Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Quality of Life

Prostate Cancer Education and Resources for Couples (PERC) program. Participants assigned to experimental condition will receive access to the PERC website.

Participants in this usual care plus NCI website group will be automatically directed to the NCI prostate cancer website after logging in to the study website homepage.

PERC uses mHealth technologies to dramatically increase couples' accessibility to posttreatment supportive care whenever and wherever they feel comfortable accessing it. PERC aims to improve QOL for both patients and partners by enhancing positive appraisals of illness and boosting self-efficacy, social support from multiple sources, and healthy behaviors for symptom self-management at home.

Prostate Cancer Education and Resources for Couples (PERC)

The usual care plus NCI website provides generic information about prostate cancer treatment options, research, causes, and statistics; coping resources that are not prostate cancer-specific; support from non-providers via a toll free phone and LiveHelp Online Chat about cancer-related questions, clinical trials, and quitting smoking.

usual care plus NCI website

Lixin (Lee) Song, RN, PhD

In this study, the investigators propose to test the efficacy of a couple-focused, web-based tailored prostate cancer symptom management program, Prostate Cancer Education and Resources for Couples (PERC) in a randomized clinical trial. A two-group (PERC versus National Cancer Institute (NCI) website plus treatment as usual) randomized controlled design will be used, and data will be collected at baseline (T1), 4 (T2), 8 (T3), and 12 months (T4) among 300 patients completing initial treatment for localized prostate cancer and their intimate partners (i.e., 600 participants in total).

This randomized clinical trial aims to test the efficacy of a couple-focused, web-based tailored prostate cancer symptom management program, Prostate Cancer Education and Resources for Couples (PERC). The study participants will include 300 patients completing initial treatment for localized prostate cancer and their intimate partners (i.e., 300 dyads and 600 individuals). After informed consent, we will conduct baseline assessment (T1), randomly assign eligible participants to either PERC or the National Cancer Institute (NCI) website, and then collect data at 4 (T2), 8 (T3), and 12 months (T4) post-T1.

The investigator and data collectors will be masked to intervention.

Efficacy of a Couple-Focused mHealth Symptom Self-management Program

Testing the Efficacy of a Couple-Focused, Tailored mHealth Intervention for Symptom Self-Management Among Men With Prostate Cancer and Their Partners

FACT-G will be used to measure change in quality of life of patient and partner from baseline (T1) to T2 (4 months post-T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Functional assessment of Cancer Therapy-General (FACT-G) is a 27 item survey which assesses physical, social/family, emotional, and functional well being on a 5 point likert scale, with 0 indicating "not at all" and 4 indicating "very much" in response to item questions. Higher scores indicate better well-being.

PROMIS Pain Interference - Short Form 6b will be used to measure change in Pain Interference among patients and their partners from Baseline (T1) to T2 (4 months post-T1), T3 (8-mon post-T1), and T4 (12-mon post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value. The pain subscale measures the extent to which patients experience problems with pain over the past 7 days using a 5-point Likert scale. Higher scores reflect greater Pain Interference.

PROMIS Fatigue -Short Form 7a will be used to measure change in Fatigue among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value.The fatigue sub-scale will measure the extent to which patients and their partners experience problems with fatigue over the past 7 days using a 5-point Likert scale. Higher scores reflect greater fatigue.

PROMIS Sleep Disturbance Short Form 8b will be used to examine change in sleep quality of patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value.The sleep disturbance sub-scale measures the extent to which participant experience sleep disturbance over the past 7 days using a 5-point Likert scale. Higher scores reflect greater sleep disturbance.

PROMIS-Emotional Distress-Anxiety Short Form 7a will be used to examine change in anxiety among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value.The anxiety sub-scale of the PROMIS item bank measures the extent to which participants experience anxiety symptoms over the past 7 days using a 5-point Likert scale, where higher scores reflect higher anxiety.

PROMIS-Emotional Distress-Depression Short From 8b will be used to measure change in depression scores among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value. The depression sub-scale of the PROMIS item bank measures the extent to which participants experience depressive symptoms in the past 7 days using a 5-point Likert scale, where higher scores indicate greater depressive symptoms.

The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. EPIC will be used to measure change in health related quality of life scores among patients from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline value minus the Baseline value. It contains 26 items within 5 domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life.

The Prostate Cancer Related Symptoms Caregiver Short Form will be used to measure changes in caregiver scores from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline value minus the Baseline value.The questionnaire is a 4-item assessment about how the patient's hormone, sexual, bowel, and urinary function has affected the caregiver over the past 4 weeks. Items are ranked on a 5-point Likert Scale where higher scores indicate greater bother associated with the patient's symptoms.

The Lewis Cancer Self-Efficacy will be used to measure change in patient and partner feelings of self-efficacy in dealing with the patient's cancer diagnosis and treatment from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Patients will rate statements about how confident they feel on a scale from 1 to 10, where higher scores indicate higher self-efficacy.

PROMIS Informational Support Short Form 8a will be used to assess changes in patient and partner reported informational support system using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value.

The PROMIS Emotional Support System-Short Form 8a will be used to assess changes in the self-reported emotional support system of patients and their partners using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value.

The PROMIS Instrumental Support-Short Form 8a will be used to assess changes in patient and partner reported instrumental support system from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value.

The ISEL-12 will be used to measure change in social support from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1) among patients and their partners. The ISEL-12 is a 12 item measure, where higher scores indicate greater social support. Change from baseline is the post-Baseline values minus the Baseline value.

Appraisal of Illness scale will be used to measure change in perception of prostate cancer and related issues among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value.The Appraisal of Illness scale is a 20 item measure that uses Likert Scales ranging from Very False to Very True.

Change in Dietary Risk Assessment scores will be used to measure changes in dietary risk from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Patients and their partners will be asked how often they consume different foods over the past month or week and will respond using a Likert Scale to report how much of each food item they have consumed.

The Measure of Older Adult's Sedentary Time will be used to measure change in self-reported sedentary time from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Participants will self-report how much time they spend doing various sedentary activities during the past week.

National Institute of Nursing Research (NINR)

UNC Lineberger Comprehensive Cancer Center

Symptoms and General Pathology

Pain

Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive the intervention (Intervention = access to a caregiver Web site that updates them on patient's symptoms and provides tailored problem solving advice).

Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing (i.e. no access to the caregiver website, or 'intervention').

Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan.

Caregiver website

Maria J. Silveira, MD MA MPH

Given the growing strain on the Veterans Administration resulting from increasing caseloads of cancer patients, interventions are badly needed that assist patients in managing their illness, improve quality of life and avoid acute episodes that result in urgent care use and increased mortality. Previous studies have found that cancer patients undergoing chemotherapy can effectively manage their own symptoms when monitored using automated telephone calls. Such technology, however, may challenge the number of Veterans who lack social support and/or independence. The goal was to develop and test a technology that not only monitors patients automatically by telephone, but also gives them self management advice and engages a friend or family member to serve as a CarePartner willing to play a limited role in identifying patient symptoms and psychosocial needs to reinforce self management and provide social support. The investigators found that this technology indeed helped patients better control their symptoms, especially when a caregiver participated in the program along with them.

Cancer is a prevalent problem that causes much suffering among Veterans and their families. Most interventions to improve symptom control require Veterans to engage in activities such as managing medications, altering diets, or accessing outside resources that may be beyond their reach due to limitations in physical and mental functioning. Friends and family inside and outside of the Veteran's household can help, but often lack the skills and resources they need to do so.

"Cancer CarePartners" was designed to address these needs by providing cancer-stricken Veterans and their informal caregivers with the information they need to make effective management decisions, decrease symptom burden, and improve outcomes. Cancer CarePartners is a Web-enabled program that alerts caregivers of patients' symptoms and provides them with a framework for identifying problems, receiving structured advice, formulating a 'task list,' and following up with their patients as they receive chemotherapy. Specifically, Cancer CarePartners includes weekly, automated telephonic symptom assessment (ATSA) with self-management (SM) support to the Veteran paired with Web-based alerts to the caregiver pointing them to a website where s/he can obtain customized advice. A randomized control trial was conducted to test the efficacy of this program in controlling symptoms as well as improving adherence to chemotherapy.

Objectives

1) To determine if Veterans undergoing chemotherapy who receive Cancer CarePartners report significant improvement in the summed severity of symptoms (the sum of 0-10 severity across 8 core symptoms) compared to Veterans receiving symptom monitoring and self-management advice; secondarily, to determine if they experience better adherence to chemotherapy and utilization. (2) To determine if caregivers participating in the intervention provide significantly more social support to patients than do controls; secondarily, to determine if they experience more caregiver burden and distress than do controls. (3) To determine whether impacts on patients are mediated by mastery. (4) To determine whether impacts on caregivers are mediated by mastery.

Methods Consenting Veterans with solid tumors undergoing chemotherapy at one of three VAMCs (Ann Arbor, Loma Linda and Fargo) who reported at least one core symptom at a moderate level or higher and had a caregiver willing to enroll in the study were randomly assigned to either 10 weeks of Cancer CarePartners or 10 weeks of automated, telephonic symptom assessment (ATSA) with self management support. Arms were balanced for non-small cell lung cancer status and caregiver type. Patients and caregivers were surveyed at intake, 10, and 14 weeks. In addition, the investigators tracked patient participation with ATSA and (in the experimental arm) caregiver use of the Cancer CarePartners Website. The investigators reviewed all medical records for content of care received during the 14 weeks on study.

Care Partners: Web-based Support for Caregivers of Veterans Undergoing Chemotherapy

Web-based Support for Caregivers of Veterans Undergoing Chemotherapy

Summed severity across 8 symptoms of interest, as measured using the MD Anderson Symptom Inventory. 8 core symptoms rated by the patient on a scale of 0 to 10. These 8 symptoms were chosen based on their prevalence of 50% or greater in the population of interest. Higher scores mean WORSE or GREATER SYMPTOM BURDEN.

Michigan State University

University of Michigan

VA Office of Research and Development

Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive access to a Web site that updates them on patient's symptoms and provides tailored problem solving advice.

Caregiver website: Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan.

CarePartners+

Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.

CarePartners-

CarePartners +

CarePartners -

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

symptom severity = the sum across 8 core symptoms rated by the patient on a scale of 0 to 10 (higher is worse).

Summed symptom severity

Recruitment rates were lower than expected.

Maria J. Silveira MD MA MPH

CarePartners Intervention +

Control

Summed Symptom Severity

Overall Study

Gland and Hormone Related Diseases

Rare Diseases

Uterine Cervical Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Uterine Neoplasms

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Uterine Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

In addition to usual care, participants assigned to this arm will have access to our Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) program.

Participants assigned to this arm will receive the standard of care that is provided to all patients.

Participants will receive personalized self-care information and guidance based on their symptoms and signs of complications (e.g., skin infection, fatigue) from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through videoconferencing/telephone from the research nurse and also their healthcare providers at the hospital(s) if they experience moderate to severe symptoms and/or abnormal sign (e.g., body temperature is greater than 98.6 C

Patient-Reported Outcomes-Informed Symptom Management System (PRISMS)

Lixin Song, RN, PhD

This is a proof-of-concept pilot randomized clinical trial to test the feasibility of the innovative Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) to enhance personalized supportive care for cancer patients and caregivers during post-treatment care transition.

In this proof-of-concept study, our multidisciplinary team will conduct a pilot randomized clinical trial to test the feasibility of the innovative Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) to enhance personalized supportive care for cancer patients and caregivers during post-treatment care transition. We will randomly assign 21 cancer patients with newly created ostomies for cancer treatment with curative intent and their primary caregivers to the PRISMS or usual care groups (21 patient-caregiver dyads, a total of 42 individuals). PRISMS is defined as a personalized psychoeducational website including monitoring and personal feedback. We will conduct pre- and post-assessments of QOL and PRO (symptoms) at baseline upon enrollment and 2 months later.

Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS)

This is a pilot study with very small sample size and specific inclusion criteria. Sharing data with others may increase the risk to patient confidentiality.

Recruitment rate will be assessed by the percentage of potentially eligible participants who have consented to participate in the study

Enrollment rate will be assessed by the percentage of potentially eligible participants who have completed the baseline survey.

Retention rate will be assessed by the percentage of enrolled participants who have completed the 2-month followup survey at the end of the study period.

Satisfaction with the PRISMS program will be assessed by the 9-item Participant Satisfaction Scale measuring the level of program satisfaction ranging from 1=not satisfied to 5=extremely satisfied. Higher total score indicates greater program satisfaction.

Perceived ease of use of the PRISMS program will be assessed by the 23-item Usability Scale measuring the ease of use in three aspects: general, content, and navigation. The scales range from 1=strongly disagree to 5=strongly agree. Higher total score indicates greater ease of use.

Quality of Life (QoL) will be assessed using the Functional Assessment of Cancer Therapy General Scale (FACT-G) v.4, a 27-item measure yielding total score and scores for physical, social/family, emotional, and functional well-being of demonstrated reliability, validity, and sensitivity to change. FACT-G consists of 4 subscales: physical well-being (PWB), functional well-being (FWB), emotional well-being (EWB) and social well-being (SWB). Scores on the four subscales are summed to produce a total score ranging from 0 to 108 with higher scores indicating better quality of life. Change in the FACT-G scores from T1 (baseline survey) to T2 (2-month followup survey) will be calculated.

The total number of ostomy-related followup visits, emergency room use and re-admissions.

Digestive System Diseases

Gastroesophageal Reflux

Esophagitis

Barrett Esophagus

Precancerous Conditions

Esophageal Diseases

Gastrointestinal Diseases

Gastrointestinal Agents

All Drugs and Chemicals

Esomeprazole

Proton Pump Inhibitors

Antacids

Anti-Ulcer Agents

Enzyme Inhibitors

The patients in this group were advised to take PPI for 8 weeks continuously, followed by on-demand PPI therapy for the following 40 weeks.

The patients in this group were advised to take PPI QD continuously for 48 weeks.

Esomeprazole 40mg

SUNG-SHUO KAO, Bachelor

On-demand PPI therapy is feasible for the long-term treatment of patients with Barrett's esophagus.

Consecutive patients with symptomatic Barrett's esophagus are recruited and receive biopsy for esophageal metaplastic mucosa and gastric mucosa over the antrum and body during endoscopy on enrollment. The biopsy protocol for esophageal metaplastic mucosa is following Seattle protocol. GERD Q score will be conducted on enrollment. Additionally, blood sampling for CYP2C19 genotyping is also conducted on enrollment. The eligible subjects will be treated by 8-week esomeprazole, and are then randomly assigned to receive either maintenance or on-demand esomeprazole therapy (40 mg q.d.) for 40 weeks. The patients were asked to come back every four weeks for the recording of symptom days and PPI tablet consumption numbers. Follow-up endoscopy with biopsy for esophageal and gastric mucosa is performed at the end of the 48th weeks. We will compare the effects of maintenance and on-demand PPI therapy on (1) histological changes of esophageal metaplastic mucosa (2) symptom control (3) tablet consumption number

On-demand PPI Therapy is Effective on Controlling Symptoms in Patients With Barrett's Esophagus.

The Impacts of On-demand Versus Continuous Esomeprazole Therapy on the Symptom Control and Histological Changes of Metaplastic Esophageal Epithelium in Patients With Barrett's Esophagus (EsoBE) - a Multicentre Randomized Controlled Trial

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy of a Couple-Focused mHealth Symptom Self-management Program	NCT03489057	Prostate Cancer	Prostate Cancer... usual care plus...	40 Years - 75 Years	UNC Lineberger Comprehensive Cancer Center
Care Partners: Web-based Support for Caregivers of Veterans Undergoing Chemotherapy	NCT00983892	Cancer	Caregiver websi...	18 Years -	VA Office of Research and Development
Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS)	NCT04492007	Colorectal Canc... Bladder Cancer Ovarian Cancer Cervical Cancer Uterine Cancer	Patient-Reporte...	18 Years - 99 Years	UNC Lineberger Comprehensive Cancer Center
On-demand PPI Therapy is Effective on Controlling Symptoms in Patients With Barrett's Esophagus.	NCT04329000	Barrett Esophag... Proton Pump Inh... Symptom Reflux	Esomeprazole 40... Esomeprazole	20 Years - 80 Years	Kaohsiung Veterans General Hospital.

Spots Global Cancer Trial Database for symptom

Every month we try and update this database with for symptom cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for symptom

Every month we try and update this database with for symptom cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for symptom cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.