S1008: Exercise, Diet, & Counseling in Improving Weight Loss in Overweight Female Breast or Colorectal Cancer Survivors
Anxiety Disorder, Breast Cancer, Cognitive/Functional Effects
About this trial
This is an interventional supportive care trial for Anxiety Disorder focused on measuring 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
Eligibility 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 โฅ 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 โค 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
Sites / Locations
- Arizona Cancer Center at University Medical Center North
- University of Arizona Health Sciences Center
- Kaiser Permanente-Deer Valley Medical Center
- Kaiser Permanente, Fremont
- Kaiser Permanente
- Kaiser Permanente, Hayward
- Kaiser Permanente-Modesto
- Kaiser Permanente-Oakland
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Kaiser Permanente-Roseville
- Kaiser Permanente-South Sacramento
- Kaiser Permanente - Sacramento
- Kaiser Permanente-San Francisco
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente-San Rafael
- Kaiser Permanente Medical Center - Santa Clara
- Kaiser Permanente-Santa Rosa
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-Vallejo
- Kaiser Permanente-Walnut Creek
- Kaiser Permanente Moanalua Medical Center
- Loyola University Medical Center
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- University of Kansas Medical Center
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas - Newton
- Cancer Center of Kansas - Parsons
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Cancer Center of Kansas - Main Office
- Via Christi Regional Medical Center
- Wichita CCOP
- Cancer Center of Kansas - Winfield
- William Beaumont Hospital
- William Beaumont Hospital - Troy
- Columbia University Medical Center
- Cancer Centers of the Carolinas - Faris
- Cancer Centers of the Carolinas - Grove Commons
- Greenville Memorial Hospital
- Greenville CCOP
- Cancer Centers of the Carolinas-Greer Medical Oncology
- Cancer Centers of the Carolinas - Seneca
- Cancer Centers of the Carolinas - Spartanburg
- Southwest Oncology Group
- Swedish Medical Center-Edmonds
- Swedish Medical Center-First Hill
- University of Washington Medical Center
Arms of the Study
Arm 1
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.