Symptoms and General Pathology

All Conditions

Nervous System Diseases

Heart and Blood Diseases

Infarction

Stroke

Cerebral Infarction

Embolic Stroke

Ischemia

Necrosis

Brain Infarction

Brain Ischemia

Cerebrovascular Disorders

Brain Diseases

Central Nervous System Diseases

Vascular Diseases

Ischemic Stroke

Cryptogenic embolic stroke with active cancer

Cryptogenic embolic stroke without active cancer

Chin-Sang Chung, MD, PhD

Although there has been increasing interest in the association between cancer and cerebrovascular disease, the underlying pathophysiology of stroke in cancer patients is still not fully understood. The aim of this study is to investigate the stroke mechanisms in patients with cancer-associated stroke.

Patients with cryptogenic embolic stroke will be prospectively enrolled and categorized into two groups according to the presence of active cancer: cryptogenic embolic stroke with active cancer (cancer-associated stroke) vs. without active cancer (cryptogenic embolic stroke). All patients will undergo brain MRI/MRA, 12-lead electrocardiography, transthoracic and transesophageal echocardiography with injection of agitated saline, and 24-hour Holter and/or telemonitoring. Duplex ultrasonography to detect venous thrombosis of the lower extremity will also be performed in patients with a positive right-to-left shunt on echocardiography.

Identification the Cause of Cerebral Infarction in Patients With Cancer

Venous thromboembolism was investigated via Doppler sonography and/or computed tomography pulmonary angiography combined with venous phase CT angiography of the lower extremities. Microembolic signal was detected via transcranial Doppler sonography on symptomatic cerebral circulation

Infarct volume was measured by diffusion-weighted MR imaging and apparent diffusion coefficient calculated from imaging data. Univariate and multivariate linear regression was performed in ESUS patients with cancer (adjusted for age, sex, overt DIC).

Survival time (in years) was measured by subtracting admission date from the date the patient had expired. Cox proportional hazard analysis was used to evaluate association between intravascular thrombosis and survival (adjusted for age, sex, NIHSS, presence of overt DIC, infarct volume, metastasis, and histologic type).

Samsung Medical Center

MD, PhD

Rare Diseases

Chronic Pain

Cancer Pain

Pain

Neurologic Manifestations

Chronic Graft Versus Host Disease

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics, Opioid

Patients in this Pilot Cohort will be in the research study for 6 weeks total including:

* a 4-week intervention period and 2-week post intervention period.
* Patients will use the app for a total of 4 weeks (4-week intervention period), and will complete surveys at baseline, 4 weeks (end of intervention period), and at 6 weeks (end of 2-week post intervention period).

Use the STAMP+CBT mobile app for 4 weeks (intervention period, 4 weeks for content introduction, extended 2 weeks for review of content if patient's request this

STAMP+CBT application

Desiree Azizoddin, PsyD

Desiree R Azizoddin, PsyD

Frederick Briccetti, MD

Pedro Sanz-Altamira, MD

The purpose of this study is to test whether a mobile application developed to help people with cancer pain is useful and helpful to patients with cancer.

This research study involves the use of a smartphone app at home in addition to surveys and potentially an interview at the end of the study.

The research study procedures include screening for eligibility, study interventions include surveys at the beginning of the study, after 4 weeks, and after 6 weeks and use of the smartphone app.

Participants will be on this research study for up to 6 weeks.

It is expected that about 15 people will take part in this research study

This research study is a Feasibility Study, which is the first-time investigators are examining this mobile application meant to help participant to learn behavioral techniques to manage cancer pain. The purpose is to make sure the app is usable and helpful for patients with cancer, and to get feedback about patient experiences after using the app for four weeks.

STAMP+CBT mHealth for Cancer Pain

Harnessing Mobile Technology to Deliver Tailored, Brief Pain-CBT for Advanced Cancer Patients on Opioids for Pain

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research

\>70% of subjects complete \>4 of the 6 pain-CBT modules and patients will complete 60% of surveys by the end of 4 weeks (completion of the 4-week intervention study period)(completion of the 4-week intervention study period)

\>80% of the acceptability items are rated 4 or higher/5; lower ratings will lead to app refinements

15 patients will be enrolled to the trial within 6 months

60% of patients who enroll to the app with complete app use at the end of the 4 weeks and surveys at 4 and 6 weeks after enrollment

Overall acceptability will be determined based on composite evaluation of acceptability ratings using the e-Acceptability scale, app content completion rates, and qualitative patient feedback.

National Palliative Care Research Center (NPCRC)

Dana-Farber Cancer Institute

Principal Investigator

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Fatigue

Hypogonadism

Eunuchism

Gonadal Disorders

Endocrine System Diseases

Quality of Life

Androgens

Testosterone

Hormones

Hormone Antagonists

Testosterone 1.62% gel will be applied daily by the participants (all participants will be trained in the application process and will be given printed instructions). The intervention will be for 6 months.

The placebo gel will be applied daily by the participants (all participants will be trained in the application process and will be given printed instructions). The intervention will be for 6 months.

The gel will be applied daily by the participants (all participants will be trained in the application process and will be given printed instructions). The intervention will be for 6 months

testosterone 1.62% gel

placebo gel

Jose Garcia, MD, Phd

Egidio Del Fabbro, MD

Milena Braga, MD

Shehzad Basaria, MD

Haley Lowe, RN, MN

Lindsey Anderson, PhD

Jose M Garcia, MD, PhD

This is a large randomized, double-blind, placebo-controlled trial to determine the efficacy of testosterone replacement on cancer-related fatigue in older men with solid or hematologic (blood) cancer who report fatigue and have low testosterone levels.

The overall objective is to conduct a double-blind, randomized, placebo-controlled, parallel group trial to determine the efficacy of 6 months of physiological testosterone replacement therapy in improving cancer related fatigue, sexual dysfunction, and body composition and muscle function in men 55 years and older with solid or hematologic (blood) cancers, who report fatigue and have testosterone deficiency. There will be 5 study visits: 1) Screening, 2) Baseline, 3) 2-Week Dose Adjustment Visit, 4) Three-month visit (Week 12), and 5) Six-month visit. Testosterone or placebo gels will be applied by eligible trial participants at home; participants will be trained on gel application procedures by research personnel.

randomized, double-blind, placebo-controlled, parallel group, trial of daily transdermal testosterone gel or placebo gel for 6-months

Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency

Erectile function will be assessed by International Index of Erective Function (IIEF).

Mood and well-being will be assessed by Positive and Negative Affect Scale (PANAS), which includes 10 questions each for Positive Affect and Negative Affect. Many behavioral scientists consider affectivity as the cleanest window on an individual's wellbeing. The most sensitive indicator of impaired wellbeing has been shown to be affective dysregulation, which is reflected in affectivity balance. The latter incorporates negative affects (e.g., anxiety, depression) as well as positive affects (e.g., joy).

Body composition changes will be assessed by measuring lean body mass and fat mass by dual energy X-ray absorptiometry (DEXA).

Muscle strength will be assessed by measuring maximal voluntary strength in the leg press exercise by the 1-RM method.

Physical function will be evaluated using the 6-minute walk test and will also be evaluated by measuring power in the lower extremities by conducting the leg press exercise.

To determine changes in daily physical activity, validated actigraphy will be used.

The Brief Assessment Scale for Caregivers (BASC) will be used to determine caregiver burden.

Loss of productivity will be evaluated using the Work Productivity and Impairment (WPAI) scale.

Sleep quality will be assessed using the validated Pittsburgh Sleep Quality Index (PSQI) scale and by using actigraphy.

Qualitative interviews will be performed by a study co-investigator which will assess lived experiences of participants at baseline and at 24 weeks by conducting semi-structured, qualitative phone interviews with a randomly selected sample of 30 men in the testosterone arm and 30 men in the placebo arm (equally divided across the 3 sites).

Primary outcome is change in fatigue score. Fatigue will be assessed by the Functional Assessment of Chronic Illness Therapy fatigue scale (FACIT-Fatigue)- The FACIT-Fatigue has been widely used in studies related to cancer-related fatigue and is able to detect clinically meaningful differences in fatigue scores in response to treatment. Population norms for the FACIT are also available, facilitating the interpretation of fatigue levels in patient populations. This instrument has been well-validated, is responsive to treatment and more sensitive to change in fatigue than other instruments. Score range: 0-52, the higher the score the better quality of life.

Secondary outcome is change in sexual activity score, assessed by the Harbor-UCLA 7-day Sexual Function Questionnaire.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Identification the Cause of Cerebral Infarction in Patients With Cancer	NCT02212496	Cryptogenic Emb... Active Cancer		18 Years -	Samsung Medical Center
STAMP+CBT mHealth for Cancer Pain	NCT05403801	Active Cancer Active Cancer T... Advanced Cancer Palliative Care Chronic Pain Du...	STAMP+CBT appli...	18 Years -	Dana-Farber Cancer Institute
STAMP+CBT mHealth for Cancer Pain	NCT05403801	Active Cancer Active Cancer T... Advanced Cancer Palliative Care Chronic Pain Du...	STAMP+CBT appli...	18 Years -	Dana-Farber Cancer Institute
Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency	NCT04301765	Hypogonadism, M... Cancer Fatigue	testosterone 1.... placebo gel	55 Years -	Seattle Institute for Biomedical and Clinical Research
STAMP+CBT mHealth for Cancer Pain	NCT05403801	Active Cancer Active Cancer T... Advanced Cancer Palliative Care Chronic Pain Du...	STAMP+CBT appli...	18 Years -	Dana-Farber Cancer Institute
Identification the Cause of Cerebral Infarction in Patients With Cancer	NCT02212496	Cryptogenic Emb... Active Cancer		18 Years -	Samsung Medical Center

Spots Global Cancer Trial Database for active cancer