Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-10 @ 6:08 PM
Study NCT ID:
NCT03823651
Status:
COMPLETED
Last Update Posted:
2024-09-27
First Post:
2019-01-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Research Program Targeting Pre- and Peri-transplant Optimization Program (R-PPOP)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anthony.sung@duke.edu', 'phone': '919-668-1000', 'title': 'Dr. Anthony Sung', 'organization': 'Duke University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected for participants from enrollment through 1 year post-transplant', 'description': '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.)', 'eventGroups': [{'id': 'EG000', 'title': 'Patient', 'description': "These are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.\n\nInterval 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.\n\nPsychiatric 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.\n\nNutrition/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\n\nReferral 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", 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 2, 'seriousNumAtRisk': 13, 'deathsNumAffected': 5, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Caregiver', 'description': 'These are the assigned caregivers for transplant patients. Caregivers will undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.\n\nPsychiatric 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.\n\nNutrition/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\n\nReferral 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', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cardiac Arrhythmia', 'notes': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgery for hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Completed at Least Half of Their High Intensity Interval Training Sessions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient', 'description': "These are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.\n\nInterval 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.\n\nPsychiatric 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.\n\nNutrition/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\n\nReferral 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"}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Participants were asked to record or report their exercise sessions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '13 patients were prescribed the HIIT intervention, but only 9 consistently recorded sessions throughout the duration of the study.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Measuring Changes in the Skin Flora (Microbiome) in Caregivers', 'timeFrame': 'baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in Fecal Samples as Measured by 16s rRNA Sequencing in Caregivers', 'timeFrame': 'baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Caregiver Quality of Life as Assessed by the Caregiver Strain Questionnaire', 'timeFrame': '1 year', 'description': 'Scored as 0 (No, least severe), 1 (Yes, sometimes) and 2 (Yes, on a regular basis, most severe)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quality of Life as Assessed by the FACT-BMT Questionnaire', 'timeFrame': '1 year', 'description': 'Scored from 0 (least severe) to 4 (most severe)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Delirium as Measured by the DOS Assessment', 'timeFrame': '1 year', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Assessing Falls', 'timeFrame': '1 year', 'description': 'Participants will answer Yes/No to whether they have had any falls in the preceding 6 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Return to Work as Assessed by the Work Assessment', 'timeFrame': '1 year', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Transplant Length of Stay', 'timeFrame': '1 year', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Graft Versus Host Disease (GVHD)', 'timeFrame': '1 year', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Intensive Care Unit Length of Stay', 'timeFrame': '1 year', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hospital Length of Stay', 'timeFrame': '1 year', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Intensive Care Unit Admission/Re-admission', 'timeFrame': '1 year', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Hospital Admission/Re-admission', 'timeFrame': '1 year', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Overall Infections', 'timeFrame': '1 year', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Fungal Infections', 'timeFrame': '1 year', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Viral Infections', 'timeFrame': '1 year', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Bacterial Infections', 'timeFrame': '1 year', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Disease-free Survival', 'timeFrame': '1 year', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Overall Survival', 'timeFrame': '1 year', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in Fecal Samples as Measured by 16s rRNA Sequencing in Transplant Patients', 'timeFrame': 'baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365, 730', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Measuring Biomarkers of Inflammation/Frailty in Blood Plasma Samples', 'timeFrame': '1 year', 'description': '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', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Measuring Changes in the Skin Flora (Microbiome) in Transplant Patients', 'timeFrame': 'baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Caregiver Support as Assessed by the Caregiver Strain Index Questionnaire', 'timeFrame': '1 year', 'description': 'Assessment is scored as 0 (never/least severe), 1 (sometimes), 2 (on a regular basis/most severe)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Social Support as Assessed by the PROMIS Social Isolation Questionnaire', 'timeFrame': '1 year', 'description': 'Assessment is scored from 1 (least severe) to 5 (most severe)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Diet as Assessed by the Food Group Tracking Digital Application', 'timeFrame': '30 days', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Diet as Assessed by the TRU-BMT Digital Application', 'timeFrame': '30 days', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Nutrition as Assessed by the 24 Hour Food Recall Survey', 'timeFrame': '30 days', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mental Health as Assessed by PROMIS Depression Questionnaire', 'timeFrame': '1 year', 'description': 'Assessment is scored from 1 (least severe) to 5 (most severe)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cognitive Function as Assessed by PROMIS Cognitive Questionnaire', 'timeFrame': '1 year', 'description': 'Assessment is scored from 5 (least severe) to 1 (most severe)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Physical Function as Assessed by PROMIS Physical Function Questionnaire', 'timeFrame': '1 year', 'description': 'Assessment is scored from 5 (least severe) to 1 (most severe)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Physical Activity as Measured by Cardiopulmonary Exercise Testing (CPET)', 'timeFrame': 'day 180', 'description': 'CPET is scored by measuring changes in V02 max', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patient', 'description': "These are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.\n\nInterval 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.\n\nPsychiatric 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.\n\nNutrition/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\n\nReferral 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"}, {'id': 'FG001', 'title': 'Caregiver', 'description': 'These are the assigned caregivers for transplant patients. Caregivers will undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.\n\nPsychiatric 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.\n\nNutrition/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\n\nReferral 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'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Caregiver to patient who died', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Caregiver to patient who was withdrawn due to physician decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Patient', 'description': "These are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.\n\nInterval 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.\n\nPsychiatric 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.\n\nNutrition/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\n\nReferral 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"}, {'id': 'BG001', 'title': 'Caregiver', 'description': 'These are the assigned caregivers for transplant patients. Caregivers will undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.\n\nPsychiatric 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.\n\nNutrition/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\n\nReferral 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'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '55', 'spread': '13.8', 'groupId': 'BG001'}, {'value': '56', 'spread': '12.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI (body mass index)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29.5', 'spread': '4.8', 'groupId': 'BG000'}, {'value': '29.5', 'spread': '4.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Caregivers were not included in BMI analysis'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '90.8', 'spread': '19.7', 'groupId': 'BG000'}, {'value': '90.8', 'spread': '19.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Caregivers not included in weight analysis'}, {'title': 'Diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Myelodysplastic syndrome', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Acute myeloid leukemia', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Diffuse large B-cell lymphoma', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Acute lymphoblastic leukemia', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Chronic lymphocytic leukemia', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Peripheral T-cell lymphoma', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Caregivers are not included in the Diagnosis category'}, {'title': 'Receiving chemotherapy during intervention', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Caregivers are not included in the chemotherapy during transplant analysis'}, {'title': 'Work Status', 'classes': [{'title': 'Employed Full-Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Employed Part-Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Homemaker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Retired', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Unemployed/Disabled', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Unemployed/Seeking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Unknown/Not Reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Martial Status', 'classes': [{'title': 'Married or living with significant other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Single, never married', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-25', 'size': 1109064, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-28T07:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-17', 'studyFirstSubmitDate': '2019-01-28', 'resultsFirstSubmitDate': '2023-10-10', 'studyFirstSubmitQcDate': '2019-01-29', 'lastUpdatePostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-17', 'studyFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Measuring Changes in the Skin Flora (Microbiome) in Caregivers', 'timeFrame': 'baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365'}, {'measure': 'Changes in Fecal Samples as Measured by 16s rRNA Sequencing in Caregivers', 'timeFrame': 'baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365'}, {'measure': 'Caregiver Quality of Life as Assessed by the Caregiver Strain Questionnaire', 'timeFrame': '1 year', 'description': 'Scored as 0 (No, least severe), 1 (Yes, sometimes) and 2 (Yes, on a regular basis, most severe)'}, {'measure': 'Quality of Life as Assessed by the FACT-BMT Questionnaire', 'timeFrame': '1 year', 'description': 'Scored from 0 (least severe) to 4 (most severe)'}, {'measure': 'Delirium as Measured by the DOS Assessment', 'timeFrame': '1 year'}, {'measure': 'Assessing Falls', 'timeFrame': '1 year', 'description': 'Participants will answer Yes/No to whether they have had any falls in the preceding 6 months'}, {'measure': 'Return to Work as Assessed by the Work Assessment', 'timeFrame': '1 year'}, {'measure': 'Transplant Length of Stay', 'timeFrame': '1 year'}, {'measure': 'Graft Versus Host Disease (GVHD)', 'timeFrame': '1 year'}, {'measure': 'Intensive Care Unit Length of Stay', 'timeFrame': '1 year'}, {'measure': 'Hospital Length of Stay', 'timeFrame': '1 year'}, {'measure': 'Rate of Intensive Care Unit Admission/Re-admission', 'timeFrame': '1 year'}, {'measure': 'Rate of Hospital Admission/Re-admission', 'timeFrame': '1 year'}, {'measure': 'Rate of Overall Infections', 'timeFrame': '1 year'}, {'measure': 'Rate of Fungal Infections', 'timeFrame': '1 year'}, {'measure': 'Rate of Viral Infections', 'timeFrame': '1 year'}, {'measure': 'Rate of Bacterial Infections', 'timeFrame': '1 year'}, {'measure': 'Disease-free Survival', 'timeFrame': '1 year'}, {'measure': 'Overall Survival', 'timeFrame': '1 year'}, {'measure': 'Changes in Fecal Samples as Measured by 16s rRNA Sequencing in Transplant Patients', 'timeFrame': 'baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365, 730'}, {'measure': 'Measuring Biomarkers of Inflammation/Frailty in Blood Plasma Samples', 'timeFrame': '1 year', 'description': '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'}, {'measure': 'Measuring Changes in the Skin Flora (Microbiome) in Transplant Patients', 'timeFrame': 'baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365'}, {'measure': 'Caregiver Support as Assessed by the Caregiver Strain Index Questionnaire', 'timeFrame': '1 year', 'description': 'Assessment is scored as 0 (never/least severe), 1 (sometimes), 2 (on a regular basis/most severe)'}, {'measure': 'Social Support as Assessed by the PROMIS Social Isolation Questionnaire', 'timeFrame': '1 year', 'description': 'Assessment is scored from 1 (least severe) to 5 (most severe)'}, {'measure': 'Diet as Assessed by the Food Group Tracking Digital Application', 'timeFrame': '30 days'}, {'measure': 'Diet as Assessed by the TRU-BMT Digital Application', 'timeFrame': '30 days'}, {'measure': 'Nutrition as Assessed by the 24 Hour Food Recall Survey', 'timeFrame': '30 days'}, {'measure': 'Mental Health as Assessed by PROMIS Depression Questionnaire', 'timeFrame': '1 year', 'description': 'Assessment is scored from 1 (least severe) to 5 (most severe)'}, {'measure': 'Cognitive Function as Assessed by PROMIS Cognitive Questionnaire', 'timeFrame': '1 year', 'description': 'Assessment is scored from 5 (least severe) to 1 (most severe)'}, {'measure': 'Physical Function as Assessed by PROMIS Physical Function Questionnaire', 'timeFrame': '1 year', 'description': 'Assessment is scored from 5 (least severe) to 1 (most severe)'}, {'measure': 'Physical Activity as Measured by Cardiopulmonary Exercise Testing (CPET)', 'timeFrame': 'day 180', 'description': 'CPET is scored by measuring changes in V02 max'}], 'primaryOutcomes': [{'measure': 'Number of Participants Who Completed at Least Half of Their High Intensity Interval Training Sessions', 'timeFrame': '6 months', 'description': 'Participants were asked to record or report their exercise sessions.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematologic Malignancy']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patient Inclusion Criteria:\n\n* Plan to undergo an allogeneic hematopoietic stem cell transplant for any cancer or non-cancer illness within the next 6 months\n* Age 18-80 years\n\nPatient Exclusion Criteria:\n\n* Both patient and caregiver are unable to read and follow directions in English (ok if only patient cannot read and follow directions in English as caregiver will be able to help).\n* Any absolute contraindications to exercise:\n* recent (\\< 6 months) acute cardiac event;\n* unstable angina;\n* uncontrolled dysrhythmias causing symptoms or hemodynamic compromise;\n* symptomatic aortic stenosis;\n* uncontrolled symptomatic heart failure;\n* acute pulmonary embolus;\n* acute myocarditis or pericarditis;\n* suspected or known dissecting aneurism; or\n* coronary artery disease.\n* Functional impairment resulting in inability to exercise\n\nCaregiver inclusion criteria\n\n* Identified by patient as their primary caregiver\n* Age 18-80 years\n\nCaregiver exclusion criteria\n\n* None'}, 'identificationModule': {'nctId': 'NCT03823651', 'briefTitle': 'A Research Program Targeting Pre- and Peri-transplant Optimization Program (R-PPOP)', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'A Research Program Targeting Pre- and Peri-transplant Optimization Program (R-PPOP)', 'orgStudyIdInfo': {'id': 'Pro00092963'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient', 'description': 'These are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.', 'interventionNames': ['Behavioral: Interval training', 'Behavioral: Psychiatric consult', 'Behavioral: Nutrition/diet evaluation', 'Behavioral: Referral to Social Worker']}, {'type': 'EXPERIMENTAL', 'label': 'Caregiver', 'description': 'These are the assigned caregivers for transplant patients. Caregivers will undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.', 'interventionNames': ['Behavioral: Psychiatric consult', 'Behavioral: Nutrition/diet evaluation', 'Behavioral: Referral to Social Worker']}], 'interventions': [{'name': 'Interval training', 'type': 'BEHAVIORAL', 'description': "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.", 'armGroupLabels': ['Patient']}, {'name': 'Psychiatric consult', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Caregiver', 'Patient']}, {'name': 'Nutrition/diet evaluation', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['Caregiver', 'Patient']}, {'name': 'Referral to Social Worker', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['Caregiver', 'Patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Adult Bone Marrow Transplant Clinic', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Anthony Sung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}