Clinical trial NCT04132219: Daughters, dUdes, Mothers and othErs Fighting Cancer Together
Official title: Daughters, (dUdes), Mothers and othErs Fighting Cancer Together
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Overweight and Obesity
Keywords: cancer survivor
overweight
obesity
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We anticipate enrolling 56 dyads of participants (2 per dyad). Each dyad will be randomized to either receive the intervention for 6 months or be placed on a 6-month waitlist and offered the opportunity to try the online intervention after final assessments are completed.
Primary purpose: PREVENTION

Brief summary: The purpose of this protocol is to conduct a 2-arm, single-blinded randomized controlled clinical trial (RCT) in which 56 dyads (defined as consisting of an overweight or obese cancer survivor of an obesity-related cancer and an overweight or obese "buddy" of his or her choosing) would be assigned either to a 6-month, diet- and exercise-based weight loss intervention delivered via an interactive website with tailored text messages, or to a 6-month wait-listed control group. The overall goals of the eHealth intervention are to reduce obesity and select circulating biomarkers (tumor necrosis factor alpha \[TNFα\], insulin, and insulin-like growth factor-1 \[IGF-1\]), as well as improve diet quality, physical activity, health-related quality of life (QoL), physical functioning and performance as compared to the control over the 6-month study period.

Detailed description: The specific aims of this protocol are to: 1) determine whether dyads (comprised of an overweight / obese cancer survivor and an overweight / obese buddy of his or her choosing) lose significantly more weight (kg) at 6-months when assigned to the eHealth intervention compared to a wait-listed control; 2) explore between-arm differences in score changes between baseline and 6-month follow-up for other key outcomes including measures of adiposity (e.g., waist circumference \[WC\] and body mass index \[BMI\]), blood pressure, diet quality, physical activity, health-related Quality of Life (QoL), physical functioning and performance; 3) Assess the impact of the intervention on select biomarkers associated with cancer risk and progression, e.g., tumor TNFα, insulin and IGF-1; and, 4) identify predictor variables associated with program efficacy, e.g., social support, self-efficacy, risk for depression, and dyad partner (spouse, relative, friend/neighbor).

Cancer survivors and their selected "buddies" who are interested in participating will be directed to a website that describes this study in detail. If interested, they will be asked to complete an online screener requiring information on race/ethnicity, gender, state of residence and eligibility criteria. Once interested participants are assessed for eligibility, consented and enrolled, they will be asked to complete online questionnaires that assess physical activity, dietary intake, health-related quality of life, risk for depression, self-efficacy, social support and barriers to diet resources. Finally, anthropometric measures, blood pressure, physical performance and circulating biomarkers will be collected in participants' homes by visiting study staff (whom the project manager will deploy after checking for a mutually convenient time for the 2-person dyad.

Eligibility criteria: Inclusion Criteria:

* Adults age 18+ for whom at least one dyad member has been diagnosed and completed curative treatment for localized renal cancer, or loco-regional ovarian, colorectal, endometrial, or female breast cancer. (Loco-regional prostate cancer survivors are also eligible but could be on active surveillance).
* Diagnosed as overweight or obese (BMI \>25 kg/m2.
* Low vegetable and fruit intake (\<2.5 cups day).
* Low physical activity (\<150 minutes per week).
* English-speaking and writing.
* Completed at least 5th grade.
* Uses the internet and owns a mobile phone.

Exclusion Criteria:

* Diagnosed with uncontrolled chronic conditions (i.e., diabetes, blood pressure, CVD, etc)
* Diagnosed with a health conditions that precludes adherence to an unsupervised weight loss intervention (e.g., pregnancy, end-stage renal disease, etc).
* Instructed by a physician to limit physical activity AND have 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.
* Diagnosed with other cancers (except non-malignant skin cancer), cancer recurrence or metastatic disease.
* Resides in a skilled nursing or assisted living facility.
* Resides more than 15 minute driving distance from dyad partner.

Primary outcomes:
measure: Body Weight
timeFrame: baseline
measure: Body Weight
timeFrame: 6 months
Secondary outcomes:
measure: Waist Circumference
timeFrame: baseline
measure: Waist Circumference
timeFrame: 6 months
measure: Physical Activity (self-reported)
timeFrame: Baseline
measure: Physical Activity (self-reported)
timeFrame: 3 months
measure: Physical Activity (self-reported)
timeFrame: 6 months
measure: Physical Activity (objective)
timeFrame: baseline
measure: Physical Activity (objective)
timeFrame: 6 months
measure: Diet Quality
timeFrame: baseline
measure: Diet Quality
timeFrame: 6 months
measure: Physical Performance (endurance)
timeFrame: Baseline
measure: Physical Performance (endurance)
timeFrame: 6 months
measure: Physical Performance (lower body strength)
timeFrame: Baseline
measure: Physical Performance (lower body strength)
timeFrame: 6 months
measure: Physical Performance (agility)
timeFrame: Baseline
measure: Physical Performance (agility)
timeFrame: 6 months
measure: Physical Performance (gait speed)
timeFrame: baseline
measure: Physical Performance (gait speed)
timeFrame: 6 months
measure: Physical Performance (Balance)
timeFrame: baseline
measure: Physical Performance (Balance)
timeFrame: 6 months
measure: Self-efficacy for calorically restricted diet
timeFrame: baseline
measure: Self-efficacy for calorically restricted diet
timeFrame: 3 months
measure: Self-efficacy for calorically restricted diet
timeFrame: 6 months
measure: Self-efficacy for increased physical activity
timeFrame: baseline
measure: Self-efficacy for increased physical activity
timeFrame: 3 months
measure: Self-efficacy for increased physical activity
timeFrame: 6 months
measure: Social support for calorically restricted diet
timeFrame: baseline
measure: Social support for increased physical activity
timeFrame: baseline
measure: Social support for calorically restricted diet
timeFrame: 3 months
measure: Social support for increased physical activity
timeFrame: 3 months
measure: Social support for calorically restricted diet
timeFrame: 6 months
measure: Social support for increased physical activity
timeFrame: 6 months
measure: Barriers for increased physical activity
timeFrame: baseline
measure: Barriers for increased physical activity
timeFrame: 3 months
measure: Barriers for increased physical activity
timeFrame: 6 months
measure: Circulating insulin
timeFrame: baseline
measure: Circulating insulin
timeFrame: 6 months
measure: Circulating glucose
timeFrame: baseline
measure: Circulating glucose
timeFrame: 6 months
measure: Circulating IL-6
timeFrame: baseline
measure: Circulating IL-6
timeFrame: 6 months
measure: Circulating CRP
timeFrame: baseline
measure: Circulating CRP
timeFrame: 6 months
measure: Circulating Total Cholesterol
timeFrame: baseline
measure: Circulating Total Cholesterol
timeFrame: 6 months
measure: Circulating HDL Cholesterol
timeFrame: baseline
measure: Circulating HDL Cholesterol
timeFrame: 6 months
measure: Circulating Tryglycerides
timeFrame: baseline
measure: Circulating Tryglycerides
timeFrame: 6 months
measure: Circulating Adiponectin
timeFrame: baseline
measure: Circulating Adiponectin
timeFrame: 6 months
measure: Circulating Leptin
timeFrame: baseline
measure: Circulating Leptin
timeFrame: 6 months
measure: Duke OARS Co-Morbidity Index
timeFrame: baseline
measure: Duke OARS Co-Morbidity Index
timeFrame: 3 months
measure: Duke OARS Co-Morbidity Index
timeFrame: 6 months
measure: PROMIS v.1.2 GLOBAL HEALTH
timeFrame: Baseline
measure: PROMIS v.1.2 GLOBAL HEALTH
timeFrame: 3 months
measure: PROMIS v.1.2 GLOBAL HEALTH
timeFrame: 6 months
measure: EQ-5D-5L
timeFrame: Baseline
measure: EQ-5D-5L
timeFrame: 3 months
measure: EQ-5D-5L
timeFrame: 6 months
measure: HEALTH / E-HEALTH LITERACY SCALE (NORMAN 2006)
timeFrame: Baseline
measure: HEALTH / E-HEALTH LITERACY SCALE (NORMAN 2006)
timeFrame: 3 months
measure: HEALTH / E-HEALTH LITERACY SCALE (NORMAN 2006)
timeFrame: 6 months
measure: Barriers to Eating a Healthy Low Calorie Diet
timeFrame: Baseline
measure: Barriers to Eating a Healthy Low Calorie Diet
timeFrame: 3 months
measure: Barriers to Eating a Healthy Low Calorie Diet
timeFrame: 6 months
measure: PROMIS Emotional Distress: Depression - Short Form 8a
timeFrame: Baseline
measure: PROMIS Emotional Distress: Depression - Short Form 8a
timeFrame: 3 months
measure: PROMIS Emotional Distress: Depression - Short Form 8a
timeFrame: 6 months
measure: Smoking status
timeFrame: Baseline
measure: Smoking status
timeFrame: 3 months
measure: Smoking status
timeFrame: 6 months
Other outcomes:
measure: Relationship to chosen partner
timeFrame: Baseline
measure: Socio-Demographic (George, et al, 1984)
timeFrame: Baseline
measure: Socio-Demographic (George, et al, 1984)
timeFrame: 3 months
measure: Socio-Demographic (George, et al, 1984)
timeFrame: 6 months
measure: Circulating Insulin (TSH)
timeFrame: Baseline
measure: Circulating Insulin (TSH)
timeFrame: 6 months
Locations:
city: Birmingham
country: United States
facility: UAB School of Health Professions, Department of Nutrition Sciences
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Wendy Demark-Wahnefried, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pekmezi DW, Crane TE, Oster RA, Rogers LQ, Hoenemeyer T, Farrell D, Cole WW, Wolin K, Badr H, Demark-Wahnefried W. Rationale and Methods for a Randomized Controlled Trial of a Dyadic, Web-Based, Weight Loss Intervention among Cancer Survivors and Partners: The DUET Study. Nutrients. 2021 Sep 29;13(10):3472. doi: 10.3390/nu13103472.