Clinical trial NCT01453452: S1008: Exercise, Diet, & Counseling in Improving Weight Loss in Overweight Female Breast or Colorectal Cancer Survivors
Official title: S1008: Feasibility Study of a Physical Activity and Dietary Change Weight Loss Intervention In Breast and Colorectal Cancer Survivors, Phase II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: SWOG Cancer Research Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-10-17
Enrollment: 50
Sex: FEMALE
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

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 ≥ 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

Primary outcomes:
measure: Attendance of ≥ 2 Curves sessions/week for a minimum of 36 of the 52 weeks of intervention
timeFrame: 1 year from registration
measure: 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
timeFrame: 1 year from registration
Secondary outcomes:
measure: Changes in anthropometric measures (weight, BMI, waist circumference, hip circumference)
timeFrame: 1 year from registration
measure: Changes in body composition (% body fat as assessed by DXA scan at 12 months only)
timeFrame: 1 year from registration
measure: 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
timeFrame: 1 year from registration
measure: Changes in dietary intake patterns based on three separate 24-hour diet recalls
timeFrame: 1 year from registration
measure: 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)
timeFrame: 3 years
measure: Changes in anxiety, depression, fatigue, sleep, satisfaction with social roles, pain, and physical function as measured by the PROMIS-43
timeFrame: 1 year from registration
measure: DNA methylation patterns
timeFrame: 3 years
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center at University Medical Center North
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Health Sciences Center
state: Arizona
city: Antioch
country: United States
facility: Kaiser Permanente-Deer Valley Medical Center
state: California
city: Fremont
country: United States
facility: Kaiser Permanente, Fremont
state: California
city: Fresno
country: United States
facility: Kaiser Permanente
state: California
city: Hayward
country: United States
facility: Kaiser Permanente, Hayward
state: California
city: Modesto
country: United States
facility: Kaiser Permanente-Modesto
state: California
city: Oakland
country: United States
facility: Kaiser Permanente-Oakland
state: California
city: Redwood City
country: United States
facility: Kaiser Permanente-Redwood City
state: California
city: Richmond
country: United States
facility: Kaiser Permanente-Richmond
state: California
city: Roseville
country: United States
facility: Kaiser Permanente-Roseville
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente-South Sacramento
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente - Sacramento
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente-San Francisco
state: California
city: San Jose
country: United States
facility: Kaiser Permanente-Santa Teresa-San Jose
state: California
city: San Rafael
country: United States
facility: Kaiser Permanente-San Rafael
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Medical Center - Santa Clara
state: California
city: Santa Rosa
country: United States
facility: Kaiser Permanente-Santa Rosa
state: California
city: South San Francisco
country: United States
facility: Kaiser Permanente-South San Francisco
state: California
city: Stockton
country: United States
facility: Kaiser Permanente-Stockton
state: California
city: Vacaville
country: United States
facility: Kaiser Permanente Medical Center-Vacaville
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente-Vallejo
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente-Walnut Creek
state: California
city: Honolulu
country: United States
facility: Kaiser Permanente Moanalua Medical Center
state: Hawaii
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Chanute
country: United States
facility: Cancer Center of Kansas - Chanute
state: Kansas
city: Dodge City
country: United States
facility: Cancer Center of Kansas - Dodge City
state: Kansas
city: Fort Scott
country: United States
facility: Cancer Center of Kansas - Fort Scott
state: Kansas
city: Independence
country: United States
facility: Cancer Center of Kansas-Independence
state: Kansas
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Kingman
country: United States
facility: Cancer Center of Kansas-Kingman
state: Kansas
city: Lawrence
country: United States
facility: Lawrence Memorial Hospital
state: Kansas
city: Liberal
country: United States
facility: Cancer Center of Kansas-Liberal
state: Kansas
city: Newton
country: United States
facility: Cancer Center of Kansas - Newton
state: Kansas
city: Parsons
country: United States
facility: Cancer Center of Kansas - Parsons
state: Kansas
city: Pratt
country: United States
facility: Cancer Center of Kansas - Pratt
state: Kansas
city: Salina
country: United States
facility: Cancer Center of Kansas - Salina
state: Kansas
city: Wellington
country: United States
facility: Cancer Center of Kansas - Wellington
state: Kansas
city: Wichita
country: United States
facility: Associates In Womens Health
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas-Wichita Medical Arts Tower
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas - Main Office
state: Kansas
city: Wichita
country: United States
facility: Via Christi Regional Medical Center
state: Kansas
city: Wichita
country: United States
facility: Wichita CCOP
state: Kansas
city: Winfield
country: United States
facility: Cancer Center of Kansas - Winfield
state: Kansas
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital - Troy
state: Michigan
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas - Faris
state: South Carolina
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas - Grove Commons
state: South Carolina
city: Greenville
country: United States
facility: Greenville Memorial Hospital
state: South Carolina
city: Greenville
country: United States
facility: Greenville CCOP
state: South Carolina
city: Greer
country: United States
facility: Cancer Centers of the Carolinas-Greer Medical Oncology
state: South Carolina
city: Seneca
country: United States
facility: Cancer Centers of the Carolinas - Seneca
state: South Carolina
city: Spartanburg
country: United States
facility: Cancer Centers of the Carolinas - Spartanburg
state: South Carolina
city: San Antonio
country: United States
facility: Southwest Oncology Group
state: Texas
city: Edmonds
country: United States
facility: Swedish Medical Center-Edmonds
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center-First Hill
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: Herbert Irving Comprehensive Cancer Center
name: Heather Greenlee, PhD, ND
role: STUDY_CHAIR
affiliation: Herbert Irving Comprehensive Cancer Center
name: Dawn Hershman, MD
role: STUDY_CHAIR
References:
citation: 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.