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

Breast Cancer Clinical Trial

Official title:

S1008: Feasibility Study of a Physical Activity and Dietary Change Weight Loss Intervention In Breast and Colorectal Cancer Survivors, Phase II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01453452
• Other study ID #: S1008
• Secondary ID: S1008U10CA037429
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: January 2017

Study information

• Verified date: January 2020
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2017
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Body Weight
• Body Weight Changes
• Breast Cancer
• Breast Neoplasms
• Cognitive/Functional Effects
• Colorectal Cancer
• Colorectal Neoplasms
• Depression
• Fatigue
• Pain
• Psychosocial Effects of Cancer and Its Treatment
• Weight Changes
• Weight Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Kaiser Permanente-Deer Valley Medical Center	Antioch	California
United States	Cancer Center of Kansas - Chanute	Chanute	Kansas
United States	Cancer Center of Kansas - Dodge City	Dodge City	Kansas
United States	Swedish Medical Center-Edmonds	Edmonds	Washington
United States	Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas
United States	Kaiser Permanente, Fremont	Fremont	California
United States	Kaiser Permanente	Fresno	California
United States	Cancer Centers of the Carolinas - Faris	Greenville	South Carolina
United States	Cancer Centers of the Carolinas - Grove Commons	Greenville	South Carolina
United States	Greenville CCOP	Greenville	South Carolina
United States	Greenville Memorial Hospital	Greenville	South Carolina
United States	Cancer Centers of the Carolinas-Greer Medical Oncology	Greer	South Carolina
United States	Kaiser Permanente, Hayward	Hayward	California
United States	Kaiser Permanente Moanalua Medical Center	Honolulu	Hawaii
United States	Cancer Center of Kansas-Independence	Independence	Kansas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Cancer Center of Kansas-Kingman	Kingman	Kansas
United States	Lawrence Memorial Hospital	Lawrence	Kansas
United States	Cancer Center of Kansas-Liberal	Liberal	Kansas
United States	Loyola University Medical Center	Maywood	Illinois
United States	Kaiser Permanente-Modesto	Modesto	California
United States	Columbia University Medical Center	New York	New York
United States	Cancer Center of Kansas - Newton	Newton	Kansas
United States	Kaiser Permanente-Oakland	Oakland	California
United States	Cancer Center of Kansas - Parsons	Parsons	Kansas
United States	Cancer Center of Kansas - Pratt	Pratt	Kansas
United States	Kaiser Permanente-Redwood City	Redwood City	California
United States	Kaiser Permanente-Richmond	Richmond	California
United States	Kaiser Permanente-Roseville	Roseville	California
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Kaiser Permanente - Sacramento	Sacramento	California
United States	Kaiser Permanente-South Sacramento	Sacramento	California
United States	Cancer Center of Kansas - Salina	Salina	Kansas
United States	Southwest Oncology Group	San Antonio	Texas
United States	Kaiser Permanente-San Francisco	San Francisco	California
United States	Kaiser Permanente-Santa Teresa-San Jose	San Jose	California
United States	Kaiser Permanente-San Rafael	San Rafael	California
United States	Kaiser Permanente Medical Center - Santa Clara	Santa Clara	California
United States	Kaiser Permanente-Santa Rosa	Santa Rosa	California
United States	Swedish Medical Center-First Hill	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington
United States	Cancer Centers of the Carolinas - Seneca	Seneca	South Carolina
United States	Kaiser Permanente-South San Francisco	South San Francisco	California
United States	Cancer Centers of the Carolinas - Spartanburg	Spartanburg	South Carolina
United States	Kaiser Permanente-Stockton	Stockton	California
United States	William Beaumont Hospital - Troy	Troy	Michigan
United States	Arizona Cancer Center at University Medical Center North	Tucson	Arizona
United States	University of Arizona Health Sciences Center	Tucson	Arizona
United States	Kaiser Permanente Medical Center-Vacaville	Vacaville	California
United States	Kaiser Permanente-Vallejo	Vallejo	California
United States	Kaiser Permanente-Walnut Creek	Walnut Creek	California
United States	Cancer Center of Kansas - Wellington	Wellington	Kansas
United States	Associates In Womens Health	Wichita	Kansas
United States	Cancer Center of Kansas - Main Office	Wichita	Kansas
United States	Cancer Center of Kansas-Wichita Medical Arts Tower	Wichita	Kansas
United States	Via Christi Regional Medical Center	Wichita	Kansas
United States	Wichita CCOP	Wichita	Kansas
United States	Cancer Center of Kansas - Winfield	Winfield	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attendance of = 2 Curves sessions/week for a minimum of 36 of the 52 weeks of intervention		1 year from registration
Primary	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	Changes in anthropometric measures (weight, BMI, waist circumference, hip circumference)		1 year from registration
Secondary	Changes in body composition (% body fat as assessed by DXA scan at 12 months only)		1 year from registration
Secondary	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
Secondary	Changes in dietary intake patterns based on three separate 24-hour diet recalls		1 year from registration
Secondary	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
Secondary	Changes in anxiety, depression, fatigue, sleep, satisfaction with social roles, pain, and physical function as measured by the PROMIS-43		1 year from registration
Secondary	DNA methylation patterns		3 years