Daughters, dUdes, Mothers and othErs Fighting Cancer Together

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cancer, Overweight and Obesity

Intervention / Treatment
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* Behavioral: eHealth Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Intervention Group<br>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<br>* 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.<br>|
| Other: Delayed Intervention Group<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer survivor, overweight, obesity