SWOG clinical trial number
S1008

Feasibility Study of a Physical Activity and Dietary Change Weight Loss Intervention In Breast and Colorectal Cancer Survivors, Phase II

Closed
Phase
Accrual
100%
Abbreviated Title
Physical activity & dietary change weight loss in breast & colorectal survivors Ph II
Activated
03/01/2012
Closed
07/01/2014
Participants
Limited: Institutions Listed on the Title Page

Research committees

Cancer Survivorship
Breast Cancer
Gastrointestinal Cancer

Eligibility Criteria Expand/Collapse

Women with previous diagnosis of breast cancer or colorectal cancer (Stage I, II, or III w/no evidence of metastatic disease) and no evidence of disease or history of metastases at reg; post-menopausal (>/= 12 months since last menses OR prior bilateral oophorectomy OR previous hysterectomy with one of both ovaries left in place AND FSH values consistent with institutional normal values. If under age 55, FSH levels must be obtained within 28 days prior to reg); 90 days-7 years post-surgery, chemotherapy and radiation therapy (current hormonal therapy allowed for breast cancer participants, other concurrent cytotoxic therapies including Herceptin are not allowed); BMI >/= 25 kg/m2 within 28 days; considered sedentary (< 150 min of moderate or vigorous physical activity/week); Zubrod PS of 0; No abnormal changes on cardiovascular stress test by EKG within 3 months prior to reg; No evidence of uncontrolled hypertension that is not effectively managed with intervention; Participants with diabetes, pre-diabetes, and/or metabolic syndrome: HgbA1C </= 8 within 28 days prior to reg; No weight loss surgery; No prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for >/= 5 years; Not active smoke within 90 days prior to reg; Willing to submit blood samples for biomarkers and given option to consent to banking; Willing and able to attend Curves® fitness center at least 3x/week for 12 months; Regular access to internet for 3 questionnaires and nutrition e-mails; Must be able to understand, speak, and read English; Must have phone and agree to participate in 14 behavioral counseling sessions and 9 phone interviews; Physician clearance to participate in weight loss and exercise prior to enrollment within 60 days of reg.

Publication Information Expand/Collapse

2018

Phase II Feasibility Study of a Physical Activity and Dietary Change Weight Loss Intervention in Breast and Colorectal Cancer Survivors (SWOG S1008)

H Greenlee;D Lew;DL Hershman;V Newman;L Hansen;S Hartman;J Korner;Z Shi;C Sardo Molmenti;A Sayegh;L Fehrenbacher;S Lo;J Klemp;K Rinn;JM Robertson;JM Unger;JR Gralow;K Albain;RS Krouse;C Fabian Obesity Oct;26(10):1539-1549

PMid: PMID30272836 | PMC number: PMC6611675

2015

Phase II feasibility study of a physical activity and dietary change weight loss intervention in a subset analysis of breast cancer survivors from SWOG S1008

H Greenlee;D Lew;J Pierce;L Hansen;V Newman;J Korner;A Sayegh;L Frehrenbacher;S Lo;J Klemp;K Rinn;J Robertson;J Unger;J Gralow;K Albain;R Krouse;C Fabian Journal of Clinical Oncology 33:5s (suppl; abstr 9572); American Society of Clinical Oncology Annual Meeting (May 29-June 2, 2015, Chicago, IL), poster session;