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

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ClinicalTrials.gov Identifier: NCT03741868
Recruitment Status : Completed
First Posted : November 15, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Lung Cancer Initiative of North Carolina
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease
Lung Neoplasm

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.

50 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).


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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Symptom Burden and Unmet Supportive Care Needs in Lung Cancer Patients Undergoing First or Second Line Immunotherapy
Actual Study Start Date : October 16, 2016
Actual Primary Completion Date : July 19, 2018
Actual Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort
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



Primary Outcome Measures :
  1. NCI-PRO-CTCAE items [ Time Frame: 30-60 minutes ]
    The NCI-PRO-CTCAE questionnaire will measure patient reported immune-mediated side effect frequency, severity, and interference on a 1 (never/better) - 5 (always/worse) scale with lower scales denoting better outcomes.

  2. PROMIS Fatigue [ Time Frame: 30-60 minutes ]
    The PROMIS Fatigue questionnaire will measure patient reported immune-mediated side effect on a 1(never/better) - 5 (always/worse) scale with lower scales denoting better outcomes.

  3. EORTC-QLQ-30 questionnaire [ Time Frame: 30- 60 minutes ]
    EORTC-QLQ-30 questionnaire will be measure the patient-reported disease and treatment related symptom severity and interference on a scale of 1-4 with lower scores denoting better outcomes.

  4. Adapted Supportive Care Needs (Financial Toxicity) [ Time Frame: 30-60 minutes ]
    Adapted Supportive Care Needs (Financial Toxicity) will measure patient reported supportive care needs on a 0 (not at all) - 4 (very much) scale with higher scores denoting better outcomes.

  5. SF34 questionnaire [ Time Frame: 30 -60 minutes ]
    SF34 questionnaire will measure Interest in Supportive Care Needs with a scale of 1 (not applicable) to 5 (high need) with lower score indicating better outcome


Secondary Outcome Measures :
  1. PROMIS Short Form Depression [ Time Frame: 30-60 minutes ]
    PROMIS Short Form Depression will measure distress on a 1 (never) to 5 (always) scale with lower scores denoting better outcome.

  2. PRO-CTCAE questionnaire [ Time Frame: 30-60 minutes ]
    PRO-CTCAE questionnaire will measure impairment from disease and treatment symptoms on a 1 (never/better) - 5 (always/worse) scale with lower scales denoting better outcomes.

  3. Prognosis Treatment and Perceptions Questionnaire [ Time Frame: 30-60 minutes ]
    Prognosis Treatment and Perceptions Questionnaire will measure the interest and use of supportive care services and prognostic understanding with a scale of 0 (never/not at all) - 4 (always/extremely)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. .
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741868


Locations
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United States, North Carolina
Laurie E Steffen
Winston-Salem, North Carolina, United States, 27157
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Lung Cancer Initiative of North Carolina
Investigators
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Principal Investigator: Laurie Steffen, Ph.D Wake Forest University Health Sciences

Publications:
Fda expands approval of pembrolizumab for first-line treatment of non-small cell lung cancer [press release]. 2017
Peterman A, Cella D. The goal interference scale: Evaluation of a new individualized health outcome measure. Quality of Life Research. 2001:197-197
Steffen LE. The role of hope in daily functioning during treatment for lung cancer. In k.E. Vowles' symposium: What does
Rost AD, Wilson K, Buchanan E, Hildebrandt MJ, Mutch D. Improving psychological adjustment among late-stage ovarian cancer patients: Examining the role of avoidance in treatment. Cognitive and Behavioral Practice. 2012;19(4):508-517. http://dx.doi.org/10.1016/j.cbpra.2012.01.003

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03741868     History of Changes
Other Study ID Numbers: IRB00046256
CCCWFU01517 ( Other Identifier: Wake Forest Comprehensive Cancer Center )
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
Lung Cancer
Immunotherapy
Stage IV cancer

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs