Adapting Multiple Behavior Interventions That Effectively Improve Cancer Survivor Health Cancer Survivor Health (AMPLIFY)

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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Cancer; Breast Cancer; Multiple Myeloma; Colorectal Cancer; Prostate Cancer; Non-Hodgkin Lymphoma; Endometrial Cancer; Thyroid Cancer; Ovary Cancer
• Intervention / Treatment: Behavioral: Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health; Other: Diet-Exercise; Other: Exercise-Diet; Other: Combined Diet and Exercise

Detailed 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 (pre-intervention), 6-, 12 (post-intervention)- 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 (pre-intervention), 6-, 12 (post-intervention)-, 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.

• Study Type: Interventional
• Enrollment (Actual): 603
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • University of Tennessee Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Project 1: Diet-Exercise; 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).	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 Names: AiM, Plan and act on LIFestYles: AMPLIFY Survivor Health; Other: Combined Diet and Exercise; Combined Diet and Exercise
Experimental: Project 2: Exercise-Diet; 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).	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 Names: AiM, Plan and act on LIFestYles: AMPLIFY Survivor Health; Other: Combined Diet and Exercise; Combined Diet and Exercise
Experimental: Project 3: Combined Diet and Exercise; 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).	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 Names: AiM, Plan and act on LIFestYles: AMPLIFY Survivor Health; Other: Diet-Exercise; Diet-Exercise; Other: Exercise-Diet; Exercise-Diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary Quality (Healthy Eating Index)	Participants completed two dietary recalls (one weekday and one weekend day) via telephone using a multipass method and the Nutrition Data Systems for Research (NDSR) software. The software averages the 2-day resulting data and calculates the Healthy Eating Index (HEI)-2015. The HEI indicates how closely someone's diet follows the Dietary Guidelines for Americans. The index range is 0 to 100 with an index closer to 100 indicating a healthier, well-balanced diet.	Pre-intervention (Baseline), 12-month post-intervention
Body Weight	Participant body weight will be measured during an in-person or remote (Zoom) visit	Pre-intervention (Baseline), 12-month post-intervention
Physical Activity (Measured by Actigraphy)	Physical activity 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.	Pre-intervention (Baseline), 12-month post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist Circumference	Waist circumference will be measured using unmarked tapes at the level of the umbilicus during the in-person or remote assessments.	Pre-intervention (Baseline),12-month post-intervention
Muscle Mass With Spillage Correction	Participants are provided with a 30 mg capsule of D3Cr and instructed to take the capsule 3 days prior to their assessment date. The night prior to assessment, they begin fasting and continue fasting until they produce the second urinary void of the day. During this void, a test strip is used. The strip is frozen (0 C or below) until analyzed. The outcome measure indicates kg of muscle mass.	Pre-intervention (Baseline), 12-month post-intervention
Percentage Muscle Mass With Spillage Correction	Participants are provided with a 30 mg capsule of D3Cr and instructed to take the capsule 3 days prior to their assessment date. The night prior to assessment, they begin fasting and continue fasting until they produce the second urinary void of the day. During this void, a test strip is used. The strip is frozen (0 C or below) until analyzed. The outcome measure indicates percentage of body weight that is muscle mass.	Pre-intervention (Baseline), 12-month post-intervention
30 Second Chair Stand	In this physical performance test the participant is instructed to sit and stand as many times as they can while crossing their arms against their shoulders for 30 seconds. the outcomes measure is the number of times participants sit and stand in 30 seconds.	Pre-intervention (Baseline), 12-month post-intervention
8' Get up and go	In this performance test we instruct participants to start from a seated position, cross their arms against their shoulder, then, when instructed, they stand walk around the cone and come back to a seated position. The outcome measure is the number of seconds from start to end of the walk	Pre-intervention (Baseline), 12-month post-intervention
2-minute Step Test	In this performance test, participants are instructed to step in place for 2 minutes. The outcomes measure is the number of steps within the two minutes that reach a certain height. This height is determined measuring first the distance from hip joint to top of knee, taking the half of that distance and applying it from the floor marking a that height on a wall or door frame with a sticker. Assessors spot and count steps that reach or exceed the sticker mark on the wall (every other step is counted)	Pre-intervention (Baseline), 12-month post-intervention
Chair Sit and Reach	This physical performance test is done as follows: Participant sits on the edge of a chair, with one leg is extended straight forward with the heel on the floor and ankle at ~90°.(The other leg remains bent with the foot flat on the floor).; Participant's hands are placed one on top of the other, and participant slowly reaches forward toward the toes of the extended leg (the test is performed on both legs, and assessor selects the most flexible side); The outcome measure is the distance in cm from the closest finger and toe. 0 inches → fingertips touch the toe Negative (-) → Participant cannot reach toes Positive (+) → Participant reaches past toes	Pre-intervention (Baseline), 12-month post-intervention
Back Scratch	This physical performance test of flexibility is done as follows: - Participant stands upright and reach one hand over the shoulder and the other up the middle of the back, attempting to touch or overlap middle fingers (both sides are tried - right over left, then left over right). Outcome measure is the distance between the closest fingers (most flexible side is recorded) Scoring: 0 inches → fingertips just touch Negative (-) → fingers do not touch (gap distance) Positive (+) → fingers overlap (amount of overlap)	Pre-intervention (Baseline), 12-month post-intervention
Physical Activity - Godin (Patient Reported Outcome)	This physical activity outcome is measured using the Godin Leisure Time Physical Activity Questionnaire which asks frequency and duration of various levels of physical activity in a week period. The resulting outcome measure (minutes per week) is the Adjusted Godin Moderate-to-Vigorous Physical Activity (MVPA) score, calculated based on reported frequency and duration of moderate and strenuous (vigorous) leisure-time activities as follows: Adjusted Godin MVPA= (frequency * duration of moderate activity) + 2 (frequency * duration of vigorous activity)	Pre-intervention (Baseline), 12-month post-intervention
Quality of Life - Physical	Quality of life - physical is assessed using the PROMIS global health subscales measuring self-reported overall physical health, including physical functioning, fatigue, pain, and general health perceptions. The outcome measure is the resulting T-scores, standardized to the U.S. general population Range: (0-100) Higher T-scores indicate better global physical health The Global Physical Health score is calculated by combining responses from survey questionnaire -- raw scores are converted to T-scores via scoring manuals.	Pre-intervention (Baseline), 12-month post-intervention
Quality of Life - Mental	Quality of life - mental is assessed using the PROMIS global health subscales measuring self-reported overall mental health, including emotional distress, psychological well-being, social satisfaction, and quality of life perceptions. The outcome measure is the resulting T-score standardized to the U.S. general population Range: (0-100) Higher T-scores indicate better global mental health	Pre-intervention (Baseline), 12-month post-intervention
Healthcare Utilization "Any ER or Hospital Visit" (Patient Reported Outcome)	Participants will complete a healthcare utilization survey to capture physician and emergency room visits, and hospitalizations.	Pre-intervention (Baseline), 12-month post-intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of Stress (Patient Reported Outcome)	Participants complete the 14-item Perceived Stress Scale (PSS-14), a validated self-report instrument that measures the degree to which individuals perceive their lives as unpredictable, uncontrollable, and overloaded over the past month. Each item is rated on a 5-point scale (0 = never to 4 = very often). Positively stated items are reverse scored, and item responses are summed to generate a raw total score (range: 0 to 56). The outcome measure is a T-score calculated using standard normalization procedures. Range = 0 to 100. Higher T-scores indicate greater perceived stress (worse outcome).	Pre-intervention (Baseline), 12-month post-intervention
Circulating Biomarkers "Cholesterol"	Circulating cholesterol levels are assessed using dried blood spot (DBS) samples collected via fingerstick following a 12-hour fast. Blood spots are dried and stored according to standard protocols, and DBS eluents are batch-tested against known standards to determine cholesterol concentrations. This outcome measure is the measure of mg/dl of total cholesterol	Pre-intervention (Baseline), 12-month post-intervention
Circulating Biomarkers "HDL"	High-density lipoprotein (HDL) cholesterol will be assessed using dried blood spot (DBS) samples collected via fingerstick following a 12-hour fast. Blood spots will be dried and stored according to standard protocols, and DBS eluents will be batch-tested against known standards to determine HDL cholesterol. Outcome measure is mg/dL of HDL Range (adults): typically, 20 to 100 mg/dL Higher HDL cholesterol indicates a better (protective) cardiovascular outcome.	Pre-intervention (Baseline), 12-month post-intervention
Circulating Biomarkers "Triglyceride"	Triglyceride levels are assessed using dried blood spot (DBS) samples collected via fingerstick following a 12-hour fast. Blood spots are dried and stored according to standard protocols, and DBS eluents will be batch-tested against known standards to determine triglyceride concentrations. Outcome measure is mg/dL of triglyceride concentration Range:50 to 500 mg/dL (adults) Higher triglyceride levels indicate a worse (higher cardiovascular risk) outcome	Pre-intervention (Baseline), 12-month post-intervention
Circulating Biomarkers "Glucose"	Fasting glucose levels will be assessed using dried blood spot (DBS) samples collected via fingerstick following a 12-hour fast. Blood spots will be dried and stored according to standard protocols, and DBS eluents will be batch-tested against known standards to determine glucose concentrations. Outcome measure is mg/dL of glucose concentration Range:70 to 200 mg/dL (adults) Higher fasting glucose levels indicate a worse metabolic outcome (greater risk of impaired glucose regulation or diabetes).	Pre-intervention (Baseline), 12-month post-intervention
Circulating Biomarkers " C-reactive Protein"	C-reactive protein (CRP) levels will be assessed using dried blood spot (DBS) samples collected via fingerstick following a 12-hour fast. Blood spots will be dried and stored according to standard protocols, and DBS eluents will be batch-tested against known standards to determine CRP concentrations. Range: (0.1 to 10 mg/DL) in adults (higher values may occur with acute inflammation) Higher CRP levels indicate greater systemic inflammation and a worse health outcome	Pre-intervention (Baseline), 12-month post-intervention
Quality of Life - EQ-5D Index	Quality of life is assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L), a standardized instrument that measures health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on 5 levels: No problems, Slight problems, Moderate problems, Severe problems and Extreme problems Responses are combined into a 5-digit health state, which is converted into a single summary index score. EQ-5D Index range: 0 to 1. Higher scores indicate better quality of life	Pre-intervention (Baseline), 12-month post-intervention
Cognitive Function	Cognitive Function is assessed using the PROMIS Cognitive Function Short Form 4a questionnaire, which evaluates memory, attention span, and concentration Outcome measure is a T-score, standardized to the U.S. general population: Range: (0-100) Higher T-scores indicate better cognitive function	Pre-intervention (Baseline), 12-month post-intervention
Cognitive Abilities	Cognitive Ability is measured with PROMIS Cognitive Abilities - Short Form 8a, which evaluates perceived cognitive abilities, including memory, attention, concentration, and mental acuity. Outcome measure is reported as T-scores, standardized to the U.S. general population: Range: (0-100) Higher T-scores indicate better cognitive abilities	Pre-intervention (Baseline), 12-month post-intervention

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Cancer Institute (NCI); University of Tennessee
• Investigators: Principal Investigator: Wendy Demark-Wahnefried, PhD, RD, University of Alabama at Birmingham

Publications and helpful links

General Publications

• Pekmezi D, Fontaine K, Rogers LQ, Pisu M, Martin MY, Schoenberger-Godwin YM, Oster RA, Kenzik K, Ivankova NV, Demark-Wahnefried W. Adapting MultiPLe behavior Interventions that eFfectively Improve (AMPLIFI) cancer survivor health: program project protocols for remote lifestyle intervention and assessment in 3 inter-related randomized controlled trials among survivors of obesity-related cancers. BMC Cancer. 2022 Apr 29;22(1):471. doi: 10.1186/s12885-022-09519-y.
• Ivankova NV, Rogers LQ, Herbey II, Martin MY, Pisu M, Pekmezi D, Thompson L, Schoenberger-Godwin YM, Oster RA, Fontaine K, Anderson JL, Kenzik K, Farrell D, Demark-Wahnefried W. Features That Middle-aged and Older Cancer Survivors Want in Web-Based Healthy Lifestyle Interventions: Qualitative Descriptive Study. JMIR Cancer. 2021 Oct 6;7(4):e26226. doi: 10.2196/26226.
• Pisu M, Omairi I, Hoenemeyer T, Halilova KI, Schoenberger YM, Rogers LQ, Kenzik KM, Oster RA, Ivankova NV, Pekmezi D, Fontaine K, Demark-Wahnefried W, Martin MY. Developing a virtual assessment protocol for the AMPLIFI Randomized Controlled Trial due to COVID-19: From assessing participants' preference to preparing the team. Contemp Clin Trials. 2021 Dec;111:106604. doi: 10.1016/j.cct.2021.106604. Epub 2021 Oct 29.
• Rogers LQ, Pekmezi D, Schoenberger-Godwin YM, Fontaine KR, Ivankova NV, Kinsey AW, Hoenemeyer T, Martin MY, Pisu M, Farrell D, Wall J, Waugaman K, Oster RA, Kenzik K, Winters-Stone K, Demark-Wahnefried W. Using the TIDieR checklist to describe development and integration of a web-based intervention promoting healthy eating and regular exercise among older cancer survivors. Digit Health. 2023 Jun 26;9:20552076231182805. doi: 10.1177/20552076231182805. eCollection 2023 Jan-Dec.
• Agnew H, Kitson S, Crosbie EJ. Interventions for weight reduction in obesity to improve survival in women with endometrial cancer. Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD012513. doi: 10.1002/14651858.CD012513.pub3.

Helpful Links

• Website for those interested in joining the study.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2020
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): September 29, 2025

Study Registration Dates

• First Submitted: June 21, 2019
• First Submitted That Met QC Criteria: June 25, 2019
• First Posted (Actual): June 27, 2019

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Web-based intervention; Physical Activity; Exercise; Diet; African American; Cancer survivor; Rural; Minority; Older; Weight Control; Lifestyle behaviors; Distance Medicine
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Immune System Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Uterine Diseases; Genital Diseases, Female; Hematologic Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Colonic Diseases; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Skin Diseases; Breast Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Urologic Neoplasms; Lymphoma; Uterine Neoplasms; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Thyroid Diseases; Behavior; Skin and Connective Tissue Diseases; Hemic and Lymphatic Diseases; Prostatic Neoplasms; Colorectal Neoplasms; Ovarian Neoplasms; Breast Neoplasms; Multiple Myeloma; Lymphoma, Non-Hodgkin; Endometrial Neoplasms; Kidney Neoplasms; Thyroid Neoplasms; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: IRB-300002068; 1P01CA229997 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data and samples will be made available to outside investigators after all aims of the P01 and all primary outcomes papers have been published (consonant with the NIH definition of "timely fashion." Requests for data or biologic samples will be handled on a case-by-case basis, and in consultation with the P01 principal investigators (Dr. Demark-Wahnefried) and other members of the investigative team.
• IPD Sharing Access Criteria: Requests for data or biologic samples will be handled on a case-by-case basis, and in consultation with the P01 principal investigators (Dr. Demark-Wahnefried) and other members of the investigative team. Individuals in receipt of data and samples must produce proof of human subjects and HIPAA training. For the transfer of biospecimens, Human Materials and Data Transfer Agreements will be established between UAB and the requesting institution. Publications resulting from the transfer of samples or data must credit the P01 grant. For data only, requesting users will be required to sign a data-use sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No