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

Study Description

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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	Phase 2

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Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	50 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Other
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 :	March 2012
Actual Primary Completion Date :	August 2015
Actual Study Completion Date :	July 2017

Arms and Interventions

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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

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Primary Outcome Measures :

1. Attendance of ≥ 2 Curves sessions/week for a minimum of 36 of the 52 weeks of intervention [ Time Frame: 1 year from registration ]
2. 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 [ Time Frame: 1 year from registration ]

Secondary Outcome Measures :

1. Changes in anthropometric measures (weight, BMI, waist circumference, hip circumference) [ Time Frame: 1 year from registration ]
2. Changes in body composition (% body fat as assessed by DXA scan at 12 months only) [ Time Frame: 1 year from registration ]
3. 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 [ Time Frame: 1 year from registration ]
4. Changes in dietary intake patterns based on three separate 24-hour diet recalls [ Time Frame: 1 year from registration ]
5. 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) [ Time Frame: 3 years ]
6. Changes in anxiety, depression, fatigue, sleep, satisfaction with social roles, pain, and physical function as measured by the PROMIS-43 [ Time Frame: 1 year from registration ]
7. DNA methylation patterns [ Time Frame: 3 years ]

Eligibility Criteria

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Ages Eligible for Study:	up to 120 Years (Child, Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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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

More Information

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Responsible Party:	Southwest Oncology Group
ClinicalTrials.gov Identifier:	NCT01453452 History of Changes
Other Study ID Numbers:	S1008; S1008 ( Other Identifier: SWOG ); U10CA037429 ( U.S. NIH Grant/Contract ); NCI-2011-03539 ( Other Identifier: CTRP )
First Posted:	October 17, 2011
Last Update Posted:	December 8, 2017
Last Verified:	December 2017

Keywords provided by Southwest Oncology Group:

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

Additional relevant MeSH terms:

Breast Neoplasms; Depression; Body Weight; Colorectal Neoplasms; Weight Loss; Fatigue; Anxiety Disorders; Body Weight Changes; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases	Behavioral Symptoms; Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Mental Disorders