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Completed

NCT Number: NCT04132219

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.

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Key information

Conditions

Cancer Body Weight Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAB School of Health Professions, Department of Nutrition Sciences

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

eHealth intervention

Behavioral

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.

Primary outcomes

  1. Body Weight

    Time frame: baseline

    Change in measured body weight

  2. Body Weight

    Time frame: 6 months

    Change in measured body weight

Secondary outcomes

  1. Waist Circumference

    Time frame: baseline

    measured with a non-stretch tape

  2. Waist Circumference

    Time frame: 6 months

    measured with a non-stretch tape

  3. Physical Activity (self-reported)

    Time frame: Baseline

    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.

  4. Physical Activity (self-reported)

    Time frame: 3 months

    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.

  5. Physical Activity (self-reported)

    Time frame: 6 months

    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. Physical Activity (objective)

    Time frame: baseline

    Accelerometry (7-day assessment)

  7. Physical Activity (objective)

    Time frame: 6 months

    Accelerometry (7-day assessment)

  8. Diet Quality

    Time frame: baseline

    Two 24-hour dietary recalls

  9. Diet Quality

    Time frame: 6 months

    Two 24-hour dietary recalls

  10. Physical Performance (endurance)

    Time frame: Baseline

    2-minute step test

  11. Physical Performance (endurance)

    Time frame: 6 months

    2-minute step test

  12. Physical Performance (lower body strength)

    Time frame: Baseline

    30-second chair stand

  13. Physical Performance (lower body strength)

    Time frame: 6 months

    30-second chair stand

  14. Physical Performance (agility)

    Time frame: Baseline

    8' foot up and go

  15. Physical Performance (agility)

    Time frame: 6 months

    8' foot up and go

  16. Physical Performance (gait speed)

    Time frame: baseline

    8' walk

  17. Physical Performance (gait speed)

    Time frame: 6 months

    8' walk

  18. Physical Performance (Balance)

    Time frame: baseline

    Side-by-side, semi-tandem and tandem stances

  19. Physical Performance (Balance)

    Time frame: 6 months

    Side-by-side, semi-tandem and tandem stances

  20. Self-efficacy for calorically restricted diet

    Time frame: baseline

    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)

  21. Self-efficacy for calorically restricted diet

    Time frame: 3 months

    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)

  22. Self-efficacy for calorically restricted diet

    Time frame: 6 months

    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)

  23. Self-efficacy for increased physical activity

    Time frame: baseline

    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%).

  24. Self-efficacy for increased physical activity

    Time frame: 3 months

    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%).

  25. Self-efficacy for increased physical activity

    Time frame: 6 months

    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%).

  26. Social support for calorically restricted diet

    Time frame: baseline

    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)

  27. Social support for increased physical activity

    Time frame: baseline

    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)

  28. Social support for calorically restricted diet

    Time frame: 3 months

    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)

  29. Social support for increased physical activity

    Time frame: 3 months

    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)

  30. Social support for calorically restricted diet

    Time frame: 6 months

    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)

  31. Social support for increased physical activity

    Time frame: 6 months

    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)

  32. Barriers for increased physical activity

    Time frame: baseline

    (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.

  33. Barriers for increased physical activity

    Time frame: 3 months

    (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.

  34. Barriers for increased physical activity

    Time frame: 6 months

    (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.

  35. Circulating insulin

    Time frame: baseline

    assays on dried blood spot eluents

  36. Circulating insulin

    Time frame: 6 months

    assays on dried blood spot eluents

  37. Circulating glucose

    Time frame: baseline

    assays on dried blood spot eluents

  38. Circulating glucose

    Time frame: 6 months

    assays on dried blood spot eluents

  39. Circulating IL-6

    Time frame: baseline

    assays on dried blood spot eluents

  40. Circulating IL-6

    Time frame: 6 months

    assays on dried blood spot eluents

  41. Circulating CRP

    Time frame: baseline

    assays on dried blood spot eluents

  42. Circulating CRP

    Time frame: 6 months

    assays on dried blood spot eluents

  43. Circulating Total Cholesterol

    Time frame: baseline

    assays on dried blood spot eluents

  44. Circulating Total Cholesterol

    Time frame: 6 months

    assays on dried blood spot eluents

  45. Circulating HDL Cholesterol

    Time frame: baseline

    assays on dried blood spot eluents

  46. Circulating HDL Cholesterol

    Time frame: 6 months

    assays on dried blood spot eluents

  47. Circulating Tryglycerides

    Time frame: baseline

    assays on dried blood spot eluents

  48. Circulating Tryglycerides

    Time frame: 6 months

    assays on dried blood spot eluents

  49. Circulating Adiponectin

    Time frame: baseline

    assays on dried blood spot eluents

  50. Circulating Adiponectin

    Time frame: 6 months

    assays on dried blood spot eluents

  51. Circulating Leptin

    Time frame: baseline

    assays on dried blood spot eluents

  52. Circulating Leptin

    Time frame: 6 months

    assays on dried blood spot eluents

  53. Duke OARS Co-Morbidity Index

    Time frame: baseline

    43-item assessment of co-morbid conditions (multiple choice) (modified by removing 1 item)

  54. Duke OARS Co-Morbidity Index

    Time frame: 3 months

    43-item assessment of co-morbid conditions (multiple choice) (modified by removing 1 item)

  55. Duke OARS Co-Morbidity Index

    Time frame: 6 months

    43-item assessment of co-morbid conditions (multiple choice) (modified by removing 1 item)

  56. PROMIS v.1.2 GLOBAL HEALTH

    Time frame: Baseline

    10-item Likert scale assessment of Quality of Life

  57. PROMIS v.1.2 GLOBAL HEALTH

    Time frame: 3 months

    10-item Likert scale assessment of Quality of Life

  58. PROMIS v.1.2 GLOBAL HEALTH

    Time frame: 6 months

    10-item Likert scale assessment of Quality of Life

  59. EQ-5D-5L

    Time frame: Baseline

    6-item Likert scale assessment of Quality of Life

  60. EQ-5D-5L

    Time frame: 3 months

    6-item Likert scale assessment of Quality of Life

  61. EQ-5D-5L

    Time frame: 6 months

    6-item Likert scale assessment of Quality of Life

  62. HEALTH / E-HEALTH LITERACY SCALE (NORMAN 2006)

    Time frame: Baseline

    7-item scale to assess e-health literacy. Two items were added from eHEALS to understand consumer's interest in using eHealth in general.

  63. HEALTH / E-HEALTH LITERACY SCALE (NORMAN 2006)

    Time frame: 3 months

    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.

  64. HEALTH / E-HEALTH LITERACY SCALE (NORMAN 2006)

    Time frame: 6 months

    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.

  65. Barriers to Eating a Healthy Low Calorie Diet

    Time frame: Baseline

    (10 items) Respondents either affirm or deny common barriers to low calorie diet.

  66. Barriers to Eating a Healthy Low Calorie Diet

    Time frame: 3 months

    (10 items) Respondents either affirm or deny common barriers to low calorie diet.

  67. Barriers to Eating a Healthy Low Calorie Diet

    Time frame: 6 months

    (10 items) Respondents either affirm or deny common barriers to low calorie diet.

  68. PROMIS Emotional Distress: Depression - Short Form 8a

    Time frame: Baseline

    (8 items) Likert scale assessment of depression

  69. PROMIS Emotional Distress: Depression - Short Form 8a

    Time frame: 3 months

    (8 items) Likert scale assessment of depression

  70. PROMIS Emotional Distress: Depression - Short Form 8a

    Time frame: 6 months

    (8 items) Likert scale assessment of depression

  71. Smoking status

    Time frame: Baseline

    2 items that ask whether respondent has ever smoked >100 cigarettes and current smoking status.

  72. Smoking status

    Time frame: 3 months

    2 items that ask whether respondent has ever smoked >100 cigarettes and current smoking status.

  73. Smoking status

    Time frame: 6 months

    2 items that ask whether respondent has ever smoked >100 cigarettes and current smoking status.

Other outcomes

  1. Relationship to chosen partner

    Time frame: Baseline

    1 item question that asks for relationship of chosen partner to cancer survivor

  2. Socio-Demographic (George, et al, 1984)

    Time frame: Baseline

    3-items that ask about income and perceptions of economic well-being

  3. Socio-Demographic (George, et al, 1984)

    Time frame: 3 months

    3-items that ask about income and perceptions of economic well-being

  4. Socio-Demographic (George, et al, 1984)

    Time frame: 6 months

    3-items that ask about income and perceptions of economic well-being

  5. Circulating Insulin (TSH)

    Time frame: Baseline

    assays on dried blood spot eluents

  6. Circulating Insulin (TSH)

    Time frame: 6 months

    assays on dried blood spot eluents

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Acronym: DUET

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 18, 2019
Registry last updated
Dec 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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