S1008: Exercise, Diet, & Counseling in Improving Weight Loss in Overweight Female Breast or Colorectal Cancer Survivors
|ClinicalTrials.gov Identifier: NCT01453452|
Recruitment Status : Completed
First Posted : October 17, 2011
Last Update Posted : January 18, 2020
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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|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 :||March 2012|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||January 2017|
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.
- Attendance of ≥ 2 Curves sessions/week for a minimum of 36 of the 52 weeks of intervention [ Time Frame: 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 [ Time Frame: 1 year from registration ]
- Changes in anthropometric measures (weight, BMI, waist circumference, hip circumference) [ Time Frame: 1 year from registration ]
- Changes in body composition (% body fat as assessed by DXA scan at 12 months only) [ Time Frame: 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 [ Time Frame: 1 year from registration ]
- Changes in dietary intake patterns based on three separate 24-hour diet recalls [ Time Frame: 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) [ Time Frame: 3 years ]
- 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 ]
- DNA methylation patterns [ Time Frame: 3 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01453452
|Study Chair:||Heather Greenlee, PhD, ND||Herbert Irving Comprehensive Cancer Center|
|Study Chair:||Dawn Hershman, MD||Herbert Irving Comprehensive Cancer Center|