YASU Research Registry: For Young Adults With Cancer

Young Adult Survivors United Cancer Research Registry

The goal of this observational research registry is to learn about health, wellbeing, and needs of survivors of young adult cancer (diagnosed between the ages of 18 and 39). The main question[s] it aims to understand are:

• What are the levels of depression, anxiety, social support, and financial distress
• Determine effectiveness of YASU programming by measuring changes over time

With this registry, the investigators also plan to identify survivors who may be eligible for participation in future research studies pertaining to young adult cancer.

Participants will be asked to complete electronic surveys every 6 to 12 months during participation in the registry.

Study Overview

• Status: Not yet recruiting
• Conditions: Melanoma; Sarcoma; Lymphoma; Leukemia; Cancer; Breast Cancer; Colorectal Cancer; Germ Cell Cancer

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Bethany Nugent, PhD, RN; Phone Number: 724-580-8292; Email: research@yasurvivors.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Any young adult diagnosed with cancer between the ages of 18 and 39 willing to register on the YASU website and consents to participation in the research registry.

Description

Inclusion Criteria:

1. Cancer diagnosis received between the ages of 18 and 39.
2. Able to speak and read English

Exclusion Criteria:

1. Inability to provide consent (such as neurological illness or mental incapacity)
2. Has not registered as a member of YASU

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	General Anxiety Disorder-7 (GAD-7). Scores range from 0-21 with higher scores indicating higher levels of anxiety.	enrollment in registry, 6 months later, yearly until death
Depressive symptoms	Patient Health Questionnaire- 9 (PHQ-9) Scores range from 0-27, with higher scores indicating more depressive symptoms.	enrollment in registry, 6 months later, yearly until death
Social Support	MOS Social Support Survey Instrument The survey consists of four separate social support subscales and an overall functional social support index. A higher score for an individual scale or for the overall support index indicates more support. MOS Social Support Survey Instrument Measure of Social Support Survey Instrument	enrollment in registry, 6 months later, yearly until death
Financial Toxicity	COST: A FACIT Measure of Financial Toxicity (COST - FACIT (Ver 2)) Scores range from 0-44. The higher the score, the better the Financial Well-Being	enrollment in registry, 6 months later, yearly until death
Needs Assessment	AYA Psycho-Oncology Screening Tool (AYA-POST) There is no scoring required for this tool.	enrollment in registry

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Name, address, email, phone number	Contact information if willing to be alerted about future research	enrollment in registry

Collaborators and Investigators

• Sponsor: Young Adult Survivors United
• Collaborators: Staunton Farm Foundation; Elsie H. Hillman Foundation

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: young adult cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Germ Cell and Embryonal
• Other Study ID Numbers: 22265 (City of Hope Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Starting once enrollment has been open for 6 months.

IPD Sharing Access Criteria

In order to be granted access to our dataset, the outside researcher would need to secure IRB approval for their proposed study and then would sign a YASU-provided confidentiality agreement.

Datasets shared with researchers outside of YASU will not include identifiers.

Future research collaborators outside of YASU may use the registry to contact participants for other studies and may have access to screen for candidates. Outside researchers who wish to use contacts from the YASU research registry in recruitment for their study will be required to secure IRB approval for their proposed study and to complete the YASU-provided confidentiality agreement prior to any possible participant contact information being shared. Once IRB-approval has been received and the agreement is completed, the PI (and/or YASU executive director) may grant the requestor access to the requested information.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No