Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2U54CA156732-11 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| University of Massachusetts, Boston | OTHER |
Not provided
Not provided
Not provided
Not provided
The purpose of this research is to determine whether a 16 week, home-based, aerobic and resistance exercise intervention will increase physical activity levels in Black and Hispanic breast, colorectal, or prostate cancer patients.
The names of the study interventions involved in this study are:
This is a randomized control trial of Black and Hispanic patients who have been newly diagnosed with breast, colorectal, or prostate cancer and are being prescribed chemotherapy to determine the effects of home-based exercise on levels of physical activity. It will also evaluate the impact of home-based exercise on cardiovascular (heart health) risk factors.
The research study procedures include: screening for eligibility and study treatment including evaluations of body composition, blood tests, fitness and strength assessments, and surveys at study entry and follow-up visits.
Participants in this study will be randomly assigned to one of three groups: 1) Supervised aerobic and resistance exercise (SUP), 2) Unsupervised aerobic and resistance exercise (UNSUP), or 3) Attention control (AC).
Participation is expected to last for 8 months.
It is expected that about 135 people will take part in this research study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supervised aerobic and resistance exercise (SUP) | Experimental | Participants will be randomly assigned to receive 3x weekly at home, virtually supervised aerobic and resistance exercise sessions with a certified exercise trainer for 16 weeks. Participants will also have a baseline test, mid intervention cardiovascular and strength tests and one postintervention and one follow up visit. |
|
| Unsupervised aerobic and resistance exercise (UNSUP) | Experimental | Participants will be randomly assigned to receive 3x weekly at home, unsupervised aerobic and resistance exercise sessions with a 1x weekly telehealth call with a certified exercise trainer for 16 weeks. Participants will also have a baseline test, mid intervention cardiovascular and strength tests and one postintervention and one follow up visit. |
|
| Attention Control (AC) | Active Comparator | Participants will be randomly assigned to receive 3x weekly at home stretching exercise for 16 weeks. Participants will also have a baseline test, mid intervention cardiovascular and strength tests and one postintervention and one follow up visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supervised Home-Based Exercise | Behavioral | Online supervised aerobic and resistance exercise |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Activity Participation | Changes from baseline in physical activity participation measured by Godin Leisure-Time Exercise Questionnaire. | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers for Cardiovascular and Metabolic Health - insulin | Fasting blood will be drawn from the antecubital vein by a trained phlebotomist. Insulin will be measured. | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up |
| Blood Pressure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christina Dieli-Conwright, PhD, MPH | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Dana Farber Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39351353 | Derived | Yan H, Gonzalo-Encabo P, Wilson RL, Christopher CN, Cannon JD, Kang DW, Gardiner J, Perez M, Norris MK, Gundersen D, Hayman LL, Freedman RA, Rebbeck TR, Shi L, Dieli-Conwright CM. Testing home-based exercise strategies in underserved minority cancer patients undergoing chemotherapy (THRIVE) trial: a study protocol. Front Oncol. 2024 Sep 16;14:1427046. doi: 10.3389/fonc.2024.1427046. eCollection 2024. |
Not provided
Not provided
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: [contact information for 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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Unsupervised Home-Based Exercise | Behavioral | Unsupervised aerobic and resistance exercise (UNSUP) |
|
| Attention Control | Behavioral | Stretching Program |
|
Blood pressure will be assessed using an automated blood pressure cuff to measure both systolic and diastolic blood pressure. |
| Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up |
| Body Composition | Body composition (lean mass and fat mass) will be assessed via bioelectrical impedance using a validated scale. | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up |
| Cardiopulmonary Fitness | Cardiopulmonary fitness will be measured by a submaximal graded exercise cycling test. | Evaluated at week 1 for baseline, week 9 for mid-point, week 16 for post-intervention assessment, and week 32 for follow-up |
| Physical Fitness | Physical Fitness will be measured by the short physical performance battery (SPPB). | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up |
| Cardiorespiratory Fitness | Cardiorespiratory fitness will be assessed by the 6-minute walk test. | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up |
| Muscular Strength | Muscular strength will be assessed with a 10 repetition maximum test. | Evaluated at week 1 for baseline, week 9 for mid-point, week 16 for post-intervention assessment, and week 32 for follow-up |
| Patient Reported Outcomes - Quality of Life | Quality of life will be assessed by EORTC QLQ C-30. | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up |
| Patient Reported Outcomes - Health-related domains | Health-related domains of patient reported outcomes will be assessed by PROMIS-29 Profile v2.1. | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up |
| Patient Reported Outcomes - Sleep | Quality of life will be assessed by the Pittsburg Sleep Quality Index (PSQI). | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up |
| Patient Reported Outcomes - Symptoms | Symptomatic toxicities will be assessed by PRO-CTCAE. | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up |
| Dietary Assessment | Dietary recall will be used to assess recent dietary patterns for two weekdays and one weekend day using NutriBase 11. | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up |
| Acceptability of Intervention Questionnaire Ratings | Intervention acceptability and feasibility will be assessed via Acceptability of Intervention and Feasibility of Intervention questionnaires. Items are measured on a 5-point Likert scale (completely disagree to completely agree). Score is calculated mean. An average rating of 4 or higher will be considered feasible/acceptable. | Evaluated at months 2 and 4 |
| Feasibility of Intervention Questionnaire Ratings | Intervention acceptability and feasibility will be assessed via Acceptability of Intervention and Feasibility of Intervention questionnaires. Items are measured on a 5-point Likert scale (completely disagree to completely agree). Score is calculated mean. An average rating of 4 or higher will be considered feasible/acceptable. | Evaluated at months 2 and 4 |
| Augmentation Index | Augmentation index (a marker for arterial stiffness) will also be assessed using Mobil-O-Graph device. | Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up |
| Biomarkers for Cardiovascular and Metabolic Health - glucose | Fasting blood will be drawn from the antecubital vein by a trained phlebotomist. Glucose will be measured. | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up |
| Biomarkers for Cardiovascular and Metabolic Health - HbA1c | Fasting blood will be drawn from the antecubital vein by a trained phlebotomist. HbA1c will be measured. | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up. |
| Biomarkers for Cardiovascular and Metabolic Health - c-peptide | Fasting blood will be drawn from the antecubital vein by a trained phlebotomist. C-peptide (biomarkers of glycemic control and insulin resistance) will be measured. | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up. |
| Biomarkers for Cardiovascular and Metabolic Health - c-reactive protein | Fasting blood will be drawn from the antecubital vein by a trained phlebotomist. C-reactive protein (CRP; biomarker of system inflammation) will be measured. | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up. |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided