Combined Modality Exercise and Appetite in Breast Cancer Survivors (CARE)

Feasibility, Acceptability, and Effects of Combined Aerobic and Resistance Exercise in Breast Cancer Survivors: A Pilot Study (the CARE Study)

The overall aim of this research is to assess the feasibility of a 12-week combined aerobic exercise (AEx) and resistance exercise (REx) intervention and elucidate the impact of AEx/REx on several physiological and behavioral components of energy balance among breast cancer survivors (BCS).

Study Overview

• Status: Terminated
• Conditions: Overweight and Obesity; Breast Cancer Female
• Intervention / Treatment: Behavioral: Combined aerobic and resistance exercise

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Univeristy of Colorado Anschutz Medical Campus
    • Denver, Colorado, United States, 80238
      • University of Colorado Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female sex
• Age: 18 - 45 years
• Body mass index [BMI]: 25 - 35 kg/m2
• Pre-menopausal before cancer diagnosis and treatment
• <1 hour/week of planned physical activity by self-report in the previous 12 months
• Diagnosis of primary stage I - III estrogen receptor/progesterone receptor-positive (ER/PR+) breast cancer, according to institutional standards.
• All chemotherapy, radiation, and surgery completed at least two weeks (14 days), but less than 6 months prior to registration

Exclusion Criteria:

• Self-reported diabetes mellitus, untreated/uncontrolled thyroid disease, history of cardiovascular disease or symptoms suggestive of cardiovascular disease (chest pain, shortness of breath at rest or with mild exertion, syncope), cancer diagnosis in the last 5 years before breast cancer (any site, excluding skin cancer), or any other medical condition affecting weight or energy metabolism.
• Uncontrolled hypertension defined as: systolic blood pressure >160 mmHg or diastolic blood pressure >100mmHg, as measured during the screening visit. Participants who are deemed ineligible based upon uncontrolled hypertension criteria will be referred to their primary care physicians for treatment. If this condition becomes controlled they will be allowed to be re-evaluated for inclusion in the current trial.
• Unable to exercise due to cardiac, pulmonary, neurological, orthopedic reasons.
• Currently smoking and/or nicotine use.
• Treatment with medications known to significantly affect appetite, weight, energy intake or expenditure in the last 3 months (e.g. appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants).
• Corticosteroid use within the last two weeks
• History of surgical procedure for weight loss at any time (e.g. gastroplasty, gastric bypass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve); history of extensive bowel resection for other reasons
• Currently pregnant, lactating or less than 6 months post-partum.
• Score of ≥ 2 on the CAGE (cut-annoyed-guilty-eye opener) questionnaire adapted to include drug use55
• Score of > 20 on the Eating Attitude Test - 26 (EATS-26), indicative of disordered eating. Participants with a score >20 on the EATS-26 will be referred to their primary care physician for further evaluation.
• Significant food intolerances/allergies that cannot be accommodated by the University of Colorado Hospital Clinical Translational Research Center Metabolic Kitchen.
• Currently participating in any formal weight loss or physical activity programs or clinical trials for weight loss.
• Other medical, psychiatric, or behavioral limitations that may interfere with participation (as determined by study physician).
• Unable or unwilling to undergo study procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Combined aerobic and resistance exercise; 12 weeks of supervised resistance exercise and unsupervised aerobic exercise.

Behavioral: Combined aerobic and resistance exercise; The 12-week intervention will build upon an ongoing resistance exercise program for cancer patients and survivors at the University of Colorado's Anschutz Health and Wellness Center. Resistance exercise will be led by certified cancer exercise specialists who provide individualized exercise programs to cancer patients and survivors. Exercise sessions are progressive, target all major muscle groups, are 50 minutes in duration, and completed 2x/week. The intervention will also include 3 self-directed moderate-intensity aerobic exercise sessions/week, building to 50 minutes at 60% heart rate maximum (determined at baseline). Target exercise will be achieved by a gradual progression of exercise duration over the first four weeks of the program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment and enrollment feasibility	Number of individuals approached, meeting inclusion criteria, reasons for exclusion, and enrolled in the study	Through study completion, up to two years
Subjective exercise adherence	Participants will be asked to rate on a 1-10 Likert scale: 1) how adherent they were to the prescribed exercise over the past week, 2) how difficult it was to adhere to the prescribed exercise over the past week, and 3) how likely they feel they can adhere to the prescribed exercise for the next month.	Changes across weeks 4, 8, and 12
Exercise self efficacy	Self Efficacy for Exercise Scale; 9 items; score range: 0-9, with higher scores indicating higher exercise self-efficacy	Changes across weeks 4, 8, and 12
Exercise enjoyment	Physical Activity Enjoyment Scale; 8 items; range: 7-56, with higher scores indicating higher exercise enjoyment	Changes across weeks 4, 8, and 12
Intervention acceptability	Subjective ability to adhere to combined AEx/REx	12 weeks
Intervention acceptability	Barriers to completing AEx/REx	12 weeks
Intervention acceptability	Open-ended opinions on the structure and content of the exercise training sessions	12 weeks
Intervention acceptability	Changes in subjective physical function, cancer-specific side effects, and overall well-being directly related to the exercise intervention	12 weeks
Objective exercise adherence	Adherence to additional study-specific AEx will be tracked through heart rate monitor data, logs of attendance, and participant diaries and compared to the REx-only intervention	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in ghrelin	Fasting ghrelin, ghrelin area under the curve in response to a control meal	Baseline, 12 weeks
Changes in peptide-YY (PYY)	Fasting PYY, PYY area under the curve in response to a control meal	Baseline, 12 weeks
Changes in subjective appetite ratings	Changes in hunger, satiety, and prospective food consumption via visual analog scales	Baseline, 12 weeks
Changes in ad libitum energy intake	Energy intake from buffet-style meal	Baseline, 12 weeks
Changes in physical activity	Step count measured by accelerometers	Baseline, 12 weeks
Changes in sedentary behavior	Time in sedentary activities measured by accelerometers	Baseline, 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in resting energy expenditure	Resting energy expenditure measured by metabolic cart and adjusted for body composition changes	Baseline, 12 weeks
Changes in body composition	Fat mass and fat-free mass in kg, measured by dual X-ray absorptiometry	Baseline, 12 weeks
Changes in fatigue	Measured by the Functional Assessment of Chronic Illness and Therapy - Fatigue; 13 questions; score range: 0-52, with higher score indicating higher fatigue	Baseline, 12 weeks

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Cancer Institute (NCI); Colorado Clinical & Translational Sciences Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2020
• Primary Completion (Actual): September 20, 2021
• Study Completion (Actual): September 20, 2021

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 6, 2020

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Body Weight; Breast Neoplasms; Overweight
• Other Study ID Numbers: 19-3032.cc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No