Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Patients complete a treatment decision counseling session/interview about genetic testing and supportive/palliative care with a qualified member of the research team in-person or via telephone. Health care providers receive a 1-page summary of session results for use in treatment shared decision making at the next office visit.

Participate in treatment decision counseling session

Counseling

Questionnaire Administration

Medical Chart Review

Neal Flomenberg, MD

This trial studies the use of genetics and shared decision making in improving care for patients with stage IVA-C non-small cell lung cancer. Developing educational tools may help patients with non-small cell lung cancer to increase patient treatment knowledge, reduce decisional conflict, and promote treatment shared decision making with their health care providers.

PRIMARY OBJECTIVES:

I. Use the information on genomic tumor diagnostics, provider treatment recommendations, and patient and provider feedback on the treatment decision making process, which will be used to develop materials and methods to adapt an existing decision counseling program (DCP) for use with patients diagnosed with advanced non-small cell lung carcinoma (NSCLC) as a standard component of clinical care.

SECONDARY OBJECTIVES:

I. Pilot test the adapted DCP in a subset of patients to determine the feasibility of delivering the DCP session.

II. Assess DCP effects on patient treatment knowledge and decisional conflict. III. Assess treatment choice.

OUTLINE:

PHASE I: Use physician input to develop draft treatment education materials and use patient input to adapt an online decision counseling application for use in helping patients clarify treatment preference.

PHASE II: Patients complete a treatment decision counseling session/interview about genetic testing and supportive/palliative care with a qualified member of the research team in-person or via telephone. Health care providers receive a 1-page summary of session results for use in treatment shared decision making at the next office visit.

After completion of study, participants are followed up at 30 and 60 days.

Genetics and Shared Decision Making in Improving Care for Patients With Stage IVA-C Non-small Cell Lung Cancer

Using Genetics and Shared Decision Making to Improve Lung Cancer Care: A Developmental Study

Results will be reported descriptively. A Decision Counseling Program (DCP) is a tool that allows patients and physicians to engage shared decision making. The DCP will be created based on genetic tumor diagnostics, provider treatment recommendations, and feedback from patients and providers gathered from interviews.

Results will be reported descriptively. The feasibility endpoint will be the proportion of consenting patients who complete the DCP, about which we will estimate an exact 95% confidence interval by the Clopper-Pearson method.

Results will be reported descriptively on pre and post surveys that will be completed by patients Survey is the Decisional Conflict Scale (DCS) Total and subscores have applicable items are a) summed; b) divide by 10; and c) multiplied by 25 Total Score Items 1-10 Score range: 0 \[No decisional conflict\] to 100 \[extremely high decisional conflict\].

Uncertainty Sub score Items 9, 10 Score range: 0 \[feels extremely certain about best choice\] to 100 \[feels extremely uncertain about best choice\] Informed Sub score Items 1, 2, 3 Score range: 0 \[feels extremely informed\] to 100 \[feels extremely uninformed\].

Values Clarity Sub score Items 4, 5 Score range: 0 \[feels extremely clear about person; a values for benefits and risks/side effects\] to 100 \[feels extremely unclear about personal value\] Support Sub score Items 6, 7, 8 Score range: 0 \[feels extremely supported in decision making\] to 100 \[feels extremely unsupported in decision making\]

Results will be reported descriptively. Will be collected on pre and post surveys that will be completed by patients. Overall summary statistics will be computed for the patient surveys. Medical records data will be reviewed in order to determine the patient treatment regimen.

Thomas Jefferson University

Healthcare providers/institutions perform usual care.

Healthcare providers/institutions receive OPTI-Surg training and informational materials.

Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach.

Best Practice

Informational Intervention

Receive OPTI-Surg program materials plus individual coaching

Informational Intervention with Coaching

George J. Chang, MD, MS

This trial studies how well the use of a pre-surgical toolkit (OPTI-Surg) works in improving surgical care and outcomes in older participants with cancer. In many elderly patients, surgery can greatly affect physical condition and the ability to return to pre-surgery levels of physical functioning. Providing pre-surgical recommendations may help improve participants' recovery rate and functioning after surgery.

PRIMARY OBJECTIVES:

I. To compare 8-week postoperative function among elderly patients between sites randomized to implement the OPTI-Surg toolkit with or without a coach versus sites randomized to usual care.

SECONDARY OBJECTIVES:

I. To compare postoperative morbidity between sites randomized to implement the OPTI-Surg toolkit with or without a coach versus sites randomized to usual care.

II. To compare the penetration of the OPTI-Surg toolkit between sites randomized to implement the OPTI-Surg toolkit with a coach versus sites randomized to implement the OPTI-Surg toolkit without a coach.

Trial Design:

OUTLINE: Healthcare providers/institutions are randomized to 1 of 3 arms. Patients/participants receive the intervention based on which arm their healthcare provider is in.

ARM I: Healthcare providers/institutions perform usual care.

ARM II: Healthcare providers/institutions receive OPTI-Surg training and informational materials.

ARM III: Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach.

After conclusion of study, participants are followed up at 8 and 12 weeks post surgery, and healthcare providers/institutions are followed up 6-9 months after the last patient is registered.

Use of a Pre-Surgical Toolkit in Improving Surgical Care and Outcomes in Older Participants With Cancer

Improving Surgical Care and Outcomes in Older Cancer Patients Through Implementation of an Efficient Pre-Surgical Toolkit (OPTI-Surg)

The primary analysis will employ a generalized linear mixed model (with Gaussian link function) with a random practice effect to account for clustering within practice and baseline CHAMPS total score as a covariate to compare 8-week CHAMPS total score between the combined OPTI-Surg no-coach and coach arms versus usual care. This analysis will include all eligible elderly patients who undergo major cancer surgery, consent to complete CHAMPS questionnaires, and have baseline and 8-week function measured. The CHAMPS questionnaire includes 41 questions and 4 subscales measuring caloric expenditure and frequency/week of all exercise-related activities and only moderate-intensity exercise-related activities. The caloric activities subscales are scored by weighting the duration items using MET values and converting them to a caloric expenditure/week. The frequency/week subscales are scored by summing the frequency scores/week for each activity.

A generalized linear mixed model (with logit link function) with a random practice effect to account for clustering within practice will be used to compare postoperative complications within 12 weeks of surgery between the combined OPTI-Surg no-coach and coach arms versus usual care followed by pairwise comparisons. This analysis will include all eligible elderly patients who undergo major cancer surgery (no documentation of postoperative complications will be considered as not having any postoperative complications).

A generalized linear mixed model (with logit link function) with a random practice effect to account for clustering within practice will also be used to compare compliance rate (i.e., percentage) for screening between the no-coach and coach arms. The endpoint is whether the EFS was administered, not the EFS scores themselves.

National Cancer Institute (NCI)

Alliance for Clinical Trials in Oncology

Participants complete questionnaires and quality of life assessments, and may also complete interviews over 45 minutes periodically.

Interview

Quality-of-Life Assessment

Xin Shelley Wang

This trial studies how well a new assessment system (MDASI or other MD Anderson-developed PRO instrument) works in measuring symptoms and the impact on quality of life in cancer patients. Development of a new assessment system may provide more information about the common symptoms that may occur in patients due to cancer and its treatment and how the symptoms impact quality of life.

PRIMARY OBJECTIVES:

I. To examine how the MD Anderson Inventory (MD Anderson Symptom Inventory \[MDASI\]) or other MD Anderson-developed patient reported outcome (PRO) instrument performs in various sample populations including community dwelling adults and patients who have different cancer types, who have undergone various treatments, and who have different and/or more severe symptoms.

II. To evaluate the MDASI or other MD Anderson-developed PRO instrument as an estimate of functional status and quality of life.

III. To assess the impact of symptom severity on standard function and health-related quality of life measures, including both quantitative and qualitative measures (patient interviews).

IV. To assess the pattern and severity of symptoms over multiple time points in order to assay the system's responsiveness to changes due to therapy or disease.

V. To explore the utility of an interactive voice response (IVR) system in enhancing the clinical care of outpatients.

VI. To explore the effect of information from an IVR symptom assessment system on the pattern of care and development of interdisciplinary protocols.

VII. To explore the feasibility of developing symptom management pathways for patients based on these symptom and quality of life data.

OUTLINE:

Participants complete questionnaires and quality of life assessments, and may also complete interviews over 45 minutes periodically.

New Assessment System in Measuring Symptom Distress in Cancer Patients

Measuring the Symptom Distress of Cancer Patients: Development of a New Assessment System

Each item is rated 0 to 10 with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imaged or complete interference. The symptom severity and interference sub scales are mean values of the items in each scale. Hence the range of each sub scale is also 0 to 10. Lower values represent a better outcome. Higher values represent a worse outcome. The symptom severity and interference sub scales are not combined to compute a total score.

Mean ratings of 11-point 0-10 scales; lower mean score = better outcome.

6-point 0-5 scale; lower score = better outcome.

Scored on 5-point 1 to 5 scales; combined scores converted to index value for US = -0.573 to 1; higher values = better outcome.

Changes in patients' symptoms over time will be determined by differences in symptom severity scores on the MD Anderson Symptom Inventory MDASI collected at multiple time points. 0 to 10 with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imaged or complete interference. The symptom severity and interference sub scales are mean values of the items in each scale. Hence the range of each sub scale is also 0 to 10. Lower values represent a better outcome. Higher values represent a worse outcome. The symptom severity and interference sub scales are not combined to compute a total score.

The European Organization for Cancer Treatment and Research Quality of Life scale (EORTC QLQ-C30) is a quality of life questionnaire that measures five functional areas (physical, social, role, cognitive, and emotional), eight symptoms (fatigue, nausea/vomiting, pain, dyspepsia, sleep disturbance, diarrhea, appetite loss, and constipation), financial impact, and overall quality of life. All of the sub scales and single-item measures range in score from 0 to 100 according to scoring algorithms.

Bayer

Bristol-Myers Squibb

Eli Lilly and Company

Genentech, Inc.

Merck Sharp & Dohme LLC

National Institutes of Health (NIH)

M.D. Anderson Cancer Center

All Drugs and Chemicals

Central Nervous System Stimulants

Nicotine

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

Participants receive counseling over the phone to help them quit smoking and learn about lung cancer screening over 15-20 minutes for 6-8 sessions over 8 weeks. Participants may also receive nicotine patches.

Participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit.

Nicotine Patch

Tobacco Cessation Counseling

Robert J. Volk

Robert J Volk

This trial studies how well a centralized care strategy works in improving the quality of smoking cessation and shared decision making among patients who smoke and are considering lung cancer screening. The centralized care strategy is a model where smokers eligible for lung cancer screening are referred to a dedicated tobacco treatment program where they receive both the shared decision-making and initiate smoking cessation counseling prior to their visit with a primary care provider. Utilizing the centralized care model may work better in helping people quit smoking and make informed decisions about lung cancer screening compared to usual care.

PRIMARY OBJECTIVE:

I. Test the effectiveness of usual care (primary care providers with training in guideline-based smoking cessation and shared decision making) versus (vs.) centralized care (smoking cessation and shared decision making delivered remotely by trained counselors) on smoking abstinence and the quality of patients' decisions about lung cancer screening.

SECONDARY OBJECTIVES:

I. Evaluate the reach, acceptability, feasibility, and fidelity of the two smoking cessation and shared decision-making implementation models in meeting the requirements from Centers for Medicare \& Medicaid Services (CMS) for the lung cancer screening patient counseling and shared decision making visit.

II. Conduct budget impact and cost-effectiveness analyses of the two implementation models for the smoking cessation and shared decision making to inform adoption of the intervention beyond the current study.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I (CENTRALIZED CARE): Participants receive counseling over the phone to help them quit smoking and learn about lung cancer screening over 15-20 minutes for 6-8 sessions over 8 weeks. Participants may also receive nicotine patches.

GROUP II (USUAL CARE): Participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit.

After completion of study, participants are followed up at 1, 8, and 12 weeks.

Centralized Lung Cancer EARly Detection Among Smokers (CLEAR Study)

Improving the Quality of Smoking Cessation and Shared Decision Making for Lung Cancer Screening: A Cluster Randomized Trial

Participants achieving the primary abstinence endpoint at 12 weeks (higher 7-day point prevalence abstinence rates)

Knowledge of lung cancer screening and benefits of smoking cessation

Assessment of the reach of the intervention

Assessment of the feasibility of implementing the intervention

Standardized measure of health-related quality of life used to generate patient utilities (will report lower decisional conflict, greater decision preparation, greater intention to stop smoking, and be more likely to make an attempt to stop smoking.)

Costs of personnel, hardware, and delivering materials to participants

Cancer Prevention Research Institute of Texas

Participants complete an online course focusing on different aspects of tobacco prevention and cessation over 1 hour each per week for 4 weeks. They also engage in 6 virtual meetings over 1 hour about tobacco use once per month.

Internet-Based Intervention

Meeting

Survey Administration

Susan Peterson

This trial aims to develop an electronic learning (eLearning) program and mobile tool for Spanish and Portuguese speaking cancer care providers to use in tobacco counseling of their patients. This study may provide information for the design and implementation of tobacco cessation training programs directed to this group of professionals in low- and middle-income countries for the Latin American region.

PRIMARY OBJECTIVES:

I. To develop and test the feasibility of an eLearning program on brief tobacco counseling specifically designed for Spanish- and Portuguese-speaking cancer care providers.

II. To linguistically/culturally tailor and test a mobile tool designed to assist in providing effective tobacco counseling and treatment.

OUTLINE:

Participants complete an online course focusing on different aspects of tobacco prevention and cessation over 1 hour each per week for 4 weeks. They also engage in 6 virtual meetings over 1 hour about tobacco use once per month.

After completion of study, participants are followed up at 3 and 6 months.

Developing an eLearning Program in Helping Spanish and Portuguese Speaking Cancer Care Providers During Tobacco Use Counselling

SWOG Tobacco Program for the Oncology Practice

Will be assessed by comparing pre- and post-test responses to the International Association for the Study of Lung Cancer survey. Item distributions, mean, median, standard deviation, minimum, maximum, and skewness will be explored. Skewness values between -1 and 1 will be considered acceptable. To examine reliability and internal consistency of each of the items assessing cancer care providers CCPs' competency for providing brief tobacco counseling, Cronbach's alphas will be calculated.

Will be used as key parameters for assessing the feasibility of the eLearning program. The Wilcoxon signed-rank test will be used to compare scores obtained in the pre- and post-tests of the eLearning program. Effect sizes will be computed as the absolute value of the difference between the post-test (T2, T3, and T4) and pre-test (T1) scores divided by the mean of the standard deviations for each.

Computing the System Usability Scale (SUS) scores in the final assessment will allow our research team to analyze cancer care provider's (CCPs) experience of using the tool. A descriptive analysis to compute the SUS score will be performed and later converted to percentile ranks. A percentile rank of 75% will indicate that the tool has high perceived usability. All statistical analyses will be performed using SPSS Statistics version 23 (International Business Machines Corporation).

Digestive System Diseases

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Immune System Diseases

Heart and Blood Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Colorectal Neoplasms

Breast Neoplasms

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Infertility

Genital Neoplasms, Female

Breast Diseases

Skin Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Urogenital Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Lymphosarcoma

Participants receive standard of care including education materials about fertility preservation from the Livestrong organization and a referral for fertility preservation, if requested.

Participants receive standard of care as in Arm I. Participants also use the decision-making the website.

Educational Intervention

Terri L Woodard

This trial studies how well a decision aid website works in helping to make decisions about fertility in participants with cancer. Decision aid websites that provide information about fertility preservation (maintaining your ability to have children of your own after cancer treatment) may help participants with cancer make fertility-preservation decisions.

PRIMARY OBJECTIVES:

I. To assess the effect of the Pathways to Fertility patient decision aid website (DA website) with women of reproductive age seen at the MD Anderson Oncofertility Service, in terms of improving patients' decisional conflict. (Part 1) II. To assess the effect of a multicomponent oncofertility decision support intervention (multicomponent DS intervention) compared to usual care with women of reproductive age at selected MD Anderson Houston Area Locations (HALs) on patients' decisional conflict. (Part 2)

SECONDARY OBJECTIVES:

I. To assess patients' decision-making process (e.g., preparation for decision making, decision self-efficacy, satisfaction) and decision quality (e.g., fertility preservation knowledge, clarity of patients' values, and congruence of preferences with the decision and/or treatment received). (Part 1) II. To assess patients' decision-making process (e.g., preparation for decision making, decision self-efficacy, satisfaction) and decision quality (e.g., fertility preservation knowledge, clarity of patients' values, and congruence of preferences with the decision about whether to accept fertility preservation referral and/or fertility preservation treatment). (Part 2)

EXPLORATORY OBJECTIVES:

I. To explore the acceptability of the DA website (e.g., length, clarity, ease of use) and feasibility of the research methods (e.g., preferences for viewing at home versus at the clinic, timing of viewing, website usage, recommendations for improvement), in preparation for future planned dissemination and implementation studies. (Part 1) II. To explore the feasibility of the multicomponent DS intervention and research methods (e.g., clinician's perspectives of the educational session and referral process, website usage, rates of referrals, recommendations for improving the intervention and referral process) as delivered in the HALs oncology clinics, in preparation for future planned dissemination and implementation studies. (Part 2)

OUTLINE:

PART 1: Participants review decision aid website and complete questionnaires to help researchers learn the website's effect.

PART 2: Participants are randomized into 1 of 2 arms.

ARM I: Participants receive standard of care including education materials about fertility preservation from the Livestrong organization and a referral for fertility preservation, if requested.

ARM II: Participants receive standard of care as in Arm I. Participants also use the decision-making the website.

Decision Aid Website in Helping to Make Decisions About Fertility in Participants With Cancer

Patient-Centered Decision Counseling for Women at Risk of Cancer-Related Infertility: Efficacy Study and Comparative-Effectiveness Randomized Trial

Will explore the acceptability of the DA website (e.g., length, clarity, ease of use) and feasibility of the research methods (e.g., preferences for viewing at home versus at the clinic, timing of viewing, website usage, recommendations for improvement), in preparation for future planned dissemination and implementation studies.

Will explore the feasibility of the multicomponent DS intervention and research methods (e.g., clinician's perspectives of the educational session and referral process, website usage, rates of referrals, recommendations for improving the intervention and referral process) as delivered in the HALs oncology clinics, in preparation for future planned dissemination and implementation studies.

Will assess the effect of the Pathways to Fertility patient decision aid website (DA website) with women of reproductive age seen at the MD Anderson Oncofertility Service, in terms of improving patients' decisional conflict.

Will assess the effect of a multicomponent oncofertility decision support intervention (multicomponent DS intervention) compared to usual care with women of reproductive age at selected MD Anderson Houston Area Locations (HALs) on patients' decisional conflict.

Will assess patients' decision-making process (e.g., preparation for decision making, decision self-efficacy, satisfaction) and decision quality (e.g., fertility preservation knowledge, clarity of patients' values, and congruence of preferences with the decision and/or treatment received).

Will assess patients' decision-making process (e.g., preparation for decision making, decision self-efficacy, satisfaction) and decision quality (e.g., fertility preservation knowledge, clarity of patients' values, and congruence of preferences with the decision about whether to accept fertility preservation referral and/or fertility preservation treatment).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Genetics and Shared Decision Making in Improving Care for Patients With Stage IVA-C Non-small Cell Lung Cancer	NCT03944265	Activating ALK ... Activating EGFR... Activating ROS1... Health Care Pro... Lung Non-Small ... Stage IV Lung C... Stage IVA Lung ... Stage IVB Lung ...	Counseling Questionnaire A... Medical Chart R...	18 Years -	Thomas Jefferson University
Use of a Pre-Surgical Toolkit in Improving Surgical Care and Outcomes in Older Participants With Cancer	NCT03857620	Malignant Neopl... Surgical Proced... Health Care Pro... Carcinoma	Best Practice Informational I... Questionnaire A... Informational I...	70 Years -	Alliance for Clinical Trials in Oncology
New Assessment System in Measuring Symptom Distress in Cancer Patients	NCT00505245	Caregiver Health Care Pro... Malignant Neopl... Physician	Interview Quality-of-Life... Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Centralized Lung Cancer EARly Detection Among Smokers (CLEAR Study)	NCT04200534	Smoking Lung Cancer	Best Practice Nicotine Patch Quality-of-Life... Questionnaire A... Tobacco Cessati...	55 Years - 77 Years	M.D. Anderson Cancer Center
Developing an eLearning Program in Helping Spanish and Portuguese Speaking Cancer Care Providers During Tobacco Use Counselling	NCT03539991	Health Care Pro...	Internet-Based ... Meeting Survey Administ...	18 Years -	M.D. Anderson Cancer Center
Genetics and Shared Decision Making in Improving Care for Patients With Stage IVA-C Non-small Cell Lung Cancer	NCT03944265	Activating ALK ... Activating EGFR... Activating ROS1... Health Care Pro... Lung Non-Small ... Stage IV Lung C... Stage IVA Lung ... Stage IVB Lung ...	Counseling Questionnaire A... Medical Chart R...	18 Years -	Thomas Jefferson University
Decision Aid Website in Helping to Make Decisions About Fertility in Participants With Cancer	NCT03141437	Breast Neoplasm Colorectal Neop... Female Reproduc... Health Care Pro... Lymphoma Plasma Cell Mye...	Best Practice Educational Int... Internet-Based ... Questionnaire A...	18 Years - 45 Years	M.D. Anderson Cancer Center

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