Breast Cancer, Breast Cancer Female, Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer
Conditions
Keywords
Breast Cancer, Stage III Breast Cancer, Stage II Breast Cancer, Stage I Breast Cancer, Exercise Intervention, Nutrition Intervention, Supportive Care
Brief summary
This research is being done to assess whether an exercise intervention with protein intake support vs a health education and support program will make it easier for women age 65 or older who are receiving chemotherapy for breast cancer to receive all of their planned chemotherapy according to schedule and at the planned dose.
Detailed description
The research study procedures include screening for eligibility. After participants are determined to be eligible and have signed consent, they will participate in a baseline visit to collect measurements (e.g., weight/height/waist measurements) and questionnaires, a memory test, functional movement and strength testing, and a physical activity assessment. After baseline measures are collected, participants will be randomized to either the THRIVE Exercise and Diet Intervention or the Heath Education and Support Program during chemotherapy. There is a follow up visit up to 4 weeks after the completion of chemotherapy to repeat measurements and questionnaires. The duration of the study will be 10-26 weeks, depending on the type of chemotherapy participants are receiving. The THRIVE Intervention will involve: * Exercise: Participants in the THRIVE Intervention arm work with an exercise coach to participate in both muscle strengthening exercises and aerobic exercises. There is one in-person exercise session at the beginning of the study. The remainder of the exercise sessions are done twice weekly via telehealth throughout chemotherapy treatment. * Protein intake support: Participants in the THRIVE Intervention will meet with a dietitian to make sure they are eating enough protein throughout their chemotherapy treatments. Participants will be asked to keep a daily protein checklist and share this with the exercise coach each week. The Health Education Support Program will involve: \- Health education tablet: Participants in the Health Education Support program will receive a tablet with information regarding mediation, stretching and gentle movement, relaxation and creative arts throughout chemotherapy.
Interventions
BEHAVIORALTHRIVE
The THRIVE Intervention will involve: 1\) one in-person exercise sessions, followed by twice-weekly, home-based exercise sessions, supervised remotely through telehealth, and 2) a remotely delivered dietary assessment and recommendations to support protein intake throughout the study
BEHAVIORALHealth Education Support Program
Participants will receive a tablet with information and resources regarding mediation, stretching and gentle movement, relaxation and creative arts during chemotherapy
Sponsors
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Case Western Reserve University
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women age \>=65 * Diagnosed with stage I-III invasive breast cancer * BMI between 18-50 kg/m2 * Scheduled to begin at least 10 weeks of neoadjuvant or adjuvant cytotoxic chemotherapy for curative intent * If enrolled in clinical chemotherapy drug trial, considered eligible if regimen includes an anthracycline or a taxane, unless the trial alters the chemotherapy agents/doses according to patient response (e.g.; I-SPY trials) * Self-reported ability to walk for 6 minutes and/or 2 blocks (with or without assistive device) * Ability to provide written informed consent. * Ability to understand, speak, and read English. This is because many of the study instruments used are not readily available in multiple languages. Additionally, site-based study staff, such as exercise physiologists, are not bilingual and not all sites have access to interpreters.
Exclusion criteria
* Following a therapeutic diet for co-morbid disease where the THRIVE-65 diet would be contraindicated as assessed by the RD * Engaging in 2 or more sessions of strength training exercise per week over a period of at least 3 consecutive months over the past year * Engaging in aerobic activity at a level that includes competitive events (e.g., marathon, triathlon, running races) over the past year * Presence of medical conditions or medications that would prohibit participation in an exercise program * Current use of weight-loss medication * Documented history of alcohol or substance abuse within the past 12 months * History of dementia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Received Dose Intensity (RDI) | Baseline to 26 weeks | Review of electronic medical records to discern chemotherapy dose received versus prescribed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported chemotoxicities | Baseline to 26 weeks | Participants will be asked to complete the PRO-CTCAE survey at each chemotherapy cycle. This well-validated survey includes symptoms and adverse events related to chemotherapy. The constructs we will measure include mouth/throat sores, nausea, constipation, diarrhea, neuropathy, concentration, memory, pain, insomnia, and fatigue. A level of 3 or higher will be the threshold for defining a chemotoxicity (yes/no). |
| Measure of hematologic chemotoxicity - Hematocrit | Baseline to 26 weeks | Review of medical record to abstract hematocrit values (% of red blood cells in blood). |
| Measure of hematologic chemotoxicity- White blood cell count | Baseline to 26 weeks | Review of medical record to abstract white blood cell count. |
| Measure of hematologic chemotoxicity - Platelet count | Baseline to 26 weeks | Review of medical record to abstract platelet count. |
| Measure of hematologic chemotoxicity - Neutrophil count | Baseline to 26 weeks | Review of medical record to abstract neutrophil count. |
| Accelerometry | Baseline to 26 weeks | Physical activity will be measured objectively using Actigraph accelerometry. Accelerometer data will include estimated average metabolic equivalents expended daily and in hours/week as well as time in sedentary, low, moderate and vigorous activity. |
| Morgenstern Physical Activity Questionnaire (PAQ-M) | Baseline to 26 weeks | Self-reported physical activity will be measured at baseline and end-of-study using the Morgenstern Physical Activity Questionnaire (PAQ-M), which has been used to reliably capture recreational, occupational and household activity in sedentary adults. |
| Diet | Baseline to 26 weeks | Dietary intake will be estimated using repeat administrations of the self-reported, validated Arizona Food Frequency Questionnaire. This questionnaire has been used extensively in large dietary intervention trials among cancer survivors. The instrument will be completed by patients during baseline and end of chemotherapy, reflecting on previous 4 weeks of usual dietary intake. |
| Strength | Baseline to 26 weeks | Participants will undergo 10 Repetition Submaximal Strength Testing at baseline and follow-up, collected by the site-based exercise trainer, using a standardized protocol. |
| MOS SF-36 Questionnaire | Baseline to 26 weeks | General health-related quality of life (including vitality) will be assessed at baseline and end-of-study using the well-validated MOS SF-36 survey. |
| Pittsburgh Sleep Quality Index (PSQI) | Baseline to 26 weeks | Sleep will be assessed at baseline and end-of-study using the PSQI, which is a widely used measure of subjective sleep disturbance; its validity and reliability have been established in various clinical populations, including patients with cancer. |
| Anthropometric measure - height | Baseline to 26 weeks | Measure of participant height in centimeters. |
| Anthropometric measure - weight | Baseline to 26 weeks | Measure of participant weight in centimeters. |
| Anthropometric measure - waist circumference | Baseline to 26 weeks | Measure of participant waist circumference in centimeters. |
Countries
United States
Contacts
CONTACTKathryn Schmitz, PhD, MPH
CONTACTJennifer Ligibel, MD
PRINCIPAL_INVESTIGATORKathryn Schmitz (contact), PhD, MPH
University of Pittsburgh
PRINCIPAL_INVESTIGATORJennifer Ligibel, MD
Dana-Farber Cancer Institute
Outcome results
None listed