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

Lung Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03741868
• Other study ID #: IRB00046256
• Secondary ID: CCCWFU01517P30CA
• Status: Completed
• Start date: October 16, 2016
• Est. completion date: February 1, 2019

Study information

• Verified date: July 2020
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 1, 2019
• Est. primary completion date: July 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasm
• Lung Neoplasms

Locations

Country	Name	City	State
United States	Laurie E Steffen	Winston-Salem	North Carolina
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Lung Cancer Initiative of North Carolina, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Clinica — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	PROMIS Short Form Depression	PROMIS Short Form Depression will measure distress on a 1 (never) to 5 (always) scale with lower scores denoting better outcome on a 5-point likert-type scale. Higher scores reflect higher distress.	Past 7 days prior to completion of survey
Secondary	Prognosis Treatment and Perceptions Questionnaire	Prognosis Treatment and Perceptions Questionnaire will measure the treatment expectations and prognostic understanding using 8 items with varied response options..	Day 1 of completion of survey