Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Caregivers receive standard care and are then given a generic resource list at week 24.

Caregiver receive a generic resource list at the start of the study.

Caregivers receive access to the CONNECT tool, watch an educational video on self care and receive a personalized list of resources based on caregiver preferences. Caregivers also receive access to and complete at least 2 calls, at baseline and at week 4, with a caregiver navigator to review the resource list and address any additional needs.

Support for Caregiver - Generic List

Support for Caregiver - Personalized List

Internet-Based Intervention - CONNECT

Patient Navigation

Karen Craver

Kathryn Weaver, PhD

Clinical trial that tests the feasibility of a web based caregiver support resource, along with caregiver navigation sessions for caregivers of patients with stage II-IV lung cancer. The Caregiver Oncology Needs Evaluation Tool (CONNECT) is a novel web-based intervention designed for the community oncology setting, to systematically connect lung cancer caregivers with tailored supportive care resources. Lung cancer caregivers provide critical and challenging care for their loved ones and are at risk for their own negative psychosocial and physical outcomes. Implementing the CONNECT program along with caregiver navigation may provide additional support to caregivers of patients with stage II-IV lung cancer.

This study is a multi-site randomized pilot trial enrolling 120 lung cancer caregiver-patient dyads (i.e., lung cancer caregivers (n=120) and their care-recipients (n=120)) across approximately 8-12 practices to assess the multi-site feasibility of a caregiver technology-based intervention (CONNECT) to identify caregivers' needs and connect them with supportive care resources. Caregivers will be randomized 1:1:1 to either the CONNECT intervention, usual care comparison group or generic resource list comparison group. CONNECT is a web-based intervention that empowers and educates caregivers about the benefits of supportive care services and systematically identifies unmet needs to connect lung cancer caregivers with tailored supportive care resources. The Central Caregiver Navigator will assist caregivers with resolving barriers to accessing resources and work with the Local Practice Referral Coordinator to process referrals. Caregivers and patients will complete measures at baseline (prior to caregiver randomization), and 12 and 24 weeks after baseline. Feasibility measures (retention, accrual rates, and participation) will be evaluated to inform the future trial. The Local Practice Referral Coordinator for each practice will report on time needed for practice participation, referral processes, and communication processes with the Central Caregiver Navigator.

Participants (i.e., patients or care-recipients) will be asked to complete study surveys at three time points:

* After consenting and before randomization of participant and caregiver. (Initial survey)
* Approximately 12 weeks after completing the first survey (12-week survey)
* Approximately 24 weeks after completing the first survey (24-week survey)

Each survey will take about 30-45 minutes to complete. The forms will ask about things such as demographics (gender, race, etc.), cancer symptoms, satisfaction with cancer care and health behaviors. You don't have to answer any question that makes you feel uncomfortable. These surveys can be done remotely over the internet, in the clinic, by phone or by mail.

Caregivers will also complete surveys at three time points and will be assigned to 1 of 3 study groups:

* Group 1 will be given the usual care provided at your clinic. At the completion of the study, this group will be given the generic supportive care resource list for their use that Group 2 received.
* Group 2 will be provided with a generic supportive care resource list.
* Group 3 will be asked to watch a brief video and complete the web-based CONNECT program either in the clinic or on your own device. The CONNECT program is designed to help identify any unmet needs and connect the caregiver with tailored supportive care resources, based on specific needs. The CONNECT Navigator will follow-up with within 2 business days of completion of the program and again 4 weeks later.

Caregiver Participants (Group 1, 2 and 3) will be asked to complete study surveys at three time points:

* After consenting and before randomization of participant and caregiver. (Initial survey)
* Approximately 12 weeks after completing the first survey (12-week survey)
* Approximately 24 weeks after completing the first survey (24-week survey)

Each survey will take about 35-45 minutes to complete. The forms will ask about things such as demographics (gender, race, etc.), caregiving experience, use of supportive care resources, quality of life, mood, and social needs (housing, transportation, utilities, etc). You don't have to answer any question that makes you feel uncomfortable.

A Web-based Program to Help Caregivers of Lung Patients Learn About Available Supportive Care Resources

Multi-Site Community Oncology Planning for the CONNECT Intervention Targeting Lung Cancer Caregivers

Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.

Number of patients who agree to participate divided by the number of months of recruitment

Proportion of eligible patients who agreed to participate

Number of patients who complete at least 75% of the 12-week assessments divided by the number randomized

Number of patients who complete at least 75% of the 24-week assessments divided by the number randomized

Calculated as the following: Number of caregivers who complete at least 75% of the 12-week assessments divided by the number randomized. Retention will be estimated and reported along with an exact 95% confidence interval.

Number of caregivers who agree to participate divided by the number of months of recruitment

Proportion of eligible caregivers who agreed to participate

Number of caregivers who complete at least 75% of the 24-week assessments divided by the number randomized.

Self-report survey developed for this study to assess the degree to which caregivers found different aspects of CONNECT, the generic resource list, or usual care helpful using a Likert response from 0 (Not at all) to 5 (Very Much)

Will be summarized across practices using mean, median, standard deviation and interquartile range.

Will be summarized using appropriate descriptive statistics.

Will be summarized across practices using mean, median, standard deviation and interquartile range

National Cancer Institute (NCI)

Wake Forest University Health Sciences

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

* Ablation Procedure- MWA will be used to treat solitary pulmonary nodules up to 3cm.
* CT scan will then be performed to evaluate the radiological changes 2 - 4 weeks after the ablation procedure.
* Surgery will be performed to remove the lung nodule and the tissue will be evaluated by pathology.

Microwave ablation of the solitary pulmonary nodule will be performed through a bronchoscopic approach using the AveCure Flexible Microwave Ablation Probe before surgery

AveCure 16 Gauge Flexible Microwave Ablation Probe

Jason Beattie, MD

Adnan Majid, MD

Mihir S Parikh, MD

Beattie Jason, MD

This research study to determine the effectiveness of the AveCure Flexible Microwave Ablation Probe to destroy cancerous lung nodules up to 3 c m in size.

This research study involves microwave ablation (MWA)

This will be a single arm, prospective cohort study.

The names of the study intervention involved in this study is:

* Cone Beam Computed Tomography (CBCT)-guided electromagnetic navigational bronchoscopy (ENB) microwave ablation (MWA)
* A rapid on-site evaluation (ROSE) will be performed before the MWA to confirm that the lesion is malignant, this can lead to longer procedure time and time under anesthesia.

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

* Participants will receive the study intervention and will be followed for 30 days.
* It is expected that about 10 people will take part in this research study.

This research study is a Pilot Study, which is the first-time investigators are examining this intervention using a bronchoscopic approach for microwave ablation of solitary pulmonary nodules.

The U.S. Food and Drug Administration (FDA) has approved this intervention as a treatment option for this disease.

Avecure Flexible Microwave Ablation Probe For Lung Nodules

Feasibility and Efficacy of the AveCure Flexible Microwave Ablation Probe for Peripheral Lung Nodule

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Feasibility of performing the procedure as planned in the enrolled patients. At least 9/10 of the planned ablations (90%) can be performed bronchoscopically according to the established protocol.

Pathological evaluation of the acute thermal effect produced by the AveCUre 16G-FMAP on targeted malignant solitary lung nodules will be described. The % necrosis, % viable tumor, and % stroma/inflammation present in the targeted nodules after ablation will be described.

A secondary analysis of the tissue surrounding the treated area will be performed. The % necrosis and of % stroma/inflammation will be described.

Immune-histochemical evaluation including TTF-1, Napsin-A, p40, or other immune-histochemical assessments will be performed if needed on a per case basis.

MedWaves, Inc

Dana-Farber Cancer Institute

Beth Israel Deaconess Medical Center

Principal Investigator

Rare Diseases

Carcinoma

Small Cell Lung Carcinoma

Carcinoma, Small Cell

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Carboplatin

Etoposide

Cisplatin

Etoposide phosphate

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Patients undergo radiation therapy and receive cisplatin or carboplatin on day 1 of each cycle and etoposide on days 1-3 for 4 cycles. Patients then receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 1 year in the absence of disease progression or unacceptable toxicity. Patients undergo PET scan during screening. Patients also undergo MRI throughout the trial as well as CT. Additionally, patients undergo blood sample collection throughout the trial.

Computed Tomography

Positron Emission Tomography

Magnetic Resonance Imaging

Biospecimen Collection

Radiation Therapy

Vanderbilt-Ingram Services for Timely Access

Vanderbilt-Ingram Service Services for Timely Access

Ryan Ryan Whitaker, MD

Ryan Whitaker, MD, PhD

This phase II trial studies how well pembrolizumab after standard treatment with radiation plus the following chemotherapy drugs: cisplatin or carboplatin, plus etoposide works in treating patients with limited stage small cell lung cancer (LS-SCLC). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab after standard treatment with radiation plus chemotherapy may increase the ability of the immune system to fight LS-SCLC.

PRIMARY OBJECTIVE:

I. To investigate progression free survival per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by the investigator in patients with limited stage small cell lung cancer treated with adjuvant pembrolizumab.

SECONDARY OBJECTIVES:

I. Assess median overall survival compared to the historical control dataset (CONVERT trial1) median overall survival (OS) of 30 months.

II. Assess the safety and tolerability of adjuvant pembrolizumab in patients with limited stage SCLC.

EXPLORATORY/TRANSLATIONAL OBJECTIVES:

I. To determine whether patients with detectable circulating tumor deoxyribonucleic acid (ctDNA) after curative intent therapy ("minimal residual disease \[MRD\] positive") experience shorter median progression free survival (PFS) compared to patients without detectable ctDNA after curative intent therapy ("MRD negative.").

II. Determination of whether patients with ctDNA clearance at any point during curative intent therapy have superior median PFS compared to patients who do not experience ctDNA clearance during curative intent therapy.

OUTLINE:

Patients undergo radiation therapy and receive cisplatin or carboplatin on day 1 of each cycle and etoposide on days 1-3 for 4 cycles. Patients then receive pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 1 year in the absence of disease progression or unacceptable toxicity. Patients undergo positron emission tomography (PET) scan during screening. Patients also undergo magnetic resonance imaging (MRI) throughout the trial as well as computed tomography (CT). Additionally, patients undergo blood sample collection throughout the trial.

After completion of study treatment, patients are followed up at 30 days, and every 12 weeks for 2 years.

Pembrolizumab After Radiation Therapy and Chemotherapy in Limited Stage Small Cell Lung Cancer

A Single Arm Trial of Adjuvant Pembrolizumab in Patients With Limited Stage Small Cell Lung Cancer

Will be assessed by National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment.

Merck Sharp & Dohme LLC

Vanderbilt-Ingram Cancer Center

Assistant Professor of Medicine

Carcinoma, Non-Small-Cell Lung

Anti-Infective Agents

Fluorides

Fluorodeoxyglucose F18

Deoxyglucose

Radiopharmaceuticals

Antimetabolites

Antiviral Agents

Participants receive fludeoxyglucose F-18 IV and after 60 minutes undergo positron emission tomography (PET) within 4 weeks of the first planned stereotactic body radiation therapy (SBRT) fraction, prior to the second planned fraction, and prior to the fifth planned fraction.

Fludeoxyglucose F-18

Positron Emission Tomography (PET)

Stereotactic Body Radiation Therapy (SBRT)

Kristin Higgins, MD

This trial studies how well fludeoxyglucose F-18 - positron emission tomography (PET) works in planning radiation therapy in participants with early non-small cell lung cancer, early stage lung cancer, or cancer that has spread to lungs from other parts of the body. Using PET in addition to the standard computed tomography to plan radiation therapy for cancer may help doctors to maximize the dose to the cancer and minimize the dose to normal tissues.

PRIMARY OBJECTIVE:

To determine the maximum inter-fraction variability of fludeoxyglucose F-18 (18-F FDG)-PET activity of thoracic tumor treatment volumes through a 5-fraction stereotactic body radiation therapy (SBRT) course as it relates to the planning feasibility of emission-guided radiation therapy, or biologically-guided radiation therapy (BgRT).

SECONDARY OBJECTIVES:

I. To compare similar inter-fraction variability of FDG-PET activity for non-thoracic SBRT target volumes for the purpose of determining the feasibility of BgRT.

II. To compare dosimetric endpoints for primary tumor coverage and dose to organs at risk between conventional SBRT planning and simulated BgRT, or emission-guided radiation therapy planning for thoracic and non-thoracic targets.

III. To compare dosimetry for primary tumor coverage and dose to organs at risk between adaptive cone beam computed tomography (CT) planning, and simulated adaptive emission-guided radiation therapy (BgRT) planning for thoracic and non-thoracic targets.

IV. To compare variability of 18-F FDG-PET in patients undergoing immunotherapy simultaneously during SBRT, or within 4 weeks of SBRT treatment with patients undergoing SBRT but not receiving immunotherapy.

OUTLINE:

Participants receive fludeoxyglucose F-18 intravenously (IV) and after 60 minutes undergo PET within 4 weeks of the first planned SBRT fraction, prior to the second planned fraction, and prior to the fifth planned fraction.

Fludeoxyglucose F-18-PET in Planning Lung Cancer Radiation Therapy

A Pilot Study of FDG-PET Variability to Establish Biology-Guided Treatment Planning Feasibility for Stereotactic Body Radiation Therapy

Metabolic tumor volumes across the treatment continuum, i.e. pre-treatment, before second fraction and before the last fraction of treatment, will be compared. The observed % change from baseline will be calculated at all time points for all 15 patients and for every tumor treated with SBRT.

Total lesion glycolysis values across the treatment continuum, i.e. pre-treatment, before second fraction and before the last fraction of treatment, will be compared. The observed % change from baseline will be calculated at all time points for all 15 patients and for every tumor treated with SBRT.

Metabolic tumor volumes across the treatment continuum, i.e. pre-treatment, before second fraction and before the last fraction of treatment, will be compared. The observed % change from baseline will be calculated at all time points for all 15 patients.

Total lesion glycolysis values across the treatment continuum, i.e. pre-treatment, before second fraction and before the last fraction of treatment, will be compared. The observed % change from baseline will be calculated at all time points for all 15 patients.

RefleXion Medical

National Institutes of Health (NIH)

Emory University

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Digestive System Diseases

Prostatic Neoplasms

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Uterine Cervical Neoplasms

Carcinoma, Renal Cell

Kidney Neoplasms

Colorectal Neoplasms

Breast Diseases

Skin Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Kidney Diseases

Adenocarcinoma

Ovarian Cancer

Ovarian Epithelial Cancer

Renal Cell Carcinoma

Patients receive ASQ brochure and complete questionnaires over 30 minutes at baseline, over 10 minutes pre-clinic visit, and over 30 minutes post-clinic visit.

Behavioral Intervention

Susan Eggly, PhD

This clinical trial implements a communication intervention to improve patient-oncologist communication in the outpatient medical oncology setting. A communication brochure called the ASQ brochure may help patients prepare for the doctor visit by thinking through the questions that patients and patients' family want to ask the doctor.

Patient-centered communication is critical to providing high-quality care. In patient-provider clinical interactions, providers are responsible for several aspects of patient-centered communication. However, to reach the goal of providing the best possible treatments, patients should also actively participate by asking questions and expressing their concerns. Question prompt lists, simple lists of questions provided to patients before clinic visits to help them prepare for the appointment, have been tested in several medical contexts and patient populations, including among an underserved, minority population in Detroit, and have been shown to contribute to improved outcomes related to better communication quality. Using a RE-AIM framework, this descriptive, mixed methods, single-arm intervention study assesses the implementation of an evidence-based communication intervention (question prompt list), the "ASQ brochure". The ASQ brochure is designed to improve patient-oncologist communication and other outcomes by improving patient self-efficacy for managing patient-physician interactions. Investigators will recruit 225 patients and implement the ASQ brochure at seven Karmanos Cancer Center network sites. Participants are newly diagnosed patients with (Stages I-IV) cancer for which systemic therapy is likely a recommended treatment.

Ask Questions (ASQ):Implementation of a Communication Intervention

Ask Questions (ASQ): Implementation of a Communication Intervention to Improve Patient-Oncologist Communication in the Outpatient Medical Oncology Setting

6 investigator-developed questions; 5-point Likert scale (strongly disagree - strongly agree)

generally (before) and in a specific physician (after): (5 items20 Likert scale)

Distress thermometer (one item, Likert scale (no distress - extreme distress)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Web-based Program to Help Caregivers of Lung Patients Learn About Available Supportive Care Resources	NCT06383988	Stage II Lung C... Stage III Lung ... Stage IV Lung C...	Support for Car... Support for Car... Internet-Based ... Patient Navigat...	18 Years -	Wake Forest University Health Sciences
Avecure Flexible Microwave Ablation Probe For Lung Nodules	NCT05281237	Stage I - II Pr... Stage I Lung Ca... Stage II Lung C... Lung Cancer Sta... Lung Cancer Sta... Lung Cancer	AveCure 16 Gaug...	22 Years -	Beth Israel Deaconess Medical Center
Pembrolizumab After Radiation Therapy and Chemotherapy in Limited Stage Small Cell Lung Cancer	NCT06140407	Limited Stage L... Stage I Lung Ca... Stage II Lung C... Stage III Lung ...	Cisplatin Carboplatin Etoposide Pembrolizumab Computed Tomogr... Positron Emissi... Magnetic Resona... Biospecimen Col... Radiation Thera...	18 Years -	Vanderbilt-Ingram Cancer Center
Fludeoxyglucose F-18-PET in Planning Lung Cancer Radiation Therapy	NCT03493789	Stage I Lung Ca... Stage I Non-Sma... Stage IA Non-Sm... Stage IB Non-Sm... Stage II Lung C... Stage II Non-Sm... Stage IIA Non-S... Stage IIB Non-S...	Fludeoxyglucose... Positron Emissi... Stereotactic Bo...	18 Years -	Emory University
Ask Questions (ASQ):Implementation of a Communication Intervention	NCT05025748	Stage II Breast... Stage III Breas... Stage IV Breast... Stage II Colore... Stage III Color... Stage IV Colore... Stage II Lung C... Stage III Lung ... Stage IV Lung C... Stage II Prosta... Stage III Prost... Stage IV Prosta... Stage II Ovaria... Stage III Ovari... Stage IV Ovaria... Stage II Cervic... Stage III Cervi... Stage II Bladde... Stage III Bladd... Stage IV Bladde... Stage II Kidney... Stage III Kidne... Stage IV Kidney...	Behavioral Inte...	18 Years -	Barbara Ann Karmanos Cancer Institute
Fludeoxyglucose F-18-PET in Planning Lung Cancer Radiation Therapy	NCT03493789	Stage I Lung Ca... Stage I Non-Sma... Stage IA Non-Sm... Stage IB Non-Sm... Stage II Lung C... Stage II Non-Sm... Stage IIA Non-S... Stage IIB Non-S...	Fludeoxyglucose... Positron Emissi... Stereotactic Bo...	18 Years -	Emory University

Spots Global Cancer Trial Database for stage ii lung cancer