Clinical trial NCT04000880: Adapting Multiple Behavior Interventions That Effectively Improve Cancer Survivor Health Cancer Survivor Health
Official title: Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Colorectal Cancer
Endometrial Cancer
Kidney Cancer
Multiple Myeloma
Ovary Cancer
Prostate Cancer
Thyroid Cancer
Non-Hodgkin Lymphoma
Keywords: Cancer survivor
Lifestyle behaviors
Web-based intervention
Diet
Exercise
Weight Control
Physical Activity
Distance Medicine
Rural
Older
Minority
African American
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: University of Tennessee
name: National Cancer Institute (NCI)
First posted: 2019-06-27
Enrollment: 603
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: SUPPORTIVE_CARE

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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in dietary quality and intake (Patient reported outcome).
timeFrame: Baseline
measure: Change in dietary quality and intake (Patient reported outcome).
timeFrame: 6 months
measure: Change in dietary quality and intake (Patient reported outcome).
timeFrame: 12 months
measure: Change in dietary quality and intake (Patient reported outcome).
timeFrame: 18 months
measure: Change in dietary quality and intake (Patient reported outcome).
timeFrame: 24 months
measure: Change in body weight
timeFrame: Baseline
measure: Change in body weight
timeFrame: 6 months
measure: Change in body weight
timeFrame: 12 months
measure: Change in body weight
timeFrame: 18 months
measure: Change in body weight
timeFrame: 24 months
measure: Change in physical activity and sleep (Measured by actigraphy)
timeFrame: Baseline
measure: Change in physical activity and sleep (Measured by actigraphy)
timeFrame: 6 months
measure: Change in physical activity and sleep (Measured by actigraphy)
timeFrame: 12 months
measure: Change in physical activity and sleep (Measured by actigraphy)
timeFrame: 18 months
measure: Change in physical activity and sleep (Measured by actigraphy)
timeFrame: 24 months
Secondary outcomes:
measure: Change in waist circumference
timeFrame: Baseline
measure: Change in waist circumference
timeFrame: 6 months
measure: Change in waist circumference
timeFrame: 12 months
measure: Change in waist circumference
timeFrame: 18 months
measure: Change in waist circumference
timeFrame: 24 months
measure: Change in muscle mass (Measured by the D3 creatine dilution method)
timeFrame: Baseline
measure: Change in muscle mass (Measured by the D3 creatine dilution method)
timeFrame: 6 months
measure: Change in muscle mass (Measured by the D3 creatine dilution method)
timeFrame: 12 months
measure: Change in muscle mass (Measured by the D3 creatine dilution method)
timeFrame: 18 months
measure: Change in muscle mass (Measured by the D3 creatine dilution method)
timeFrame: 24 months
measure: Change in physical performance
timeFrame: Baseline
measure: Change in physical performance
timeFrame: 6 Months
measure: Change in physical performance
timeFrame: 12 months
measure: Change in physical performance
timeFrame: 18 months
measure: Change in physical performance
timeFrame: 24 months
measure: Change in physical activity (Patient reported outcome)
timeFrame: Baseline
measure: Change in physical activity (Patient reported outcome)
timeFrame: 3 months
measure: Change in physical activity (Patient reported outcome)
timeFrame: 6 months
measure: Change in physical activity (Patient reported outcome)
timeFrame: 9 months
measure: Change in physical activity (Patient reported outcome)
timeFrame: 12 months
measure: Change in physical activity (Patient reported outcome)
timeFrame: 15 months
measure: Change in physical activity (Patient reported outcome)
timeFrame: 18 months
measure: Change in physical activity (Patient reported outcome)
timeFrame: 21 months
measure: Change in physical activity (Patient reported outcome)
timeFrame: 24 months
measure: Change in quality of life (Patient reported outcome)
timeFrame: Baseline
measure: Change in quality of life (Patient reported outcome)
timeFrame: 3 Months
measure: Change in quality of life (Patient reported outcome)
timeFrame: 6 Months
measure: Change in quality of life (Patient reported outcome)
timeFrame: 9 Months
measure: Change in quality of life (Patient reported outcome)
timeFrame: 12 months
measure: Change in quality of life (Patient reported outcome)
timeFrame: 15 months
measure: Change in quality of life (Patient reported outcome)
timeFrame: 18 months
measure: Change in quality of life (Patient reported outcome)
timeFrame: 21 months
measure: Change in quality of life (Patient reported outcome)
timeFrame: 24 months
measure: Change in healthcare utilization (Patient reported outcome)
timeFrame: Baseline
measure: Change in healthcare utilization (Patient reported outcome)
timeFrame: 3 months
measure: Change in healthcare utilization (Patient reported outcome)
timeFrame: 6 months
measure: Change in healthcare utilization (Patient reported outcome)
timeFrame: 9 months
measure: Change in healthcare utilization (Patient reported outcome)
timeFrame: 12 months
measure: Change in healthcare utilization (Patient reported outcome)
timeFrame: 15 months
measure: Change in healthcare utilization (Patient reported outcome)
timeFrame: 18 months
measure: Change in healthcare utilization (Patient reported outcome)
timeFrame: 21 months
measure: Change in healthcare utilization (Patient reported outcome)
timeFrame: 24 months
Other outcomes:
measure: Change in Levels of Stress (Patient reported outcome)
timeFrame: baseline
measure: Change in Levels of Stress (Patient reported outcome)
timeFrame: 6 months
measure: Change in Levels of Stress (Patient reported outcome)
timeFrame: 12 months
measure: Change in Levels of Stress (Patient reported outcome)
timeFrame: 18 months
measure: Change in Levels of Stress (Patient reported outcome)
timeFrame: 24 months
measure: Change in CIrculating Biomarkers
timeFrame: baseline
measure: Change in CIrculating Biomarkers
timeFrame: 6 months
measure: Change in CIrculating Biomarkers
timeFrame: 12 months
measure: Change in CIrculating Biomarkers
timeFrame: 18 months
measure: Change in CIrculating Biomarkers
timeFrame: 24 months
measure: Change in Comorbidity and Symptoms (Patient reported outcome)
timeFrame: baseline
measure: Change in Comorbidity and Symptoms (Patient reported outcome)
timeFrame: 6 months
measure: Change in Comorbidity and Symptoms (Patient reported outcome)
timeFrame: 12 months
measure: Change in Comorbidity and Symptoms (Patient reported outcome)
timeFrame: 18 months
measure: Change in Comorbidity and Symptoms (Patient reported outcome)
timeFrame: 24 months
measure: Social Support, self-efficacy and barriers for adhering to a caloric restricted diet or increased PA (Patient Reported Outcomes)
timeFrame: baseline
measure: Social Support, self-efficacy and barriers for adhering to a caloric restricted diet or increased PA (Patient Reported Outcomes)
timeFrame: 6 months
measure: Social Support, self-efficacy and barriers for adhering to a caloric restricted diet or increased PA (Patient Reported Outcomes)
timeFrame: 12 months
measure: Social Support, self-efficacy and barriers for adhering to a caloric restricted diet or increased PA (Patient Reported Outcomes)
timeFrame: 18 months
measure: Social Support, self-efficacy and barriers for adhering to a caloric restricted diet or increased PA (Patient Reported Outcomes)
timeFrame: 24 months
measure: Quality of Life, EQ-5D-5L
timeFrame: baseline
measure: Quality of Life, EQ-5D-5L
timeFrame: 6 months
measure: Quality of Life, EQ-5D-5L
timeFrame: 18 months
measure: Quality of Life, EQ-5D-5L
timeFrame: 24 months
measure: Health literacy and Ehealth literacy scales (eHEALS)
timeFrame: baseline
measure: Health literacy and Ehealth literacy scales (eHEALS)
timeFrame: 6 months
measure: Health literacy and Ehealth literacy scales (eHEALS)
timeFrame: 12 months
measure: Health literacy and Ehealth literacy scales (eHEALS)
timeFrame: 18 months
measure: Health literacy and Ehealth literacy scales (eHEALS)
timeFrame: 24 months
measure: Health related status
timeFrame: baseline
measure: Health related status
timeFrame: 6 months
measure: Health related status
timeFrame: 12 months
measure: Health related status
timeFrame: 18 months
measure: Health related status
timeFrame: 24 months
measure: PROMIS Cognitive Function + PROMIS Cognitive Abilities - 8a
timeFrame: baseline
measure: PROMIS Cognitive Function + PROMIS Cognitive Abilities - 8a
timeFrame: 6 months
measure: PROMIS Cognitive Function + PROMIS Cognitive Abilities - 8a
timeFrame: 12 months
measure: PROMIS Cognitive Function + PROMIS Cognitive Abilities - 8a
timeFrame: 18 months
measure: PROMIS Cognitive Function + PROMIS Cognitive Abilities - 8a
timeFrame: 24 months
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
Study officials:
affiliation: University of Alabama at Birmingham
name: Wendy Demark-Wahnefried, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.