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S1008: Exercise, Diet, & Counseling in Improving Weight Loss in Overweight Female Breast or Colorectal Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01453452
Recruitment Status : Completed
First Posted : October 17, 2011
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Tracking Information
First Submitted Date  ICMJE October 14, 2011
First Posted Date  ICMJE October 17, 2011
Last Update Posted Date January 18, 2020
Study Start Date  ICMJE March 2012
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2013)
  • Attendance of ≥ 2 Curves sessions/week for a minimum of 36 of the 52 weeks of intervention [ Time Frame: 1 year from registration ]
  • Increase in fruit and vegetable consumption by 1 full serving per day (not including iceberg lettuce, potatoes, or fruit juices) OR reduce caloric intake by 100 kcal/day [ Time Frame: 1 year from registration ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 14, 2011)
  • Attendance of ≥ 2 Curves sessions/week for a minimum of 36 of the 52 weeks of intervention
  • Increase in fruit and vegetable consumption by 1 full serving per day (not including iceberg lettuce, potatoes, or fruit juices) OR reduce caloric intake by 100 kcal/day
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2013)
  • Changes in anthropometric measures (weight, BMI, waist circumference, hip circumference) [ Time Frame: 1 year from registration ]
  • Changes in body composition (% body fat as assessed by DXA scan at 12 months only) [ Time Frame: 1 year from registration ]
  • Changes in minutes spent per week in moderate-to-vigorous intensity aerobic activity using Curves attendance records and a 7-day physical activity recall assessment [ Time Frame: 1 year from registration ]
  • Changes in dietary intake patterns based on three separate 24-hour diet recalls [ Time Frame: 1 year from registration ]
  • Changes in metabolic and hormonal biomarkers associated with breast and colorectal cancer-recurrence risk (fasting insulin, fasting glucose, hemoglobin A1C, bioavailable estradiol, free testosterone, and adiponectin) [ Time Frame: 3 years ]
  • Changes in anxiety, depression, fatigue, sleep, satisfaction with social roles, pain, and physical function as measured by the PROMIS-43 [ Time Frame: 1 year from registration ]
  • DNA methylation patterns [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2011)
  • Changes in anthropometric measures (weight, BMI, waist circumference, hip circumference)
  • Changes in body composition (% body fat as assessed by DXA scan at 12 months only)
  • Changes in minutes spent per week in moderate-to-vigorous intensity aerobic activity using Curves attendance records and a 7-day physical activity recall assessment
  • Changes in dietary intake patterns based on three separate 24-hour diet recalls
  • Changes in metabolic and hormonal biomarkers associated with breast and colorectal cancer-recurrence risk (fasting insulin, fasting glucose, hemoglobin A1C, bioavailable estradiol, free testosterone, and adiponectin)
  • Changes in anxiety, depression, fatigue, sleep, satisfaction with social roles, pain, and physical function as measured by the PROMIS-43
  • DNA methylation patterns
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE S1008: Exercise, Diet, & Counseling in Improving Weight Loss in Overweight Female Breast or Colorectal Cancer Survivors
Official Title  ICMJE S1008: Feasibility Study of a Physical Activity and Dietary Change Weight Loss Intervention In Breast and Colorectal Cancer Survivors, Phase II
Brief Summary

RATIONALE: Physical activity, diet, and counseling may help breast and colorectal cancer survivors to lose weight and improve their quality of life.

PURPOSE: This phase II trial studies how well exercise, diet, and counseling work in improving physical activity and weight loss in overweight women who are breast and colorectal cancer survivors.

Detailed Description

OBJECTIVES:

Primary

  • To determine the feasibility of a 12-month community-based combined physical activity and dietary change weight-loss intervention in overweight and sedentary female breast and colorectal cancer survivors recruited via the Southwest Oncology Group (SWOG).
  • To estimate the effect size of the intervention on weight loss at 12 months.

Secondary

  • To measure changes in anthropometric measures from baseline (body mass index [BMI], waist and hip circumference) at 6 and 12 months and body composition (% body fat as assessed by dual-energy X-ray absorptiometry [DXA] scan) at 12 months.
  • To measure changes in minutes spent per week in moderate-to-vigorous aerobic activity from baseline using Curves attendance records and a 7-day physical activity assessment at 6 and 12 months.
  • To measure changes from baseline to 6 and 12 months in dietary intake of carotenoids via serum carotenoid measures.
  • To assess changes from baseline to 6 and 12 months in perceived benefit of dietary change, physical activity, and weight loss after a cancer diagnosis.
  • To measure changes from baseline in metabolic and hormonal biomarkers associated with breast and colorectal cancer recurrence risk (fasting insulin, fasting glucose, hemoglobin A1C, bioavailable estradiol, free testosterone, and adiponectin) at 6 and 12 months.
  • To assess changes from baseline in anxiety, depression, fatigue, sleep, satisfaction with social roles, pain, and physical function using the PROMISE-43 at 6 and 12 months.
  • To assess baseline predictors (medical history, health behaviors, quality of life) of subjects who adhere to and complete the intervention.
  • To assess the diversity of subjects who enroll and complete the intervention.
  • To assess the availability and acceptability of the Curves fitness centers at 12 months.
  • To explore changes in DNA methylation.
  • To assess the intervention and study process via open-ended interviews with SWOG sites and Curves franchises.
  • To measure changes in anthropometric measures and assess feasibility of extended follow-up at 24 and 36 months.
  • To assess the safety of the Curves® fitness centers for this population by assessing self-reported changes in lymphedema and any injuries as measured at 6 and 12 months.

OUTLINE: Participants are stratified according to type of cancer (breast vs colorectal).

Participants are instructed to practice 30-45 minutes of medium-to-hard exercise 5-7 days a week at a Curves fitness center (paid by study) or outside Curves for 12 months. Participants receive written materials on physical activity guidelines for survivors and a pedometer to track their physical activity outside Curves. They also receive the Curves Fitness & Weight Management Plan and are instructed to follow a "higher carbohydrate" diet plan, which promotes a 1,500 kcal/day diet that is high in fruit and vegetables consisting of 30% protein, 45% carbohydrates, and 25% fat. In addition, participants receive the dietary guidelines for cancer survivors, which recommend eating 5 or more servings of fruit/vegetables per day, a diet high in whole grains, low in saturated fat, low in sugary foods, and low in alcohol. Participants receive 14 behavioral-counseling sessions by telephone with the goal to increase intervention adherence and participation retention. Each session lasts 40 minutes and occurs weekly on weeks 1-5 and then every 6 weeks by month 6. Participants receive monthly email newsletters with health tips and motivational messages to encourage adherence and retention to the study program. Counselors also conduct three 24-hour dietary recall assessments and 1 physical activity assessment at 6 and 12 months.

Participants complete a PROMIS-43 quality-of-life questionnaire at 6 and 12 months via internet, mail, or telephone.

Participants also undergo blood sample collection at baseline and at 6 and 12 months for fasting glucose and insulin tests, and biomarker studies. Anthropometric measurements (height, weight, waist, and hip circumference) are also collected.

After completion of study intervention, participants are followed up at 24 and 36 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Anxiety Disorder
  • Breast Cancer
  • Cognitive/Functional Effects
  • Colorectal Cancer
  • Depression
  • Fatigue
  • Pain
  • Psychosocial Effects of Cancer and Its Treatment
  • Weight Changes
Intervention  ICMJE
  • Behavioral: behavioral dietary intervention
    Reduce caloric intake by 500 kcal/day, increase fruit and vegetable intake to 5 or more servings per day, and limit daily calories from fat to be < 30%. Diet will be measured using 3 repeated 24-hr diet recalls. Participants will receive information on the recommended dietary modifications via mailed materials and telephone counseling sessions.
  • Behavioral: exercise intervention
    150 min/wk of moderate exercise through use of the Curves® centers, engage in physical activity outside of Curves®, and use pedometers to track activity.
  • Other: counseling intervention
    14 40-min behavioral counseling sessions via telephone with the goal of increasing intervention adherence and increasing participant retention.
  • Procedure: quality-of-life assessment
    PROMIS-43 - online questionnaire to assess quality of life.
Study Arms  ICMJE Experimental: Exercise and Lifestyle counseling
Patients will receive behavioral dietary intervention & counseling intervention by phone, exercise intervention at Curves(R) facility, and take a quality-of-life assessment online.
Interventions:
  • Behavioral: behavioral dietary intervention
  • Behavioral: exercise intervention
  • Other: counseling intervention
  • Procedure: quality-of-life assessment
Publications * Greenlee H, Lew DL, Hershman DL, Newman VA, Hansen L, Hartman SJ, Korner J, Shi Z, Sardo Molmenti CL, Sayegh A, Fehrenbacher L, Lo S, Klemp J, Rinn K, Robertson JM, Unger J, Gralow J, Albain K, Krouse R, Fabian C. Phase II Feasibility Study of a Weight Loss Intervention in Female Breast and Colorectal Cancer Survivors (SWOG S1008). Obesity (Silver Spring). 2018 Oct;26(10):1539-1549. doi: 10.1002/oby.22269. Epub 2018 Sep 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2011)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Participants must be women with a previous diagnosis of stage I, II, or III invasive breast cancer or colorectal cancer

    • Participants must have no evidence of disease at the time of registration and no history of metastases (M0)
  • Participants must have a body mass index ≥ 25 kg/m^2 measured within 28 days of registration
  • Participants must be considered sedentary (defined as < 60 minutes of moderate to vigorous physical activity per week; moderate exercise defined as exercising to the point of sweating)
  • Participants must be willing to submit blood samples for biomarkers (insulin, glucose, HgbA1C, estradiol, and testosterone) and undergo DXA scans, and must be given the option to consent for specimen submission for banking and future translational medicine studies
  • Participants must be willing and able to attend a Curves fitness center at least 3 times per week for 12 months

PATIENT CHARACTERISTICS:

  • Participants must be post-menopausal, as defined by at least one of the following:

    • At least 12 months since the last menstrual period
    • Prior bilateral oophorectomy
    • Previous hysterectomy with one or both ovaries left in place (or previous hysterectomy in which documentation of bilateral oophorectomy is unavailable) AND follicle-stimulating hormone (FSH) values consistent with the institutional normal values for the post-menopausal state

      • If participant is under the age of 55, FSH levels must be obtained within 28 days prior to registration
  • Zubrod performance status of 0
  • Participants must have no abnormal changes on a regular (non-nuclear) cardiovascular exercise stress test (using a treadmill or bicycle) as measured by electrocardiogram (EKG)

    • EKG must be within institutional limits of normal
    • Results of previous cardiac exercise stress test may be used as long as it was done within 3 months prior to registration
  • Participants must not have evidence of uncontrolled hypertension
  • Participants with diabetes, pre-diabetes, and/or metabolic syndrome must have HgbA1C ≤ 8% within the past 28 days

    • Current use of diabetes medications is allowed
  • No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the participant has been disease-free for > 5 years
  • Participants must not be active smokers within past 90 days; active smoking is defined as any smoking, even a puff
  • Participants must have regular access to the internet in order to receive monthly nutrition-program newsletter e-mails and to complete study questionnaires online
  • Participants must be able to understand, speak, and read English
  • Participants must have a home phone or cell phone and agree to participate in the 14 (40-minute) behavioral counseling sessions and 9 (20-30-minute) telephone interviews
  • Participants must have a baseline physical exam and physician clearance (primary care provider, medical oncologist, or surgical oncologist) to participate in the weight loss and exercise prior to enrollment within 60 days of registration; copy of physician clearance document must be submitted

PRIOR CONCURRENT THERAPY:

  • Participants must be 90 days to 730 days post-surgery, chemotherapy, and radiation therapy

    • Current hormonal therapy is allowed among breast cancer participants
    • Other concurrent anti-cancer therapies, including Herceptin, are not allowed
    • Surgery is defined as any major surgical procedure (resection or reconstructive) that would preclude inclusion in the exercise program

      • If the participant has had a remedial surgical procedure (e.g., revision of reconstruction) or persistent complications from her original operation, approval will be obtained from the participant's surgeon prior to enrollment

        • Persistent complications may include, but are not limited to, prolonged wound healing, hernias, or ostomy prolapse
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE up to 120 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01453452
Other Study ID Numbers  ICMJE S1008
S1008 ( Other Identifier: SWOG )
U10CA037429 ( U.S. NIH Grant/Contract )
NCI-2011-03539 ( Other Identifier: CTRP )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Southwest Oncology Group
Study Sponsor  ICMJE Southwest Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Heather Greenlee, PhD, ND Herbert Irving Comprehensive Cancer Center
Study Chair: Dawn Hershman, MD Herbert Irving Comprehensive Cancer Center
PRS Account Southwest Oncology Group
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP