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TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients (THRIVE-65)

Primary Purpose

Breast Cancer, Stage III Breast Cancer, Breast Cancer Female

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

THRIVE

Health Education Support Program

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer, Stage III Breast Cancer, Stage II Breast Cancer, Stage I Breast Cancer, Exercise Intervention, Nutrition Intervention, Supportive Care

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

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 anthracycline or taxane-based 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 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 within past 3 years
Engaging in 90 minutes or more of weekly aerobic activity of moderate intensity (e.g. brisk walking, aerobics/dance or bicycling) for at least 3 consecutive months within the past 3 years
Presence of medical conditions or medications that would prohibit participation in an exercise program
Current use of weight-loss medication
Self-report alcohol or substance abuse within the past 12 months, including at-risk drinking (defined as current consumption of >14 alcoholic drinks per week)
History of dementia

Sites / Locations

Dana Farber Cancer InstituteRecruiting
Case Western Reserve University/University Hospitals ClevelandRecruiting
University of PittsburghRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

HEALTH EDUCATION AND SUPPORT CONTROL GROUP

THRIVE: EXERCISE INTERVENTION WITH PROTEIN INTAKE SUPPORT

Arm Description

The research study procedures include screening for eligibility and a baseline visit to collect measurements and questionnaires. After the baseline appointment, participants randomized into the Heath Education Support Program will receive a tablet from the study that is pre-loaded with material to help support them during chemotherapy. The tablet materials will include supportive care and resources that focus on movement (light stretching and gentle yoga), soothing music, meditation/mindfulness, and recipes/cooking demos. Participants in this arm will be asked to fill out questionnaires at the start of each chemotherapy cycle to indicate any side effects from chemotherapy and the amount of time they spend engaging with the tablet. At the end of participants' chemotherapy, they will be asked to complete end-of-study measures.

The research study procedures include screening for eligibility and a baseline visit to collect measurements and questionnaires. After the baseline appointment, participants randomized into the THRIVE Exercise and Diet Intervention will work with a coach to gradually build exercise and stay active during chemotherapy treatment. Participants will work with an exercise coach to reach the muscle strengthening and aerobic exercise goals of the study. Participants will also consult with a dietician to ensure adequate protein intake during the study. Participants in this arm will be asked to fill out questionnaires at the start of each chemotherapy cycle to indicate any side effects from chemotherapy. At the end of participants' chemotherapy, they will be asked to complete end-of-study measures.

Outcomes

Primary Outcome Measures

Received Dose Intensity (RDI)

Review of electronic medical records to discern chemotherapy dose received versus prescribed.

Secondary Outcome Measures

Patient-reported chemotoxicities

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

Review of medical record to abstract hematocrit values (% of red blood cells in blood).

Measure of hematologic chemotoxicity- White blood cell count

Review of medical record to abstract white blood cell count.

Measure of hematologic chemotoxicity - Platelet count

Review of medical record to abstract platelet count.

Measure of hematologic chemotoxicity - Neutrophil count

Review of medical record to abstract neutrophil count.

Accelerometry

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)

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

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

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

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)

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

Measure of participant height in centimeters.

Anthropometric measure - weight

Measure of participant weight in centimeters.

Anthropometric measure - waist circumference

Measure of participant waist circumference in centimeters.

Full Information

NCT ID

NCT05535192

First Posted

August 29, 2022

Last Updated

March 27, 2023

Sponsor

Dana-Farber Cancer Institute

Collaborators

National Cancer Institute (NCI), Case Western Reserve University, University of Pittsburgh

1. Study Identification

Unique Protocol Identification Number

NCT05535192

Brief Title

TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients

Acronym

THRIVE-65

Official Title

TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients (THRIVE-65)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 20, 2023 (Actual)

Primary Completion Date

September 30, 2026 (Anticipated)

Study Completion Date

February 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

Collaborators

National Cancer Institute (NCI), Case Western Reserve University, University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 2-4 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 are two in-person exercise sessions at the beginning of the study. The remainder of the exercise sessions are done 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Stage III Breast Cancer, Breast Cancer Female, Stage I Breast Cancer, Stage II Breast Cancer

Keywords

Breast Cancer, Stage III Breast Cancer, Stage II Breast Cancer, Stage I Breast Cancer, Exercise Intervention, Nutrition Intervention, Supportive Care

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HEALTH EDUCATION AND SUPPORT CONTROL GROUP

Arm Type

Active Comparator

Arm Description

Arm Title

THRIVE: EXERCISE INTERVENTION WITH PROTEIN INTAKE SUPPORT

Arm Type

Experimental

Arm Description

The research study procedures include screening for eligibility and a baseline visit to collect measurements and questionnaires. After the baseline appointment, participants randomized into the THRIVE Exercise and Diet Intervention will work with a coach to gradually build exercise and stay active during chemotherapy treatment. Participants will work with an exercise coach to reach the muscle strengthening and aerobic exercise goals of the study. Participants will also consult with a dietician to ensure adequate protein intake during the study. Participants in this arm will be asked to fill out questionnaires at the start of each chemotherapy cycle to indicate any side effects from chemotherapy. At the end of participants' chemotherapy, they will be asked to complete end-of-study measures.

Intervention Type

Behavioral

Intervention Name(s)

THRIVE

Intervention Description

The THRIVE Intervention will involve: 1) two 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

Intervention Type

Behavioral

Intervention Name(s)

Health Education Support Program

Intervention Description

Participants will receive a tablet with information and resources regarding mediation, stretching and gentle movement, relaxation and creative arts during chemotherapy

Primary Outcome Measure Information:

Title

Received Dose Intensity (RDI)

Description

Review of electronic medical records to discern chemotherapy dose received versus prescribed.

Time Frame

Baseline to 26 weeks

Secondary Outcome Measure Information:

Title

Patient-reported chemotoxicities

Description

Time Frame

Baseline to 26 weeks

Title

Measure of hematologic chemotoxicity - Hematocrit

Description

Review of medical record to abstract hematocrit values (% of red blood cells in blood).

Time Frame

Baseline to 26 weeks

Title

Measure of hematologic chemotoxicity- White blood cell count

Description

Review of medical record to abstract white blood cell count.

Time Frame

Baseline to 26 weeks

Title

Measure of hematologic chemotoxicity - Platelet count

Description

Review of medical record to abstract platelet count.

Time Frame

Baseline to 26 weeks

Title

Measure of hematologic chemotoxicity - Neutrophil count

Description

Review of medical record to abstract neutrophil count.

Time Frame

Baseline to 26 weeks

Title

Accelerometry

Description

Time Frame

Baseline to 26 weeks

Title

Morgenstern Physical Activity Questionnaire (PAQ-M)

Description

Time Frame

Baseline to 26 weeks

Title

Diet

Description

Time Frame

Baseline to 26 weeks

Title

Strength

Description

Participants will undergo 10 Repetition Submaximal Strength Testing at baseline and follow-up, collected by the site-based exercise trainer, using a standardized protocol.

Time Frame

Baseline to 26 weeks

Title

MOS SF-36 Questionnaire

Description

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.

Time Frame

Baseline to 26 weeks

Title

Pittsburgh Sleep Quality Index (PSQI)

Description

Time Frame

Baseline to 26 weeks

Title

Anthropometric measure - height

Description

Measure of participant height in centimeters.

Time Frame

Baseline to 26 weeks

Title

Anthropometric measure - weight

Description

Measure of participant weight in centimeters.

Time Frame

Baseline to 26 weeks

Title

Anthropometric measure - waist circumference

Description

Measure of participant waist circumference in centimeters.

Time Frame

Baseline to 26 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 anthracycline or taxane-based 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 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 within past 3 years Engaging in 90 minutes or more of weekly aerobic activity of moderate intensity (e.g. brisk walking, aerobics/dance or bicycling) for at least 3 consecutive months within the past 3 years Presence of medical conditions or medications that would prohibit participation in an exercise program Current use of weight-loss medication Self-report alcohol or substance abuse within the past 12 months, including at-risk drinking (defined as current consumption of >14 alcoholic drinks per week) History of dementia

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kathryn Schmitz, PhD, MPH

Phone

412-623-6216

schmitzk@upmc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Jennifer Ligibel, MD

Phone

617-632-3800

jennifer_ligibel@dfci.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathryn Schmitz (contact), PhD, MPH

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jennifer Ligibel, MD

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Nathan Berger, MD

Organizational Affiliation

Case Western Reserve University/University Hospitals Cleveland

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jennifer Ligibel, MD

Phone

617-632-3800

Jennifer_Ligibel@dfci.harvard.edu

First Name & Middle Initial & Last Name & Degree

Jennifer Ligibel, MD

Facility Name

Case Western Reserve University/University Hospitals Cleveland

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nathan Berger, MD

nab@case.edu

First Name & Middle Initial & Last Name & Degree

Cynthia Owusu, MD

cxo34@case.edu

Facility Name

University of Pittsburgh

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kathryn Schmitz, PhD, MPH

Phone

412-623-6216

schmitzk@upmc.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Learn more about this trial

TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients

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