Clinical trial NCT04188678: Resiliency in Older Adults Undergoing Bone Marrow Transplant
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2019-12-06
Enrollment: 126
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients older than 60 who have undergone alloBMT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Unwillingness or inability to return at 6 months after transplantation for repeated evaluation
* Non-English-speaking

Primary outcomes:
measure: Change in Physical Performance as assessed by Short Physical Performance Battery (SPPB)
timeFrame: Pre-BMT, Day 30 and Day 180 post transplant
measure: Change in ability to perform activities of daily living as assessed by Instrumental Activities of Daily Living questionnaire
timeFrame: Pre-BMT, Day 30 and Day 180 post transplant
measure: Change in upper extremity function as assessed by accelerometry
timeFrame: 7 consecutive days pre-BMT, at Day 30 and at Day 180
measure: Change in catecholamines levels as assessed in overnight urine collection samples
timeFrame: Pre-BMT, Day 30 and Day 180 post transplant
measure: Change in Frailty as assessed by the Frailty Phenotype instrument
timeFrame: Pre-BMT, Day 30 and Day 180 post transplant
measure: Change in Pittsburgh Fatigability Scale for Older Adults score
timeFrame: Pre-BMT, Day 30 and Day 180 post transplant
measure: Change in Borg Rating of Perceived Exertion Scale score
timeFrame: Pre-BMT, Day 30 and Day 180 post transplant
measure: Change in medical history and diseases/conditions self reporting
timeFrame: Pre-BMT and Day 180 post transplant
measure: Change in health behaviors as assessed by a questionnaire
timeFrame: Pre-BMT and Day 180 post transplant
measure: Change in reporting of patients traumas as assessed by the Hospitalizations, Surgeries, and Falls Questionnaire
timeFrame: Pre-BMT and Day 180 post transplant
measure: Change in pain reporting as assessed by the Pain Assessment Questionnaire
timeFrame: Pre-BMT and Day 180 post transplant
measure: Change in anxiety reporting as assessed by the anxiety questionnaire
timeFrame: Pre-BMT and Day 180 post transplant
measure: Change in trauma reporting as assessed by the trauma questionnaire
timeFrame: Pre-BMT and Day 180 post transplant
measure: Change in cognitive function as assessed by Modified Mini-Mental State Examination
timeFrame: Pre-BMT, Day 30, Day 56 and Day 180 post transplant
measure: Change in cognitive ability as assessed by the Montreal Cognitive Assessment
timeFrame: Pre-BMT, Day 30, Day 56 and Day 180 post transplant
measure: Change in cognitive function as assessed by the Digit Symbol Substitution Test (DSST)
timeFrame: Pre-BMT, Day 30, Day 56 and Day 180 post transplant
measure: Change in ability to cope with life challenges as assessed by the Coping Self-Efficacy Scale
timeFrame: Pre-BMT and Day 180 post transplant
measure: Change in sense of well-being as assessed by the Subscale of Ryff Psychological Well-being Scale
timeFrame: Pre-BMT and Day 180 post transplant
measure: Change in perception and satisfaction with life as assessed by the Meaning in Life Questionnaire and Scale
timeFrame: Pre-BMT and Day 180 post transplant
measure: Change in personality as measured by the Ten Item Personality Inventory (TIPI) Scale
timeFrame: Pre-BMT and Day 180 post transplant
measure: Change in optimism as assessed by the Life Orientation Scale-Revised
timeFrame: Pre-BMT and Day 180 post transplant
measure: Change in perceived loneliness as assessed by the Loneliness Scale
timeFrame: Pre-BMT and Day 180 post transplant
measure: Change in perceived socio-economic status as assessed by the US socioeconomic questionnaire
timeFrame: Pre-BMT and Day 180 post transplant
measure: Change in perceived financial strain as assessed by Financial Strain questionnaire
timeFrame: Pre-BMT and Day 180 post transplant
measure: Change in feeling of community inclusion as assessed by the Social Cohesion Questionnaire
timeFrame: Pre-BMT and Day 180 post transplant
measure: Change in feeling of isolation as assessed by the Social Isolation/Engagement Questionnaire
timeFrame: Pre-BMT and Day 180 post transplant
measure: Change in perceived confidence in spirituality as assessed by the Religion/Spirituality Questionnaire
timeFrame: Pre-BMT and Day 180 post transplant
measure: Change in feelings of depression as assessed by the Patient Health Questionnaire
timeFrame: Pre-BMT and Day 180 post transplant
measure: Change in perceived childhood trauma as assessed by the Adverse Childhood Events (ACE) Scale
timeFrame: Pre-BMT and Day 180 post transplant
measure: Changes in perceived stress as assessed by the Perceived Stress Scale
timeFrame: Pre-BMT and Day 180 post transplant
measure: Change in bone marrow cell ratios as assessed by Bone Marrow Aspirate
timeFrame: pre-transplant and at Day 180 post-transplant
measure: Change in hemoglobin tests.
timeFrame: pre-transplant and then at Day 30, Day 56 and Day 180 post-transplant
measure: changes in salivary plasma free cortisol collection
timeFrame: single 24 hour period before BMT and at Day 180 post-transplant
measure: Change in cortisol level
timeFrame: pre-transplant and at Day 180 post-transplant
measure: Changes in interleukin (IL)-6 level
timeFrame: pre-transplant and at Day 180 post-transplant
measure: Change in dehydroepiandrosterone (DHEA) level
timeFrame: pre-transplant and at Day 180 post-transplant
measure: Change in glucose tolerance as assessed by the Oral Glucose Tolerance Test (OGTT)
timeFrame: pre-transplant and at Day 180 post-transplant
measure: Change in heart rate variability as assessed by the "myPatch" Holter monitor
timeFrame: During clinic visits at pre-transplant, Day 30, Day 56 and Day 180
measure: Change in attention as assessed by the Flanker Inhibitory Control and Attention Test score
timeFrame: pre-transplant, once a week from Day of transplant to Day 60 and at Day 180 post-transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Philip Imus, MD
role: PRINCIPAL_INVESTIGATOR
References: