Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Prostatic Neoplasms

Breast Neoplasms

Ovarian Neoplasms

Lymphoma

Thyroid Neoplasms

Thyroid Diseases

Carcinoma, Renal Cell

Body Weight

Kidney Neoplasms

Endometrial Neoplasms

Urogenital Neoplasms

Genital Diseases

Urogenital Diseases

Male Urogenital Diseases

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Endocrine Gland Neoplasms

Endocrine System Diseases

Urologic Neoplasms

Kidney Diseases

Urologic Diseases

Ovarian Diseases

Adnexal Diseases

Gonadal Disorders

Ovarian Cancer

Lymphosarcoma

Renal Cell Carcinoma

Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).

Participants will receive the diet and exercise content simultaneously in combined web-based sessions. Participants will receive and participate in web-based sessions that focus on diet and exercise for 12 months. Participants will be encouraged to track their diet, weight and physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).

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.

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

Diet-Exercise

Exercise-Diet

Combined Diet and Exercise

Wendy Demark-Wahnefried, PhD, RD

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.

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.

Participants will participate in one of three arms:

1. Diet followed by Exercise intervention
2. Exercise followed by Diet intervention
3. Combined Diet and Exercise intervention

Single blinded trial in which the study participant and select individuals in the research team (i.e., interventionists) will be aware of randomization status, but the assessors and investigators will not.

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

We agree to share any remaining biospecimens, including plasma, sera, and buffy coat (some stored in RNAlater® and some stored alone). Samples will be accompanied by a limited dataset of deidentified participant data that investigators need for analyses. To facilitate the data sharing, we plan to build a central archive that will allow public access to data dictionaries and limited-access anonymized datasets. We will develop a single password protected Share Point web system so that all data dictionaries, documentation, and data accessibility will have a consistent user interface. All datasets will conform to the "Standards for Privacy of Individually Identifiable Health Information" rule of the Health Insurance Portability and Accountability Act (HIPAA). Data will be made available as either a SAS export dataset, or as a tab-delimited ASCII file.

Participants will complete the 14-item Perceived Stress Scale

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

The 43-item Older Americans Resources \& Services (OARS) Questionnaire will be administered

Validated items from Sallis et al, Clark, et al, Rogers, et al, McAiley, et al

comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression

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

Questions include: smoking status, falls, serious health events

Developed, evaluated, and distributed by the National Institutes of Health to measure perceived cognitive functioning

Participants will complete two dietary recalls (one weekday and one weekend day)

Participant body weight will be measured during an in-person or remote (Zoom) visit

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.

Waist circumference will be measured using unmarked tapes at the level of the umbilicus during the in-person or remote assessments.

Waist circumference will be measured using an unmarked tape at the level of the umbilicus during the in-person or remote assessments.

Waist circumference will be measured using an unmarked tape at the level of the umbilicus during in-person or remote assessments.

Waist circumference will be measured using an marked tape at the level of the umbilicus during the in-person or remote assessments.

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

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.

Physical activity will be measured via validated questionnaires (e.g., the Godin Leisure Time Physical Activity and the Global Physical Activity Questionnaires).

Participants will complete questionnaires (PROMIS Cancer-Related Item Bank and Short Form 12) to self-report quality of life.

Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Adapting Multiple Behavior Interventions That Effectively Improve Cancer Survivor Health Cancer Survivor Health	NCT04000880	Breast Cancer Colorectal Canc... Endometrial Can... Kidney Cancer Multiple Myelom... Ovary Cancer Prostate Cancer Thyroid Cancer Non-Hodgkin Lym...	Adapting MultiP... Diet-Exercise Exercise-Diet Combined Diet a...	50 Years -	University of Alabama at Birmingham
Adapting Multiple Behavior Interventions That Effectively Improve Cancer Survivor Health Cancer Survivor Health	NCT04000880	Breast Cancer Colorectal Canc... Endometrial Can... Kidney Cancer Multiple Myelom... Ovary Cancer Prostate Cancer Thyroid Cancer Non-Hodgkin Lym...	Adapting MultiP... Diet-Exercise Exercise-Diet Combined Diet a...	50 Years -	University of Alabama at Birmingham

Spots Global Cancer Trial Database for combined diet and exercise