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

NCT01453452 | Completed DMC

• 3 other identifiers: S1008U10CA037429NCI-2011-03539
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 58

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.

Conditions

Anxiety Disorder; Breast Cancer; Cognitive/Functional Effects; Colorectal Cancer; Depression; Fatigue; Pain; Psychosocial Effects of Cancer and Its Treatment; Weight Changes

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Attendance of ≥ 2 Curves sessions/week for a minimum of 36 of the 52 weeks of intervention

  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

  1 year from registration

Secondary Outcomes (7)

• Changes in anthropometric measures (weight, BMI, waist circumference, hip circumference)

  1 year from registration

• Changes in body composition (% body fat as assessed by DXA scan at 12 months only)

  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

  1 year from registration

• Changes in dietary intake patterns based on three separate 24-hour diet recalls

  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)

  3 years

Study Arms (1)

Exercise and Lifestyle counseling

EXPERIMENTAL

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; Behavioral: exercise intervention; Other: counseling intervention; Procedure: quality-of-life assessment

Interventions

behavioral dietary intervention BEHAVIORAL

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.

Exercise and Lifestyle counseling

exercise intervention BEHAVIORAL

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.

Exercise and Lifestyle counseling

counseling intervention OTHER

14 40-min behavioral counseling sessions via telephone with the goal of increasing intervention adherence and increasing participant retention.

Exercise and Lifestyle counseling

quality-of-life assessment PROCEDURE

PROMIS-43 - online questionnaire to assess quality of life.

Exercise and Lifestyle counseling

Eligibility Criteria

• Age: Up to 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (58)

Arizona Cancer Center at University Medical Center North

Tucson, Arizona, 85719, United States

Location

University of Arizona Health Sciences Center

Tucson, Arizona, 85724, United States

Location

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, 94531, United States

Location

Kaiser Permanente, Fremont

Fremont, California, 94538, United States

Location

Kaiser Permanente

Fresno, California, 93720, United States

Location

Kaiser Permanente, Hayward

Hayward, California, 94545, United States

Location

Kaiser Permanente-Modesto

Modesto, California, 95356, United States

Location

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

Location

Kaiser Permanente-Redwood City

Redwood City, California, 94063, United States

Location

Kaiser Permanente-Richmond

Richmond, California, 94801, United States

Location

Kaiser Permanente-Roseville

Roseville, California, 95661, United States

Location

Kaiser Permanente-South Sacramento

Sacramento, California, 95823, United States

Location

Kaiser Permanente - Sacramento

Sacramento, California, 95825, United States

Location

Kaiser Permanente-San Francisco

San Francisco, California, 94115, United States

Location

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, 95119, United States

Location

Kaiser Permanente-San Rafael

San Rafael, California, 94903, United States

Location

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051, United States

Location

Kaiser Permanente-Santa Rosa

Santa Rosa, California, 95403, United States

Location

Kaiser Permanente-South San Francisco

South San Francisco, California, 94080, United States

Location

Kaiser Permanente-Stockton

Stockton, California, 95210, United States

Location

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, 95688, United States

Location

Kaiser Permanente-Vallejo

Vallejo, California, 94589, United States

Location

Kaiser Permanente-Walnut Creek

Walnut Creek, California, 94596, United States

Location

Kaiser Permanente Moanalua Medical Center

Honolulu, Hawaii, 96819, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Cancer Center of Kansas - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, 66701, United States

Location

Cancer Center of Kansas-Independence

Independence, Kansas, 67301, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Cancer Center of Kansas-Kingman

Kingman, Kansas, 67068, United States

Location

Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States

Location

Cancer Center of Kansas-Liberal

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas - Salina

Salina, Kansas, 67401, United States

Location

Cancer Center of Kansas - Wellington

Wellington, Kansas, 67152, United States

Location

Associates In Womens Health

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas - Main Office

Wichita, Kansas, 67214, United States

Location

Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Wichita CCOP

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas - Winfield

Winfield, Kansas, 67156, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

William Beaumont Hospital - Troy

Troy, Michigan, 48098, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Cancer Centers of the Carolinas - Faris

Greenville, South Carolina, 29605, United States

Location

Cancer Centers of the Carolinas - Grove Commons

Greenville, South Carolina, 29605, United States

Location

Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Greenville CCOP

Greenville, South Carolina, 29615, United States

Location

Cancer Centers of the Carolinas-Greer Medical Oncology

Greer, South Carolina, 29650, United States

Location

Cancer Centers of the Carolinas - Seneca

Seneca, South Carolina, 29672, United States

Location

Cancer Centers of the Carolinas - Spartanburg

Spartanburg, South Carolina, 29307, United States

Location

Southwest Oncology Group

San Antonio, Texas, 78245, United States

Location

Swedish Medical Center-Edmonds

Edmonds, Washington, 98026, United States

Location

Swedish Medical Center-First Hill

Seattle, Washington, 98122-4307, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• 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.

  PMID: 30272836 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Breast Neoplasms; Colorectal Neoplasms; Depression; Fatigue; Pain; Body Weight Changes; Colonic Neoplasms; Rectal Neoplasms

Interventions

Counseling

Condition Hierarchy (Ancestors)

Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Body Weight

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Heather Greenlee, PhD, ND

  Herbert Irving Comprehensive Cancer Center

  STUDY CHAIR

• Dawn Hershman, MD

  Herbert Irving Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2011
• First Posted: October 17, 2011
• Study Start: March 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: January 1, 2017
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

US (58)