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Recruiting NCT04892823

Social Relationships and Accelerated Aging in Hematopoietic Cell Transplant Survivors

Observational Hematopoietic and Lymphoid Cell Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biospecimen Collection, Electronic Health Record Review, Questionnaire Administration.
Who it may be relevant to
Registry conditions: Hematopoietic and Lymphoid Cell Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Accelerated Biological and Phenotypic Aging in Hematopoietic Cell Transplant Survivors: Social Support as a Protective Factor

Overview

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.

Interventions

  • Procedure Biospecimen Collection
    Undergo collection of blood sample
  • Other Electronic Health Record Review
    Review of medical records
  • Other Questionnaire Administration
    Complete questionnaires

Primary outcome measures

  • The number of participants with gene expression of cellular senescence marker p16. [Time frame: Day 100 and 1 year post-transplant]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Froedtert Hospital and the Medical College of Wisconsin — Milwaukee

Identifiers

NCT: NCT04892823 · 43000 · NCI-2021-02616 · 43000 · K01AG065485

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗