LeukemiaREBOUNDNCT04188678
Resiliency in Older Adults Undergoing Bone Marrow Transplant
An observational study of Leukemia and Lymphoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
The objective of this research is to measure certain indicators of resiliency to better understand which participants who are over 60 years old will respond more positively to bone marrow transplant. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Leukemia, Lymphoma, Blood Cancer
- What is being tested?
- Bone Marrow Transplant (BMT)
- Type of treatment
- Pill or oral medicine
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2018to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 60 who have undergone alloBMT
Who may be able to join
- Undergoing allogeneic bone marrow transplant at Johns Hopkins Hospital, the indication for which is a hematologic malignancy
- Age ≥60 years
- Ability to walk without human assistance
- Enrollment in concomitant clinical research is permitted but not required
- English-speaking
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Unwillingness or inability to return at 6 months after transplantation for repeated evaluation
- Non-English-speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
About this study
Official title: REBOUND: REsiliency in Older Adults UNDergoing BOne Marrow Transplant - A Pilot Study of Resiliency Measures in Older Patients Undergoing Allogeneic Blood and Marrow Transplant
The objective of this research is to measure certain indicators of resiliency to better understand which participants who are over 60 years old will respond more positively to bone marrow transplant. This research is being done to determine if there are traits that make recipients more likely to bounce back following allogeneic bone marrow transplant (BMT).
Read the detailed description
Allogeneic blood and marrow transplantation (alloBMT) is the only potentially curative therapy for many forms of leukemia, lymphoma, and other hematologic malignancies. As with many forms of cancer, many of the most common indications for alloBMT disproportionally affect older people. Although treatments have improved for older adults undergoing therapies for these diseases, the outcomes are variable and there is little biological knowledge to help identify specific factors that would predict why some people do well with treatment and others develop functional and cognitive decline and other adverse health outcomes.
Data specific to patients older than 60 who have undergone alloBMT are sparse even though the 1 year non-relapse mortality rate in patients older than age 50 at Johns Hopkins is 12%. In none of these studies have geriatric assessment measures in domains such as cognition and function been evaluated. Given the low incidence of non-relapse mortality in the investigators' older patients, the investigators have a unique opportunity to study the factors that influence not only mortality but function after hematopoietic stem cell transplantation. The investigators aim to be able to counsel patients more specifically about likely outcomes after transplant.
- Conditions
- Leukemia, Lymphoma, Blood Cancer, Myelodysplastic Syndrome, Acute Myelogenous Leukemia, Non-Hodgkins Lymphoma
- Being tested
- Bone Marrow Transplant (BMT)
- Keywords
- Allogeneic blood and marrow transplantation (alloBMT), Resiliency, REBOUND, over age 60
- Medical subject headings
- Leukemia, Lymphoma, Hematologic Neoplasms, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow Transplant (BMT)Other
Bone marrow transplantation will be conducted according to the investigators' institution's standard of care, or else according to research protocol (if applicable).Study visits that include the performance of assessments will occur prior to the start of conditioning chemotherapy and at 1 month and 6 months post-BMT. All dates are +/- 7 days. The initial study visit will take place during standard of care pre-transplant evaluations, which typically span 3-4 days. The post-BMT visits will take place before or after regularly-scheduled BMT follow up.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm- Bone Marrow Transplant | Study visits will include the performance of assessments prior to the start of conditioning chemotherapy and at 1 month and 6 months post-BMT. Assessments include:
1. Physical function assessments
2. questionnaires about general health and current health compared to health one year ago
3. assessments that measure cognition, attention and memory
4. assessments regarding personality and psychological and social stressors
5. Physiological measures including
* blood tests- 160 mL of blood during evaluations, and 90mL of blood at the day 180 visit.
* bone marrow aspirate collected during standard of care bone marrow biopsies pre-transplant and at day 180
* Saliva collections pre-transplant
* ACTH Stimulation Test
* Oral Glucose Tolerance Test
* Holter Monitor- to record hear rate variability
* MRI pre-transplant and at Day 180 in a subset of 10 subjects Receives: Other: Bone Marrow Transplant (BMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Performance as assessed by Short Physical Performance Battery (SPPB)
5 measured criteria: unintentional weight loss, exhaustion, low energy expenditure, low grip strength, and slowed waking speed. Scores of 3, 4 and 5 are consistent with frailty, scores of 1 and 2 are consistent with pre-frailty status, and a score of 0 is consistent with a robust or resilient status.
Measured: Pre-BMT, Day 30 and Day 180 post transplant
Change in ability to perform activities of daily living as assessed by Instrumental Activities of Daily Living questionnaire
questions about ability to perform activities of daily living (IADL). Scored low functioning (0) to high functioning (8).
Measured: Pre-BMT, Day 30 and Day 180 post transplant
Change in upper extremity function as assessed by accelerometry
device worn on wrist for a 24hr period that measures physical activity and sedentary activity. Higher scores= more active.
Measured: 7 consecutive days pre-BMT, at Day 30 and at Day 180
Change in catecholamines levels as assessed in overnight urine collection samples
Changes in catecholamines level will be assessed in overnight urine collection samples. Levels fluctuate. Analysis will use the Johns Hopkins University (JHU) normal reference range for an adult is Metanephrine (normotensive):45-290 μg/24 hours. Metanephrine (hypertensive): 35-460 μg/24 hours .
Measured: Pre-BMT, Day 30 and Day 180 post transplant
Change in Frailty as assessed by the Frailty Phenotype instrument
Frailty Phenotype instrument is used to measure participants' walking speed and grip strength, includes questions about exhaustion, physical activity, weight loss. Higher scores indicate better functional state.
Measured: Pre-BMT, Day 30 and Day 180 post transplant
Change in Pittsburgh Fatigability Scale for Older Adults score
self-report tool that normalizes activities in terms of intensity and duration (PFS) this has a range of 0-50 with higher scores indicating greater physical fatigability.
Measured: Pre-BMT, Day 30 and Day 180 post transplant
Change in Borg Rating of Perceived Exertion Scale score
scale will be used immediately after a slow-paced 5-minute treadmill walk to assess fatigability (RPE). Higher score indicates higher perceived exertion.
Measured: Pre-BMT, Day 30 and Day 180 post transplant
Change in medical history and diseases/conditions self reporting
Questionnaire of past medical history as reported by a subject. This questionnaire does not have a score.
Measured: Pre-BMT and Day 180 post transplant
Change in health behaviors as assessed by a questionnaire
This assessment is of self determined overall health as reported by a participant, it has no score.
Measured: Pre-BMT and Day 180 post transplant
Change in reporting of patients traumas as assessed by the Hospitalizations, Surgeries, and Falls Questionnaire
Questionnaire includes items on hospitalizations, surgeries, and falls. it has no score.
Measured: Pre-BMT and Day 180 post transplant
Change in pain reporting as assessed by the Pain Assessment Questionnaire
questions on overall bodily pain intensity/frequency and pain-related function/interference. Higher scores equal more pain.
Measured: Pre-BMT and Day 180 post transplant
Change in anxiety reporting as assessed by the anxiety questionnaire
Questions to assess the presence and severity of anxiety; higher scores = more anxiety.
Measured: Pre-BMT and Day 180 post transplant
Change in trauma reporting as assessed by the trauma questionnaire
Questions to assess a participants reporting of any past experiences of several kinds of trauma. It has no score.
Measured: Pre-BMT and Day 180 post transplant
Change in cognitive function as assessed by Modified Mini-Mental State Examination
measure of global cognitive function (range 0-100). A score of 100 represents total cognitive function according to 3MS.
Measured: Pre-BMT, Day 30, Day 56 and Day 180 post transplant
Change in cognitive ability as assessed by the Montreal Cognitive Assessment
measures global cognitive function (MoCA). Scores range between 0 and 30. A score of 26 or over is considered to be normal.
Measured: Pre-BMT, Day 30, Day 56 and Day 180 post transplant
Change in cognitive function as assessed by the Digit Symbol Substitution Test (DSST)
participant fill in a series of symbols correctly coded within 90 seconds. The higher the score, the better the participant's performance.
Measured: Pre-BMT, Day 30, Day 56 and Day 180 post transplant
Change in ability to cope with life challenges as assessed by the Coping Self-Efficacy Scale
11-point Likert scale measures perceived ability to cope effectively with life. Scale is 0-10 with 10 = best ability to cope and 0 = no ability to cope.
Measured: Pre-BMT and Day 180 post transplant
Change in sense of well-being as assessed by the Subscale of Ryff Psychological Well-being Scale
7-item Likert type scale (from strongly disagree to strongly agree) measures sense of direction and perception of purpose. Scale is 0-7 with 7 = best sense of well-being and 0 = no sense of well-being.
Measured: Pre-BMT and Day 180 post transplant
Change in perception and satisfaction with life as assessed by the Meaning in Life Questionnaire and Scale
Likert-type scale measuring perception of meaning and satisfaction with life (MLQ) Scale is 0-7 with 7 = best sense that life has meaning and 0 = no sense that life has meaning.
Measured: Pre-BMT and Day 180 post transplant
Change in personality as measured by the Ten Item Personality Inventory (TIPI) Scale
7 point Likert-type scale of disagree to agree with various aspects of personality measuring: extraversion, agreeableness, neuroticism, openness, conscientiousness. TIPI scale scoring. Extraversion: 1, 6R; Agreeableness: 2R, 7; Conscientiousness; 3, 8R; Emotional Stability: 4R, 9; Openness to Experiences: 5, 10R. ("R" denotes reverse-scored items)
Measured: Pre-BMT and Day 180 post transplant
Change in optimism as assessed by the Life Orientation Scale-Revised
5 point Likert scale, assessing optimism. 0= strongly disagree; 4 = strongly agree. The total score is from 0 to 24; higher scores indicate more optimism.
Measured: Pre-BMT and Day 180 post transplant
Change in perceived loneliness as assessed by the Loneliness Scale
Revised University of California, Los Angeles (UCLA) Loneliness Scale. Each question is rated on a 4-point scale: 1 = never; 2 = Rarely; 3 = Sometimes 4 = Always. All items are summed to give a total score. Higher scores indicate more loneliness
Measured: Pre-BMT and Day 180 post transplant
Change in perceived socio-economic status as assessed by the US socioeconomic questionnaire
10-rung ladder to assess a participant's perception of participant's status in society. To score this measure, researchers simply note the number of the rung (1-10) on which the respondent placed their "X".
Measured: Pre-BMT and Day 180 post transplant
Change in perceived financial strain as assessed by Financial Strain questionnaire
2 item measure evaluating difficulty and anxiety about money. Higher scores equal higher financial strain.
Measured: Pre-BMT and Day 180 post transplant
Change in feeling of community inclusion as assessed by the Social Cohesion Questionnaire
Participants rate their community by rate of agreement. Response is Agree a lot, a little, do not agree with 3 statements about their community.
Measured: Pre-BMT and Day 180 post transplant
Change in feeling of isolation as assessed by the Social Isolation/Engagement Questionnaire
7-item measure evaluating social isolation, participation and engagement with others. Higher scores= greater sense of isolation.
Measured: Pre-BMT and Day 180 post transplant
Change in perceived confidence in spirituality as assessed by the Religion/Spirituality Questionnaire
5-Item measure for use in epidemiological studies regarding spirituality. Score range from 5-27, with higher scores = more sense of spirituality
Measured: Pre-BMT and Day 180 post transplant
Change in feelings of depression as assessed by the Patient Health Questionnaire
Measures depressive symptoms in the last 2 weeks (PHQ-8)
Measured: Pre-BMT and Day 180 post transplant
Change in perceived childhood trauma as assessed by the Adverse Childhood Events (ACE) Scale
10-item measure to assess childhood abuse and household dysfunction. Response is yes/no. The ACE Scale is scored by summing the number of items for which respondents answered "yes."
Measured: Pre-BMT and Day 180 post transplant
Changes in perceived stress as assessed by the Perceived Stress Scale
5-point Likert scale measures the cognitive appraisal and perceptions of stress in life. Higher score= high level of perceived stress.
Measured: Pre-BMT and Day 180 post transplant
Change in bone marrow cell ratios as assessed by Bone Marrow Aspirate
aspirate will be collected during standard of care bone marrow biopsies and analyzed using JHU normal reference ranges.
Measured: pre-transplant and at Day 180 post-transplant
Change in hemoglobin tests.
160 mL of blood during evaluations, and 90mL of blood at the day 180 visit. Assessment will be documents using Hopkins normal reference ranges
Measured: pre-transplant and then at Day 30, Day 56 and Day 180 post-transplant
changes in salivary plasma free cortisol collection
Saliva collected at home by participants at 4 time points during a single 24 hour period. The mean salivary cortisol concentration is 15.5 +/- 0.8 nmol/L (range, 10.2-27.3) at 0800 h and 3.9 +/- 0.2 nmol/L (range, 2.2-4.1) at 2000 h.
Measured: single 24 hour period before BMT and at Day 180 post-transplant
Change in cortisol level
This is part of the ACTH Stimulation test to assess the reactivity of hypothalamic-pituitary-adrenal (HPA) axis. Test After the baseline blood draw is taken, 1mcg (low dose) Cosyntropin (synthetic ACTH) will be given intravenously by a research nursing staff followed by serial blood sampling to test for cortisol levels (mcg/dL).
Measured: pre-transplant and at Day 180 post-transplant
Changes in interleukin (IL)-6 level
This is part of the ACTH Stimulation test to assess the reactivity of HPA axis. After the baseline blood draw is taken, 1mcg (low dose) Cosyntropin (synthetic ACTH) will be given intravenously by a research nursing staff followed by serial blood sampling to test for IL-6 levels (pg/ml).
Measured: pre-transplant and at Day 180 post-transplant
Change in dehydroepiandrosterone (DHEA) level
This is part of the ACTH Stimulation test to assess the reactivity of HPA axis. After the baseline blood draw is taken, 1mcg (low dose) Cosyntropin (synthetic ACTH) will be given intravenously by a research nursing staff followed by serial blood sampling to test for DHEA levels (µg/dL).
Measured: pre-transplant and at Day 180 post-transplant
Change in glucose tolerance as assessed by the Oral Glucose Tolerance Test (OGTT)
Participants will fast overnight and then be given the 75 gram glucose oral load followed by blood draws at 0, 30. 60 and 120 minutes. At 120min, below 140mg/dL= normal blood sugar. 200mg/dL or higher= diabetes
Measured: pre-transplant and at Day 180 post-transplant
Change in heart rate variability as assessed by the "myPatch" Holter monitor
lightweight digital device that records and stores electrocardiogram (ECG) data on a continuous basis during study visits. A normal resting heart rate for adults ranges from 60 to 100 beats per minute. Generally, a lower heart rate at rest implies more efficient heart function.
Measured: During clinic visits at pre-transplant, Day 30, Day 56 and Day 180
Change in attention as assessed by the Flanker Inhibitory Control and Attention Test score
Measures attention and inhibitory control. Scoring is 0-10. Details and interpretations are available in the NIH toolbox scoring and interpretation guide.
Measured: pre-transplant, once a week from Day of transplant to Day 60 and at Day 180 post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start28 Sep 2018
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Philip Imus, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188678
- Sponsor's protocol ID
- J1849
- Other IDs
- UH2AG056933, IRB00165139
- Acronym
- REBOUND
- Status last verified
- Oct 2025
- First submitted
- 26 Nov 2019
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REBOUND: REsiliency in Older Adults UNDergoing BOne Marrow Transplant - A Pilot Study of Resiliency Measures in Older Patients Undergoing Allogeneic Blood and Marrow Transplant
- ClinicalTrials.gov ID
- NCT04188678
- Acronym / sponsor ID
- REBOUND / J1849
- Conditions
- Leukemia, Lymphoma, Blood Cancer, Myelodysplastic Syndrome, Acute Myelogenous Leukemia, Non-Hodgkins Lymphoma
- Keywords
- Allogeneic blood and marrow transplantation (alloBMT), Resiliency, REBOUND, over age 60
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 6 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this research is to measure certain indicators of resiliency to better understand which participants who are over 60 years old will respond more positively to bone marrow transplant. This research is being done to determine if there are traits that make recipients more likely to bounce back following allogeneic bone marrow transplant (BMT).
Detailed description
Allogeneic blood and marrow transplantation (alloBMT) is the only potentially curative therapy for many forms of leukemia, lymphoma, and other hematologic malignancies. As with many forms of cancer, many of the most common indications for alloBMT disproportionally affect older people. Although treatments have improved for older adults undergoing therapies for these diseases, the outcomes are variable and there is little biological knowledge to help identify specific factors that would predict why some people do well with treatment and others develop functional and cognitive decline and other adverse health outcomes.
Data specific to patients older than 60 who have undergone alloBMT are sparse even though the 1 year non-relapse mortality rate in patients older than age 50 at Johns Hopkins is 12%. In none of these studies have geriatric assessment measures in domains such as cognition and function been evaluated. Given the low incidence of non-relapse mortality in the investigators' older patients, the investigators have a unique opportunity to study the factors that influence not only mortality but function after hematopoietic stem cell transplantation. The investigators aim to be able to counsel patients more specifically about likely outcomes after transplant.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm- Bone Marrow Transplant | – | Other: Bone Marrow Transplant (BMT)Study visits will include the performance of assessments prior to the start of conditioning chemotherapy and at 1 month and 6 months post-BMT. Assessments include: 1. Physical function assessments 2. questionnaires about general health and current health compared to health one year ago 3. assessments that measure cognition, attention and memory 4. assessments regarding personality and psychological and social stressors 5. Physiological measures including * blood tests- 160 mL of blood during evaluations, and 90mL of blood at the day 180 visit. * bone marrow aspirate collected during standard of care bone marrow biopsies pre-transplant and at day 180 * Saliva collections pre-transplant * ACTH Stimulation Test * Oral Glucose Tolerance Test * Holter Monitor- to record hear rate variability * MRI pre-transplant and at Day 180 in a subset of 10 subjects |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 60 who have undergone alloBMT
Key inclusion criteria (6 listed)
- Undergoing allogeneic bone marrow transplant at Johns Hopkins Hospital, the indication for which is a hematologic malignancy
- Age ≥60 years
- Ability to walk without human assistance
- Enrollment in concomitant clinical research is permitted but not required
- English-speaking
Key exclusion criteria (2 listed)
- Unwillingness or inability to return at 6 months after transplantation for repeated evaluation
- Non-English-speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Marrow Transplant (BMT)Bone marrow transplantation will be conducted according to the investigators' institution's standard of care, or else according to research protocol (if applicable).Study visits that include the performance of assessments will occur prior to the start of conditioning chemotherapy and at 1 month and 6 months post-BMT. All dates are +/- 7 days. The initial study visit will take place during standard of care pre-transplant evaluations, which typically span 3-4 days. The post-BMT visits will take place before or after regularly-scheduled BMT follow up. | Other | Interventional Arm- Bone Marrow Transplant |
Primary outcome
Change in Physical Performance as assessed by Short Physical Performance Battery (SPPB)
Time frame: Pre-BMT, Day 30 and Day 180 post transplant
5 measured criteria: unintentional weight loss, exhaustion, low energy expenditure, low grip strength, and slowed waking speed. Scores of 3, 4 and 5 are consistent with frailty, scores of 1 and 2 are consistent with pre-frailty status, and a score of 0 is consistent with a robust or resilient status.
Change in ability to perform activities of daily living as assessed by Instrumental Activities of Daily Living questionnaire
Time frame: Pre-BMT, Day 30 and Day 180 post transplant
questions about ability to perform activities of daily living (IADL). Scored low functioning (0) to high functioning (8).
Change in upper extremity function as assessed by accelerometry
Time frame: 7 consecutive days pre-BMT, at Day 30 and at Day 180
device worn on wrist for a 24hr period that measures physical activity and sedentary activity. Higher scores= more active.
Change in catecholamines levels as assessed in overnight urine collection samples
Time frame: Pre-BMT, Day 30 and Day 180 post transplant
Changes in catecholamines level will be assessed in overnight urine collection samples. Levels fluctuate. Analysis will use the Johns Hopkins University (JHU) normal reference range for an adult is Metanephrine (normotensive):45-290 μg/24 hours. Metanephrine (hypertensive): 35-460 μg/24 hours .
Change in Frailty as assessed by the Frailty Phenotype instrument
Time frame: Pre-BMT, Day 30 and Day 180 post transplant
Frailty Phenotype instrument is used to measure participants' walking speed and grip strength, includes questions about exhaustion, physical activity, weight loss. Higher scores indicate better functional state.
Change in Pittsburgh Fatigability Scale for Older Adults score
Time frame: Pre-BMT, Day 30 and Day 180 post transplant
self-report tool that normalizes activities in terms of intensity and duration (PFS) this has a range of 0-50 with higher scores indicating greater physical fatigability.
Change in Borg Rating of Perceived Exertion Scale score
Time frame: Pre-BMT, Day 30 and Day 180 post transplant
scale will be used immediately after a slow-paced 5-minute treadmill walk to assess fatigability (RPE). Higher score indicates higher perceived exertion.
Change in medical history and diseases/conditions self reporting
Time frame: Pre-BMT and Day 180 post transplant
Questionnaire of past medical history as reported by a subject. This questionnaire does not have a score.
Change in health behaviors as assessed by a questionnaire
Time frame: Pre-BMT and Day 180 post transplant
This assessment is of self determined overall health as reported by a participant, it has no score.
Change in reporting of patients traumas as assessed by the Hospitalizations, Surgeries, and Falls Questionnaire
Time frame: Pre-BMT and Day 180 post transplant
Questionnaire includes items on hospitalizations, surgeries, and falls. it has no score.
Change in pain reporting as assessed by the Pain Assessment Questionnaire
Time frame: Pre-BMT and Day 180 post transplant
questions on overall bodily pain intensity/frequency and pain-related function/interference. Higher scores equal more pain.
Change in anxiety reporting as assessed by the anxiety questionnaire
Time frame: Pre-BMT and Day 180 post transplant
Questions to assess the presence and severity of anxiety; higher scores = more anxiety.
Change in trauma reporting as assessed by the trauma questionnaire
Time frame: Pre-BMT and Day 180 post transplant
Questions to assess a participants reporting of any past experiences of several kinds of trauma. It has no score.
Change in cognitive function as assessed by Modified Mini-Mental State Examination
Time frame: Pre-BMT, Day 30, Day 56 and Day 180 post transplant
measure of global cognitive function (range 0-100). A score of 100 represents total cognitive function according to 3MS.
Change in cognitive ability as assessed by the Montreal Cognitive Assessment
Time frame: Pre-BMT, Day 30, Day 56 and Day 180 post transplant
measures global cognitive function (MoCA). Scores range between 0 and 30. A score of 26 or over is considered to be normal.
Change in cognitive function as assessed by the Digit Symbol Substitution Test (DSST)
Time frame: Pre-BMT, Day 30, Day 56 and Day 180 post transplant
participant fill in a series of symbols correctly coded within 90 seconds. The higher the score, the better the participant's performance.
Change in ability to cope with life challenges as assessed by the Coping Self-Efficacy Scale
Time frame: Pre-BMT and Day 180 post transplant
11-point Likert scale measures perceived ability to cope effectively with life. Scale is 0-10 with 10 = best ability to cope and 0 = no ability to cope.
Change in sense of well-being as assessed by the Subscale of Ryff Psychological Well-being Scale
Time frame: Pre-BMT and Day 180 post transplant
7-item Likert type scale (from strongly disagree to strongly agree) measures sense of direction and perception of purpose. Scale is 0-7 with 7 = best sense of well-being and 0 = no sense of well-being.
Change in perception and satisfaction with life as assessed by the Meaning in Life Questionnaire and Scale
Time frame: Pre-BMT and Day 180 post transplant
Likert-type scale measuring perception of meaning and satisfaction with life (MLQ) Scale is 0-7 with 7 = best sense that life has meaning and 0 = no sense that life has meaning.
Change in personality as measured by the Ten Item Personality Inventory (TIPI) Scale
Time frame: Pre-BMT and Day 180 post transplant
7 point Likert-type scale of disagree to agree with various aspects of personality measuring: extraversion, agreeableness, neuroticism, openness, conscientiousness. TIPI scale scoring. Extraversion: 1, 6R; Agreeableness: 2R, 7; Conscientiousness; 3, 8R; Emotional Stability: 4R, 9; Openness to Experiences: 5, 10R. ("R" denotes reverse-scored items)
Change in optimism as assessed by the Life Orientation Scale-Revised
Time frame: Pre-BMT and Day 180 post transplant
5 point Likert scale, assessing optimism. 0= strongly disagree; 4 = strongly agree. The total score is from 0 to 24; higher scores indicate more optimism.
Change in perceived loneliness as assessed by the Loneliness Scale
Time frame: Pre-BMT and Day 180 post transplant
Revised University of California, Los Angeles (UCLA) Loneliness Scale. Each question is rated on a 4-point scale: 1 = never; 2 = Rarely; 3 = Sometimes 4 = Always. All items are summed to give a total score. Higher scores indicate more loneliness
Change in perceived socio-economic status as assessed by the US socioeconomic questionnaire
Time frame: Pre-BMT and Day 180 post transplant
10-rung ladder to assess a participant's perception of participant's status in society. To score this measure, researchers simply note the number of the rung (1-10) on which the respondent placed their "X".
Change in perceived financial strain as assessed by Financial Strain questionnaire
Time frame: Pre-BMT and Day 180 post transplant
2 item measure evaluating difficulty and anxiety about money. Higher scores equal higher financial strain.
Change in feeling of community inclusion as assessed by the Social Cohesion Questionnaire
Time frame: Pre-BMT and Day 180 post transplant
Participants rate their community by rate of agreement. Response is Agree a lot, a little, do not agree with 3 statements about their community.
Change in feeling of isolation as assessed by the Social Isolation/Engagement Questionnaire
Time frame: Pre-BMT and Day 180 post transplant
7-item measure evaluating social isolation, participation and engagement with others. Higher scores= greater sense of isolation.
Change in perceived confidence in spirituality as assessed by the Religion/Spirituality Questionnaire
Time frame: Pre-BMT and Day 180 post transplant
5-Item measure for use in epidemiological studies regarding spirituality. Score range from 5-27, with higher scores = more sense of spirituality
Change in feelings of depression as assessed by the Patient Health Questionnaire
Time frame: Pre-BMT and Day 180 post transplant
Measures depressive symptoms in the last 2 weeks (PHQ-8)
Change in perceived childhood trauma as assessed by the Adverse Childhood Events (ACE) Scale
Time frame: Pre-BMT and Day 180 post transplant
10-item measure to assess childhood abuse and household dysfunction. Response is yes/no. The ACE Scale is scored by summing the number of items for which respondents answered "yes."
Changes in perceived stress as assessed by the Perceived Stress Scale
Time frame: Pre-BMT and Day 180 post transplant
5-point Likert scale measures the cognitive appraisal and perceptions of stress in life. Higher score= high level of perceived stress.
Change in bone marrow cell ratios as assessed by Bone Marrow Aspirate
Time frame: pre-transplant and at Day 180 post-transplant
aspirate will be collected during standard of care bone marrow biopsies and analyzed using JHU normal reference ranges.
Change in hemoglobin tests.
Time frame: pre-transplant and then at Day 30, Day 56 and Day 180 post-transplant
160 mL of blood during evaluations, and 90mL of blood at the day 180 visit. Assessment will be documents using Hopkins normal reference ranges
changes in salivary plasma free cortisol collection
Time frame: single 24 hour period before BMT and at Day 180 post-transplant
Saliva collected at home by participants at 4 time points during a single 24 hour period. The mean salivary cortisol concentration is 15.5 +/- 0.8 nmol/L (range, 10.2-27.3) at 0800 h and 3.9 +/- 0.2 nmol/L (range, 2.2-4.1) at 2000 h.
Change in cortisol level
Time frame: pre-transplant and at Day 180 post-transplant
This is part of the ACTH Stimulation test to assess the reactivity of hypothalamic-pituitary-adrenal (HPA) axis. Test After the baseline blood draw is taken, 1mcg (low dose) Cosyntropin (synthetic ACTH) will be given intravenously by a research nursing staff followed by serial blood sampling to test for cortisol levels (mcg/dL).
Changes in interleukin (IL)-6 level
Time frame: pre-transplant and at Day 180 post-transplant
This is part of the ACTH Stimulation test to assess the reactivity of HPA axis. After the baseline blood draw is taken, 1mcg (low dose) Cosyntropin (synthetic ACTH) will be given intravenously by a research nursing staff followed by serial blood sampling to test for IL-6 levels (pg/ml).
Change in dehydroepiandrosterone (DHEA) level
Time frame: pre-transplant and at Day 180 post-transplant
This is part of the ACTH Stimulation test to assess the reactivity of HPA axis. After the baseline blood draw is taken, 1mcg (low dose) Cosyntropin (synthetic ACTH) will be given intravenously by a research nursing staff followed by serial blood sampling to test for DHEA levels (µg/dL).
Change in glucose tolerance as assessed by the Oral Glucose Tolerance Test (OGTT)
Time frame: pre-transplant and at Day 180 post-transplant
Participants will fast overnight and then be given the 75 gram glucose oral load followed by blood draws at 0, 30. 60 and 120 minutes. At 120min, below 140mg/dL= normal blood sugar. 200mg/dL or higher= diabetes
Change in heart rate variability as assessed by the "myPatch" Holter monitor
Time frame: During clinic visits at pre-transplant, Day 30, Day 56 and Day 180
lightweight digital device that records and stores electrocardiogram (ECG) data on a continuous basis during study visits. A normal resting heart rate for adults ranges from 60 to 100 beats per minute. Generally, a lower heart rate at rest implies more efficient heart function.
Change in attention as assessed by the Flanker Inhibitory Control and Attention Test score
Time frame: pre-transplant, once a week from Day of transplant to Day 60 and at Day 180 post-transplant
Measures attention and inhibitory control. Scoring is 0-10. Details and interpretations are available in the NIH toolbox scoring and interpretation guide.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Imus, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia and Lymphoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Performance as assessed by Short Physical Performance Battery (SPPB) (time frame: Pre-BMT, Day 30 and Day 180 post transplant). The study lists 39 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.