Social Relationships and Accelerated Aging in Hematopoietic Cell Transplant Survivors

Hematopoietic and Lymphoid Cell Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04892823
• Other study ID #: 43000
• Secondary ID: NCI-2021-0261643
• Status: Recruiting
• Start date: May 18, 2021
• Est. completion date: May 31, 2025

Study information

• Verified date: July 2023
• Source: Medical College of Wisconsin
• Contact: Medical College of Wisconsin Cancer Center Clinical Trials Offic
• Phone: 866-680-0505
• Email: cccto[@]mcw.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematopoietic and Lymphoid Cell Neoplasm

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood sample

Other:
• Electronic Health Record Review
Review of medical records
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	Froedtert Hospital and the Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sex differences	Multiple regression models will examine interactions between social support, strain, and isolation and biological sex as separate predictors of biological (Aim 1) and change in phenotypic (Aim 2) aging, accounting for covariates.	through study completion, an average of 1 year
Primary	Associations between social support, strain, and isolation and phenotypic aging	Multiple regression models will examine subjective and objective measures of each social process as separate predictors of change in phenotypic aging over the 1-year period, accounting for covariates.	through study completion, an average of 1 year
Primary	Associations between social support, strain, and isolation and biological aging	Raw gene expression data will be quantile-normalized and log2-transformed. Similar to Aim 1, multiple regression models will examine each social process as separate predictors of change in cellular senescence marker p16INK4a over the 1-year period, accounting for covariates. Mixed linear models will examine associations between each social process and deoxyribonucleic acid damage response (DDR) and senescence-associated secretory phenotype (SASP) gene profiles, estimated by maximum likelihood to account for systematic differences across genes by treating them as repeated measurements with an unstructured covariance matrix. Bioinformatics analyses will use regression models to identify genes with > 1.5-fold difference.	through study completion, an average of 1 year
Primary	Biological aging as a mediator linking social processes and phenotypic aging	A regression-based mediation approach will examine biological aging (p16INK4a messenger ribonucleic acid, DDR and SASP composites) as mediating variables in associations between each social process and change in phenotypic aging, using the PROCESS macro for SPSS statistical software.	through study completion, an average of 1 year