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

NCT03741868 | Completed

• 3 other identifiers: IRB00046256CCCWFU01517P30CA012197
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Neoplasm

Keywords

Lung Cancer; Immunotherapy; Stage IV cancer

Outcome Measures

Primary Outcomes (5)

• NCI-PRO-CTCAE items

  The NCI-PRO-CTCAE questionnaire will measure patient reported immune-mediated side effect frequency, severity, and interference of selected symptoms on a varied 1-5 scale with lower scales denoting better outcomes. Higher scores reflect greater symptom severity

  Past 7 days prior to completion of survey

• PROMIS Fatigue

  The PROMIS Fatigue questionnaire will measure patient reported fatigue on a varied 1-5 scale with lower scales denoting better outcomes. 8 items responded to on a 1-5 likert type scale, with higher scores reflecting greater fatigue.

  Past 7 days prior to completion of survey

• EORTC-QLQ-30 questionnaire

  EORTC-QLQ-30 questionnaire will measure the patient-reported disease and treatment related symptom severity and interference of 5 functional subscales and 9 symptom subscales. Items are rated on a four-point scale with 1 = not at all to 4 = very much. Subscales are transformed linearly to have a range of 0-100, with higher scores reflecting better function on the 5 functional scales or a higher symptom burden on the symptom scales

  Past 7 days prior to completion of survey or 7 days after completion of survey

• Functional Assessment of Chronic Illness Therapy - Comprehensive Score for Financial Toxicity (FACIT-COST)

  The FACIT-COST will measure patient reported financial toxicity on a 0 (not at all) - 4 (very much) scale with higher scores denoting better outcomes. Scores calculated following the FACIT scoring procedures such that a higher score represents less financial distress.

  Past 7 days prior to completion of survey

• Supportive Care Needs Survey-Short Form 34 (SCNSF34) questionnaire

  The Supportive Care Needs Survey-Short Form 34 questionnaire will measure unmet supportive care needs with a scale of 1 (not applicable) to 5 (high need) with lower score indicating better outcome. Responses are provided on a divided 5-point Likert scale (no unmet need indicated by 1 = not applicable or 2 = satisfied; unmet need indicated by 3 = low need, 4 = moderate need, or 5 = high need). The measure contains 5 domains: health system and information, patient care and support, physical and daily living, psychological, and sexual.

  Past 30 days prior to completion of survey

Secondary Outcomes (2)

• PROMIS Short Form Depression

  Past 7 days prior to completion of survey

• Prognosis Treatment and Perceptions Questionnaire

  Day 1 of completion of survey

Study Arms (1)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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. .

You may qualify if:

• 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

You may not qualify if:

• Unable to provide informed consent

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator
• Lung Cancer Initiative of North Carolina: collaborator

Study Sites (2)

Laurie E Steffen

Winston-Salem, North Carolina, 27157, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (2)

• 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.

  PMID: 31917067 RESULT

• 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.

  PMID: 36912809 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Laurie Steffen, Ph.D

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 15, 2018
• Study Start: October 16, 2016
• Primary Completion: July 19, 2018
• Study Completion: February 1, 2019
• Last Updated: July 24, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)