Evaluating the Effectiveness of an Individualized Nutrition and Physical Activity Counseling Program

• ClinicalTrials.gov Identifier: NCT04365569
• Recruitment Status: Recruiting
• First Posted: April 28, 2020
• Last Update Posted: January 6, 2023
• Sponsor: Case Comprehensive Cancer Center
• Information provided by (Responsible Party): Case Comprehensive Cancer Center

Study Description

Brief Summary:

More than 65% of breast cancer survivors are overweight and less than one-third participate in recommended levels of physical exercise. Obese breast cancer survivors have been found to have greater than a two-fold increase in mortality compared to women with normal body mass index (BMI). The current standard for weight loss interventions involves in-person counseling. However, this incurs costs related to travel for counseling sessions, potentially limiting program participation, compliance and sustainability.This is a pilot study of an individualized in-person and telephone-based nutrition and exercise counseling program.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Behavioral: Nutrition and physical activity counseling program	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Evaluating the Effectiveness of an Individualized Nutrition and Physical Activity Counseling Program on Body Weight, Composition, Cardiovascular Function and Quality of Life in Breast Cancer Survivors
• Actual Study Start Date: January 6, 2021
• Estimated Primary Completion Date: June 2023
• Estimated Study Completion Date: December 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Individualized, nutrition and physical activity intervention; Initial in-person consult with a registered dietitian, with further in-person follow-ups and monthly telephone consults	Behavioral: Nutrition and physical activity counseling program; 6-month interventional, counseling program based on nutrition and physical activity consisting of: 1. Nutritional counseling by a Registered Dietitian (RD) 2) Implementation of an adequate physical activity program

Outcome Measures

Primary Outcome Measures :

1. Percent of participants achieving 10% weight loss [ Time Frame: At baseline ]
   Efficacy of intervention as assessed by percent of participants achieving 10% weight loss
2. Percent of participants achieving 10% weight loss [ Time Frame: At 3 months ]
   Efficacy of intervention as assessed by percent of participants achieving 10% weight loss
3. Percent of participants achieving 10% weight loss [ Time Frame: At 6 months ]
   Efficacy of intervention as assessed by percent of participants achieving 10% weight loss
4. Compliance to the recommended dietary pattern [ Time Frame: At 3 months ]
   Assess compliance to the recommended dietary pattern, diet quality scores will be calculated by the RD after monthly telephone consults or in-person at 3 months and 6 months into the intervention. Each of the 3 elements will be scored from 0-3, resulting in a total score range from 0-9
5. Compliance to physical activity goal [ Time Frame: At 6 months ]
   Percent of participants complying with proposed activity goal of 150 minutes of moderate intensity physical activity or 75 minutes of vigerous intensity physical activity (or a combination of both) per week over six months

Secondary Outcome Measures :

1. Body fat percentage [ Time Frame: Baseline ]
   Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis
2. Body fat percentage [ Time Frame: 3 months ]
   Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis
3. Body fat percentage [ Time Frame: 6 months ]
   Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis
4. Glycemic control as measured by HbA1c [ Time Frame: At 3 months ]
   Glycemic control as measured by HbA1c
5. Glycemic control as measured by HbA1c [ Time Frame: At 6 months ]
   Glycemic control as measured by HbA1c
6. Cholesterol [ Time Frame: At 3 months ]
   Effect of the intervention on lipid profile as measured by high density cholesterol levels
7. Cholesterol [ Time Frame: At 6 months ]
   Effect of the intervention on lipid profile as measured by high density cholesterol levels
8. Low density lipoprotein [ Time Frame: At 3 months ]
   Effect of the intervention on lipid profile as measured by low density lipoprotein levels
9. Low density lipoprotein [ Time Frame: At 6 months ]
   Effect of the intervention on lipid profile as measured by low density lipoprotein levels
10. high density lipoprotein [ Time Frame: At 3 months ]
    Effect of the intervention on lipid profile as measured by high density lipoprotein levels
11. high density lipoprotein [ Time Frame: At 6 months ]
    Effect of the intervention on lipid profile as measured by high density lipoprotein levels
12. Triglycerides [ Time Frame: At 3 months ]
    Effect of the intervention on lipid profile as measured by triglyceride levels
13. Triglycerides [ Time Frame: At 6 months ]
    Effect of the intervention on lipid profile as measured by triglyceride levels
14. Serum vitamin D [ Time Frame: At 3 months ]
    Effect of the intervention on serum vitamin D
15. Serum vitamin D [ Time Frame: At 6 months ]
    Effect of the intervention on serum vitamin D
16. Serum C-reactive protein (CRP) [ Time Frame: At 3 months ]
    Effect of the intervention on CRP
17. Serum C-reactive protein (CRP) [ Time Frame: At 6 months ]
    Effect of the intervention on CRP
18. Maximum oxygen uptake as measured by VO2 max [ Time Frame: Baseline ]
    Maximum oxygen uptake as measured by VO2 max
19. Maximum oxygen uptake as measured by VO2 max [ Time Frame: At 3 months ]
    Maximum oxygen uptake as measured by VO2 max
20. Maximum oxygen uptake as measured by VO2 max [ Time Frame: At 6 months ]
    Maximum oxygen uptake as measured by VO2 max

Other Outcome Measures:

1. Quality of life as measured by Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) [ Time Frame: Baseline, 3 months and 6 months ]
   Quality of life as measured by Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B), a 36-item self-report questionnaire to assess the quality of life as reported by breast cancer survivors with scores ranging from 0 to 123, and lower scores indicating better health.
2. Quality of life as measured by Brief Pain Inventory (BPI) [ Time Frame: Baseline, 3 months and 6 months ]
   Quality of life as measured by Brief Pain Inventory (BPI), a 9-item self-administered questionnaire that can evaluate the effect of an individual's pain on their daily functioning. This is a 10-point scale with 0 being the best possible score, meaning "no pain", and 10 being the worst possible score, meaning "pain as bad as you can imagine"
3. Quality of life as measured by Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: Baseline, 3 months and 6 months ]
   Quality of life as measured by Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report questionnaire measuring anxiety which uses a four-point rating scale (ranging from 0 to 3) asking how often in the last two weeks participants have experienced symptoms pertaining to feeling anxious, worried, difficulty relaxing, and irritability. Higher scores indicate higher distress. with a possible score range of 0 to 21 with higher scores indicating worse anxiety.
4. Quality of life as measured by Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline, 3 months and 6 months ]
   Quality of life as measured by Patient Health Questionnaire-9 (PHQ-9), which objectifies degree of depression severity with a possible score range of 0 to 27 and higher scores indicating worse outcomes
5. Quality of life as measured by NCCN Distress Thermometer [ Time Frame: Baseline, 3 months and 6 months ]
   Quality of life as measured by NCCN Distress Thermometer, which measures distress on a scale of 0 to 10, with higher scores indicating worse distress
6. Factors associated with adherence to the program [ Time Frame: At 6 months ]
   Factors to be assessed include age, race, time since diagnosis, time since last chemotherapy, medical comorbidities and other lifestyle factors such as alcohol consumption and smoking

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Breast cancer diagnosis (stage 0-III)
• Body mass index of 25mg/k2 or greater
• Actively being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Maroone Cancer Center
• Able and willing to participate in nutrition counseling at Maroone Cancer Center
• Able (cleared by participant's primary oncologist) and willing to perform cardiopulmonary exercise testing
• Participants must have the ability to understand and the willingness to sign a written informed consent document
• Performance status 0 or 1 as per ECOG scale [see Appendix IV]

Exclusion Criteria:

• Body mass index below 25kg/m2
• No prior history of breast cancer
• History of metastatic disease
• Not being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Maroone Cancer Center
• Unable or unwilling to participate in nutrition counseling at Maroone Cancer Center
• Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Participants actively undergoing chemotherapy, immunotherapy or radiation treatment. However, participants currently taking hormonal therapy, such as selective estrogen receptor modulators (SERMS), or aromatase inhibitors, may be included in the study.

Contacts and Locations

Contacts

Contact: Elizabeth Stone, MD; +1 954-659-5840; stonee@ccf.org

Locations

United States, Florida

Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center; Recruiting

Weston, Florida, United States, 33331

Contact: Elizabeth Stone, MD 954-659-5840 stonee@ccf.org

Principal Investigator: Elizabeth Stone, MD

Sponsors and Collaborators

Case Comprehensive Cancer Center

Investigators

• Principal Investigator: Elizabeth Stone, MD; Cleveland Clinic, Case Comprehensive Cancer Center

More Information

• Responsible Party: Case Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT04365569
• Other Study ID Numbers: CASE11119
• First Posted: April 28, 2020
• Last Update Posted: January 6, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Will share IPD with other researchers within the same institution, but not outside the institution
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases