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Completed

NCT Number: NCT03741868

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Laurie E Steffen, Winston-Salem, North Carolina, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. NCI-PRO-CTCAE items

    Time frame: Past 7 days prior to completion of survey

    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

  2. PROMIS Fatigue

    Time frame: Past 7 days prior to completion of survey

    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.

  3. EORTC-QLQ-30 questionnaire

    Time frame: Past 7 days prior to completion of survey or 7 days after completion of survey

    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

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

    Time frame: Past 7 days prior to completion of survey

    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.

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

    Time frame: Past 30 days prior to completion of survey

    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.

Secondary outcomes

  1. PROMIS Short Form Depression

    Time frame: Past 7 days prior to completion of survey

    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.

  2. Prognosis Treatment and Perceptions Questionnaire

    Time frame: Day 1 of completion of survey

    Prognosis Treatment and Perceptions Questionnaire will measure the treatment expectations and prognostic understanding using 8 items with varied response options..

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Lung Cancer Initiative of North Carolina
  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Nov 15, 2018
Registry last updated
Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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