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

Phase 2
Open (Enrolling)
Anxiety Disorder, Breast Cancer, Cognitive/Functional Effects, Colorectal Cancer, Depression, Fatigue, Pain, Psychosocial Effects of Cancer and Its Treatment, Weight Changes

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Trial Information

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



- 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.


- 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

- 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

- 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.

Inclusion Criteria


- 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

- 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


- 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 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


- Participants must be 90 days to 730 days post-surgery, chemotherapy, and radiation

- 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

- Persistent complications may include, but are not limited to,
prolonged wound healing, hernias, or ostomy prolapse

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

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

Outcome Time Frame:

1 year from registration

Safety Issue:


Principal Investigator

Heather Greenlee, PhD, ND

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

March 2012

Completion Date:

April 2016

Related Keywords:

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



Columbia UniversityNew York, New York  10032-3784