers, policy makers, and patients.

The study will fulfill the following aims:

Aim 1: Develop personalized messages (e.g., phone scripts, text messages, patient portal prompts) and define an intervention using boot camp translation to increase colon cancer screening among Latino populations.

Aim 2: Assess the reach, effectiveness, and differences by subgroup (e.g., preferred language) of a three-arm colorectal cancer screening program among Latino FQHC patients, in 2 clinics, through a patient randomized-controlled trial.

In addition to Usual Care, the arms are:

* Automated Prompts-an automated data-driven program for delivering FIT kit prompts (using automated phone calls, text messages, and/or emails) to patients due for colorectal cancer screening.
* Automated Plus Live Prompts-a higher-intensity program using automated, data-driven strategies for delivering FIT kit prompts plus linguistically and culturally tailored live prompts.

Aim 3: Test the spread of the program across additional clinics using a two-arm randomized approach and develop an implementation guide that includes outreach materials, strategies for incorporating patient input, and resources.

Phase I: The investigators will conduct a three-arm patient-randomized trial to compare 1) usual care, 2) automated prompts, and 3) automated plus live prompts. (Number of Arms: 3)

Phase II: This spread trial will use a stepped-wedge design, which is a variant of a crossover randomized trial, where clinics cross over from usual practice to the best practices program. In the stepped-wedge design, a baseline period controls for the level and rate of change of the outcomes prior to program implementation and the staggered implementation minimizes confounding due to changes in the secular trend. By randomizing practices to when they receive an intervention instead of whether they receive it, the stepped wedge design ensures that all practices eventually receive the intervention, an important consideration for clinic leadership. Furthermore, the wedge-defined clusters act as their own controls as they each receive both intervention conditions. (Number of Arms: 2)

Participatory Research to Advance Colon Cancer Prevention

Oregon Health and Science University

AltaMed Health Services Corporation

Kaiser Permanente

Gastrointestinal Agents

Polyethylene glycol 3350

Laxatives

Cathartics

2-L split-dose Miralax-Gatorade bowel prep

2-L split-dose Miralax-Gatorade bowel prep for colonoscopy

Miralax-Gatorade Prep

4-L split dose Golytely is the current standard prep at the VA

Golytely

Yu-Xiao Yang, MD MSCE

From the patients' perspective, the most formidable part of the colonoscopy experience is the process of bowel cleansing. A poorly tolerated bowel preparation regimen often leads to incompletion of scheduled colonoscopies which in turn undermines the effectiveness of colonoscopy, increases cost, and decreases patient satisfaction. The current standard bowel preparation in the VA is of larger volume and less palatable than another commonly used bowel preparation regimen. The investigators propose to compare these two commonly used bowel preparations with respect to the overall completion rate of scheduled colonoscopies in a real-world VA practice setting. The results of the study can be immediately applied to maximize the effectiveness of colonoscopy and increase patient satisfaction in the VA.

Anticipated Impacts on Veterans Health Care: by identifying a colonoscopy bowel preparation regimen which is the most effective in real-world VA practice and can be immediately implemented on a VA-wide scale, the proposed study will maximize the effectiveness of colonoscopy in reducing colorectal cancer (CRC) risk among Veterans, increase Veteran satisfaction, and reduce VA healthcare cost. Background: CRC is a leading cause of cancer-related death among Veterans. Colonoscopy can effectively reduce CRC incidence and mortality. However, non-adherence to screening colonoscopy substantially undermines this benefit. Existing evidence indicates that a disagreeable bowel preparation is a leading barrier to completing a colonoscopy from the patients' perspective. The taste and the volume of the bowel preparation determine patient tolerability and compliance to the preparation instructions, which in turn affects the incompletion (e.g., cancellation/no-show/reschedule) rate of scheduled colonoscopies as well as the effectiveness of the completed colonoscopies and patient satisfaction. The two most commonly used preparations currently in the US are the split-dose 4L polyethylene glycol (PEG) and the split-dose 2L MiraLAX/Gatorade preparations. While a high-volume regimen may in theory be more effective than a lower volume one, it may be associated with lower tolerability and adherence in real-world practice. Three small trials have compared these two preparations. However, data from these explanatory trials cannot inform policy decisions because they were conducted under artificial conditions, restricted among narrow patient populations, and most importantly not designed to capture the full impact of bowel preparation on the completion rate or effectiveness of colonoscopy. To address this critical knowledge gap, the investigators are proposing a pragmatic trial to determine the optimal split-dose bowel preparation in the general Veteran population. Objectives: to compare the real-world effectiveness of the two most commonly used split-dose colonoscopy bowel preparation regimens in the US (i.e., 4L PEG and 2L MiraLAX/Gatorade) with respect to the completion rate of scheduled colonoscopies, adenoma detection rate and secondarily preparation quality, cancellation/no-show rate and patient-oriented outcomes (e.g., willingness to repeat the preparation).

Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens

patients with inadequate bowel preparation who are recommended to have earlier-than-usual follow-up colonoscopy

The completion rate of scheduled colonoscopy will be defined as the proportion of patients who show up for their scheduled colonoscopy and have endoscopist-rated "adequate" bowel preparation quality, among those scheduled for a colonoscopy.

the ADR is estimated as the proportion of patients with at least one adenoma detected among all patients scheduled for colonoscopy.

The proportion of patients who cancel or no-show in each group.

this is a binary indictor based on endoscopist rating of excellent or good quality bowel preparation

VA Office of Research and Development

Clinics in usual care will go about clinic practices to complete recommended screening for colorectal cancer.

Clinics randomized to the Auto-Plus arm will engage in all activities (send an introductory letter to participants, then a FIT Kit, then a reminder letter encouraging the return of the FIT Kit) in addition to a PDSA (Plan Do Study Act) cycle to refine or improve their process.

Clinics randomized to the Auto-Plus arm will engage in all activities in the Auto arm (send an introductory letter to participants, then a FIT Kit, then a reminder letter encouraging the return of the FIT Kit) in addition to one other outreach effort.

Auto Plus

Beverly Green, PhD

Only an estimated 50 million US adults aged 50-75 are up-to-date on colorectal cancer (CRC) screening according to guidelines set by the federal government. CRC is 90% curable with timely detection and appropriate treatment of precancerous polyps; increased screening could reduce incidence by up to 50%. Groups least likely to undergo screening, those with minimal education, low income, low access to health care, recent immigrants or Hispanics, are the same people who frequently receive care at Federally Qualified Healthcare Center's (FQHCs). The use of fecal occult blood tests (FOBT) and fecal immunochemical tests (FIT) is exceedingly low in FQHCs (7-9% of patients in the past year) and far below national averages and target rates. Our results will provide valuable information on how to use electronic health record (EHR) resources to optimize guideline-based screening in FQHC clinics whose patient populations have disproportionately low CRC screening rates.

This project, in conjunction with the research team, will use an advisory panel to direct the research activities. The advisory panel will be made up of clinicians, leaders, researchers, and patients. The panel and team will guide the development of materials, the outreach to patients, and the research protocol to best reach FQHC patients who are due for colorectal cancer screening.

This project will be conducted in two phases, Phase I is conducting a pilot at two FQHC's, and Phase II is rolling out the intervention to between 20-30 clinics.

Phase I (Pilot Aims)

* Aim 1 Conduct preliminary analyses of EHR data at two pilot clinics.
* Aim 2: Use codes and methods developed in Aim 1 to test the feasibility, reach, effectiveness, and cost of an EHR-based CRC screening intervention using a subset of 100 patients at each of two pilot clinics. We will use codes defined in Aim 1 to create a Solutions-based, Epic-integrated system to track CRC screening, mail FIT kits, and track patient test results and receipt of follow-up care. The system will be pilot-tested in two clinics.
* Aim 3: Use results from the pilot intervention to prepare for a large-scale, cluster-randomized pragmatic trial across 18 OCHIN clinics (see Phase II).

Transition from Phase I to Phase II

-Changes to our original proposal include going from a three arm to a two-arm pragmatic cluster trial with revised evaluation and power calculation and refinements to the intervention components for both usual care (now described as enhanced usual care) and the intervention (now described as enhanced auto).

Phase II (Full trial Aims)

* Primary Aim 1. Assess the effectiveness of a large-scale, two-arm CRC screening program among diverse CLINIC patients, and assess difference in CRC screening outcomes (overall and by age, sex, insurance status, Hispanic ethnicity/race). The intervention will consist of an automated data-driven, EHR-linked program for mailing FIT kits (with linguistically appropriate pictographic instructions and return postage) to patients due for CRC screening.
* Primary Aim 2. Assess the costs and long-term cost-effectiveness of the automated program.

We have also included two secondary aims:

* Secondary Aim 1. Assess adoption, implementation, reach and potential maintenance and spread of the program, using a mixed-method rapid assessment process, field notes, and other ethnographic data.
* Secondary Aim 2. Adapt and pilot-test the adaptation of STOP CRC in an alternate EHR platform, Allscripts, and develop an implementation guide to assist sites in adopting the program.

Strategies and Opportunities to Stop Colon Cancer in Priority Populations

Binary indication of FIT completion within 12 months or through August 3, 2015 (when usual care clinics received access to study tools). Proportion of completed FIT is represented below with a confidence interval of the difference in completed FIT.

Binary indication of any CRC screening (fecal test, sigmoidoscopy, or colonoscopy) during the evaluation interval.

National Institutes of Health (NIH)

National Center for Complementary and Integrative Health (NCCIH)

As our intervention mailed FIT kits to eligible patients (and our primary outcome was completion of FIT), we did not have a systematic way of capturing Severe Adverse Events. Nevertheless, we agreed to document and report to our Data Safety Monitoring Board any Severe Adverse Events we learned about anecdotally from participating clinics, of which there were none.

Usual care clinics continued their standard processes for CRC screening, which typically consisted of providing information and ordering tests during routine clinical encounters. Usual Care clinics were offered training and intervention materials in August 2015, and therefore patients were followed through the end of the study.

Usual Care

The intervention consisted of mailed FIT kits, a customized EHR process and training to support its use. All patients were followed through the end of the study.

Intervention

Usual care clinics continued their standard processes for CRC screening, which typically consisted of providing information and ordering tests during routine clinical encounters

The intervention consisted of mailed FIT kits, a customized electronic health record (EHR) process and training to support its use.

Total

Participants aged 50-64

Participants aged 65-75

Reported range reflects the range of clinic proportions.

Age, Customized

Female

Male

Sex/Gender, Customized

Hispanic

Data represent the proportion of Hispanic study participants across the individual clinics. Reported range reflects the range of clinic proportions.

Race/Ethnicity, Customized

White

Non-White, other

Data represent the proportion of study participants by race (categories: white and non-white, other) across the individual clinics. Reported range reflects the range of clinic proportions.

United States

Region of Enrollment

English

Spanish

Other

Data represent the proportion of study participants by preferred language across the individual clinics. Reported range reflects the range of clinic proportions.

Language

Medicaid

Medicare

Uninsured

Commercial

Data represent the proportion of study participants by Insurance status across the individual clinics. Reported range reflects the range of clinic proportions.

Insurance Status

<100 percent

100-150 percent

151-200 percent

≥201percent

Unknown

Data represent the proportion of study participants by federal poverty stratification across the individual clinics. Reported range reflects the range of clinic proportions.

* \<100 represents a household income below the federal poverty level
* 100-150 represents a household income between 100-150% of the federal poverty level, and so on

Federal Poverty Level

1 visit

2-5 visits

≥6 visits

Data represent the proportion of study participants by number of physician visits in past year across the individual clinics. Reported range reflects the range of clinic proportions.

Physician Visits in past year

Data represent the portion of study participants who have ever had FIT screening across the individual clinics. Reported range reflects the range of clinic proportions.

% Ever had FIT screening

Data represent the portion of study participants with diabetes diagnosis across the individual clinics. Reported range reflects the range of clinic proportions.

% with Diabetes (ever)

Data represent the portion of study participants with flu shot in the past year across the individual clinics. Reported range reflects the range of clinic proportions.

% with Flu Shot in past year

Data represent the proportion of female study participants with a mammogram in the past 2 years across the individual clinics. Reported range reflects the range of clinic proportions. \*The percentages are based only on women in the 26 clinics. These data represent the median proportion of women in a clinic with a mammogram.

This baseline measure was only assessed in females.

Proportion of Females with Mammogram in past 2 years

Data represent the proportion of female study participants with papanicolaou screening in past 3 years across the individual clinics. Reported range reflects the range of clinic proportions.

\*The percentages are based only on women in the 26 clinics. These data represent the median proportion of women in a clinic with papanicolaou screening.

Proportion of Females with Papanicolaou screening in past 3 years

The baseline analysis was conducted at the clinic level

* FIT samples were not processed if missing collection dates
* under-capture of colonoscopy
* screening/diagnostic colonoscopy indistinguishable
* mailed an introduction letter and having a FIT order served as proxy for having been mailed a FIT.

Gloria D. Coronado

Usual care clinics continued their standard processes for CRC screening, which typically consisted of providing information and ordering tests during routine clinical encounters.

The intervention consisted of mailed FIT kits, a customized EHR process and training to support its use.

Adult, age 50 to 74 years, clinic visit within 12 months of accrual, and due for CRC screening; no EHR evidence of completed FIT in past 11 months, flexible sigmoidoscopy in past 4 years, colonoscopy in past 9 years, an order for FIT in past 6 months or referral for sigmoidoscopy or colonoscopy in past year.

FIT Completion

Any CRC Screening

Usual care clinics continued their standard processes for CRC screening, which typically consisted of providing information and ordering tests during routine clinical encounters. Usual Care clinics were offered training and intervention materials in August 2015.

Overall Study

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Urinary Bladder Neoplasms

Urologic Diseases

Urinary Bladder Diseases

Urogenital Neoplasms

Non-Muscle Invasive Bladder Neoplasms

Urologic Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Immunologic Factors

BCG Vaccine

Adjuvants, Immunologic

Patients with a diagnosis of recurrent high-grade NMIBC that failed first-line BCG and who have selected radical cystectomy as their second-line treatment

Patients with a diagnosis of recurrent high-grade NMIBC that failed first-line BCG and who have selected medical management as their second-line treatment

John L Gore, MD

Bladder cancer is the most common urinary tract cancer and the 5th most common cancer in the US (1). Yet bladder cancer research is underfunded relative to other common cancers. As a result, bladder cancer care is prone to evidence gaps that produce decision uncertainty for both patients and clinicians. The Comparison of Intravesical Therapy and Surgery as Treatment Options (CISTO) for Bladder Cancer Study has the potential to fill these critical evidence gaps, change care pathways for the management of NMIBC (non-muscle-invasive bladder cancer), and provide for personalized, patient-centered care. The purpose of CISTO is to conduct a large prospective study that directly compares the impact of medical management versus bladder removal in recurrent high-grade NMIBC patients with BCG (Bacillus Calmette-Guerin) failure on clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).

Most bladder cancer patients (74%) present with NMIBC where the cancer is limited to the lining or support layer of the bladder. High-grade NMIBC is treated initially with endoscopic resection and intravesical immunotherapy, followed by bladder instillations of BCG. Most patients with high-risk, high-grade NMIBC are able to retain their bladders and avoid more invasive treatments. However, 24-61% of patients will have their cancers recur within 12 months of treatment with BCG (BCG failures), and they have limited treatment options. National guidelines recommend consideration between two alternatives: additional medical management and radical cystectomy (removal of the bladder). Selecting between these options involves weighing the risk of progression of bladder cancer and loss of a window of potential cure versus the risk of morbidity and loss of quality of life (QOL) with bladder removal. This complex decision-making engages patients and their caregivers, who may be impacted by the urinary, sexual, and bowel dysfunctions that can occur with NMIBC treatment.

The investigators will evaluate this research question on a large scale in real world practice settings including academic and community-based practices and examine patient-centered outcomes. The investigators have engaged stakeholders with diverse perspectives relevant to this research question, including patients, caregivers, national patient advocacy organizations, national medical specialty organizations, guideline developers, health care payers, and industry. By engaging broad expertise relevant to this research question, the investigators will ensure that the study results will help NMIBC patients whose cancer recurs after BCG treatment make more informed decisions that improve the health outcomes that are important to them.

CISTO is an observational study that will not affect the treatment that patients chose. Patient surveys will occur at study entry and at follow-up assessments for up to four years. There will also be a qualitative sub-study that will include interviews of approximately 50 patients and 25 caregivers recruited from the observational cohort study.

CISTO: Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer

De-identified study data will be shared according to the PCORI policy for data management and data sharing.

The primary evaluation of patient-reported quality of life, as measured by the EORTC QLQ-C30 at 12 months, will be conducted using targeted maximum likelihood estimation (TMLE) analysis. All of the subscales and single-item measures range in score from 0 to 100 and a high scale score represents a higher response level (ranging from 0 = low to 100 = high/healthy level of function; from 0 = low to 100 = high quality-of-life; from 0 = low to 100 = high level of symptomatology/problems). Subscale and global health status scores are each calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100. Each subscale requires responses for at least 50% of the items in that subscale in order to be calculated.

The evaluation of the effect of treatment choice on the trajectory of patient-reported quality of life, as measured by the EORTC QLQ-C30 at up to 48 months, will be conducted using both mixed effects and generalized estimating equations (GEE) longitudinal models.

The evaluation of the effect of treatment choice on patient-reported urinary function, as measured by the Bladder Cancer Index (BCI) at 12 months, will be conducted using TMLE analysis. The evaluation of the effect of treatment choice on the trajectory of urinary function at up to 48 months as measured by the BCI will be conducted using both mixed effects and GEE longitudinal models. The BCI consists of 36 items, with 4- or 5-point Likert response scales, covering 3 primary domains: urinary, bowel, and sexual. For each domain a summary score and two subscale scores (function and bother) are constructed. Scores are calculated by transforming item responses into a 0 to 100 scale and calculating the mean of the standardized items. Higher scores indicate better health status. To calculate a score, a minimum of 80% completed items is required.

The evaluation of the effect of treatment choice on patient-reported sexual function, as measured by the BCI at 12 months, will be conducted using TMLE analysis. The evaluation of the effect of treatment choice on the trajectory of sexual function at up to 48 months as measured by the BCI will be conducted using both mixed effects and GEE longitudinal models.

Patients' generic quality of life as measured in quality adjusted life years (QALY) by a series of time tradeoff (TTO) questions at 12 months post-enrollment will be modeled as a function of patient preferences, as measured by additional TTO items measuring QALY for bladder cancer-related health states, while controlling for patients' baseline quality of life, demographic and clinical characteristics using beta regression, stratified by treatment arm.

Patient-reported decisional regret will be measured using three items with 5-point Likert response scales which have been validated in a previous study of prostate cancer patients. These three items will be summed to yield a score from 0 to 12, with higher scores indicating greater regret. The evaluation of the effect of treatment choice on patient-reported decisional regret at 12 months will be conducted using TMLE analysis. The evaluation of the effect of treatment choice on patient-reported decisional regret at up to 48 months will be conducted using both mixed effects and GEE longitudinal models.

The evaluation of the effect of treatment choice on patient-reported financial distress, as measured by COST at 12-months, will be conducted using TMLE analysis. The evaluation of the effect of treatment choice on the trajectory of patient financial distress at up to 48 months will be conducted using both mixed effects and GEE longitudinal models. The COST questionnaire consists of 11 items, each scored on a 5-point Likert scale from zero to four. After reversing some items as indicated in the scoring manual (by reversing the sign on the original zero to four score and adding four), all item response scores are summed into a single financial toxicity score ranging from 0 to 44, with higher scores indicating greater financial toxicity. Each subscale requires responses for at least 50% of the items in that subscale in order to be calculated. Item nonresponse is accounted for by substituting the mean of the completed items in the subscale.

The evaluation of the effect of treatment choice on healthcare utilization, as measured by 12-month hospital and urology clinic days, will be conducted using TMLE analysis. The evaluation of the effect of treatment choice on the trajectory of patient healthcare utilization at up to 48 months will be conducted using both mixed effects and GEE longitudinal models.

The evaluation of the effect of treatment choice on patient self-reported return to work/normal activities will be conducted using TMLE analysis.

The evaluation of the effect of treatment choice on patient 12-month disease-free survival will be conducted using TMLE analysis. The evaluation of the effect of treatment choice on patient disease-free survival at up to 48 months will be conducted using TMLE-based survival analysis.

The evaluation of the effect of treatment choice on patient 12-month metastasis-free survival will be conducted using TMLE analysis. The evaluation of the effect of treatment choice on patient metastasis-free survival at up to 48 months will be conducted using TMLE-based survival analysis.

The evaluation of the effect of treatment choice on patient 12-month progression to muscle-invasive bladder cancer will be conducted using TMLE analysis. The evaluation of the effect of treatment choice on patient progression to muscle-invasive bladder cancer at up to 48 months will be conducted using TMLE-based survival analysis.

The evaluation of the effect of treatment choice on patient 12-month bladder cancer-specific survival will be conducted using TMLE analysis. The evaluation of the effect of treatment choice on patient bladder cancer-specific survival at up to 48 months will be conducted using TMLE-based survival analysis.

Patient-Centered Outcomes Research Institute

University of Washington

Associate Professor, School of Medicine: Urology

Nervous System Diseases

Ear, Nose, and Throat Diseases

Sarcopenia

Peripheral Nervous System Diseases

Vertigo

Dizziness

Muscular Atrophy

Atrophy

Neuromuscular Manifestations

Neurologic Manifestations

Pathological Conditions, Anatomical

Neuromuscular Diseases

Vestibular Diseases

Labyrinth Diseases

Labyrinthitis

Ear Diseases

Otorhinolaryngologic Diseases

Sensation Disorders

Patients in the intervention groups will receive neoadjuvant, adjuvant or first line palliative chemotherapy (for metastatic disease). In addition, all patients will undergo three months' targeted specialized physical group-based exercise and Comprehensive Geriatric Assessment with corresponding interventions

Patients in the usual care groups will receive standard treatment with neoadjuvant, adjuvant or first line palliative chemotherapy (for metastatic disease). If the patients have other health complaints, these will, as current standard procedure, be treated by oncologist or by referral to general practitioner

Vestibular rehabilitation, balance- and progressive resistance training for three months' three times/week and Comprehensive Geriatric Assessement including corresponding interventions

Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement

Katrine S Piper, PhD-Student

Jan Christensen, PhD

Cecilia M Lund, PhD

The goal of this clinical trial is to learn about the cause of dizziness and decline in walking ability in in older adults ≥65 years during chemotherapy treatment for colorectal cancer. Another goal is to investigate if a comprehensive geriatric assessment and three months' specialized physical group-based exercise three times/week can counteract muscle weakness, vertigo, instability, impaired walking balance, and neuropathy

Frequent adverse effects of chemotherapy in older adults are nausea and fatigue, but our research group have discovered a problem with many also suffering from sarcopenia, vertigo, dizziness, and peripheral neuropathy (CIPN) leading to balance and walking impairments causing increased risk of falls. Moreover, these symptoms are often underreported with inadequate awareness among health professionals leading to deficient focus on the need for targeted rehabilitation. A comprehensive geriatric assessment (CGA) can increase the number of frail, older patients completing chemotherapy and CGA-based interventions can decrease chemotherapy toxicity and improve health-related quality of life (HRQoL). Physical exercise has been shown to reduce muscle weakness, vertigo, dizziness, and impaired balance among older adults requiring limited resources. Therefore, this project aims to investigate the effectiveness of CGA and physical exercise to counteract muscle weakness, vertigo, instability, and impaired walking balance, during chemotherapy and to investigate the interaction between vertigo, postural stability and walking performance, and neuropathy and the prevalence of sarcopenia. The activities of specialized physical exercise planned in this intervention will, as hypothesized, result in a change in muscle strength, walking balance, self-perceived balance disabilities/dizziness, and fear of falling along with changes in peripheral nerve function and autonomic function and severity of CIPN which are the outcomes of this study. Accordingly, expectations are that this intervention will affect the HRQoL among older cancer patients with vertigo and walking impairments and reduce the number of falls and hospital admissions leading to a socioeconomic benefit.

The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer

Changes in walking speed using 10 meter walk test measuring gaitspeed in meters per second

Changes in postural control (standing balance) using HUR SmartBalance platform

Changes in peripheral vestibular function using Video Head Impulse Test (vHIT)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Participatory Research to Advance Colon Cancer Prevention	NCT03167125	Colorectal Canc...	Automated Promp... Automated Plus ...	50 Years - 75 Years	Kaiser Permanente
Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens	NCT03298945	Colorectal Canc...	Miralax-Gatorad... Golytely	18 Years -	VA Office of Research and Development
Strategies and Opportunities to Stop Colon Cancer in Priority Populations	NCT01742065	Colorectal Canc...	Auto Plus	50 Years - 74 Years	Kaiser Permanente
CISTO: Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer	NCT03933826	Bladder Cancer Cancer of the B... Non-muscle Inva...		18 Years -	University of Washington
The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer	NCT05710809	Colorectal Canc... Oncologic Compl... Comprehensive G... Vestibular Reha... Geriatric Oncol... Sarcopenia Vertigo Cancer Rehabilitation Exercise Geriatric Elderly Frail Older Adults Chemotherapy Chemotherapy-in... Resistance Trai... Balance Trainin... Postural Stabil... Pragmatic Trial Personal Medici... Individualised	Targeted specia...	65 Years -	Rigshospitalet, Denmark
A Pragmatic Trial of the Effect of a Mailed Patient Flyer About Prostate Specific Antigen (PSA) Testing Prior to an Annual Exam	NCT01516801	Prostate Cancer...	PSA flyer	50 Years - 74 Years	University of Colorado, Denver
A Pragmatic Trial of the Effect of a Mailed Patient Flyer About Prostate Specific Antigen (PSA) Testing Prior to an Annual Exam	NCT01516801	Prostate Cancer...	PSA flyer	50 Years - 74 Years	University of Colorado, Denver
Participatory Research to Advance Colon Cancer Prevention	NCT03167125	Colorectal Canc...	Automated Promp... Automated Plus ...	50 Years - 75 Years	Kaiser Permanente
A Pragmatic Trial of the Effect of a Mailed Patient Flyer About Prostate Specific Antigen (PSA) Testing Prior to an Annual Exam	NCT01516801	Prostate Cancer...	PSA flyer	50 Years - 74 Years	University of Colorado, Denver
Participatory Research to Advance Colon Cancer Prevention	NCT03167125	Colorectal Canc...	Automated Promp... Automated Plus ...	50 Years - 75 Years	Kaiser Permanente

Spots Global Cancer Trial Database for pragmatic trial