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

Sponsor

Southwest Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT01453452

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

58.1

Duration (Months)

0.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	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	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
Changes in anxiety, depression, fatigue, sleep, satisfaction with social roles, pain, and physical function as measured by the PROMIS-43 [1 year from registration]
DNA methylation patterns [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 120 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Arizona Cancer Center at University Medical Center North	Tucson	Arizona	United States	85719
2	University of Arizona Health Sciences Center	Tucson	Arizona	United States	85724
3	Kaiser Permanente-Deer Valley Medical Center	Antioch	California	United States	94531
4	Kaiser Permanente, Fremont	Fremont	California	United States	94538
5	Kaiser Permanente	Fresno	California	United States	93720
6	Kaiser Permanente, Hayward	Hayward	California	United States	94545
7	Kaiser Permanente-Modesto	Modesto	California	United States	95356
8	Kaiser Permanente-Oakland	Oakland	California	United States	94611
9	Kaiser Permanente-Redwood City	Redwood City	California	United States	94063
10	Kaiser Permanente-Richmond	Richmond	California	United States	94801
11	Kaiser Permanente-Roseville	Roseville	California	United States	95661
12	Kaiser Permanente-South Sacramento	Sacramento	California	United States	95823
13	Kaiser Permanente - Sacramento	Sacramento	California	United States	95825
14	Kaiser Permanente-San Francisco	San Francisco	California	United States	94115
15	Kaiser Permanente-Santa Teresa-San Jose	San Jose	California	United States	95119
16	Kaiser Permanente-San Rafael	San Rafael	California	United States	94903
17	Kaiser Permanente Medical Center - Santa Clara	Santa Clara	California	United States	95051
18	Kaiser Permanente-Santa Rosa	Santa Rosa	California	United States	95403
19	Kaiser Permanente-South San Francisco	South San Francisco	California	United States	94080
20	Kaiser Permanente-Stockton	Stockton	California	United States	95210
21	Kaiser Permanente Medical Center-Vacaville	Vacaville	California	United States	95688
22	Kaiser Permanente-Vallejo	Vallejo	California	United States	94589
23	Kaiser Permanente-Walnut Creek	Walnut Creek	California	United States	94596
24	Kaiser Permanente Moanalua Medical Center	Honolulu	Hawaii	United States	96819
25	Loyola University Medical Center	Maywood	Illinois	United States	60153
26	Cancer Center of Kansas - Chanute	Chanute	Kansas	United States	66720
27	Cancer Center of Kansas - Dodge City	Dodge City	Kansas	United States	67801
28	Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas	United States	66701
29	Cancer Center of Kansas-Independence	Independence	Kansas	United States	67301
30	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
31	Cancer Center of Kansas-Kingman	Kingman	Kansas	United States	67068
32	Lawrence Memorial Hospital	Lawrence	Kansas	United States	66044
33	Cancer Center of Kansas-Liberal	Liberal	Kansas	United States	67901
34	Cancer Center of Kansas - Newton	Newton	Kansas	United States	67114
35	Cancer Center of Kansas - Parsons	Parsons	Kansas	United States	67357
36	Cancer Center of Kansas - Pratt	Pratt	Kansas	United States	67124
37	Cancer Center of Kansas - Salina	Salina	Kansas	United States	67401
38	Cancer Center of Kansas - Wellington	Wellington	Kansas	United States	67152
39	Associates In Womens Health	Wichita	Kansas	United States	67208
40	Cancer Center of Kansas-Wichita Medical Arts Tower	Wichita	Kansas	United States	67208
41	Cancer Center of Kansas - Main Office	Wichita	Kansas	United States	67214
42	Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
43	Wichita CCOP	Wichita	Kansas	United States	67214
44	Cancer Center of Kansas - Winfield	Winfield	Kansas	United States	67156
45	William Beaumont Hospital	Royal Oak	Michigan	United States	48073
46	William Beaumont Hospital - Troy	Troy	Michigan	United States	48098
47	Columbia University Medical Center	New York	New York	United States	10032
48	Cancer Centers of the Carolinas - Faris	Greenville	South Carolina	United States	29605
49	Cancer Centers of the Carolinas - Grove Commons	Greenville	South Carolina	United States	29605
50	Greenville Memorial Hospital	Greenville	South Carolina	United States	29605
51	Greenville CCOP	Greenville	South Carolina	United States	29615
52	Cancer Centers of the Carolinas-Greer Medical Oncology	Greer	South Carolina	United States	29650
53	Cancer Centers of the Carolinas - Seneca	Seneca	South Carolina	United States	29672
54	Cancer Centers of the Carolinas - Spartanburg	Spartanburg	South Carolina	United States	29307
55	Southwest Oncology Group	San Antonio	Texas	United States	78245
56	Swedish Medical Center-Edmonds	Edmonds	Washington	United States	98026
57	Swedish Medical Center-First Hill	Seattle	Washington	United States	98122-4307
58	University of Washington Medical Center	Seattle	Washington	United States	98195

Sponsors and Collaborators

Southwest Oncology Group
National Cancer Institute (NCI)

Investigators

Study Chair: Heather Greenlee, PhD, ND, Herbert Irving Comprehensive Cancer Center
Study Chair: Dawn Hershman, MD, Herbert Irving Comprehensive Cancer Center