Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Patients receive educational materials in the mail about lung cancer screening with a cover letter from their physician. A week later, they receive a phone call from the study staff to assess their eligibility. Eligible and interested patients receive an office visit at the JLCSP for shared decision-making and possible lung cancer screening.

Patients receive educational materials in the mail about lung cancer screening with a cover letter from their physician. A week later, they receive a phone call from the study staff to assess their eligibility. Patients then undergo a decision counseling session through a semi-structured Decision Counseling Program that includes a review of the mailed educational materials and completion of an interactive exercise intended to clarify personal preference related to screening options (to have LDCT or not to have LDCT). Patients interested in screening schedule an office visit at JLCSP for possible screening or are referred to their primary care physician for consultation.

Best Practice

Cancer Educational Materials

Receive shared decision making and lung cancer screening information

Behavioral, Psychological or Informational Intervention

Counseling

Ronald Myers

This trial studies how well proactive outreach and shared decision making works in improving lung cancer screening rates in primary care patients. Proactive outreach and shared decision making strategies may help to improve the detection of lung cancer at an earlier stage through screening.

PRIMARY OBJECTIVES:

I. To compare the combined intervention group (Outreach Contact Group \[OC\]/Outreach Contact and Decision Counseling Group \[OC-DCP\]) versus the control usual care group (UC) with respect to time to screening with low dose computed tomography (LDCT).

SECONDARY OBJECTIVES:

I. To compare the combined intervention (OC/OC-DCP) and usual care (UC) groups with respect to the fraction of patients who are referred/scheduled for screening.

II. To compare the combined intervention (OC/OC-DCP) and usual care (UC) groups with respect to the proportion of the referred/scheduled patients who actually keep their screening appointment.

III. To determine cost of implementing the OC and OC-DCP interventions.

EXPLORATORY OBJECTIVES:

I. To compare the two intervention groups (OC-DCP versus \[vs.\] OC) on the primary and secondary study endpoints (time to LDCT screening, proportion of patients referred/scheduled for screening, proportion of patients keeping their screening appointments, and cost).

II. To assess the feasibility of patient eligibility review by providers in the OC and OC-DCP arms.

III. To assess the difference in success in identifying eligible patients between arms.

IV. To assess the difference in reaching referred patients between arms.

OUTLINE: Patients are randomized to 1 of 3 groups.

GROUP I (USUAL CARE): Patients receive usual care.

GROUP II (OUTREACH CONTACT): Patients receive educational materials in the mail about lung cancer screening with a cover letter from their physician. A week later, they receive a phone call from the study staff to assess their eligibility. Eligible and interested patients receive an office visit at the Jefferson Lung Cancer Screening Program (JLCSP) for shared decision-making and possible lung cancer screening.

GROUP III (OUTREACH + DECISION COUNSELING PROGRAM): Patients receive educational materials in the mail about lung cancer screening with a cover letter from their physician. A week later, they receive a phone call from the study staff to assess their eligibility. Patients then undergo a decision counseling session through a semi-structured Decision Counseling Program that includes a review of the mailed educational materials and completion of an interactive exercise intended to clarify personal preference related to screening options (to have LDCT or not to have LDCT). Patients interested in screening schedule an office visit at JLCSP for possible screening or are referred to their primary care physician for consultation.

After completion of study, patients are followed up for 90 days.

Proactive Outreach and Shared Decision Making in Improving Lung Cancer Screening Rates in Primary Care Patients

Proactive Outreach and Shared Decision Making to Improve Lung Cancer Screening Rates Among Primary Care Patients

Will be assessed through a review of electronic health records data at the end of the study. The main analysis will compare the combined intervention group and the usual care group (Outreach Contact \[OC\]/OC-Decision Counseling Program \[DCP\] versus \[vs.\] usual care \[UC\]) with the Kaplan-Meier method and the log-rank test (stratified by practice). Further analyses will rely on Cox proportional hazards regression to explore the difference between OC and OC-DCP groups, as well as differences across practices and patient characteristics (age, gender, race, current vs. former smoking, etc.).

Thomas Jefferson University

Patients or parents/legal guardians of patients receive FRP brochure at the time of iMPACT consent.

Patients or parents/legal guardians of patients receive FRP brochure at the time of iMPACT consent and a follow-up phone call on day 3 after iMPACT consent.

Follow-Up Care

Questionnaire

Hala Borno, MD

This trial studies how well a follow-up phone call regarding financial reimbursement program (FRP) works in improving cancer patients' access to therapeutic cancer clinical trials. Follow-up phone call intervention regarding FRP may improve recruitment of cancer patients to cancer therapeutic clinical trials.

There are limited financial models that address the economic hardship associated with clinical research participation and how it might restrict clinical research access. The Lazarex Foundation offers a financial reimbursement program (FRP) to help patients and caregivers cover the out-of-pocket costs associated with clinical trial participation for almost ten years.

iMPACT is a pilot study to assess the overall feasibility of conducting a multi-center trial of the Lazarex sliding scale FRP among sociodemographically diverse patients of all cancer types enrolling/potentially enrolling in therapeutic clinical trials (TCTs). The study will formalize informing patients or parents/legal guardians of patients about the Lazarex sliding-scale FRP in order to evaluate whether operationalizing intensive follow-up about the Lazarex FRP improves recruitment to cancer TCTs.

All patients or parents/legal guardians of patients will be offered information about the FRP at initial time of TCT discussion/consent for the iMPACT study, however, participants will be randomized 1:1 to receive an additional follow-up call about the FRP or no follow-up call (usual care). Participants who are randomized to usual care will be provided a phone number for the Lazarex Foundation that they or their parent or legal guardian may contact directly. Therefore all patients or parents/legal guardians of patients in the study have access to FRP eligibility assessment through the Lazarex Foundation.

Participants or parents/legal guardians of participants will be surveyed at baseline (time of consent to iMPACT) and interviewed 30 days after consent to iMPACT. If a participant enrolls in a therapeutic clinical trial, he/she will also be given an additional survey after TCT participation and interviewed up to 90 days after TCT participation.

Impact of Phone Call About Financial Reimbursement Program on Access to Cancer Clinical Trials

A Pilot Feasibility Study for Improving Patient Access to Cancer Clinical Trials (iMPACT): A Financial Reimbursement Program for Patients in Cancer Therapeutic Clinical Trials

The point estimate and 95% confidence interval (CI) of the proportion will be obtained within each site, furthermore, by cancer type and by phase of the clinical trial within each site.

Two-sample proportion test between two arms will be used between two arms within each site. The point estimate and 95% confidence interval (CI) of the proportion will be obtained within each site by cancer type and by phase of the clinical trial.

Lazarex Cancer Foundation

University of California, San Francisco

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Participants attend 1-2 monthly peer educator-led education sessions about PCA genetic testing over 3 hours each for 18 months.

Participants receive mailed informational materials about PCA risk, family history, and genetic testing.

Receive prostate cancer educational materials

Questionnaire Administration

Educational Intervention

This trial studies how well a peer-based health education program works in reducing barriers and changing attitudes and beliefs of prostate cancer genetic screening in African American participants with or without a previous personal or family history of prostate cancer. Participating in a peer-based health educational program may help participants learn more about prostate cancer and how their personal or family history of disease may increase their risk of prostate cancer.

The Peer Genetic Study

Peer-Based Intervention for Genetic Evaluation for Prostate Cancer Among African American Men: The Peer Genetic Study

Will be assessed by the 4-item Sure of myself; Understand information; Risk-benefit ratio; Encouragement (SURE) scale. To compute a summary decisional conflict score, the Likert-scaled responses will be averaged across the SURE item responses provided by a subject completing at least 2 of the 4 questions. The change in decisional conflict scores between baseline and endpoint at 2-months will be calculated and group means for these changes compared between subjects randomized to receive control materials vs. those randomized to receive the peer health education intervention (i.e., by intention to treat). The significance of the difference will be evaluated at the 0.05 level using a two-sided Student's t-test. The assumptions for this test will be carefully evaluated. If the changes are substantially skewed, they will be summarized with group medians and evaluated for significant differences by the nonparametric Wilcoxon's rank sum test.

Will be summarized in tables with descriptive statistics or graphically in data plots at each time they are assessed along with changes in responses over time. Will investigate imbalances in these data for potential confounding of primary and exploratory endpoint analyses and investigate disparities and intervention effect modification in various subgroups of subjects.

Will be summarized in tables with descriptive statistics or graphically in data plots at each time they are assessed along with changes in responses over time.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Proactive Outreach and Shared Decision Making in Improving Lung Cancer Screening Rates in Primary Care Patients	NCT03929926	Lung Cancer	Best Practice Cancer Educatio... Behavioral, Psy... Counseling	55 Years - 80 Years	Thomas Jefferson University
Impact of Phone Call About Financial Reimbursement Program on Access to Cancer Clinical Trials	NCT03943082	Malignant Neopl... Hematopoietic a...	Cancer Educatio... Follow-Up Care Questionnaire	7 Years -	University of California, San Francisco
Proactive Outreach and Shared Decision Making in Improving Lung Cancer Screening Rates in Primary Care Patients	NCT03929926	Lung Cancer	Best Practice Cancer Educatio... Behavioral, Psy... Counseling	55 Years - 80 Years	Thomas Jefferson University
The Peer Genetic Study	NCT05011799	Healthy Subject Prostate Carcin...	Cancer Educatio... Questionnaire A... Educational Int...	35 Years - 69 Years	Thomas Jefferson University

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