Adapting Multiple Behavior Interventions That Effectively Improve Cancer Survivor Health Cancer Survivor Health

Breast Cancer Clinical Trial

— AMPLIFY  

Official title:

Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04000880
• Other study ID #: IRB-300002068
• Secondary ID: 1P01CA229997
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 4, 2020
• Est. completion date: August 31, 2024

Study information

• Verified date: February 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study will test the efficacy of interactive, web-based interventions that improve diet, physical activity and weight management changes among early stage survivors of breast, prostate, colorectal, endometrial, renal, thyroid, and ovarian cancers, as well as multiple myeloma and non-Hodgkin Lymphoma. Overarching outcomes also include physical function and performance, muscle mass, quality of life, and health utilities.

Description:

For this web-based behavioral intervention trial aimed at improving lifestyle behaviors of individuals at higher risk for cancer, other comorbidities and functional decline, 652 cancer survivors (a large proportion of whom will be age 65 or over, rural, and of minority status) will be enrolled and randomly assigned to one of the following study arms: 1) A diet and exercise intervention which would begin immediately, with the first 6 months focused on promoting healthful changes in diet consistent with the American Institute for Cancer Research Guidelines and designed to invoke an average weight loss of one pound per week, and the second 6 months focused on increasing physical activity. The 163 cancer survivors assigned to this arm would be evaluated at baseline, 6-, 12- and 18-months; 2) An exercise and diet intervention which would begin immediately, with the first 6 months focused on increasing physical activity, and the second 6 months focused on promoting healthful changes in diet consistent with the American Institute for Cancer Research Guidelines and designed to invoke an average weight loss of one pound per week. The 163 cancer survivors assigned to this arm would be evaluated at baseline, 6-, 12- and 18-months; and 3) A 12-month combined diet and exercise intervention focused on promoting healthful changes in diet consistent with the American Institute for Cancer Research Guidelines and designed to invoke an average weight loss of one pound per week, while at the same time promoting physical activity. The 326 cancer survivors assigned to this arm will be evaluated at baseline, 6-, 12-, and 18-months. Weight status, waist circumference, body composition, diet quality, physical activity, physical performance, quality of life, comorbidity, and health utilities will be measured at baseline and each follow-up time point, as will mediators of behavior change, e.g., social support, self-efficacy and barriers. Additionally, dried blood spots obtained from fingersticks will be analyzed for cytokines (IL-6 and hsCRP) and biomarkers of gluco- and lipid regulation, i.e., glucose, and blood lipids (TG) and insulin.

It is hypothesized that cancer survivors assigned to all three of these study arms will experience significant improvements in weight status, body composition, diet quality, physical activity, physical performance, and quality of life. These improvements also will translate into lower health utility scores and prove cost effective. It also is anticipated that analyses will uncover significant mediators, such as self-efficacy, and moderators, such as level of educational attainment associated with program efficacy. Finally, we hypothesize that while all study arms will experience significant benefit, the sequenced arm participants (arms 1 and 2) will have significantly greater odds of achieving improved diet quality, weight loss, and moderate intensity aerobic physical activity of at least 150 minutes a week as measured by accelerometer) post-intervention than survivors randomized to the simultaneous arm.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 603
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Age 50 years or older

• Resident of the continental United States

• Diagnosed with multiple myeloma, non-Hodgkin lymphoma, or localized kidney or ovarian cancer; or [localized (includes in situ) through regional] breast, colorectum, endometrium, thyroid, or prostate cancer.

• Completed primary treatment (surgery, radiation or chemotherapy). Active surveillance among men with prostate cancer or women with ductal carcinoma in situ is acceptable.

• Completion of the 8th grade of school. Able to read and write English.

• Normal blood pressure or those with high blood pressure for whom physician permission was granted.

• Community dwelling.

• Reside in an area that receives wireless coverage.

• Have an active email address or be willing to have one created for the study.

• Current body mass index of greater than or equal to 25 kg/m2, but less than 50 kg/m2.

• Current physical activity level is less than 150 minutes of moderate-to-vigorous exercise per week.

Exclusion Criteria:

• Participation in another diet and exercise program.

• Evidence of progressive cancer of the eligible types.

• Recurrence of the eligible cancer types (exceptions are biochemical recurrence of prostate cancer).

• A physician has provided instruction to limit current physical activity.

• Pre-existing medical conditions that preclude adherence to an unsupervised weight loss intervention (e.g., pregnancy, severe orthopedic conditions, impending hip or knee replacement (within 6 months), end-stage renal disease, paralysis, dementia, blindness, unstable angina, untreated stage 3 hypertension, or recent history of heart attack, congestive heart failure or pulmonary conditions that required oxygen or hospitalization within 6 months).

• Second primary cancers, with the exception of non-melanoma skin cancer, or if the initial and second cancers are both deemed eligible cancers.

• Reside in a skilled nursing or assisted living facility.

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Kidney Cancer
• Kidney Neoplasms
• Multiple Myeloma
• Non-Hodgkin Lymphoma
• Ovarian Neoplasms
• Ovary Cancer
• Prostate Cancer
• Thyroid Cancer

Intervention

Behavioral:
• Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health
AMPLIFI will provide participants with a secure website where they receive and participate in educational sessions tailored to their assigned topics for the intervention arm. The website will provide a resource library for static documents, tips of the day, tracking of health behaviors, and goal-setting.

Other:
• Diet-Exercise
Diet-Exercise
• Exercise-Diet
Exercise-Diet
• Combined Diet and Exercise
Combined Diet and Exercise

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Tennessee Health Science Center	Memphis	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Cancer Institute (NCI), University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Levels of Stress (Patient reported outcome)	Participants will complete the 14-item Perceived Stress Scale	baseline
Other	Change in Levels of Stress (Patient reported outcome)	Participants will complete the 14-item Perceived Stress Scale	6 months
Other	Change in Levels of Stress (Patient reported outcome)	Participants will complete the 14-item Perceived Stress Scale	12 months
Other	Change in Levels of Stress (Patient reported outcome)	Participants will complete the 14-item Perceived Stress Scale	18 months
Other	Change in Levels of Stress (Patient reported outcome)	Participants will complete the 14-item Perceived Stress Scale	24 months
Other	Change in CIrculating Biomarkers	Fingersticks done after a 12-hour fast will collect 5 blood spots which will be dried (DBS). DBS eluents will be batch-tested against known standards for insulin, glucose, leptin, adiponectin, high density lipoprotein and total cholesterol, tryglycerides, interleukin-6, c-reactive protein and tumor necrosis factor alpha	baseline
Other	Change in CIrculating Biomarkers	Fingersticks done after a 12-hour fast will collect 5 blood spots which will be dried (DBS). DBS eluents will be batch-tested against known standards for insulin, glucose, leptin, adiponectin, high density lipoprotein and total cholesterol, tryglycerides, interleukin-6, c-reactive protein and tumor necrosis factor alpha	6 months
Other	Change in CIrculating Biomarkers	Fingersticks done after a 12-hour fast will collect 5 blood spots which will be dried (DBS). DBS eluents will be batch-tested against known standards for insulin, glucose, leptin, adiponectin, high density lipoprotein and total cholesterol, tryglycerides, interleukin-6, c-reactive protein and tumor necrosis factor alpha	12 months
Other	Change in CIrculating Biomarkers	Fingersticks done after a 12-hour fast will collect 5 blood spots which will be dried (DBS). DBS eluents will be batch-tested against known standards for insulin, glucose, leptin, adiponectin, high density lipoprotein and total cholesterol, tryglycerides, interleukin-6, c-reactive protein and tumor necrosis factor alpha	18 months
Other	Change in CIrculating Biomarkers	Fingersticks done after a 12-hour fast will collect 5 blood spots which will be dried (DBS). DBS eluents will be batch-tested against known standards for insulin, glucose, leptin, adiponectin, high density lipoprotein and total cholesterol, tryglycerides, interleukin-6, c-reactive protein and tumor necrosis factor alpha	24 months
Other	Change in Comorbidity and Symptoms (Patient reported outcome)	The 43-item Older Americans Resources & Services (OARS) Questionnaire will be administered	baseline
Other	Change in Comorbidity and Symptoms (Patient reported outcome)	The 43-item Older Americans Resources & Services (OARS) Questionnaire will be administered	6 months
Other	Change in Comorbidity and Symptoms (Patient reported outcome)	The 43-item Older Americans Resources & Services (OARS) Questionnaire will be administered	12 months
Other	Change in Comorbidity and Symptoms (Patient reported outcome)	The 43-item Older Americans Resources & Services (OARS) Questionnaire will be administered	18 months
Other	Change in Comorbidity and Symptoms (Patient reported outcome)	The 43-item Older Americans Resources & Services (OARS) Questionnaire will be administered	24 months
Other	Social Support, self-efficacy and barriers for adhering to a caloric restricted diet or increased PA (Patient Reported Outcomes)	Validated items from Sallis et al, Clark, et al, Rogers, et al, McAiley, et al	baseline
Other	Social Support, self-efficacy and barriers for adhering to a caloric restricted diet or increased PA (Patient Reported Outcomes)	Validated items from Sallis et al, Clark, et al, Rogers, et al, McAiley, et al	6 months
Other	Social Support, self-efficacy and barriers for adhering to a caloric restricted diet or increased PA (Patient Reported Outcomes)	Validated items from Sallis et al, Clark, et al, Rogers, et al, McAiley, et al	12 months
Other	Social Support, self-efficacy and barriers for adhering to a caloric restricted diet or increased PA (Patient Reported Outcomes)	Validated items from Sallis et al, Clark, et al, Rogers, et al, McAiley, et al	18 months
Other	Social Support, self-efficacy and barriers for adhering to a caloric restricted diet or increased PA (Patient Reported Outcomes)	Validated items from Sallis et al, Clark, et al, Rogers, et al, McAiley, et al	24 months
Other	Quality of Life, EQ-5D-5L	comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression	baseline
Other	Quality of Life, EQ-5D-5L	comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression	6 months
Other	Quality of Life, EQ-5D-5L	comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression	18 months
Other	Quality of Life, EQ-5D-5L	comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression	24 months
Other	Health literacy and Ehealth literacy scales (eHEALS)	The eHealth Literacy Scale measures (1) to assess consumers' perceived skills at using information technology for health and (2) to aid in determining the fit between eHealth programs and consumers. Norman, 2006	baseline
Other	Health literacy and Ehealth literacy scales (eHEALS)	The eHealth Literacy Scale measures (1) to assess consumers' perceived skills at using information technology for health and (2) to aid in determining the fit between eHealth programs and consumers. Norman, 2006	6 months
Other	Health literacy and Ehealth literacy scales (eHEALS)	The eHealth Literacy Scale measures (1) to assess consumers' perceived skills at using information technology for health and (2) to aid in determining the fit between eHealth programs and consumers. Norman, 2006	12 months
Other	Health literacy and Ehealth literacy scales (eHEALS)	The eHealth Literacy Scale measures (1) to assess consumers' perceived skills at using information technology for health and (2) to aid in determining the fit between eHealth programs and consumers. Norman, 2006	18 months
Other	Health literacy and Ehealth literacy scales (eHEALS)	The eHealth Literacy Scale measures (1) to assess consumers' perceived skills at using information technology for health and (2) to aid in determining the fit between eHealth programs and consumers. Norman, 2006	24 months
Other	Health related status	Questions include: smoking status, falls, serious health events	baseline
Other	Health related status	Questions include: smoking status, falls, serious health events	6 months
Other	Health related status	Questions include: smoking status, falls, serious health events	12 months
Other	Health related status	Questions include: smoking status, falls, serious health events	18 months
Other	Health related status	Questions include: smoking status, falls, serious health events	24 months
Other	PROMIS Cognitive Function + PROMIS Cognitive Abilities - 8a	Developed, evaluated, and distributed by the National Institutes of Health to measure perceived cognitive functioning	baseline
Other	PROMIS Cognitive Function + PROMIS Cognitive Abilities - 8a	Developed, evaluated, and distributed by the National Institutes of Health to measure perceived cognitive functioning	6 months
Other	PROMIS Cognitive Function + PROMIS Cognitive Abilities - 8a	Developed, evaluated, and distributed by the National Institutes of Health to measure perceived cognitive functioning	12 months
Other	PROMIS Cognitive Function + PROMIS Cognitive Abilities - 8a	Developed, evaluated, and distributed by the National Institutes of Health to measure perceived cognitive functioning	18 months
Other	PROMIS Cognitive Function + PROMIS Cognitive Abilities - 8a	Developed, evaluated, and distributed by the National Institutes of Health to measure perceived cognitive functioning	24 months
Primary	Change in dietary quality and intake (Patient reported outcome).	Participants will complete two dietary recalls (one weekday and one weekend day)	Baseline
Primary	Change in dietary quality and intake (Patient reported outcome).	Participants will complete two dietary recalls (one weekday and one weekend day)	6 months
Primary	Change in dietary quality and intake (Patient reported outcome).	Participants will complete two dietary recalls (one weekday and one weekend day)	12 months
Primary	Change in dietary quality and intake (Patient reported outcome).	Participants will complete two dietary recalls (one weekday and one weekend day)	18 months
Primary	Change in dietary quality and intake (Patient reported outcome).	Participants will complete two dietary recalls (one weekday and one weekend day)	24 months
Primary	Change in body weight	Participant body weight will be measured during an in-person or remote (Zoom) visit	Baseline
Primary	Change in body weight	Participant body weight will be measured during an in-person or remote (Zoom) visit	6 months
Primary	Change in body weight	Participant body weight will be measured during an in-person or remote (Zoom) visit	12 months
Primary	Change in body weight	Participant body weight will be measured during an in-person or remote (Zoom) visit	18 months
Primary	Change in body weight	Participant body weight will be measured during an in-person or remote (Zoom) visit	24 months
Primary	Change in physical activity and sleep (Measured by actigraphy)	Physical activity and sleep will be measured objectively via blank screen accelerometers which are small devices (1x2 inches) that will be worn at the waist during waking hours and switched to a wrist band during sleep for a 7-day period at each assessment point.	Baseline
Primary	Change in physical activity and sleep (Measured by actigraphy)	Physical activity and sleep will be measured objectively via blank screen accelerometers which are small devices (1x2 inches) that will be worn at the waist during waking hours and switched to a wrist band during sleep for a 7-day period at each assessment point.	6 months
Primary	Change in physical activity and sleep (Measured by actigraphy)	Physical activity and sleep will be measured objectively via blank screen accelerometers which are small devices (1x2 inches) that will be worn at the waist during waking hours and switched to a wrist band during sleep for a 7-day period at each assessment point.	12 months
Primary	Change in physical activity and sleep (Measured by actigraphy)	Physical activity and sleep will be measured objectively via blank screen accelerometers which are small devices (1x2 inches) that will be worn at the waist during waking hours and switched to a wrist band during sleep for a 7-day period at each assessment point.	18 months
Primary	Change in physical activity and sleep (Measured by actigraphy)	Physical activity and sleep will be measured objectively via blank screen accelerometers which are small devices (1x2 inches) that will be worn at the waist during waking hours and switched to a wrist band during sleep for a 7-day period at each assessment point.	24 months
Secondary	Change in waist circumference	Waist circumference will be measured using unmarked tapes at the level of the umbilicus during the in-person or remote assessments.	Baseline
Secondary	Change in waist circumference	Waist circumference will be measured using an unmarked tape at the level of the umbilicus during the in-person or remote assessments.	6 months
Secondary	Change in waist circumference	Waist circumference will be measured using an unmarked tape at the level of the umbilicus during in-person or remote assessments.	12 months
Secondary	Change in waist circumference	Waist circumference will be measured using an marked tape at the level of the umbilicus during the in-person or remote assessments.	18 months
Secondary	Change in waist circumference	Waist circumference will be measured using an unmarked tape at the level of the umbilicus during the in-person or remote assessments.	24 months
Secondary	Change in muscle mass (Measured by the D3 creatine dilution method)	To assess muscle mass, participants will take a capsule containing deuterium-labelled creatine [creatine is a substance commonly found in protein-containing foods and deuterium is a naturally-occurring element], the administration of which is proven as safe with several studies conducted in humans across the lifespan from pre-term infants to elders and will use a urine test strip 3 days later on their 2nd void of the day	Baseline
Secondary	Change in muscle mass (Measured by the D3 creatine dilution method)	To assess muscle mass, participants will take a capsule containing deuterium-labelled creatine [creatine is a substance commonly found in protein-containing foods and deuterium is a naturally-occurring element], the administration of which is proven as safe with several studies conducted in humans across the lifespan from pre-term infants to elders and will use a urine test strip 3 days later on their 2nd void of the day	6 months
Secondary	Change in muscle mass (Measured by the D3 creatine dilution method)	To assess muscle mass, participants will take a capsule containing deuterium-labelled creatine [creatine is a substance commonly found in protein-containing foods and deuterium is a naturally-occurring element], the administration of which is proven as safe with several studies conducted in humans across the lifespan from pre-term infants to elders and will use a urine test strip 3 days later on their 2nd void of the day	12 months
Secondary	Change in muscle mass (Measured by the D3 creatine dilution method)	To assess muscle mass, participants will take a capsule containing deuterium-labelled creatine [creatine is a substance commonly found in protein-containing foods and deuterium is a naturally-occurring element], the administration of which is proven as safe with several studies conducted in humans across the lifespan from pre-term infants to elders and will use a urine test strip 3 days later on their 2nd void of the day	18 months
Secondary	Change in muscle mass (Measured by the D3 creatine dilution method)	To assess muscle mass, participants will take a capsule containing deuterium-labelled creatine [creatine is a substance commonly found in protein-containing foods and deuterium is a naturally-occurring element], the administration of which is proven as safe with several studies conducted in humans across the lifespan from pre-term infants to elders and will use a urine test strip 3 days later on their 2nd void of the day	24 months
Secondary	Change in physical performance	Participants will complete the Senior Fitness Battery during the in-person or remote assessments, which includes chair stands, 3m walk, 8' up and go, balance testing (side-by-side, semi-tandem and tandem stances), reaching (stretching exercises of the arms and legs, and the 2-minute step test.	Baseline
Secondary	Change in physical performance	Participants will complete the Senior Fitness Battery during the in-person or remote assessments, which includes chair stands, 3m walk, 8' up and go, balance testing (side-by-side, semi-tandem and tandem stances), reaching (stretching exercises of the arms and legs, and the 2-minute step test.	6 Months
Secondary	Change in physical performance	Participants will complete the Senior Fitness Battery during the in-person or remote assessments, which includes chair stands, 3m walk, 8' up and go, balance testing (side-by-side, semi-tandem and tandem stances), reaching (stretching exercises of the arms and legs, and the 2-minute step test.	12 months
Secondary	Change in physical performance	Participants will complete the Senior Fitness Battery during the in-person or remote assessments, which includes chair stands, 3m walk, 8' up and go, balance testing (side-by-side, semi-tandem and tandem stances), reaching (stretching exercises of the arms and legs, and the 2-minute step test.	18 months
Secondary	Change in physical performance	Participants will complete the Senior Fitness Battery during the in-person or remote assessments, which includes chair stands, 3m walk, 8' up and go, balance testing (side-by-side, semi-tandem and tandem stances), reaching (stretching exercises of the arms and legs, and the 2-minute step test.	24 months
Secondary	Change in physical activity (Patient reported outcome)	Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires).	Baseline
Secondary	Change in physical activity (Patient reported outcome)	Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires).	3 months
Secondary	Change in physical activity (Patient reported outcome)	Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires).	6 months
Secondary	Change in physical activity (Patient reported outcome)	Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires).	9 months
Secondary	Change in physical activity (Patient reported outcome)	Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires).	12 months
Secondary	Change in physical activity (Patient reported outcome)	Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires).	15 months
Secondary	Change in physical activity (Patient reported outcome)	Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires).	18 months
Secondary	Change in physical activity (Patient reported outcome)	Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires).	21 months
Secondary	Change in physical activity (Patient reported outcome)	Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires).	24 months
Secondary	Change in quality of life (Patient reported outcome)	Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life.	Baseline
Secondary	Change in quality of life (Patient reported outcome)	Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life.	3 Months
Secondary	Change in quality of life (Patient reported outcome)	Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life.	6 Months
Secondary	Change in quality of life (Patient reported outcome)	Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life.	9 Months
Secondary	Change in quality of life (Patient reported outcome)	Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life.	12 months
Secondary	Change in quality of life (Patient reported outcome)	Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life.	15 months
Secondary	Change in quality of life (Patient reported outcome)	Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life.	18 months
Secondary	Change in quality of life (Patient reported outcome)	Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life.	21 months
Secondary	Change in quality of life (Patient reported outcome)	Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life.	24 months
Secondary	Change in healthcare utilization (Patient reported outcome)	Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.	Baseline
Secondary	Change in healthcare utilization (Patient reported outcome)	Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.	3 months
Secondary	Change in healthcare utilization (Patient reported outcome)	Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.	6 months
Secondary	Change in healthcare utilization (Patient reported outcome)	Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.	9 months
Secondary	Change in healthcare utilization (Patient reported outcome)	Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.	12 months
Secondary	Change in healthcare utilization (Patient reported outcome)	Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.	15 months
Secondary	Change in healthcare utilization (Patient reported outcome)	Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.	18 months
Secondary	Change in healthcare utilization (Patient reported outcome)	Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.	21 months
Secondary	Change in healthcare utilization (Patient reported outcome)	Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.	24 months

External Links

•   Website for those interested in joining the study.