Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the feasibility and outcomes of a research pre- and peri-transplant optimization program (R-PPOP) to improve multiple domains of health including physical function, cognitive function, mental health, and diet and nutrition for patients planning to undergo or undergoing hematopoietic stem cell transplantation (HCT).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient | Experimental | These are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker. |
|
| Caregiver | Experimental | These are the assigned caregivers for transplant patients. Caregivers will undergo psychiatric consult, nutrition/diet evaluation and referral to social worker. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interval training | Behavioral | Patients will be asked to complete up to 3 x 30-minute structured high intensity interval training aerobic exercise sessions/week. For the first session, patients will come to the Duke Center for Living for in person evaluation and training. After the initial training session in person, a subsequent training session will take place at the patient's home via iPad/iPhone videoconference using a device provided to the patient to provide additional support and the opportunity to answer questions. Subsequent sessions will be done independently by patients, but study staff will be available via iPad/iPhone if questions arise. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Completed at Least Half of Their High Intensity Interval Training Sessions | Participants were asked to record or report their exercise sessions. | 6 months |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Measuring Changes in the Skin Flora (Microbiome) in Caregivers | baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365 | |
| Changes in Fecal Samples as Measured by 16s rRNA Sequencing in Caregivers | baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365 |
Patient Inclusion Criteria:
Patient Exclusion Criteria:
Caregiver inclusion criteria
Caregiver exclusion criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anthony Sung, MD | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Adult Bone Marrow Transplant Clinic | Durham | North Carolina | 27705 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
29 subjects (16 patients and 13 caregivers) signed the consent form for this study. 5 subjects (3 patients and 2 caregivers) did not begin the study after signing the consent form. 24 subjects began study activity after signing the consent form.
Participants were recruited from the Duke Adult Bone Marrow Transplant program between May 2019 and November 2021. The first subject was consented on May 6, 2019 and the last subject was consented on November 2, 2021.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Patient | These are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker. Interval training: Patients will be asked to complete up to 3 x 30-minute structured high intensity interval training aerobic exercise sessions/week. For the first session, patients will come to the Duke Center for Living for in person evaluation and training. After the initial training session in person, a subsequent training session will take place at the patient's home via iPad/iPhone videoconference using a device provided to the patient to provide additional support and the opportunity to answer questions. Subsequent sessions will be done independently by patients, but study staff will be available via iPad/iPhone if questions arise. Psychiatric consult: Subjects who score below threshold on the PHQ2/PHQ9, PC-PTSD/PCL-5, PROMIS-Depression and/or PROMIS-Anxiety assessments will be referred to a psychiatrist for follow up. Nutrition/diet evaluation: PG-SGA, ASA24, food group tracking Assessments and Vit D, Vit A, albumin, prealbumin, lipids, A1c levels will be used to provide weekly feedback for one month Referral to Social Worker: Subjects who score below threshold on the PROMIS-Emotional Support and/or PROMIS-Social Isolation assessments will be referred to a social worker for follow up |
| FG001 | Caregiver | These are the assigned caregivers for transplant patients. Caregivers will undergo psychiatric consult, nutrition/diet evaluation and referral to social worker. Psychiatric consult: Subjects who score below threshold on the PHQ2/PHQ9, PC-PTSD/PCL-5, PROMIS-Depression and/or PROMIS-Anxiety assessments will be referred to a psychiatrist for follow up. Nutrition/diet evaluation: PG-SGA, ASA24, food group tracking Assessments and Vit D, Vit A, albumin, prealbumin, lipids, A1c levels will be used to provide weekly feedback for one month Referral to Social Worker: Subjects who score below threshold on the PROMIS-Emotional Support and/or PROMIS-Social Isolation assessments will be referred to a social worker for follow up |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Patient | These are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker. Interval training: Patients will be asked to complete up to 3 x 30-minute structured high intensity interval training aerobic exercise sessions/week. For the first session, patients will come to the Duke Center for Living for in person evaluation and training. After the initial training session in person, a subsequent training session will take place at the patient's home via iPad/iPhone videoconference using a device provided to the patient to provide additional support and the opportunity to answer questions. Subsequent sessions will be done independently by patients, but study staff will be available via iPad/iPhone if questions arise. Psychiatric consult: Subjects who score below threshold on the PHQ2/PHQ9, PC-PTSD/PCL-5, PROMIS-Depression and/or PROMIS-Anxiety assessments will be referred to a psychiatrist for follow up. Nutrition/diet evaluation: PG-SGA, ASA24, food group tracking Assessments and Vit D, Vit A, albumin, prealbumin, lipids, A1c levels will be used to provide weekly feedback for one month Referral to Social Worker: Subjects who score below threshold on the PROMIS-Emotional Support and/or PROMIS-Social Isolation assessments will be referred to a social worker for follow up |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Completed at Least Half of Their High Intensity Interval Training Sessions | Participants were asked to record or report their exercise sessions. | 13 patients were prescribed the HIIT intervention, but only 9 consistently recorded sessions throughout the duration of the study. | Posted | Count of Participants | Participants | 6 months |
|
Adverse event data was collected for participants from enrollment through 1 year post-transplant
Adverse events are self-reported by study participants. The patients on this study are undergoing allogeneic stem cell transplantation, which is a procedure that is associated with high rates of adverse outcomes and morbidity. As such, we only record adverse events that are directly reported to us by the study participant or that are directly related to the study activity (i.e. falls during 6 minute walk test, emotional distress from answering study questionnaires, etc.)
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patient | These are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker. Interval training: Patients will be asked to complete up to 3 x 30-minute structured high intensity interval training aerobic exercise sessions/week. For the first session, patients will come to the Duke Center for Living for in person evaluation and training. After the initial training session in person, a subsequent training session will take place at the patient's home via iPad/iPhone videoconference using a device provided to the patient to provide additional support and the opportunity to answer questions. Subsequent sessions will be done independently by patients, but study staff will be available via iPad/iPhone if questions arise. Psychiatric consult: Subjects who score below threshold on the PHQ2/PHQ9, PC-PTSD/PCL-5, PROMIS-Depression and/or PROMIS-Anxiety assessments will be referred to a psychiatrist for follow up. Nutrition/diet evaluation: PG-SGA, ASA24, food group tracking Assessments and Vit D, Vit A, albumin, prealbumin, lipids, A1c levels will be used to provide weekly feedback for one month Referral to Social Worker: Subjects who score below threshold on the PROMIS-Emotional Support and/or PROMIS-Social Isolation assessments will be referred to a social worker for follow up |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrhythmia | Cardiac disorders | Non-systematic Assessment | Atrial Fibrillation |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anthony Sung | Duke University Medical Center | 919-668-1000 | anthony.sung@duke.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2022 | Mar 28, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Psychiatric consult | Behavioral | Subjects who score below threshold on the PHQ2/PHQ9, PC-PTSD/PCL-5, PROMIS-Depression and/or PROMIS-Anxiety assessments will be referred to a psychiatrist for follow up. |
|
| Nutrition/diet evaluation | Behavioral | PG-SGA, ASA24, food group tracking Assessments and Vit D, Vit A, albumin, prealbumin, lipids, A1c levels will be used to provide weekly feedback for one month |
|
| Referral to Social Worker | Behavioral | Subjects who score below threshold on the PROMIS-Emotional Support and/or PROMIS-Social Isolation assessments will be referred to a social worker for follow up |
|
| Caregiver Quality of Life as Assessed by the Caregiver Strain Questionnaire | Scored as 0 (No, least severe), 1 (Yes, sometimes) and 2 (Yes, on a regular basis, most severe) | 1 year |
| Quality of Life as Assessed by the FACT-BMT Questionnaire | Scored from 0 (least severe) to 4 (most severe) | 1 year |
| Delirium as Measured by the DOS Assessment | 1 year |
| Assessing Falls | Participants will answer Yes/No to whether they have had any falls in the preceding 6 months | 1 year |
| Return to Work as Assessed by the Work Assessment | 1 year |
| Transplant Length of Stay | 1 year |
| Graft Versus Host Disease (GVHD) | 1 year |
| Intensive Care Unit Length of Stay | 1 year |
| Hospital Length of Stay | 1 year |
| Rate of Intensive Care Unit Admission/Re-admission | 1 year |
| Rate of Hospital Admission/Re-admission | 1 year |
| Rate of Overall Infections | 1 year |
| Rate of Fungal Infections | 1 year |
| Rate of Viral Infections | 1 year |
| Rate of Bacterial Infections | 1 year |
| Disease-free Survival | 1 year |
| Overall Survival | 1 year |
| Changes in Fecal Samples as Measured by 16s rRNA Sequencing in Transplant Patients | baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365, 730 |
| Measuring Biomarkers of Inflammation/Frailty in Blood Plasma Samples | Biomarker panel to be analyzed: CRP, Eotaxin, Eotaxin-3, FGF (basic), Flt-1/VEGFR-1, GM-CSF, ICAM-1, IFN-γ, IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IL-17A/F, IL-17B, IL-17C, IL-17D, IL-1RA, IL-1α, IL-1β, IL-2, IL-21, IL-22, IL-23, IL-27, IL-3, IL-31, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-9, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, MIP-3α, PlGF, SAA, TARC, Tie-2, TNF-α, TNF-β, TSLP, VCAM-1, VEGF-A, VEGF-C, VEGF-D | 1 year |
| Measuring Changes in the Skin Flora (Microbiome) in Transplant Patients | baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365 |
| Caregiver Support as Assessed by the Caregiver Strain Index Questionnaire | Assessment is scored as 0 (never/least severe), 1 (sometimes), 2 (on a regular basis/most severe) | 1 year |
| Social Support as Assessed by the PROMIS Social Isolation Questionnaire | Assessment is scored from 1 (least severe) to 5 (most severe) | 1 year |
| Diet as Assessed by the Food Group Tracking Digital Application | 30 days |
| Diet as Assessed by the TRU-BMT Digital Application | 30 days |
| Nutrition as Assessed by the 24 Hour Food Recall Survey | 30 days |
| Mental Health as Assessed by PROMIS Depression Questionnaire | Assessment is scored from 1 (least severe) to 5 (most severe) | 1 year |
| Cognitive Function as Assessed by PROMIS Cognitive Questionnaire | Assessment is scored from 5 (least severe) to 1 (most severe) | 1 year |
| Physical Function as Assessed by PROMIS Physical Function Questionnaire | Assessment is scored from 5 (least severe) to 1 (most severe) | 1 year |
| Physical Activity as Measured by Cardiopulmonary Exercise Testing (CPET) | CPET is scored by measuring changes in V02 max | day 180 |
| Caregiver to patient who died |
|
| Caregiver to patient who was withdrawn due to physician decision |
|
| BG001 | Caregiver | These are the assigned caregivers for transplant patients. Caregivers will undergo psychiatric consult, nutrition/diet evaluation and referral to social worker. Psychiatric consult: Subjects who score below threshold on the PHQ2/PHQ9, PC-PTSD/PCL-5, PROMIS-Depression and/or PROMIS-Anxiety assessments will be referred to a psychiatrist for follow up. Nutrition/diet evaluation: PG-SGA, ASA24, food group tracking Assessments and Vit D, Vit A, albumin, prealbumin, lipids, A1c levels will be used to provide weekly feedback for one month Referral to Social Worker: Subjects who score below threshold on the PROMIS-Emotional Support and/or PROMIS-Social Isolation assessments will be referred to a social worker for follow up |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI (body mass index) | Caregivers were not included in BMI analysis | Mean | Standard Deviation | kg/m2 |
|
| Weight | Caregivers not included in weight analysis | Mean | Standard Deviation | kg |
|
| Diagnosis | Caregivers are not included in the Diagnosis category | Count of Participants | Participants |
|
| Receiving chemotherapy during intervention | Caregivers are not included in the chemotherapy during transplant analysis | Count of Participants | Participants |
|
| Work Status | Count of Participants | Participants |
|
| Martial Status | Count of Participants | Participants |
|
|
|
| Other Pre-specified | Measuring Changes in the Skin Flora (Microbiome) in Caregivers | Not Posted | baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365 | Participants |
| Other Pre-specified | Changes in Fecal Samples as Measured by 16s rRNA Sequencing in Caregivers | Not Posted | baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365 | Participants |
| Other Pre-specified | Caregiver Quality of Life as Assessed by the Caregiver Strain Questionnaire | Scored as 0 (No, least severe), 1 (Yes, sometimes) and 2 (Yes, on a regular basis, most severe) | Not Posted | 1 year | Participants |
| Other Pre-specified | Quality of Life as Assessed by the FACT-BMT Questionnaire | Scored from 0 (least severe) to 4 (most severe) | Not Posted | 1 year | Participants |
| Other Pre-specified | Delirium as Measured by the DOS Assessment | Not Posted | 1 year | Participants |
| Other Pre-specified | Assessing Falls | Participants will answer Yes/No to whether they have had any falls in the preceding 6 months | Not Posted | 1 year | Participants |
| Other Pre-specified | Return to Work as Assessed by the Work Assessment | Not Posted | 1 year | Participants |
| Other Pre-specified | Transplant Length of Stay | Not Posted | 1 year | Participants |
| Other Pre-specified | Graft Versus Host Disease (GVHD) | Not Posted | 1 year | Participants |
| Other Pre-specified | Intensive Care Unit Length of Stay | Not Posted | 1 year | Participants |
| Other Pre-specified | Hospital Length of Stay | Not Posted | 1 year | Participants |
| Other Pre-specified | Rate of Intensive Care Unit Admission/Re-admission | Not Posted | 1 year | Participants |
| Other Pre-specified | Rate of Hospital Admission/Re-admission | Not Posted | 1 year | Participants |
| Other Pre-specified | Rate of Overall Infections | Not Posted | 1 year | Participants |
| Other Pre-specified | Rate of Fungal Infections | Not Posted | 1 year | Participants |
| Other Pre-specified | Rate of Viral Infections | Not Posted | 1 year | Participants |
| Other Pre-specified | Rate of Bacterial Infections | Not Posted | 1 year | Participants |
| Other Pre-specified | Disease-free Survival | Not Posted | 1 year | Participants |
| Other Pre-specified | Overall Survival | Not Posted | 1 year | Participants |
| Other Pre-specified | Changes in Fecal Samples as Measured by 16s rRNA Sequencing in Transplant Patients | Not Posted | baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365, 730 | Participants |
| Other Pre-specified | Measuring Biomarkers of Inflammation/Frailty in Blood Plasma Samples | Biomarker panel to be analyzed: CRP, Eotaxin, Eotaxin-3, FGF (basic), Flt-1/VEGFR-1, GM-CSF, ICAM-1, IFN-γ, IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IL-17A/F, IL-17B, IL-17C, IL-17D, IL-1RA, IL-1α, IL-1β, IL-2, IL-21, IL-22, IL-23, IL-27, IL-3, IL-31, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-9, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, MIP-3α, PlGF, SAA, TARC, Tie-2, TNF-α, TNF-β, TSLP, VCAM-1, VEGF-A, VEGF-C, VEGF-D | Not Posted | 1 year | Participants |
| Other Pre-specified | Measuring Changes in the Skin Flora (Microbiome) in Transplant Patients | Not Posted | baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365 | Participants |
| Other Pre-specified | Caregiver Support as Assessed by the Caregiver Strain Index Questionnaire | Assessment is scored as 0 (never/least severe), 1 (sometimes), 2 (on a regular basis/most severe) | Not Posted | 1 year | Participants |
| Other Pre-specified | Social Support as Assessed by the PROMIS Social Isolation Questionnaire | Assessment is scored from 1 (least severe) to 5 (most severe) | Not Posted | 1 year | Participants |
| Other Pre-specified | Diet as Assessed by the Food Group Tracking Digital Application | Not Posted | 30 days | Participants |
| Other Pre-specified | Diet as Assessed by the TRU-BMT Digital Application | Not Posted | 30 days | Participants |
| Other Pre-specified | Nutrition as Assessed by the 24 Hour Food Recall Survey | Not Posted | 30 days | Participants |
| Other Pre-specified | Mental Health as Assessed by PROMIS Depression Questionnaire | Assessment is scored from 1 (least severe) to 5 (most severe) | Not Posted | 1 year | Participants |
| Other Pre-specified | Cognitive Function as Assessed by PROMIS Cognitive Questionnaire | Assessment is scored from 5 (least severe) to 1 (most severe) | Not Posted | 1 year | Participants |
| Other Pre-specified | Physical Function as Assessed by PROMIS Physical Function Questionnaire | Assessment is scored from 5 (least severe) to 1 (most severe) | Not Posted | 1 year | Participants |
| Other Pre-specified | Physical Activity as Measured by Cardiopulmonary Exercise Testing (CPET) | CPET is scored by measuring changes in V02 max | Not Posted | day 180 | Participants |
| 5 |
| 13 |
| 0 |
| 13 |
| 2 |
| 13 |
| EG001 | Caregiver | These are the assigned caregivers for transplant patients. Caregivers will undergo psychiatric consult, nutrition/diet evaluation and referral to social worker. Psychiatric consult: Subjects who score below threshold on the PHQ2/PHQ9, PC-PTSD/PCL-5, PROMIS-Depression and/or PROMIS-Anxiety assessments will be referred to a psychiatrist for follow up. Nutrition/diet evaluation: PG-SGA, ASA24, food group tracking Assessments and Vit D, Vit A, albumin, prealbumin, lipids, A1c levels will be used to provide weekly feedback for one month Referral to Social Worker: Subjects who score below threshold on the PROMIS-Emotional Support and/or PROMIS-Social Isolation assessments will be referred to a social worker for follow up | 0 | 11 | 0 | 11 | 0 | 11 |
| Hip Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Surgery for hip fracture | Surgical and medical procedures | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Diffuse large B-cell lymphoma |
|
| Acute lymphoblastic leukemia |
|
| Chronic lymphocytic leukemia |
|
| Peripheral T-cell lymphoma |
|