Clinical trial NCT03741868: Symptom Burden and Unmet Supportive Care Needs in Lung Cancer Patients Undergoing First or Second Line Immunotherapy
Official title: Symptom Burden and Unmet Supportive Care Needs in Lung Cancer Patients Undergoing First or Second Line Immunotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Neoplasm
Keywords: Lung Cancer
Immunotherapy
Stage IV cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Lung Cancer Initiative of North Carolina
First posted: 2018-11-15
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Women of all races and ethnicity who meet the above-described eligibility criteria are eligible for this trial.
* Based on WFBCCC population estimates, we expect approximately 41% of participants to be women. Translating this to our sample size estimate of 60, we plan to enroll at least 25 women. Similarly, we expect approximately 1% of study participants to be Hispanic/Latin. 10% Black or African American, 1% American Indian/Alaska Native, 1% Asian. .

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: NCI-PRO-CTCAE items
timeFrame: Past 7 days prior to completion of survey
measure: PROMIS Fatigue
timeFrame: Past 7 days prior to completion of survey
measure: EORTC-QLQ-30 questionnaire
timeFrame: Past 7 days prior to completion of survey or 7 days after completion of survey
measure: Functional Assessment of Chronic Illness Therapy - Comprehensive Score for Financial Toxicity (FACIT-COST)
timeFrame: Past 7 days prior to completion of survey
measure: Supportive Care Needs Survey-Short Form 34 (SCNSF34) questionnaire
timeFrame: Past 30 days prior to completion of survey
Secondary outcomes:
measure: PROMIS Short Form Depression
timeFrame: Past 7 days prior to completion of survey
measure: Prognosis Treatment and Perceptions Questionnaire
timeFrame: Day 1 of completion of survey
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Laurie E Steffen
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Laurie Steffen, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.