Symptom Burden and Unmet Supportive Care Needs in Lung Cancer Patients Undergoing First or Second Line Immunotherapy

NCT ID: NCT03741868

Last Updated: 2020-07-24

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

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-16

Study Completion Date

2019-02-01

Brief Summary

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Doctors are recruiting patients receiving care for lung cancer at the Wake Forest Baptist Comprehensive Cancer Center asking about needs and experiences during immunotherapy. Immunotherapy is a new treatment for lung cancer. The research is to better understand patients' perspectives on what immunotherapy is like and will provide important information to help understand the symptoms patients experience, the impact of treatment on daily life, ways that people adapt to the challenges of treatment, and services that may help people live better during treatment.

Detailed Description

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The overall primary objective of this pilot study is to describe patient-reported symptom burden, unmet supportive care needs, and use of and interest in supportive care services in stage IV non-small cell lung cancer patients undergoing first or second line immunotherapy and to identify psychosocial factors associated with these outcomes.

60 stage IV non-small cell lung cancer patients will be recruited through the Wake Forest Baptist Comprehensive Cancer Center. The study team will use purposive sampling to assure representation of patients at different stages in immunotherapy (i.e., initiating treatment, anticipating scan results, after onset of immune-related side effects).

Conditions

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Lung Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Stage IV non-small cell lung cancer

60 - stage IV non-small cell lung cancer patients will be recruited through the Wake Forest Baptist Comprehensive Cancer Center to complete the quantitative portion of the study. We will use purposive sampling to assure representation of patients at different stages in immunotherapy (i.e., initiating treatment, anticipating scan results, after onset of immune-related side effects).12-15 of the 60 patients who complete the survey and who express interest in providing feedback on programs and participating in future research will be recruited to complete the qualitative portion of the study

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed stage IV (per AJCC 7th edition) non-small cell lung cancer.
* Receiving first or second line immunotherapy.
* ECOG Performance status of 0-3.
* English-speaking

Exclusion Criteria

* Unable to provide informed consent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Lung Cancer Initiative of North Carolina

UNKNOWN

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurie Steffen, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Laurie E Steffen

Winston-Salem, North Carolina, United States

Site Status

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

References

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Steffen McLouth LE, Lycan TW Jr, Levine BJ, Gabbard J, Ruiz J, Farris M, Grant SC, Pajewski NM, Weaver KE, Petty WJ. Patient-Reported Outcomes From Patients Receiving Immunotherapy or Chemoimmunotherapy for Metastatic Non-Small-Cell Lung Cancer in Clinical Practice. Clin Lung Cancer. 2020 May;21(3):255-263.e4. doi: 10.1016/j.cllc.2019.11.015. Epub 2019 Nov 29.

Reference Type RESULT
PMID: 31917067 (View on PubMed)

McLouth LE, Gabbard J, Levine BJ, Golden SL, Lycan TW, Petty WJ, Weaver KE. Prognostic Awareness, Palliative Care Use, and Barriers to Palliative Care in Patients Undergoing Immunotherapy or Chemo-Immunotherapy for Metastatic Lung Cancer. J Palliat Med. 2023 Jun;26(6):831-836. doi: 10.1089/jpm.2022.0352. Epub 2023 Mar 13.

Reference Type DERIVED
PMID: 36912809 (View on PubMed)

Other Identifiers

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CCCWFU01517

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00046256

Identifier Type: -

Identifier Source: org_study_id

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