Daughters, dUdes, Mothers and othErs Fighting Cancer Together

Cancer Clinical Trial

— DUET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04132219
• Other study ID #: IRB-300003882
• Status: Completed
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: February 15, 2022

Study information

• Verified date: May 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: February 15, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Overweight
• Overweight and Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	UAB School of Health Professions, Department of Nutrition Sciences	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (1)

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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relationship to chosen partner	1 item question that asks for relationship of chosen partner to cancer survivor	Baseline
Other	Socio-Demographic (George, et al, 1984)	3-items that ask about income and perceptions of economic well-being	Baseline
Other	Socio-Demographic (George, et al, 1984)	3-items that ask about income and perceptions of economic well-being	3 months
Other	Socio-Demographic (George, et al, 1984)	3-items that ask about income and perceptions of economic well-being	6 months
Other	Circulating Insulin (TSH)	assays on dried blood spot eluents	Baseline
Other	Circulating Insulin (TSH)	assays on dried blood spot eluents	6 months
Primary	Body Weight	Change in measured body weight	baseline
Primary	Body Weight	Change in measured body weight	6 months
Secondary	Waist Circumference	measured with a non-stretch tape	baseline
Secondary	Waist Circumference	measured with a non-stretch tape	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Physical Activity (objective)	Accelerometry (7-day assessment)	baseline
Secondary	Physical Activity (objective)	Accelerometry (7-day assessment)	6 months
Secondary	Diet Quality	Two 24-hour dietary recalls	baseline
Secondary	Diet Quality	Two 24-hour dietary recalls	6 months
Secondary	Physical Performance (endurance)	2-minute step test	Baseline
Secondary	Physical Performance (endurance)	2-minute step test	6 months
Secondary	Physical Performance (lower body strength)	30-second chair stand	Baseline
Secondary	Physical Performance (lower body strength)	30-second chair stand	6 months
Secondary	Physical Performance (agility)	8' foot up and go	Baseline
Secondary	Physical Performance (agility)	8' foot up and go	6 months
Secondary	Physical Performance (gait speed)	8' walk	baseline
Secondary	Physical Performance (gait speed)	8' walk	6 months
Secondary	Physical Performance (Balance)	Side-by-side, semi-tandem and tandem stances	baseline
Secondary	Physical Performance (Balance)	Side-by-side, semi-tandem and tandem stances	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Circulating insulin	assays on dried blood spot eluents	baseline
Secondary	Circulating insulin	assays on dried blood spot eluents	6 months
Secondary	Circulating glucose	assays on dried blood spot eluents	baseline
Secondary	Circulating glucose	assays on dried blood spot eluents	6 months
Secondary	Circulating IL-6	assays on dried blood spot eluents	baseline
Secondary	Circulating IL-6	assays on dried blood spot eluents	6 months
Secondary	Circulating CRP	assays on dried blood spot eluents	baseline
Secondary	Circulating CRP	assays on dried blood spot eluents	6 months
Secondary	Circulating Total Cholesterol	assays on dried blood spot eluents	baseline
Secondary	Circulating Total Cholesterol	assays on dried blood spot eluents	6 months
Secondary	Circulating HDL Cholesterol	assays on dried blood spot eluents	baseline
Secondary	Circulating HDL Cholesterol	assays on dried blood spot eluents	6 months
Secondary	Circulating Tryglycerides	assays on dried blood spot eluents	baseline
Secondary	Circulating Tryglycerides	assays on dried blood spot eluents	6 months
Secondary	Circulating Adiponectin	assays on dried blood spot eluents	baseline
Secondary	Circulating Adiponectin	assays on dried blood spot eluents	6 months
Secondary	Circulating Leptin	assays on dried blood spot eluents	baseline
Secondary	Circulating Leptin	assays on dried blood spot eluents	6 months
Secondary	Duke OARS Co-Morbidity Index	43-item assessment of co-morbid conditions (multiple choice) (modified by removing 1 item)	baseline
Secondary	Duke OARS Co-Morbidity Index	43-item assessment of co-morbid conditions (multiple choice) (modified by removing 1 item)	3 months
Secondary	Duke OARS Co-Morbidity Index	43-item assessment of co-morbid conditions (multiple choice) (modified by removing 1 item)	6 months
Secondary	PROMIS v.1.2 GLOBAL HEALTH	10-item Likert scale assessment of Quality of Life	Baseline
Secondary	PROMIS v.1.2 GLOBAL HEALTH	10-item Likert scale assessment of Quality of Life	3 months
Secondary	PROMIS v.1.2 GLOBAL HEALTH	10-item Likert scale assessment of Quality of Life	6 months
Secondary	EQ-5D-5L	6-item Likert scale assessment of Quality of Life	Baseline
Secondary	EQ-5D-5L	6-item Likert scale assessment of Quality of Life	3 months
Secondary	EQ-5D-5L	6-item Likert scale assessment of Quality of Life	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Barriers to Eating a Healthy Low Calorie Diet	(10 items) Respondents either affirm or deny common barriers to low calorie diet.	Baseline
Secondary	Barriers to Eating a Healthy Low Calorie Diet	(10 items) Respondents either affirm or deny common barriers to low calorie diet.	3 months
Secondary	Barriers to Eating a Healthy Low Calorie Diet	(10 items) Respondents either affirm or deny common barriers to low calorie diet.	6 months
Secondary	PROMIS Emotional Distress: Depression - Short Form 8a	(8 items) Likert scale assessment of depression	Baseline
Secondary	PROMIS Emotional Distress: Depression - Short Form 8a	(8 items) Likert scale assessment of depression	3 months
Secondary	PROMIS Emotional Distress: Depression - Short Form 8a	(8 items) Likert scale assessment of depression	6 months
Secondary	Smoking status	2 items that ask whether respondent has ever smoked >100 cigarettes and current smoking status.	Baseline
Secondary	Smoking status	2 items that ask whether respondent has ever smoked >100 cigarettes and current smoking status.	3 months
Secondary	Smoking status	2 items that ask whether respondent has ever smoked >100 cigarettes and current smoking status.	6 months