NCT04892823

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

May 18, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 19, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

5 years

First QC Date

May 10, 2021

Last Update Submit

July 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The number of participants with gene expression of cellular senescence marker p16.

    This will be measured by mRNA/gene expression.

    Day 100 and 1 year post-transplant

Study Arms (1)

Supportive care (EAR, questionnaires, biospecimen collection)

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 lives. 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.

Procedure: Biospecimen CollectionOther: Electronic Health Record ReviewOther: Questionnaire Administration

Interventions

Undergo collection of blood sample

Supportive care (EAR, questionnaires, biospecimen collection)

Review of medical records

Supportive care (EAR, questionnaires, biospecimen collection)

Complete questionnaires

Supportive care (EAR, questionnaires, biospecimen collection)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing HCT for hematologic cancers.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Kelly Rentscher, PhD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 10, 2021

First Posted

May 19, 2021

Study Start

May 18, 2021

Primary Completion

May 31, 2026

Study Completion

May 31, 2026

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations