Registry Trial and Needs Assessment of Patients With Young-onset Lung Cancer: Impact of a Dedicated Care Program on Patient Experience and Outcomes

NCT ID: NCT07220096

Last Updated: 2025-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-25

Study Completion Date

2031-05-31

Brief Summary

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The goal of this research study is to learn about:

The effect of enrolling in the YOLC program on patient satisfaction with care provided,

The needs of patients younger than 50 with lung cancer and their family, and

The impact of participating in peer support networks on these patients.

Detailed Description

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Primary Objectives:

1. To determine whether enrollment in a dedicated program (YOLC) results in improved patient satisfaction with care provided.
2. To characterize the distinct needs of patients under age 50 diagnosed with lung cancer as well as those of their families, and how these needs may change over time throughout the care pathway.
3. To evaluate the impact of participation in peer support networks and whether it has a beneficial effect on the primary and secondary endpoints.

Secondary Objectives:

1. To determine whether enrollment in a dedicated program (YOLC) results in improved patient satisfaction with care provided.
2. To characterize the distinct needs of patients under age 50 diagnosed with lung cancer as well as those of their families, and how these needs may change over time throughout the care pathway.
3. To evaluate the impact of participation in peer support networks and whether it has a beneficial effect on the primary and secondary endpoints.
4. Overall survival, defined by time from diagnosis to death from any cause
5. Clinical trial enrollment, defined by participation in any therapeutic clinical trial related to lung cancer treatment after diagnosis
6. Completion of multi-disciplinary consultations, defined by patients completing consultations with at least one other specialist other than a thoracic medical oncologist or thoracic surgeon from time of initial consultation for the YOLC Program
7. Quality of life, as defined by FACT-LUNG
8. Financial toxicity, as defined by patient-reported financial burden, including out-of-pocket costs, insurance coverage issues, and impact of overall financial well-being (measured using validated financial toxicity scale such as COST-FACIT

Conditions

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Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Assessment of Patients with Young-Onset Lung Cancer

This is a registry trial enrolling participants with NSCLC diagnosed and histologically confirmed prior to the age of 50 years identified. Each participant will participate in an intake survey as well as periodic recurring surveys to provide feedback to the YOLC Program, to elucidate the individual participant's care needs, and to assess changes in personal goals, wellness, financial impact, and family support over time

Survey

Intervention Type OTHER

Participants will complete an intake survey and repeat surveys at the following time points:

* Baseline
* 3 months
* 6 months
* 9 months
* 12 months
* 18 months
* 24 months
* 36 months
* 48 months
* 60 months

Interventions

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Survey

Participants will complete an intake survey and repeat surveys at the following time points:

* Baseline
* 3 months
* 6 months
* 9 months
* 12 months
* 18 months
* 24 months
* 36 months
* 48 months
* 60 months

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age greater than 18 years and under 50 years
* Histologic confirmation of NSCLC
* Able to complete an English-language survey independently or with the assistance of a native-language interpreter
* Pregnant women- may be enrolled due to age range of subjects. (Low risk)

Exclusion Criteria

* Medical, psychiatric, cognitive, or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study.
* The following special patient population will be excluded from study group:

* Individuals who are not yet adults (infants, children, teenagers)
* Prisoners
* Cognitively-impaired adults
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Singhi, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Eric Singhi, MD

Role: CONTACT

713-745-2263

Facility Contacts

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Eric Singhi, MD

Role: primary

713-745-2263

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

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NCI-2025-07304

Identifier Type: OTHER

Identifier Source: secondary_id

2025-0646

Identifier Type: -

Identifier Source: org_study_id

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