Daughters, dUdes, Mothers and othErs Fighting Cancer Together (DUET)

Daughters, (dUdes), Mothers and othErs Fighting Cancer Together

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Overweight and Obesity
• Intervention / Treatment: Behavioral: eHealth Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • UAB School of Health Professions, Department of Nutrition Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Intervention Group; Dyads randomized to the Immediate Intervention Group will receive a "Welcome Box" at completion of the baseline assessment. The Welcome Box will include two of each of the following: 1) Letters describing the project logistics and the important roles of each dyad member); 2) WiFi-enabled Scales (with instructions to weigh daily); 3) Portion Doctor ®Tableware (with instructions to use the portion plates at least once a day); 4) Fitbit® Inspire Activity Monitors (with instructions to share data with the dyad member and the study office); and 5) Instructions on how to create a secured account on the DUET website and instructions for logging on.	Behavioral: eHealth Intervention; Every week, each dyad member will receive a tailored text message that provides a new fun fact or that encourages them to log-on to the website to access findings of new research and how the results might apply to them. They will be directed to specific pages in the Web-based program and asked to select strategies from a list that they will practice during the upcoming week. Graphic displays of their progress will be provided along with SCT-based feedback. They will be directed to the website to record their behavioral goals for the upcoming week. Tips also will be provided for effective communication to enhance couple efficacy. All usage will be tracked to assess adherence.
Other: Delayed Intervention Group; Participants assigned to the Delayed Intervention Group will receive a "Welcome Box" which on the outside is identical (and also is comparably weighted with bottled water) to that given to the Immediate Intervention group. This box would include: 1) Letters describing the project logistics and the important roles of each dyad member; and 2) monthly online study newsletters on topics unrelated to diet and exercise, but still of interest to cancer survivors and dyad members such as coping with stress, reducing exposure to radiation, sun safety, etc. to enhance retention and will be offered the opportunity to receive the online intervention after completing final 6-month assessments.	Behavioral: eHealth Intervention; Every week, each dyad member will receive a tailored text message that provides a new fun fact or that encourages them to log-on to the website to access findings of new research and how the results might apply to them. They will be directed to specific pages in the Web-based program and asked to select strategies from a list that they will practice during the upcoming week. Graphic displays of their progress will be provided along with SCT-based feedback. They will be directed to the website to record their behavioral goals for the upcoming week. Tips also will be provided for effective communication to enhance couple efficacy. All usage will be tracked to assess adherence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight	Change in measured body weight	baseline
Body Weight	Change in measured body weight	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist Circumference	measured with a non-stretch tape	baseline
Waist Circumference	measured with a non-stretch tape	6 months
Physical Activity (self-reported)	Godin Leisure Time Physical Activity Questionnaire (4-item survey) - individuals provide the number of minutes of vigorous, moderate and light physical activity per week. The minimum is 0 - theoretically, the maximum is 10,080 (the number of minutes in a week), then they are asked if this level of activity is "typical." The higher the number of minutes of totaled moderate + vigorous activity, the better.	Baseline
Physical Activity (self-reported)	Godin Leisure Time Physical Activity Questionnaire (4-item survey) - individuals provide the number of minutes of vigorous, moderate and light physical activity per week. The minimum is 0 - theoretically, the maximum is 10,080 (the number of minutes in a week), then they are asked if this level of activity is "typical." The higher the number of minutes of totaled moderate + vigorous activity, the better.	3 months
Physical Activity (self-reported)	Godin Leisure Time Physical Activity Questionnaire (4-item survey) - individuals provide the number of minutes of vigorous, moderate and light physical activity per week. The minimum is 0 - theoretically, the maximum is 10,080 (the number of minutes in a week), then they are asked if this level of activity is "typical." The higher the number of minutes of totaled moderate + vigorous activity, the better.	6 months
Physical Activity (objective)	Accelerometry (7-day assessment)	baseline
Physical Activity (objective)	Accelerometry (7-day assessment)	6 months
Diet Quality	Two 24-hour dietary recalls	baseline
Diet Quality	Two 24-hour dietary recalls	6 months
Physical Performance (endurance)	2-minute step test	Baseline
Physical Performance (endurance)	2-minute step test	6 months
Physical Performance (lower body strength)	30-second chair stand	Baseline
Physical Performance (lower body strength)	30-second chair stand	6 months
Physical Performance (agility)	8' foot up and go	Baseline
Physical Performance (agility)	8' foot up and go	6 months
Physical Performance (gait speed)	8' walk	baseline
Physical Performance (gait speed)	8' walk	6 months
Physical Performance (Balance)	Side-by-side, semi-tandem and tandem stances	baseline
Physical Performance (Balance)	Side-by-side, semi-tandem and tandem stances	6 months
Self-efficacy for calorically restricted diet	Clark et al. survey (20 items). Respondents either affirm or deny that they can resist high fat, high calorie foods under a variety of situations. Individuals who have maximum willpower achieve the top score of 20, whereas those with lesser willpower score lower (the minimum score is zero)	baseline
Self-efficacy for calorically restricted diet	Clark et al. survey (20 items). Respondents either affirm or deny that they can resist high fat, high calorie foods under a variety of situations. Individuals who have maximum willpower achieve the top score of 20, whereas those with lesser willpower score lower (the minimum score is zero)	3 months
Self-efficacy for calorically restricted diet	Clark et al. survey (20 items). Respondents either affirm or deny that they can resist high fat, high calorie foods under a variety of situations. Individuals who have maximum willpower achieve the top score of 20, whereas those with lesser willpower score lower (the minimum score is zero)	6 months
Self-efficacy for increased physical activity	Sallis et al. survey (6 items in total). Respondents rate themselves on each item from 0 to 100% on their level of confidence. The higher the total score (maximum of 100%) the better (Minimum 0%).	baseline
Self-efficacy for increased physical activity	Sallis et al. survey (6 items in total). Respondents rate themselves on each item from 0 to 100% on their level of confidence. The higher the total score (maximum of 100%) the better (Minimum 0%).	3 months
Self-efficacy for increased physical activity	Sallis et al. survey (6 items in total). Respondents rate themselves on each item from 0 to 100% on their level of confidence. The higher the total score (maximum of 100%) the better (Minimum 0%).	6 months
Social support for calorically restricted diet	Sallis et al. instrument (4 items). Respondents rate the level of support they obtain to follow a healthy, low calorie diet on a 5-point scale ranging from ("never"= 0 to "everyday" = 4. Individuals who have maximum support achieve the top score of 16, whereas those with lesser support score lower (the minimum score is zero)	baseline
Social support for increased physical activity	Sallis et al. instrument (4 items in total) Respondents rate the level of support they obtain to increase their level of physical activity on a 5-point scale ranging from ("never"= 0 to "everyday" = 4. Individuals who have maximum support achieve the top score of 16, whereas those with lesser support score lower (the minimum score is zero)	baseline
Social support for calorically restricted diet	Sallis et al. instrument (4 items). Respondents rate the level of support they obtain to follow a healthy, low calorie diet on a 5-point scale ranging from ("never"= 0 to "everyday" = 4. Individuals who have maximum support achieve the top score of 16, whereas those with lesser support score lower (the minimum score is zero)	3 months
Social support for increased physical activity	Sallis et al. instrument (4 items in total) Respondents rate the level of support they obtain to increase their level of physical activity on a 5-point scale ranging from ("never"= 0 to "everyday" = 4. Individuals who have maximum support achieve the top score of 16, whereas those with lesser support score lower (the minimum score is zero)	3 months
Social support for calorically restricted diet	Sallis et al. instrument (4 items). Respondents rate the level of support they obtain to follow a healthy, low calorie diet on a 5-point scale ranging from ("never"= 0 to "everyday" = 4. Individuals who have maximum support achieve the top score of 16, whereas those with lesser support score lower (the minimum score is zero)	6 months
Social support for increased physical activity	Sallis et al. instrument (4 items in total) Respondents rate the level of support they obtain to increase their level of physical activity on a 5-point scale ranging from ("never"= 0 to "everyday" = 4. Individuals who have maximum support achieve the top score of 16, whereas those with lesser support score lower (the minimum score is zero)	6 months
Barriers for increased physical activity	(15 items in total) Respondents either affirm or deny common barriers to exercise. Individuals who report more barriers achieve the top score of 21, whereas those with fewer barriers score lower (the minimum score is zero) and that is considered better.	baseline
Barriers for increased physical activity	(15 items in total) Respondents either affirm or deny common barriers to exercise. Individuals who report more barriers achieve the top score of 21, whereas those with fewer barriers score lower (the minimum score is zero) and that is considered better.	3 months
Barriers for increased physical activity	(15 items in total) Respondents either affirm or deny common barriers to exercise. Individuals who report more barriers achieve the top score of 21, whereas those with fewer barriers score lower (the minimum score is zero) and that is considered better.	6 months
Circulating insulin	assays on dried blood spot eluents	baseline
Circulating insulin	assays on dried blood spot eluents	6 months
Circulating glucose	assays on dried blood spot eluents	baseline
Circulating glucose	assays on dried blood spot eluents	6 months
Circulating IL-6	assays on dried blood spot eluents	baseline
Circulating IL-6	assays on dried blood spot eluents	6 months
Circulating CRP	assays on dried blood spot eluents	baseline
Circulating CRP	assays on dried blood spot eluents	6 months
Circulating Total Cholesterol	assays on dried blood spot eluents	baseline
Circulating Total Cholesterol	assays on dried blood spot eluents	6 months
Circulating HDL Cholesterol	assays on dried blood spot eluents	baseline
Circulating HDL Cholesterol	assays on dried blood spot eluents	6 months
Circulating Tryglycerides	assays on dried blood spot eluents	baseline
Circulating Tryglycerides	assays on dried blood spot eluents	6 months
Circulating Adiponectin	assays on dried blood spot eluents	baseline
Circulating Adiponectin	assays on dried blood spot eluents	6 months
Circulating Leptin	assays on dried blood spot eluents	baseline
Circulating Leptin	assays on dried blood spot eluents	6 months
Duke OARS Co-Morbidity Index	43-item assessment of co-morbid conditions (multiple choice) (modified by removing 1 item)	baseline
Duke OARS Co-Morbidity Index	43-item assessment of co-morbid conditions (multiple choice) (modified by removing 1 item)	3 months
Duke OARS Co-Morbidity Index	43-item assessment of co-morbid conditions (multiple choice) (modified by removing 1 item)	6 months
PROMIS v.1.2 GLOBAL HEALTH	10-item Likert scale assessment of Quality of Life	Baseline
PROMIS v.1.2 GLOBAL HEALTH	10-item Likert scale assessment of Quality of Life	3 months
PROMIS v.1.2 GLOBAL HEALTH	10-item Likert scale assessment of Quality of Life	6 months
EQ-5D-5L	6-item Likert scale assessment of Quality of Life	Baseline
EQ-5D-5L	6-item Likert scale assessment of Quality of Life	3 months
EQ-5D-5L	6-item Likert scale assessment of Quality of Life	6 months
HEALTH / E-HEALTH LITERACY SCALE (NORMAN 2006)	7-item scale to assess e-health literacy. Two items were added from eHEALS to understand consumer's interest in using eHealth in general.	Baseline
HEALTH / E-HEALTH LITERACY SCALE (NORMAN 2006)	7-item scale to assess health and e-health literacy. Two items were added from eHEALS to understand consumer's interest in using eHealth in general.	3 months
HEALTH / E-HEALTH LITERACY SCALE (NORMAN 2006)	7-item scale to assess health and e-health literacy. Two items were added from eHEALS to understand consumer's interest in using eHealth in general.	6 months
Barriers to Eating a Healthy Low Calorie Diet	(10 items) Respondents either affirm or deny common barriers to low calorie diet.	Baseline
Barriers to Eating a Healthy Low Calorie Diet	(10 items) Respondents either affirm or deny common barriers to low calorie diet.	3 months
Barriers to Eating a Healthy Low Calorie Diet	(10 items) Respondents either affirm or deny common barriers to low calorie diet.	6 months
PROMIS Emotional Distress: Depression - Short Form 8a	(8 items) Likert scale assessment of depression	Baseline
PROMIS Emotional Distress: Depression - Short Form 8a	(8 items) Likert scale assessment of depression	3 months
PROMIS Emotional Distress: Depression - Short Form 8a	(8 items) Likert scale assessment of depression	6 months
Smoking status	2 items that ask whether respondent has ever smoked >100 cigarettes and current smoking status.	Baseline
Smoking status	2 items that ask whether respondent has ever smoked >100 cigarettes and current smoking status.	3 months
Smoking status	2 items that ask whether respondent has ever smoked >100 cigarettes and current smoking status.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship to chosen partner	1 item question that asks for relationship of chosen partner to cancer survivor	Baseline
Socio-Demographic (George, et al, 1984)	3-items that ask about income and perceptions of economic well-being	Baseline
Socio-Demographic (George, et al, 1984)	3-items that ask about income and perceptions of economic well-being	3 months
Socio-Demographic (George, et al, 1984)	3-items that ask about income and perceptions of economic well-being	6 months
Circulating Insulin (TSH)	assays on dried blood spot eluents	Baseline
Circulating Insulin (TSH)	assays on dried blood spot eluents	6 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Publications and helpful links

General Publications

• 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. Erratum In: Nutrients. 2022 Jul 29;14(15):

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Actual): February 15, 2022
• Study Completion (Actual): February 15, 2022

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (Actual): October 18, 2019

Study Record Updates

• Last Update Posted (Estimate): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: obesity; overweight; cancer survivor
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: IRB-300003882

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan at the moment to share IDP.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No