Advanced Lung CarcinomaNCT05342571
A Biobehavioral/Cognitive Treatment for Stress, Depression, and Anxiety in Patients With Stage IV Lung Cancer
A study testing Behavioral, Psychological or Informational Intervention, Biospecimen Collection and Electronic Health Record Review in people with Advanced Lung Carcinoma and Metastatic Lung Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This phase IIb trial studies the effect of a biobehavioral/cognitive (ABC) treatment on stress, depression, and anxiety in patients with stage IV lung cancer. Advanced lung cancer and stress or depression are associated with increased inflammation and decreased immunity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Lung Carcinoma, Metastatic Lung Carcinoma, Stage IV Lung Cancer AJCC v8
- What is being tested?
- Behavioral, Psychological or Informational Intervention, Biospecimen Collection and Electronic Health Record Review
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 1 Sep 2022
- Phase
- Interventional
- 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
Who may be able to join
- Individuals diagnosed with advanced (stage IV) lung cancer with diagnosis and staging confirmed by pathology report
- Moderate to severe symptoms of depression (>= 8 on Patients Health Questionaire-9) and/or moderate to severe symptoms of anxiety (>= 10 on Generalized Anxiety Disorder-7; GAD-7)
- English-speaking
- Willingness to provide access to medical records, provide biospecimens, and responses to patient reported outcome (PRO) assessments
- Ability to understand and willingness to sign an informed consent document
Who cannot join
- Patients to be treated with definitive chemo-radiotherapy
- Presence of untreated brain metastases
- Previous lung cancer diagnosis
- Presence of disabling hearing, vision, or impairing psychiatric conditions (e.g., psychosis, bipolar disorder, substance abuse) preventing consent or completion of self-report measures in English
- Imminent risk of suicide that precludes outpatient treatment
- Currently receiving psychological treatment/counseling
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Stress and Immunity in Lung Cancer Patients: Pilot Test of a Biobehavioral/Cognitive (ABC) Treatment for Stress, Depression, and Anxiety
This phase IIb trial studies the effect of a biobehavioral/cognitive (ABC) treatment on stress, depression, and anxiety in patients with stage IV lung cancer. Advanced lung cancer and stress or depression are associated with increased inflammation and decreased immunity. ABC is a combination of biobehavioral intervention, which studies the interaction between behavioral and biological processes, and cognitive therapy for the treatment for anxiety and depressive disorders. Giving ABC during lung cancer treatment may reduce stress, depression, and anxiety, and improve patients' quality of life and health.
Read the detailed description
PRIMARY OBJECTIVES:
- Conduct a phase IIb pilot of a biobehavioral/cognitive (ABC) therapy intervention for patients with advanced (stage IV) lung cancer (N=40) with moderate to severe depressive symptoms and determine feasibility and treatment adherence.
II. Mode of delivery (in person, virtual), frequency of contact, and duration of contacts are studied to identify efficiencies to achieve clinical change.
SECONDARY OBJECTIVES:
- Pre/post treatment change on patient reported outcomes (PROs) for depressive symptoms, anxiety symptoms, cancer specific stress, and physical symptoms.
II. Compare patients' ABC outcomes to responses of a matched sample (n=40) of patients previously accrued to BLCIO (Beating Lung Cancer in Ohio; ClinicalTrials.gov Identifier: NCT03199651) completing the same measures at equivalent time points using archival, deidentified data.
TERTIARY OBJECTIVES:
- To evaluate effects of ABC on prognostic cell numbers/ratios (i.e., neutrophil/lymphocyte ratio, platelet/lymphocyte ratio, and advanced lung cancer inflammation indices) from patients pre to post ABC and comparable time points for the matched BLCIO sample using electronic medical record (eMR) data.
II. To evaluate effects of ABC on immunity, conducting correlative studies of inflammation, immune suppressive cells, and downstream effects on T- and natural killer (NK) cell function, using serum samples from ABC patients drawn at accrual, prior to cancer treatment, and 1 and 2 months during treatment.
OUTLINE:
INTENSIVE I PHASE: Patients participate in ABC sessions consisting of weekly, hour-long sessions for 10 weeks.
INTENSIVE II PHASE: Patients not achieving full remission after the first 10 weeks receive 4 additional weekly sessions.
MAINTENANCE PHASE (Optional): Patients may participate in 1 ABC session monthly for 4 months. These maintenance sessions serve as "booster" sessions.
Patients' medical records are reviewed, and will receive a patient guidebook to provide session-by-session descriptions to assist the patient to focus on the content and homework assignment completion. Patients also complete surveys at pre-treatment, every 2 months during cancer treatment, at post-treatment, and at 1 and 2 months follow-up. Patients also undergo blood collection at the time of initial diagnostic work-up, and at protocol weeks 5, 10, and 15.
- Conditions
- Advanced Lung Carcinoma, Metastatic Lung Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
- Being tested
- Behavioral, Psychological or Informational Intervention, Biospecimen Collection, Electronic Health Record Review, Informational Intervention, Survey Administration
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral, Psychological or Informational InterventionOther
Participate in ABC session
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected
Undergo blood sample collection
Electronic Health Record ReviewOther
Medical records reviewed
Informational InterventionOther
Receive patient guidebook
Survey AdministrationOther
Complete surveys
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (ABC session, surveys, biospecimen collection) | Experimental | Phase 1 of the intervention (10 weeks) will follow the following agenda: 1) Overview and progressive muscle relaxation, 2) Seeking and asking for disease-related and treatment-related information, 3) Problem solving skills, 4) Breathing techniques and sleep hygiene, 5) Assertive communication skills, 6) Identifying social network, 7) Asking for support, 8) Further information on social support, 9) Physical activity, and 10) Review of major topics, transition. Phase 2 of the intervention (4 weeks) which will be completed only by patients who do not experience remission in depressive symptoms by the end of phase 1, will follow the following agenda: 1) Identifying negative thoughts and problematic thinking patterns, 2) Generating alternative thoughts, 3) Behavioral activation, and 4) Review and wrap-up, transition to optional maintenance. Each session in Phase 1 and Phase 2 occurs once per week, for 60 minutes each. Maintenance sessions occur monthly, 60 minutes each. Receives: Other: Behavioral, Psychological or Informational Intervention; Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Informational Intervention; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability, measured by Patient Satisfaction Survey (PSS)
Descriptive statistics of Patient Satisfaction Survey scores will examine if patient satisfaction scores for a biobehavioral/cognitive (ABC) treatment are "mostly satisfied." The PSS is a 15-item measure which asks patients to rate each ABC intervention component on a 4-point Likert scale ranging from 1 ("not helpful at all") to 4 ("very helpful). Items are summed and averaged. An average score of 3 or higher is considered to represent treatment satisfaction.
Measured: Up to 2 months post-treatment
Retention
Descriptive statistics of patient enrollment and retention rate for ABC will also be used. Patient enrollment will be measured by counting the number of patients who sign consent and enroll onto the trial. Retention will be measured by calculating the number of patients who complete 7 of 14 sessions (50%).
Measured: Baseline up to 2 months post-treatment
Change of depressive symptoms using Patient Health Questionnaire-9 (PHQ-9)
Dependent-samples t-tests will examine feasibility by testing change of depressive symptoms via the PHQ-9 from pre- to post-treatment. The PHQ-9 scores can range from 0 to 27, with higher scores indicating more severe depression.
Measured: Baseline up to 2 months post-treatment
Change of anxiety symptoms using Generalized Anxiety Disorder Scale (GAD-7)
Dependent-samples t-tests will examine feasibility by testing change of anxiety symptoms via the GAD-7 from pre- to post-treatment. The GAD-7 scores can range from 0 to 21, with higher scores indicating more severe anxiety.
Measured: Baseline up to 2 months post-treatment
Biospecimen analysis: Neutrophil/lymphocyte ratio (NLR)
Neutrophil/lymphocyte ratio (NLR) will be calculated by collecting neutrophil count and lymphocyte count from laboratory tests, and dividing neutrophil by lymphocyte count to receive the ratio. This will be conducted at 4 time points: baseline, week 5, week 10, and week 15. Changes in NLR over time will be evaluated using longitudinal mixed models within a joint modeling framework.
Measured: Baseline to Week 15
Biospecimen analysis: Platelet/lymphocyte ratio (PLR)
Platelet/lymphocyte ratio (PLR) will be calculated by collecting platelet count and lymphocyte count from laboratory tests, and dividing platelets by lymphocyte count to receive the ratio. This will be conducted at 4 time points: baseline, week 5, week 10, and week 15. Changes in PLR over time will be evaluated using longitudinal mixed models within a joint modeling framework.
Measured: Baseline to Week 15
Biospecimen analysis: Inflammation (Interleukin-6)
Inflammation will be calculated by conducting the Interleukin-6 (IL-6) immunoassay on patient blood samples. This will be conducted at 4 time points: baseline, week 5, week 10, and week 15. Changes in NLR over time will be evaluated using longitudinal mixed models within a joint modeling framework.
Measured: Baseline to Week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Jun 2021
- Primary completion30 Jul 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Andersen, Ohio State University Comprehensive Cancer Center
- Investigators
- Barbara Andersen, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342571
- Sponsor's protocol ID
- OSU-20339
- Other IDs
- NCI-2020-08120
- Status last verified
- Oct 2023
- First submitted
- 29 Nov 2021
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress and Immunity in Lung Cancer Patients: Pilot Test of a Biobehavioral/Cognitive (ABC) Treatment for Stress, Depression, and Anxiety
- ClinicalTrials.gov ID
- NCT05342571
- Acronym / sponsor ID
- OSU-20339
- Conditions
- Advanced Lung Carcinoma, Metastatic Lung Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 22 Apr 2022 (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.
This phase IIb trial studies the effect of a biobehavioral/cognitive (ABC) treatment on stress, depression, and anxiety in patients with stage IV lung cancer. Advanced lung cancer and stress or depression are associated with increased inflammation and decreased immunity. ABC is a combination of biobehavioral intervention, which studies the interaction between behavioral and biological processes, and cognitive therapy for the treatment for anxiety and depressive disorders. Giving ABC during lung cancer treatment may reduce stress, depression, and anxiety, and improve patients' quality of life and health.
Detailed description
PRIMARY OBJECTIVES:
- Conduct a phase IIb pilot of a biobehavioral/cognitive (ABC) therapy intervention for patients with advanced (stage IV) lung cancer (N=40) with moderate to severe depressive symptoms and determine feasibility and treatment adherence.
II. Mode of delivery (in person, virtual), frequency of contact, and duration of contacts are studied to identify efficiencies to achieve clinical change.
SECONDARY OBJECTIVES:
- Pre/post treatment change on patient reported outcomes (PROs) for depressive symptoms, anxiety symptoms, cancer specific stress, and physical symptoms.
II. Compare patients' ABC outcomes to responses of a matched sample (n=40) of patients previously accrued to BLCIO (Beating Lung Cancer in Ohio; ClinicalTrials.gov Identifier: NCT03199651) completing the same measures at equivalent time points using archival, deidentified data.
TERTIARY OBJECTIVES:
- To evaluate effects of ABC on prognostic cell numbers/ratios (i.e., neutrophil/lymphocyte ratio, platelet/lymphocyte ratio, and advanced lung cancer inflammation indices) from patients pre to post ABC and comparable time points for the matched BLCIO sample using electronic medical record (eMR) data.
II. To evaluate effects of ABC on immunity, conducting correlative studies of inflammation, immune suppressive cells, and downstream effects on T- and natural killer (NK) cell function, using serum samples from ABC patients drawn at accrual, prior to cancer treatment, and 1 and 2 months during treatment.
OUTLINE:
INTENSIVE I PHASE: Patients participate in ABC sessions consisting of weekly, hour-long sessions for 10 weeks.
INTENSIVE II PHASE: Patients not achieving full remission after the first 10 weeks receive 4 additional weekly sessions.
MAINTENANCE PHASE (Optional): Patients may participate in 1 ABC session monthly for 4 months. These maintenance sessions serve as "booster" sessions.
Patients' medical records are reviewed, and will receive a patient guidebook to provide session-by-session descriptions to assist the patient to focus on the content and homework assignment completion. Patients also complete surveys at pre-treatment, every 2 months during cancer treatment, at post-treatment, and at 1 and 2 months follow-up. Patients also undergo blood collection at the time of initial diagnostic work-up, and at protocol weeks 5, 10, and 15.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (ABC session, surveys, biospecimen collection) | Experimental | Other: Behavioral, Psychological or Informational Intervention, Procedure: Biospecimen Collection, Other: Electronic Health Record Review, Other: Informational Intervention, Other: Survey AdministrationPhase 1 of the intervention (10 weeks) will follow the following agenda: 1) Overview and progressive muscle relaxation, 2) Seeking and asking for disease-related and treatment-related information, 3) Problem solving skills, 4) Breathing techniques and sleep hygiene, 5) Assertive communication skills, 6) Identifying social network, 7) Asking for support, 8) Further information on social support, 9) Physical activity, and 10) Review of major topics, transition. Phase 2 of the intervention (4 weeks) which will be completed only by patients who do not experience remission in depressive symptoms by the end of phase 1, will follow the following agenda: 1) Identifying negative thoughts and problematic thinking patterns, 2) Generating alternative thoughts, 3) Behavioral activation, and 4) Review and wrap-up, transition to optional maintenance. Each session in Phase 1 and Phase 2 occurs once per week, for 60 minutes each. Maintenance sessions occur monthly, 60 minutes each. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals diagnosed with advanced (stage IV) lung cancer with diagnosis and staging confirmed by pathology report
- Moderate to severe symptoms of depression (>= 8 on Patients Health Questionaire-9) and/or moderate to severe symptoms of anxiety (>= 10 on Generalized Anxiety Disorder-7; GAD-7)
- English-speaking
- Willingness to provide access to medical records, provide biospecimens, and responses to patient reported outcome (PRO) assessments
- Ability to understand and willingness to sign an informed consent document
Key exclusion criteria (6 listed)
- Patients to be treated with definitive chemo-radiotherapy
- Presence of untreated brain metastases
- Previous lung cancer diagnosis
- Presence of disabling hearing, vision, or impairing psychiatric conditions (e.g., psychosis, bipolar disorder, substance abuse) preventing consent or completion of self-report measures in English
- Imminent risk of suicide that precludes outpatient treatment
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 |
|---|---|---|
| Behavioral, Psychological or Informational InterventionParticipate in ABC session | Other | Supportive care (ABC session, surveys, biospecimen collection) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen CollectedUndergo blood sample collection | Procedure or surgery | Supportive care (ABC session, surveys, biospecimen collection) |
| Electronic Health Record ReviewMedical records reviewed | Other | Supportive care (ABC session, surveys, biospecimen collection) |
| Informational InterventionReceive patient guidebook | Other | Supportive care (ABC session, surveys, biospecimen collection) |
| Survey AdministrationComplete surveys | Other | Supportive care (ABC session, surveys, biospecimen collection) |
Primary outcome
Acceptability, measured by Patient Satisfaction Survey (PSS)
Time frame: Up to 2 months post-treatment
Descriptive statistics of Patient Satisfaction Survey scores will examine if patient satisfaction scores for a biobehavioral/cognitive (ABC) treatment are "mostly satisfied." The PSS is a 15-item measure which asks patients to rate each ABC intervention component on a 4-point Likert scale ranging from 1 ("not helpful at all") to 4 ("very helpful). Items are summed and averaged. An average score of 3 or higher is considered to represent treatment satisfaction.
Retention
Time frame: Baseline up to 2 months post-treatment
Descriptive statistics of patient enrollment and retention rate for ABC will also be used. Patient enrollment will be measured by counting the number of patients who sign consent and enroll onto the trial. Retention will be measured by calculating the number of patients who complete 7 of 14 sessions (50%).
Change of depressive symptoms using Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline up to 2 months post-treatment
Dependent-samples t-tests will examine feasibility by testing change of depressive symptoms via the PHQ-9 from pre- to post-treatment. The PHQ-9 scores can range from 0 to 27, with higher scores indicating more severe depression.
Change of anxiety symptoms using Generalized Anxiety Disorder Scale (GAD-7)
Time frame: Baseline up to 2 months post-treatment
Dependent-samples t-tests will examine feasibility by testing change of anxiety symptoms via the GAD-7 from pre- to post-treatment. The GAD-7 scores can range from 0 to 21, with higher scores indicating more severe anxiety.
Biospecimen analysis: Neutrophil/lymphocyte ratio (NLR)
Time frame: Baseline to Week 15
Neutrophil/lymphocyte ratio (NLR) will be calculated by collecting neutrophil count and lymphocyte count from laboratory tests, and dividing neutrophil by lymphocyte count to receive the ratio. This will be conducted at 4 time points: baseline, week 5, week 10, and week 15. Changes in NLR over time will be evaluated using longitudinal mixed models within a joint modeling framework.
Biospecimen analysis: Platelet/lymphocyte ratio (PLR)
Time frame: Baseline to Week 15
Platelet/lymphocyte ratio (PLR) will be calculated by collecting platelet count and lymphocyte count from laboratory tests, and dividing platelets by lymphocyte count to receive the ratio. This will be conducted at 4 time points: baseline, week 5, week 10, and week 15. Changes in PLR over time will be evaluated using longitudinal mixed models within a joint modeling framework.
Biospecimen analysis: Inflammation (Interleukin-6)
Time frame: Baseline to Week 15
Inflammation will be calculated by conducting the Interleukin-6 (IL-6) immunoassay on patient blood samples. This will be conducted at 4 time points: baseline, week 5, week 10, and week 15. Changes in NLR over time will be evaluated using longitudinal mixed models within a joint modeling framework.
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 23 Oct 2023.
- The JameslineLink provided by the sponsor.
- 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.
Barbara Andersen, PhD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral, Psychological or Informational Intervention, Biospecimen Collection and Electronic Health Record Review in people with Advanced Lung Carcinoma and Metastatic Lung Carcinoma, run by Ohio State University Comprehensive Cancer Center 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 5 inclusion and 6 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 23 Oct 2023. 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 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?
Acceptability, measured by Patient Satisfaction Survey (PSS) (time frame: Up to 2 months post-treatment). The study lists 7 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 23 Oct 2023.