Neoplasms

Nervous System Diseases

All Conditions

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) questionnaire given to patients with a primary brain tumor and their caregivers.

Two questionnaires taking about 10 minutes to complete.

Questionnaire

Mark R. Gilbert, MD

The goal of this study is to compare patient ratings of how severe their own symptoms may be, with their caregivers' ratings of how severe they think the patients' symptoms may be. This will be compared using a questionnaire that is given to patients with brain tumors and their caregivers.

Researchers will also study any effects that these patients' neurocognitive function may have on these patients' and their caregivers' ratings of how severe the brain cancer symptoms may be.

Study Visit:

If you and your caregiver agree to take part in this study, you will both complete 2 questionnaires. You will be in separate rooms when you complete the questionnaires.

The first questionnaire is a demographic questionnaire that asks basic questions such as your age and employment status.

Your second questionnaire asks about any brain cancer symptoms that you may be experiencing, and asks you to rate how severe they may be.

Your caregiver's second questionnaire asks the same questions as yours. It asks the caregiver to rate how severe he or she believes your symptoms may be.

In total, the questionnaires should take about 10 minutes to complete.

Symptom Review:

The study staff will review the questionnaire responses right away. If you rate any symptom as severe as 7 or higher, the study staff will tell you to contact your doctor who is treating the cancer. The study staff will also contact your doctor who is treating the cancer. Otherwise, your questionnaire responses will only be used for research and there are no plans to contact your doctor.

Length of Study Participation:

After you and your caregiver complete the questionnaires this one time, your and your caregivers' active participation in this study will be over.

The study chair will also collect information from your medical record. This information will include your medical history and the results of the neurocognitive testing (routine tests of "thinking" skills such as your memory and concentration).

This is an investigational study. Up to 120 patients and 120 caregivers will take part in this study. All will be enrolled at M. D. Anderson.

Brain Tumor Patient-Caregiver Congruence, MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT)

Primary Brain Tumor Patient and Caregiver Congruence in Symptom Report Using the M.D. Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT)

M.D. Anderson Cancer Center

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Behaviors and Mental Disorders

Neoplasm Metastasis

Syndrome

Dehydration

Water-Electrolyte Imbalance

Metabolic Diseases

Quality of Life

Culturally Tailored Nurse Symptom Management group (CTNSM) - participants in the CTNSM group will receive one in-person or telehealth face-to-face education session followed by a weekly telephone call and/or text message during the first 12 weeks of standard of care chemotherapy. In addition, participants can receive standard of care chemotherapy education.

Participants in the control group will only be receiving the standard of care chemotherapy education.

The Culturally Tailored Nurse-delivered telephone/text message symptom-management intervention (CTNSM) intervention is an in-person or telehealth face-to-face education session followed by a weekly telephone call and/or text message conducted for the first 12 weeks of standard of care chemotherapy .

CTNSM

Standard of Care chemotherapy education is a one-time patient education session about general treatment-related side effects patients can experience from chemotherapy and the interventions to mitigate the symptoms.

Standard of Care Chemotherapy Education

Natasha Solle, PhD

The purpose of the study is to see whether or not a telephone/ text message intervention, delivered by a registered nurse, is helpful in managing symptoms and can also prevent dehydration caused by chemotherapy treatment when given together for patients with metastatic breast, colon, lung or prostate cancer.

Culturally Tailored Nurse Coaching Study for Cancer Symptom Management

Utilizing a Culturally Tailored Nurse Coaching Intervention to Decrease Symptom Severity and Prevent Dehydration in Patients With Metastatic Cancer

MD Anderson Symptom Inventory (MDASI) is a 19 item scale with a score range from 0-10 per symptom question that measures symptom severity plus symptom interference combined to measure total symptom burden. The higher score indicates worsening of symptoms.

Incidents of unscheduled medical visits for IV hydration

The CDSES is a 10 item scale with a score range from 0-10 per symptom question that measures perceived self-efficacy. The higher score indicates better perceived self-efficacy.

The PIHS is a 12 item scale with a score range from 0-8 per question that measures symptoms self-management. The higher score indicates better symptom self-management.

Feasibility will be reported as a percentage of completed calls or text messages.

Health Related Quality of Life (HRQoL) will be measured by the Functional Assessment of Cancer Therapy -Breast (FACT-B). FACT-B has a total scoring of 0-148 with the higher scoring indicating better HRQoL.

Health Related Quality of Life (HRQoL) will be measured by the Functional Assessment of Cancer Therapy -Prostate (FACT-P). FACT-P has a total scoring of 0-156 with the higher scoring indicating better HRQoL.

Health Related Quality of Life (HRQoL) will be measured by the Functional Assessment of Cancer Therapy -Colon (FACT-C). FACT-C has a total scoring of 0-144 with the higher scoring indicating better HRQoL.

Health Related Quality of Life (HRQoL) will be measured by the Functional Assessment of Cancer Therapy -Lung Cancer (FACT-LC). FACT-LC has a total scoring of 0-144 with the higher scoring indicating better HRQoL.

Oncology Nursing Society

University of Miami

assistant research professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

1-on-1 interview + Questionnaires, Part 1 of Study

1-on-1 interview with study doctor or staff member, during regularly scheduled, standard of care clinic visit taking 30 minutes.

Interview

Complete 3 Questionnaires during clinic visit, about 10 minutes to complete all.

Survey

Diane C. Bodurka, MD, BS

Objectives:

The objective of this study is to delineate and measure the symptom burden experienced by patients with ovarian cancer.

The Primary Aim is to develop and validate an ovarian-cancer module of the M. D. Anderson Symptom Inventory (MDASI-Ovarian Cancer) to measure the severity of multiple symptoms and the impact of these symptoms on daily functioning in patients with ovarian cancers.

The Secondary Aims are:

To develop a detailed description of symptom severity and interference with daily activities experienced by patients with ovarian cancer; To assess the impact of symptom severity on standard functioning and quality of life (QOL) measures, including Eastern Cooperative Oncology Group Performance Status (ECOG PS), Functional Assessment of Cancer Therapy-Ovary (FACT-O), and a single-item QOL scale, in patients with ovarian cancer; To define the qualitative symptom burden of patients with ovarian cancer receiving various treatments.

PART 1:

Interview:

If you agree to take part in this study, you will be interviewed about what it is like to have ovarian cancer and any symptoms that you may have experienced. This will be a 1-on-1 interview with the study doctor or a member of the study staff. It will take place during 1 of your regularly scheduled, standard of care clinic visit and should take about 30 minutes to complete.

The interview will be digitally recorded. The electronic recording of the interview will be given a code number and stored on a password-protected computer at M. D. Anderson. No identifying information will be directly linked to your interview recording. Only the researcher in charge of the computer will have access to the code numbers and be able to link the interview recording to you.

Questionnaires:

After the interview, you will also complete a symptom questionnaire, a quality-of-life questionnaire, and a demographic questionnaire that asks questions about your age, race, and marital status. You will complete the questionnaires after the interview during the same clinic visit. It should take about 10 minutes to complete all 3 questionnaires.

You should contact the study doctor or study nurse right away if at any time you are experiencing severe, troublesome, or intolerable symptoms. You should also remember to rate them on the symptom questionnaire.

The questionnaires will also be given a code number and stored in a locked file cabinet at MD Anderson. No identifying information will be directly linked to your questionnaires. Only the researcher in charge of the study will have access to the code numbers and be able to link the questionnaires to you.

Length of Study:

After you have completed the interview and the questionnaires, your participation on this study will be over.

Additional Information:

Any information about your symptoms that is collected as part of this study is for research purposes only. All study materials, including the interview recording and questionnaires, will only be used for the purposes of this study and will be destroyed after the study results have been reported.

If you rate a symptom as severe on the symptom questionnaire, a study staff member will ask you if you have already told, or plan to tell your regular care doctor or nurse about the symptom. If you have not already told you regular care doctor or nurse, a study staff member will tell your regular care doctor or nurse about the symptom for you.

This is an investigational study.

Up to 15 participants will take part in this study. All will be enrolled at MD Anderson.

PART 2:

Questionnaires:

If you agree to take part in this study, you will complete the following:

1. A symptom questionnaire, 2 quality-of-life questionnaires, and a demographic questionnaire that asks questions about your age, race, and marital status. It should take about 20 minutes to complete all 4 questionnaires.
2. About 1 to 5 days after you complete the first set of questionnaires, you will be asked to complete a questionnaire either through phone interview with the study staff or through a mail-in survey . If you complete the questionnaire by mail-in survey, the study staff will give you a copy of the questionnaire and a stamped pre-addressed envelope. The questionnaire will take 5-10 minutes to complete.

You should contact the study doctor or study nurse right away if at any time you are experiencing severe, troublesome, or intolerable symptoms. You should also remember to rate them on the symptom questionnaire.

The questionnaires will be given a code number and stored in a locked file cabinet at M. D. Anderson. No identifying information will be directly linked to your questionnaires. Only the researcher in charge of the study will have access to the code numbers and be able to link the questionnaires to you.

Opinion Questionnaire:

If you are one of the first 20 patients enrolled in the study, you will be asked questions about your opinion of the symptom questionnaire. For example, you will be asked if the symptom questionnaire was easy to understand and complete, and if there were any other questions that should be included. The study staff will use your opinion to decide if changes should be made to the questionnaire or if important symptom questions are missing from the questionnaire. This questionnaire should take about 5 minutes to complete.

Length of Study:

After you have completed the questionnaires, your participation on this study will be over.

Additional Information :

Any information about your symptoms that is collected as part of this study is for research purposes only. The questionnaires will only be used for the purposes of this study and will be destroyed after the study results have been reported.

If you rate a symptom as severe on the symptom questionnaire, a study staff member will ask you if you have already told, or plan to tell your regular care doctor or nurse about the symptom. If you have not already told you regular care doctor or nurse, a study staff member will tell your regular care doctor or nurse about the symptom for you.

This is an investigational study.

Up to 128 participants will take part in this study. All will be enrolled at MD Anderson and Lyndon B. Johnson General Hospital.

M. D. Anderson Symptom Inventory - Ovarian Cancer

M. D. Anderson Symptom Inventory - Ovarian Cancer: Development and Validation in Patients With Ovarian Cancer

Genentech, Inc.

Digestive System Diseases

Skin and Connective Tissue Diseases

Gastrointestinal Stromal Tumors

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Patient interview and developmental questionnaires

Content Expert Panel (doctors, nurses) + Patients and Caregivers Questionnaire Development

10 minutes to complete 3 questionnaires for development of MDASI-GIST

Questionnaires

Each interview will take approximately 30 minutes.

MDASI-GIST Questionnaire

Loretta A. Williams, PhD, MSN

The goal of this research study is to better understand the symptoms experienced by patients with GIST.

There are 3 parts to this study. In Part 1, participants will complete 1 set of interviews and questionnaires about GIST symptoms. In Part 2, the importance of some symptoms to patients with GIST will be rated by doctors, nurses, patients, and family caregivers. In Part 3, participants will complete questionnaires about GIST symptoms over 1 year.

You are being asked to take part in Part 3 of the study.

Symptom Questionnaires:

If you agree to take part in this study, you will complete questionnaires about symptoms you are having. You will be asked to fill these out 1 time a week during the first 2 months after surgery, 1 time a week during the first 3 months of a new therapy, and every 2 weeks at other times. The questionnaire will ask you to rate how severe your symptoms are and how the symptoms effect the activities of your daily life. The symptom questionnaire should take about 5 minutes to complete. You will complete the questionnaire during the first study visit and at your regular clinic visits.

Between clinic visits, you will be called every 1-2 weeks to complete the questionnaire using an automated telephone system. You can decide what time is most convenient for the automated phone system to call you. If you are not available when the automated system calls, it will call you again at a later time. If you are not reached by the automated phone system after several tries, the study staff will call you. You will be given a secure user name and identification number to use with the automated phone system. The study staff will teach you how to use the automated phone system.

At the clinic visit closest to 3 months after you start the study, you may be seen by a research staff member a second time 1 to 3 days after you completed the symptom questionnaire and asked to fill out the symptom questionnaire again. The research staff member may contact you by phone prior to this clinic visit to arrange times to meet you for the 2 assessments.

Quality-of-Life/Demographic Questionnaires:

At the first visit and the regular clinic visits, you will also rate your overall quality-of-life. This should take about 1 minute to complete.

At the first visit, you will also be asked some demographic questions (such as your age and marital status). Answering these questions should take about 1 minute.

Opinion Questionnaire:

If you are 1 of the first 40 patients enrolled in the study, you will be asked questions about your opinion of the symptom questionnaire at the clinic visit closest to 3 months after you start the study. For example, you will be asked if the symptom questionnaire was easy to understand and complete, and if there were any other questions that should be included. The study staff will use your opinion to decide if changes should be made to the questionnaire or if important symptom questions are missing from the questionnaire. This questionnaire should take about 5 minutes to complete.

Length of Study:

You will be on study for 1 year. You will be off study after you complete the last symptom questionnaire.

This is an investigational study.

Up to 188 participants will take part in this study. Up to 150 participants will be enrolled in Part 3 of this study. All will be enrolled at MD Anderson.

Symptom Inventory for Gastrointestinal Stromal Tumors

Symptom Burden in Patients With Gastrointestinal Stromal Tumors (GISTs)

Descriptive statistics used to assess the distributional characteristics and demographics of the study population and to report how patients rate symptom severity and interference with function.

Novartis

Blood and Lymph Conditions

Hematologic Neoplasms

Hematologic Diseases

Dale E Theobald, PhD, MD

Donna L Butler, MSN

Dale E. Theobald, PhD, MD

The primary research objective of this protocol is to evaluate the impact of integrating a home-based symptom monitoring system in the day-to-day care of cancer patients in community settings on the frequency of supportive symptom interventions, symptom severity, and quality of life.

Patients will be randomly assigned to one of two groups. One group will be offered an Internet assisted home-based symptom reporting system Cancer Symptom Monitor (CSM) for a twelve-month study period. Patient and care team evaluations will be measured using quantitative and qualitative methods (via focus groups). The second group will receive "standard care" without home-based symptom monitoring. Both groups will be evaluated at baseline, 1, 2, 3, 6, 9, \& 12 months, for symptom levels and overall quality of life during the twelve-month study period.

Home-Based Symptom Monitoring: Its Impact on Cancer Care Team Behaviors and Patient Outcomes

Amgen

Community Cancer Care

This arm includes self-care coaching (SCC) message during daily self-reported symptom severity report (SSR) calls to the automated system.

Alert reports are generated during the patient's daily symptom severity monitoring call if alert thresholds are reached. These alerts are monitored and follow-up care is given by a nurse practitioner.

Alert reports are generated during the patient's daily symptom severity monitoring call if alert thresholds are reached. Nurse practitioner follow-up calls utilize the evidenced based SCH decision support system (DSS) when symptoms exceed alert thresholds

Complete intervention with all components used in prior efficacy study (Symptom Severity Report (SSR)+Self Care Coaching (SCC) +Nurse Practitioner (NP) +Decision Support System (DSS))

Symptom severity reporting (SSR), automated self-care coaching (SCC) based on daily symptom reporting plus activity tracker (AT)

Automated self-management coaching paired to symptom reports during daily symptom monitoring call

Alerts generate if a patient reports symptoms above pre-set thresholds during daily symptom reporting calls . These alerts are monitored and follow up is given by a Nurse Practitioner.

Nurse Practitioner

A Clinical Decision Support System (DSS), based on evidenced based guidelines, will be used to assist the nurse practitioner in follow up to symptom alerts.

An activity tracker will be provided to evaluate its use, acceptability and impact on fatigue severity. The purpose of providing the activity tracker is to extend the self-management coaching intervention given when participants report fatigue and receive coaching about exercise as part of the intervention.

Automated patient-reporting of 11 common cancer treatment symptoms

Symptom Severity

Kathleen Mooney, PhD

This project will determine the most important and cost effective components of SymptomCare@Home, a new approach to cancer chemotherapy symptom care that has been shown to reduce problematic symptoms through automated daily monitoring, self-management coaching, and oncology team follow-up care using decisional support for patients at home when their symptoms are most likely at their worse. Once the key parts of the intervention and its cost effectiveness are known, it can be moved into everyday cancer care.

Cancer patients receiving chemotherapy experience multiple poorly controlled symptoms at home in the interim weeks between clinic visits and the next infusion. Their care during this interim time period is suboptimal. Technology can be utilized to bridge the gap between patient symptom needs at home and oncology team response. Automated patient-reported symptom home monitoring and management systems offer a new approach to symptom care. Our research team has developed and tested SymptomCare@Home (SCH). This multi-component automated system monitors daily patient-reported symptoms at home, provides tailored automated self-management coaching based on the specific symptoms reported and transmits unrelieved symptom alert reports to an oncology provider who, using the SCH decision support system provides follow-up telephone-delivered symptom care. We have demonstrated that SCH dramatically reduces physical and psychological symptom severity. However there remain several gaps in translating a successful, multi-component symptom intervention into clinical practice. These include understanding 1) the contribution and value of each part of the intervention so that the active components are selected for clinical implementation and 2) the costs associated with the intervention and its components. Therefore the aims of this project are to deconstruct the SCH symptom monitoring and management system to determine the relative contribution and costs of its components to achieving symptom reduction, maintain general health functioning and reduce healthcare utilization. We will also examine who benefits most and least from the individual components and from the overall system. A 5 group randomized control trial design will be utilized with 750 participants (150/group) beginning a new course of chemotherapy who will call the SCH system daily and report the presence and severity of 11 symptoms throughout a course of chemotherapy or up to 6 months. This study is both significant and innovative because it shifts the current clinical practice paradigm for providing symptom care episodically during clinic visits to an innovative approach that is patient-centric, providing symptom care when and where the patient needs it. The study will address questions not generally asked in multi-component interventions, determining the active ingredients and their costs. Determining the value of new approaches to care such as automated telehealth interventions is essential to the decision process of healthcare systems and payers who decide what to adopt and reimburse. It is also vitally important to patients so that new symptom care innovations are adopted that better meet their needs and dramatically reduce their symptoms.

SymptomCare@Home: Deconstructing an Effective Symptom Management Intervention

SymptomCare@Home (SCH): Deconstructing an Effective, Technology-assisted, Symptom Management Intervention

We will present our findings at conferences and publish the findings. We welcome analysis and use by other investigators once our primary aims have been analyzed and disseminated. The PI will share de-identified data to other investigators for study, including demographics, diagnosis, chemotherapy treatment, symptom patterns, work attendance, overall health function and health care utilization. Data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and can be used for secondary study purposes. The PI agrees to make available data within one year of the completion of the funded project period and manuscripts pertaining to the aims. De-identified data will be available directly from the PI. The PI agrees to share data in a manner that is fully consistent with NIH data sharing policies and applicable laws and regulations.

An End of Study Telephone Interview will be conducted at the end of a patient's participation in the project to obtain data on patient satisfaction with the symptom monitoring system and to obtain suggestions for improvement of the system.

During daily automated calls, patients provided information about common chemotherapy symptoms on a 0-10 scale.

This will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 + 2 items from the PROMIS 10 (92-95)

For patients who indicated they worked during their treatment, the system asked daily if they missed work if it was a regular workday.

The 25 item patient-reported Work Limitations Questionnaire will be used to measure work performance.

Each week patients reported during their daily phone calls whether or not they had been in contact with a health care provider, were seen in an emergency department or urgent care facility, or had an unscheduled hospitalization. If they reported they did have a medical encounter, the research staff would call and conduct a short telephone interview to collect data about the nature of the medical encounter including whether the medical encounter was related to the symptoms being monitored.

We will measure baseline physical activity using the 3 item Godin's Leisure-Time Exercise Questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Brain Tumor Patient-Caregiver Congruence, MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT)	NCT00748774	Brain Tumor	Questionnaire	18 Years -	M.D. Anderson Cancer Center
Culturally Tailored Nurse Coaching Study for Cancer Symptom Management	NCT04874584	Dehydration Symptom Cluster Quality of Life Self Efficacy Chemotherapy Ef...	CTNSM Standard of Car...	18 Years -	University of Miami
M. D. Anderson Symptom Inventory - Ovarian Cancer	NCT01037751	Ovarian Cancer	Interview Survey	18 Years -	M.D. Anderson Cancer Center
Symptom Inventory for Gastrointestinal Stromal Tumors	NCT01178307	Gastrointestina...	Questionnaires Interview MDASI-GIST Ques...	18 Years -	M.D. Anderson Cancer Center
Home-Based Symptom Monitoring: Its Impact on Cancer Care Team Behaviors and Patient Outcomes	NCT00300001	Cancer Solid Tumor Hematologic Mal...		18 Years -	Community Cancer Care
SymptomCare@Home: Deconstructing an Effective Symptom Management Intervention	NCT02779725	Cancer	SCC Nurse Practitio... DSS AT Symptom Severit...	18 Years -	University of Utah

Spots Global Cancer Trial Database for symptom severity