Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Patients and FCGs receive the MSM intervention consisting of videos, a handbook, and research nurse coaching over 40-60 minutes, approximately 3-7 days before surgery and within 24 hours of planned discharge. Patients and FCGs also receive research nurse support via telephone(separate sessions for FCGs and patients) over 20-30 minutes at 2 and 7 days, and 2 months post-discharge.

Patients and FCGs receive attention control intervention consisting of videos (American Cancer Society video on "Clinical Trials"), American Cancer Society print materials, and assistance from a CRA approximately 3-7 days before surgery and within 24 hours of planned discharge. Patients and FCGs also receive assistance from CRAs via telephone at 2 and 7 days, and 2 months post-discharge.

Informational Intervention

Receive MSM intervention research nurse coaching

Media Intervention

Quality-of-Life Assessment

Questionnaire Administration

Virginia Sun, RN, PhD

Jae Kim, MD

This randomized phase III trial studies how well a multimedia self-management intervention works in preparing family caregivers and patients with stage I-III lung cancer for lung cancer surgery. The multimedia self-management intervention, Preparing for your Lung Cancer Surgery, is a nurse-led, caregiver-based, multimedia intervention that may improve patient recovery after surgery, lower caregiving burden, and improve distress and quality of life.

PRIMARY OBJECTIVES:

I. Test the effects of the multimedia self-management (MSM) intervention on family caregivers (FCG) outcomes and cancer support services use at discharge and 3-month post-discharge, comparing intervention and attention control groups.

II. Test the effects of the MSM intervention on patient outcomes and healthcare resource use at discharge and 3-months post-discharge, comparing intervention and attention control groups.

III. Test the effects of the MSM intervention on outcome mediators at discharge and 3-months post-discharge, comparing intervention and attention control groups.

SECONDARY OBJECTIVES:

I. Explore moderators (age, sex, marital status, caregiver relationship to patient, caregiver employment status, co-morbidities) of FCG and patient outcomes and reciprocal relationships.

II. Determine, through exit interviews, participant's experience with the MSM intervention.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients and FCGs receive the MSM intervention consisting of videos, a handbook, and research nurse coaching over 40-60 minutes, approximately 3-7 days before surgery and within 24 hours of planned discharge. Patients and FCGs also receive research nurse support by telephone (separate sessions for FCGs and patients) over 20-30 minutes at 2 and 7 days, and 2 months post-discharge.

GROUP II: Patients and FCGs receive attention control intervention consisting of videos (American Cancer Society video on "Clinical Trials"), American Cancer Society print materials, and assistance from a clinical research associate (CRA) approximately 3-7 days before surgery and within 24 hours of planned discharge. Patients and FCGs also receive assistance from CRAs via telephone calls at 2 and 7 days, and 2 months post-discharge.

Multimedia Self-Management Intervention for Lung Cancer Surgery Family Caregivers and Patients

A Multimedia Self-management Intervention to Prepare Family Caregivers and Patients for Lung Cancer Surgery

National Cancer Institute (NCI)

City of Hope Medical Center

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Multiple Myeloma

Neoplasms, Plasma Cell

Prostatic Neoplasms

Adenocarcinoma

Stomach Neoplasms

Breast Neoplasms

Esophageal Neoplasms

Pancreatic Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Lymphoma

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Urinary Bladder Neoplasms

Melanoma

Thyroid Neoplasms

Thyroid Diseases

Carcinoma, Renal Cell

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Sarcoma

Kidney Neoplasms

Colorectal Neoplasms

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Neoplasms, Glandular and Epithelial

Breast Diseases

Skin Diseases

Hematologic 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

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Gonadal Disorders

Stomach Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Head and Neck Neoplasms

Esophageal Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Kidney Diseases

Stomach Cancer

Esophageal Cancer

Pancreatic Cancer

Myeloid Leukemia

Acute Myeloid Leukemia

Ovarian Cancer

Ovarian Epithelial Cancer

Lymphosarcoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Graft Versus Host Disease

Renal Cell Carcinoma

Acute Non Lymphoblastic Leukemia

Chronic Lymphocytic Leukemia

Participants complete a questionnaire at baseline. Participants undergo collection of blood samples at registration and at 12 months after registration. Patients with a cancer diagnosis may undergo collection of tissue samples at registration and 12 months after registration.

Undergo collection of tissue and blood samples

Biospecimen Collection

Marie Wood, MD

Site Public Contact

Alison K. Conlin

Nicholas DiBella

John A. Ellerton

Shahzad Siddique

Jay W. Carlson

Luis Mariscal

Lisa Bailey

Mark E. Reeves

Pankaj Gupta

Constantin A. Dasanu

Tyler Y. Kang

Gigi Q. Chen

Jessica D. McDermott

Marie E. Wood

Talib Dosani

Lucile L. Adams-Campbell

Vijaya K. Gadiyaram

Alan Bruce Grosset

Christopher M. Reynolds

Wayne B. Harris

William E. Burak

John M. Schallenkamp

This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.

PRIMARY OBJECTIVE:

I. To provide a blinded reference set of cancer versus (vs.) non-cancer blood samples that will be used to validate assays for inclusion in a prospective clinical trial focused on utility of blood-based multi-cancer early detection.

SECONDARY OBJECTIVES:

I. Evaluate test performance at the time of initial cancer diagnosis by tumor type.

II. Evaluate test performance at the time of initial cancer diagnosis by clinical stage.

OUTLINE:

Participants complete a questionnaire at baseline. Participants undergo collection of blood samples at registration and at 12 months after registration. Patients with a cancer diagnosis may undergo collection of tissue samples at registration and 12 months after registration.

After completion of study, participants are followed up at 1 year.

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

Blinded Reference Set for Multicancer Early Detection Blood Tests

Diagnostic ability will be assessed across the entire cohort of 2000 subjects by estimating the sensitivity and specificity with 95% confidence intervals.

Diagnostic ability is assessed within each cancer type and within each cancer type and stage combination by estimating the sensitivity and specificity with 95% confidence intervals. The width of these confidence intervals will vary by sample size and the sensitivity and specificity rates.

Diagnostic ability is assessed within each cancer stage and within each cancer type and stage combination by estimating the sensitivity and specificity with 95% confidence intervals. The width of these confidence intervals will vary by sample size and the sensitivity and specificity rates.

Alliance for Clinical Trials in Oncology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Multimedia Self-Management Intervention for Lung Cancer Surgery Family Caregivers and Patients	NCT03686007	Caregiver Stage I Lung Ca... Stage IA Lung C... Stage IB Lung C... Stage II Lung C... Stage IIA Lung ... Stage IIB Lung ... Stage III Lung ... Stage IIIA Lung... Stage IIIB Lung...	Informational I... Informational I... Informational I... Informational I... Media Intervent... Media Intervent... Quality-of-Life... Questionnaire A...	21 Years -	City of Hope Medical Center
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection	NCT05334069	Acute Lymphobla... Acute Myeloid L... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Chronic Lymphoc... Chronic Myeloid... Gastroesophagea... Head and Neck C... Hematopoietic a... Invasive Breast... Kidney Carcinom... Malignant Hepat... Malignant Solid... Melanoma Muscle-Invasive... RISS Stage I Pl... RISS Stage II P... RISS Stage III ... Sarcoma Stage I Bladder... Stage I Breast ... Stage I Colorec... Stage I Esophag... Stage I Gastric... Stage I Lung Ca... Stage I Ovarian... Stage I Pancrea... Stage I Prostat... Stage I Uterine... Stage II Bladde... Stage II Breast... Stage II Colore... Stage II Esopha... Stage II Gastri... Stage II Lung C... Stage II Ovaria... Stage II Pancre... Stage II Prosta... Stage II Uterin... Stage III Bladd... Stage III Breas... Stage III Color... Stage III Esoph... Stage III Gastr... Stage III Lung ... Stage III Ovari... Stage III Pancr... Stage III Prost... Stage III Uteri... Stage IV Bladde... Stage IV Breast... Stage IV Colore... Stage IV Esopha... Stage IV Gastri... Stage IV Lung C... Stage IV Ovaria... Stage IV Pancre... Stage IV Prosta... Stage IV Uterin... Thyroid Gland C...	Questionnaire A... Biospecimen Col...	40 Years - 75 Years	Alliance for Clinical Trials in Oncology

Spots Global Cancer Trial Database for stage ii lung cancer ajcc v7