Clinical trial NCT04892823: Social Relationships and Accelerated Aging in Hematopoietic Cell Transplant Survivors
Official title: Accelerated Biological and Phenotypic Aging in Hematopoietic Cell Transplant Survivors: Social Support as a Protective Factor
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-05-19
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing HCT for hematologic cancers.

Brief summary: This project aims to elucidate the important protective elements of social relationships and identify concrete, modifiable behavioral factors that contribute to biological and phenotypic aging in hematopoietic cell transplantation (HCT) survivors and can be used to develop biologically informed interventions to improve quality of life and prolong the healthspan of individuals with accelerated aging.

Detailed description: PRIMARY OBJECTIVES:

I. Examine associations between social support, strain, and isolation and phenotypic aging over the 1-year recovery period.

II. Examine associations between social support, strain, and isolation and biological aging over the 1-year recovery period.

III. Test biological aging as a mediator linking social processes and phenotypic aging.

EXPLORATORY OBJECTIVE:

I. Test sex differences in Aims 1 and 2.

OUTLINE:

Adopting a prospective design, participants will complete comprehensive assessments of social processes at 100 days and 1 year after HCT that combine reports of social support, strain, and isolation with a naturalistic observation tool, the Electronically Activated Recorder (EAR), which captures ambient sound bites to assess social interactions in survivors' daily lives16. At each time point, participants will also provide reports of symptoms to characterize phenotypic aging, including cognitive, physical, and functional complaints, and blood samples to assess biological aging, including cellular senescence, DNA damage, SASP, and cellular stress using genome-wide RNA sequencing. Relevant clinical information that could influence biological aging will also be collected from patients' medical records to consider as covariates.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years and older who are competent to give their informed consent.
* Ability to read, speak, and understand English.
* Received a hematopoietic cell transplant within the previous 100 days.

Exclusion Criteria:

* Less then Aged 18 years and older who are competent to give their informed consent.
* Cannot read, speak, and understand English.
* Has not received a hematopoietic cell transplant within the previous 100 days.

Primary outcomes:
measure: The number of participants with gene expression of cellular senescence marker p16.
timeFrame: Day 100 and 1 year post-transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital and the Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Kelly Rentscher, PhD
role: PRINCIPAL_INVESTIGATOR
References: