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

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Recruiting
CT.gov ID
NCT04000880
Collaborator
University of Tennessee Health Science Center (Other), National Cancer Institute (NCI) (NIH)
652
2
3
53.9
326
6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health
  • Other: Diet-Exercise
  • Other: Exercise-Diet
  • Other: Survivorship Topics - Combined Diet and Exercise
N/A

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, 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 would receive the intervention after a 6-month delay and will be evaluated at baseline, 6-, 12-, 18- and 24-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 arm 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 Design

Study Type:
Interventional
Anticipated Enrollment :
652 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will participate in one of three arms: Diet followed by Exercise intervention Exercise followed by Diet intervention Survivorship Topics followed by Combined Diet and Exercise interventionParticipants will participate in one of three arms:Diet followed by Exercise intervention Exercise followed by Diet intervention Survivorship Topics followed by Combined Diet and Exercise intervention
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Supportive Care
Official Title:
Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health
Actual Study Start Date :
Mar 4, 2020
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

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: Survivorship Topics - Combined Diet and Exercise
    Survivorship Topics - 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: Survivorship Topics - Combined Diet and Exercise
    Survivorship Topics - Combined Diet and Exercise

    Experimental: Project 3: Survivorship Topics- Combined Diet and Exercise

    For the first six months of the study, participants will be in the Survivorship Topics group, where they receive health information on topics other than diet and exercise. Participants will then join the intervention, receiving 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

    Outcome Measures

    Primary Outcome Measures

    1. Change in dietary quality and intake (Patient reported outcome). [Baseline]

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

    2. Change in dietary quality and intake (Patient reported outcome). [6 months]

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

    3. Change in dietary quality and intake (Patient reported outcome). [12 months]

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

    4. Change in dietary quality and intake (Patient reported outcome). [18 months]

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

    5. Change in dietary quality and intake (Patient reported outcome). [24 months]

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

    6. Change in body weight [Baseline]

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

    7. Change in body weight [6 months]

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

    8. Change in body weight [12 months]

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

    9. Change in body weight [18 months]

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

    10. Change in body weight [24 months]

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

    11. Change in physical activity and sleep (Measured by actigraphy) [Baseline]

      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. Change in physical activity and sleep (Measured by actigraphy) [6 months]

      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.

    13. Change in physical activity and sleep (Measured by actigraphy) [12 months]

      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.

    14. Change in physical activity and sleep (Measured by actigraphy) [18 months]

      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.

    15. Change in physical activity and sleep (Measured by actigraphy) [24 months]

      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.

    Secondary Outcome Measures

    1. Change in waist circumference [Baseline]

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

    2. Change in waist circumference [6 months]

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

    3. Change in waist circumference [12 months]

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

    4. Change in waist circumference [18 months]

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

    5. Change in waist circumference [24 months]

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

    6. Change in muscle mass (Measured by the D3 creatine dilution method) [Baseline]

      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

    7. Change in muscle mass (Measured by the D3 creatine dilution method) [6 months]

      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

    8. Change in muscle mass (Measured by the D3 creatine dilution method) [12 months]

      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

    9. Change in muscle mass (Measured by the D3 creatine dilution method) [18 months]

      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

    10. Change in muscle mass (Measured by the D3 creatine dilution method) [24 months]

      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

    11. Change in physical performance [Baseline]

      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. Change in physical performance [6 Months]

      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.

    13. Change in physical performance [12 months]

      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.

    14. Change in physical performance [18 months]

      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.

    15. Change in physical performance [24 months]

      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.

    16. Change in physical activity (Patient reported outcome) [Baseline]

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

    17. Change in physical activity (Patient reported outcome) [3 months]

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

    18. Change in physical activity (Patient reported outcome) [6 months]

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

    19. Change in physical activity (Patient reported outcome) [9 months]

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

    20. Change in physical activity (Patient reported outcome) [12 months]

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

    21. Change in physical activity (Patient reported outcome) [15 months]

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

    22. Change in physical activity (Patient reported outcome) [18 months]

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

    23. Change in physical activity (Patient reported outcome) [21 months]

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

    24. Change in physical activity (Patient reported outcome) [24 months]

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

    25. Change in quality of life (Patient reported outcome) [Baseline]

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

    26. Change in quality of life (Patient reported outcome) [3 Months]

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

    27. Change in quality of life (Patient reported outcome) [6 Months]

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

    28. Change in quality of life (Patient reported outcome) [9 Months]

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

    29. Change in quality of life (Patient reported outcome) [12 months]

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

    30. Change in quality of life (Patient reported outcome) [15 months]

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

    31. Change in quality of life (Patient reported outcome) [18 months]

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

    32. Change in quality of life (Patient reported outcome) [21 months]

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

    33. Change in quality of life (Patient reported outcome) [24 months]

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

    34. Change in healthcare utilization (Patient reported outcome) [Baseline]

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

    35. Change in healthcare utilization (Patient reported outcome) [3 months]

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

    36. Change in healthcare utilization (Patient reported outcome) [6 months]

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

    37. Change in healthcare utilization (Patient reported outcome) [9 months]

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

    38. Change in healthcare utilization (Patient reported outcome) [12 months]

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

    39. Change in healthcare utilization (Patient reported outcome) [15 months]

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

    40. Change in healthcare utilization (Patient reported outcome) [18 months]

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

    41. Change in healthcare utilization (Patient reported outcome) [21 months]

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

    42. Change in healthcare utilization (Patient reported outcome) [24 months]

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

    Other Outcome Measures

    1. Change in Levels of Stress (Patient reported outcome) [baseline]

      Participants will complete the 14-item Perceived Stress Scale

    2. Change in Levels of Stress (Patient reported outcome) [6 months]

      Participants will complete the 14-item Perceived Stress Scale

    3. Change in Levels of Stress (Patient reported outcome) [12 months]

      Participants will complete the 14-item Perceived Stress Scale

    4. Change in Levels of Stress (Patient reported outcome) [18 months]

      Participants will complete the 14-item Perceived Stress Scale

    5. Change in Levels of Stress (Patient reported outcome) [24 months]

      Participants will complete the 14-item Perceived Stress Scale

    6. Change in CIrculating Biomarkers [baseline]

      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

    7. Change in CIrculating Biomarkers [6 months]

      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

    8. Change in CIrculating Biomarkers [12 months]

      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

    9. Change in CIrculating Biomarkers [18 months]

      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

    10. Change in CIrculating Biomarkers [24 months]

      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

    11. Change in Comorbidity and Symptoms (Patient reported outcome) [baseline]

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

    12. Change in Comorbidity and Symptoms (Patient reported outcome) [6 months]

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

    13. Change in Comorbidity and Symptoms (Patient reported outcome) [12 months]

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

    14. Change in Comorbidity and Symptoms (Patient reported outcome) [18 months]

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

    15. Change in Comorbidity and Symptoms (Patient reported outcome) [24 months]

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

    16. Social Support, self-efficacy and barriers for adhering to a caloric restricted diet or increased PA (Patient Reported Outcomes) [baseline]

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

    17. Social Support, self-efficacy and barriers for adhering to a caloric restricted diet or increased PA (Patient Reported Outcomes) [6 months]

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

    18. Social Support, self-efficacy and barriers for adhering to a caloric restricted diet or increased PA (Patient Reported Outcomes) [12 months]

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

    19. Social Support, self-efficacy and barriers for adhering to a caloric restricted diet or increased PA (Patient Reported Outcomes) [18 months]

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

    20. Social Support, self-efficacy and barriers for adhering to a caloric restricted diet or increased PA (Patient Reported Outcomes) [24 months]

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

    21. Quality of Life, EQ-5D-5L [baseline]

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

    22. Quality of Life, EQ-5D-5L [6 months]

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

    23. Quality of Life, EQ-5D-5L [18 months]

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

    24. Quality of Life, EQ-5D-5L [24 months]

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

    25. Health literacy and Ehealth literacy scales (eHEALS) [baseline]

      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

    26. Health literacy and Ehealth literacy scales (eHEALS) [6 months]

      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

    27. Health literacy and Ehealth literacy scales (eHEALS) [12 months]

      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

    28. Health literacy and Ehealth literacy scales (eHEALS) [18 months]

      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

    29. Health literacy and Ehealth literacy scales (eHEALS) [24 months]

      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

    30. Health related status [baseline]

      Questions include: smoking status, falls, serious health events

    31. Health related status [6 months]

      Questions include: smoking status, falls, serious health events

    32. Health related status [12 months]

      Questions include: smoking status, falls, serious health events

    33. Health related status [18 months]

      Questions include: smoking status, falls, serious health events

    34. Health related status [24 months]

      Questions include: smoking status, falls, serious health events

    35. PROMIS Cognitive Function + PROMIS Cognitive Abilities - 8a [baseline]

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

    36. PROMIS Cognitive Function + PROMIS Cognitive Abilities - 8a [6 months]

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

    37. PROMIS Cognitive Function + PROMIS Cognitive Abilities - 8a [12 months]

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

    38. PROMIS Cognitive Function + PROMIS Cognitive Abilities - 8a [18 months]

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

    39. PROMIS Cognitive Function + PROMIS Cognitive Abilities - 8a [24 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294
    2 University of Tennessee Health Science Center Memphis Tennessee United States 38163

    Sponsors and Collaborators

    • University of Alabama at Birmingham
    • University of Tennessee Health Science Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Wendy Demark-Wahnefried, PhD, RD, University of Alabama at Birmingham

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Wendy Demark-Wahnefried, PhD, Professor, University of Alabama at Birmingham
    ClinicalTrials.gov Identifier:
    NCT04000880
    Other Study ID Numbers:
    • IRB-300002068
    • 1P01CA229997
    First Posted:
    Jun 27, 2019
    Last Update Posted:
    Feb 25, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Wendy Demark-Wahnefried, PhD, Professor, University of Alabama at Birmingham
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 25, 2022