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Completed

NCT Number: NCT04000880

Adapting Multiple Behavior Interventions That Effectively Improve Cancer Survivor Health 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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral

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

Diet-Exercise

Other

Diet-Exercise

Exercise-Diet

Other

Exercise-Diet

Combined Diet and Exercise

Other

Combined Diet and Exercise

Primary outcomes

  1. Dietary Quality (Healthy Eating Index)

    Time frame: Pre-intervention (Baseline), 12-month post-intervention

    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.

  2. Body Weight

    Time frame: Pre-intervention (Baseline), 12-month post-intervention

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

  3. Physical Activity (Measured by Actigraphy)

    Time frame: Pre-intervention (Baseline), 12-month post-intervention

    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.

Secondary outcomes

  1. Waist Circumference

    Time frame: Pre-intervention (Baseline),12-month post-intervention

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

  2. Muscle Mass With Spillage Correction

    Time frame: Pre-intervention (Baseline), 12-month post-intervention

    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.

  3. Percentage Muscle Mass With Spillage Correction

    Time frame: Pre-intervention (Baseline), 12-month post-intervention

    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.

  4. 30 Second Chair Stand

    Time frame: Pre-intervention (Baseline), 12-month post-intervention

    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.

  5. 8' Get up and go

    Time frame: Pre-intervention (Baseline), 12-month post-intervention

    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

  6. 2-minute Step Test

    Time frame: Pre-intervention (Baseline), 12-month post-intervention

    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)

  7. Chair Sit and Reach

    Time frame: Pre-intervention (Baseline), 12-month post-intervention

    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
  8. Back Scratch

    Time frame: Pre-intervention (Baseline), 12-month post-intervention

    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)

  9. Physical Activity - Godin (Patient Reported Outcome)

    Time frame: Pre-intervention (Baseline), 12-month post-intervention

    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)

  10. Quality of Life - Physical

    Time frame: Pre-intervention (Baseline), 12-month post-intervention

    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.

  11. Quality of Life - Mental

    Time frame: Pre-intervention (Baseline), 12-month post-intervention

    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

  12. Healthcare Utilization "Any ER or Hospital Visit" (Patient Reported Outcome)

    Time frame: Pre-intervention (Baseline), 12-month post-intervention

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

Other outcomes

  1. Levels of Stress (Patient Reported Outcome)

    Time frame: Pre-intervention (Baseline), 12-month post-intervention

    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).

  2. Circulating Biomarkers "Cholesterol"

    Time frame: Pre-intervention (Baseline), 12-month post-intervention

    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

  3. Circulating Biomarkers "HDL"

    Time frame: Pre-intervention (Baseline), 12-month post-intervention

    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.

  4. Circulating Biomarkers "Triglyceride"

    Time frame: Pre-intervention (Baseline), 12-month post-intervention

    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

  5. Circulating Biomarkers "Glucose"

    Time frame: Pre-intervention (Baseline), 12-month post-intervention

    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).

  6. Circulating Biomarkers " C-reactive Protein"

    Time frame: Pre-intervention (Baseline), 12-month post-intervention

    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

  7. Quality of Life - EQ-5D Index

    Time frame: Pre-intervention (Baseline), 12-month post-intervention

    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

  8. Cognitive Function

    Time frame: Pre-intervention (Baseline), 12-month post-intervention

    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

  9. Cognitive Abilities

    Time frame: Pre-intervention (Baseline), 12-month post-intervention

    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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Cancer Institute (NCI)
  • University of Tennessee

Registry information

Official study title

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

Acronym: AMPLIFY

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jun 27, 2019
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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