Lung NeoplasmNCT03741868
Symptom Burden and Unmet Supportive Care Needs in Lung Cancer Patients Undergoing First or Second Line Immunotherapy
An observational study of Lung Neoplasm, run by Wake Forest University Health Sciences at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Neoplasm
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Oct 2016to 1 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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. .
Who may be able to join
- 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
Who cannot join
- Unable to provide informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Laurie E Steffen
Winston-Salem, North Carolina, 27157
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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).
- Conditions
- Lung Neoplasm
- Keywords
- Lung Cancer, Immunotherapy, Stage IV cancer
- Medical subject headings
- Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Past 30 days prior to completion of survey
Secondary outcomes (2)
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.
Measured: Past 7 days prior to completion of survey
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..
Measured: Day 1 of completion of survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start16 Oct 2016
- Primary completion19 Jul 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Lung Cancer Initiative of North Carolina
- Responsible party
- Sponsor
- Investigators
- Laurie Steffen, Ph.D, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741868
- Sponsor's protocol ID
- IRB00046256
- Other IDs
- CCCWFU01517, P30CA012197
- Status last verified
- Jul 2020
- First submitted
- 12 Nov 2018
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31917067McLouth 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.
PubMed 36912809
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Burden and Unmet Supportive Care Needs in Lung Cancer Patients Undergoing First or Second Line Immunotherapy
- ClinicalTrials.gov ID
- NCT03741868
- Acronym / sponsor ID
- IRB00046256
- Conditions
- Lung Neoplasm
- Keywords
- Lung Cancer, Immunotherapy, Stage IV cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Lung Cancer Initiative of North Carolina
- Study start
- 16 Oct 2016 (actual)
- Primary completion
- 19 Jul 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 15 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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. .
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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
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.
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.
2 secondary outcomes
PROMIS Short Form Depression
Time frame: Past 7 days prior to completion of survey
Prognosis Treatment and Perceptions Questionnaire
Time frame: Day 1 of completion of survey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Results publication: PubMed 31917067Steffen 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.
- Derived from this study: PubMed 36912809McLouth 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurie Steffen, Ph.D principal investigator
Wake Forest University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasm, run by Wake Forest University Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NCI-PRO-CTCAE items (time frame: Past 7 days prior to completion of survey). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03741868, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.