S1008: Exercise, Diet, & Counseling in Improving Weight Loss in Overweight Female Breast or Colorectal Cancer Survivors
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|