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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01453452
First received: October 14, 2011
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Anxiety Disorder
Breast Cancer
Cognitive/Functional Effects
Colorectal Cancer
Depression
Fatigue
Pain
Psychosocial Effects of Cancer and Its Treatment
Weight Changes
Behavioral: behavioral dietary intervention
Behavioral: exercise intervention
Other: counseling intervention
Procedure: quality-of-life assessment
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: S1008: Feasibility Study of a Physical Activity and Dietary Change Weight Loss Intervention In Breast and Colorectal Cancer Survivors, Phase II

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Attendance of ≥ 2 Curves sessions/week for a minimum of 36 of the 52 weeks of intervention [ Time Frame: 1 year from registration ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in anthropometric measures (weight, BMI, waist circumference, hip circumference) [ Time Frame: 1 year from registration ] [ Designated as safety issue: No ]
  • Changes in body composition (% body fat as assessed by DXA scan at 12 months only) [ Time Frame: 1 year from registration ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Changes in dietary intake patterns based on three separate 24-hour diet recalls [ Time Frame: 1 year from registration ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • DNA methylation patterns [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01453452

  Show 58 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Heather Greenlee, PhD, ND Herbert Irving Comprehensive Cancer Center
Study Chair: Dawn Hershman, MD Herbert Irving Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01453452     History of Changes
Other Study ID Numbers: S1008, S1008, U10CA037429, NCI-2011-03539
Study First Received: October 14, 2011
Last Updated: July 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
weight changes
fatigue
depression
anxiety disorder
pain
cognitive/functional effects
psychosocial effects of cancer and its treatment
cancer survivor
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage I colon cancer
stage IIA colon cancer
stage IIB colon cancer
stage IIC colon cancer
stage IIIA colon cancer
stage IIIB colon cancer
stage IIIC colon cancer
stage I rectal cancer
stage IIA rectal cancer
stage IIB rectal cancer
stage IIC rectal cancer
stage IIIA rectal cancer
stage IIIB rectal cancer
stage IIIC rectal cancer

Additional relevant MeSH terms:
Anxiety Disorders
Body Weight Changes
Breast Neoplasms
Colorectal Neoplasms
Depression
Depressive Disorder
Fatigue
Weight Loss
Mental Disorders
Body Weight
Signs and Symptoms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on July 28, 2014