SmokingNCT02835066
Patient Function/Fitness and Psychosocial Health in Improving Health-Related Quality of Life in Patients With Stage I-IV Non-Small Cell Lung Cancer
An observational study of Smoking and Lung Neoplasms, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This pilot trial studies patient function/fitness and psychosocial health in improving health-related quality of life and decreasing treatment-related toxicity in patients with stage I-IV non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Lung Neoplasms
- What is being tested?
- Integrated Fitness Assessment, Psychosocial Assessment and Care and Quality-of-Life Assessment
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jul 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Non-Small Cell Lung Cancer
Who may be able to join
- Newly diagnosed lung cancer
Who cannot join
- Previous or active lung cancer treatment at the time of registration
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: A Pilot Study Investigating Patient Function/Fitness and Psychosocial Health in Patients With Non-Small Cell Lung Cancer
This pilot trial studies patient function/fitness and psychosocial health in improving health-related quality of life and decreasing treatment-related toxicity in patients with stage I-IV non-small cell lung cancer. Studying function/fitness and psychosocial health may help doctors improve conventional therapy in patients with non-small cell lung cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the correlation of patient-reported health-related quality of life (HRQOL) outcomes with clinical/treatment variables as well as a panel of both function/fitness and psychosocial health assessments in non-small cell lung cancer (NSCLC).
SECONDARY OBJECTIVES:
- To investigate the panel of function/fitness and psychosocial health assessments with patient's smoking history/status as a predictor for treatment related toxicity.
TERTIARY OBJECTIVES:
- The documentation of the NSCLC lung population from this prospective combined with others.
OUTLINE:
Patients scheduled for surgery, radiation therapy, or chemotherapy complete the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-core 30 (C30) and QLQ-Lung Cancer 13 (LC13) in addition to psychosocial health and smoking status questions from baseline up to 2 weeks prior to the start of treatment, 5-6 weeks after treatment begins, and 5-6 months from the start of treatment. During the same time points, patients also undergo function/fitness assessments including standard health measurements, short physical performance battery (SPPB), 6 minute walk test (6MWT), and a grip strength test.
After completion of study treatment, patients are followed up every 3-6 months.
- Conditions
- Smoking, Lung Neoplasms
- Being tested
- Integrated Fitness Assessment, Psychosocial Assessment and Care, Quality-of-Life Assessment
- Keywords
- Stage I, Stage II, Stage IIIA, Stage IIIB, Stage IV, Non-Small Cell
- Medical subject headings
- Smoking, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Fitness AssessmentOther
Undergo function/fitness assessment
Psychosocial Assessment and CareProcedure or surgery
Also called Psychosocial Assessment, Psychosocial Care, Psychosocial Care/Assessment, Psychosocial Studies
Undergo psychosocial health assessments
Quality-of-Life AssessmentProcedure or surgery
Also called Quality of Life Assessment
Complete EORTC QLQ-C30 and QLQ-LC13 questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-Correlative (HRQOL, fitness and psychosocial health) | Patients scheduled for surgery, radiation therapy, or chemotherapy complete the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-core 30 (C30) and QLQ-Lung Cancer 13 (LC13) in addition to psychosocial health and smoking status questions from baseline up to 2 weeks prior to the start of treatment, 5-6 weeks after treatment begins, and 5-6 months from the start of treatment. During the same time points, patients also undergo function/fitness assessments including standard health measurements, short physical performance battery (SPPB), 6 minute walk test (6MWT), and a grip strength test. Receives: Other: Integrated Fitness Assessment; Procedure: Psychosocial Assessment and Care; Procedure: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient function/fitness
Assessed by standard health measurements.
Measured: Up to 6 months
Patient well-being
Assessed by questionnaires.
Measured: Up to 6 months
Patient function/fitness
Assessed by performance-based measures.
Measured: Up to 6 months
Patient well-being
Assessed by psychosocial health questions.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Brian Lally, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835066
- Sponsor's protocol ID
- CCCWFU 98515
- Other IDs
- NCI-2016-00649, CCCWFU 98515, P30CA012197
- Status last verified
- Jul 2018
- First submitted
- 12 May 2016
- Last updated
- 27 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Investigating Patient Function/Fitness and Psychosocial Health in Patients With Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02835066
- Acronym / sponsor ID
- CCCWFU 98515
- Conditions
- Smoking, Lung Neoplasms
- Keywords
- Stage I, Stage II, Stage IIIA, Stage IIIB, Stage IV, Non-Small Cell
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 15 Jul 2016 (estimated)
- 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.
This pilot trial studies patient function/fitness and psychosocial health in improving health-related quality of life and decreasing treatment-related toxicity in patients with stage I-IV non-small cell lung cancer. Studying function/fitness and psychosocial health may help doctors improve conventional therapy in patients with non-small cell lung cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine the correlation of patient-reported health-related quality of life (HRQOL) outcomes with clinical/treatment variables as well as a panel of both function/fitness and psychosocial health assessments in non-small cell lung cancer (NSCLC).
SECONDARY OBJECTIVES:
- To investigate the panel of function/fitness and psychosocial health assessments with patient's smoking history/status as a predictor for treatment related toxicity.
TERTIARY OBJECTIVES:
- The documentation of the NSCLC lung population from this prospective combined with others.
OUTLINE:
Patients scheduled for surgery, radiation therapy, or chemotherapy complete the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-core 30 (C30) and QLQ-Lung Cancer 13 (LC13) in addition to psychosocial health and smoking status questions from baseline up to 2 weeks prior to the start of treatment, 5-6 weeks after treatment begins, and 5-6 months from the start of treatment. During the same time points, patients also undergo function/fitness assessments including standard health measurements, short physical performance battery (SPPB), 6 minute walk test (6MWT), and a grip strength test.
After completion of study treatment, patients are followed up every 3-6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (HRQOL, fitness and psychosocial health) | – | Other: Integrated Fitness Assessment, Procedure: Psychosocial Assessment and Care, Procedure: Quality-of-Life AssessmentPatients scheduled for surgery, radiation therapy, or chemotherapy complete the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-core 30 (C30) and QLQ-Lung Cancer 13 (LC13) in addition to psychosocial health and smoking status questions from baseline up to 2 weeks prior to the start of treatment, 5-6 weeks after treatment begins, and 5-6 months from the start of treatment. During the same time points, patients also undergo function/fitness assessments including standard health measurements, short physical performance battery (SPPB), 6 minute walk test (6MWT), and a grip strength test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Non-Small Cell Lung Cancer
Key inclusion criteria (1 listed)
- Newly diagnosed lung cancer
Key exclusion criteria (1 listed)
- Previous or active lung cancer treatment at the time of registration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Fitness AssessmentUndergo function/fitness assessment | Other | Ancillary-Correlative (HRQOL, fitness and psychosocial health) |
| Psychosocial Assessment and CareAlso: Psychosocial Assessment, Psychosocial Care, Psychosocial Care/Assessment, Psychosocial StudiesUndergo psychosocial health assessments | Procedure or surgery | Ancillary-Correlative (HRQOL, fitness and psychosocial health) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentComplete EORTC QLQ-C30 and QLQ-LC13 questionnaires | Procedure or surgery | Ancillary-Correlative (HRQOL, fitness and psychosocial health) |
Primary outcome
Patient function/fitness
Time frame: Up to 6 months
Assessed by standard health measurements.
Patient well-being
Time frame: Up to 6 months
Assessed by questionnaires.
Patient function/fitness
Time frame: Up to 6 months
Assessed by performance-based measures.
Patient well-being
Time frame: Up to 6 months
Assessed by psychosocial health questions.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
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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.
Brian Lally principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking and Lung Neoplasms, run by Wake Forest University Health Sciences at 1 site 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 1 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: withdrawn, as of the sponsor's last update on 27 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Patient function/fitness (time frame: Up to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2018.