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

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• SWOG Cancer Research Network

  lead NETWORK

Principal Investigators

• Heather Greenlee, PhD, ND · Herbert Irving Comprehensive Cancer Center

• Dawn Hershman, MD · Herbert Irving Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

120 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-03-31

Primary Completion

2015-08-31

Completion

2017-01-31

Countries

• United States

Study Locations