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Completed

NCT Number: NCT04365569

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center

Weston, Florida, 33331, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutrition and physical activity counseling program

Behavioral

6-month interventional, counseling program based on nutrition and physical activity consisting of:

  • Nutritional counseling by a Registered Dietitian (RD) 2) Implementation of an adequate physical activity program

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 28, 2020
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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