Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Recurrence

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Patients perform moderate intensity exercise on a stationary bike for 20-50 minutes, three days a week for 16 weeks.

Patients perform HIIT exercise on a standard stationary bike, three days a week for 16 weeks.

Patients perform HIIT exercise on a cybercycle using racing or other games, three days a week for 16 weeks.

moderate exercise intervention

Perform HIIT exercise therapy on a standard stationary bike

vigorous exercise intervention - standard

Ancillary studies: Functional Assessment of Cancer Therapy-General (FACT-G), Godin Leisure-Time Exercise questionnaire, 24-hour diet recalls, USDA 5 Step Multiple Pass Method, Memorial Anxiety Scale for Prostate Cancer, Pittsburgh Sleep Quality Index (PSQI)

questionnaire administration

laboratory biomarker analysis

perform HIIT exercise on cybercycles aided by electronic racing and other games

vigorous exercise intervention - cybercycling

The exercise physiologists will keep exercise logs and tracking sheets that log the date, start and stop time (duration) of exercise sessions as well as time in the THR and RPE for each exercise session.

Exercise Logs

We will assess barriers to adhering to the exercise protocol by asking an open-ended question to solicit barriers. If the patient calls to cancel an exercise session, he will be called and probed for reasons

Adherence

Height will be measured to the nearest 0.1 cm and weight will be measured to the nearest 0.1 kg. Waist and hip circumference will be measured to the nearest 1/8 inch. Whole body dual-energy X-ray absorptiometry scans will be conducted at baseline and end of treatment to quantify total body fat.

Exercise and body composition test

Nora Nock, PhD

This randomized pilot clinical trial compares vigorous or moderate exercise in enhancing active surveillance in patients with prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Active surveillance involves watching the patient's condition but not giving any treatment unless test results show that the patient's condition is getting worse. Exercise may improve fitness, quality of life, brain health, and blood biomarkers in patients with prostate cancer on active surveillance. It is not yet known whether vigorous or moderate exercise works better in enhancing active surveillance in patients with localized prostate cancer.

PRIMARY OBJECTIVES:

I. To determine the feasibility of performing vigorous intensity aerobic exercise using progressive, high-intensity interval training (HIIT) with standard stationary cycling and 'cybercycling' compared to moderate intensity aerobic exercise with standard stationary cycling in prostate cancer (PCa) survivors on active surveillance (AS).

II. To explore the potential effects of vigorous intensity aerobic exercise (HIIT) using standard cycling and 'cybercycling' compared to moderate intensity standard cycling on changes in quality of life (QoL), cognition, fitness circulating inflammatory biomarkers and PCa-specific markers of progression (prostate specific antigen \[PSA\], time to AT) in PCa survivors in active surveillance (AS); and, to explore if these effects may be mediated by changes in body fat.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients perform moderate intensity exercise on a stationary bike for 20-50 minutes, three days a week for 16 weeks.

ARM II: Patients perform HIIT exercise on a standard stationary bike, three days a week for 16 weeks.

ARM III: Patients perform HIIT exercise on a cybercycle using racing or other games, three days a week for 16 weeks.

After completion of study, patients are followed up at 6 and 12 months.

Vigorous or Moderate Exercise in Enhancing Active Surveillance in Patients With Localized Prostate Cancer

Enhancing Active Surveillance With Exercise (EASE): A Pilot Randomized Trial in Localized Prostate Cancer Survivors

Average number of people who attend each session

Average number of minutes in HIIT intervals which are defined as exercising at 80-90% WR_peak

the target heart rate zone will be determined using the Karvonen formula: THR=((HRmax - HRrest) × % Intensity) + HRrest. Total time in this zone will be recorded every 5 minutes and the overall average will be recorded

The EMI-2 is a validated, 51 item instrument where each question is scored 0-5 and higher scores indicate greater motivation. Average changes will be analyzed using t-tests as well as mixed linear models adjusted for potential confounding factors.

A 25 item scale scored 0-4 where lower indicate greater quality of life. Paired t-tests will be used to evaluate change as well as mixed linear models adjusted for potential confounding factors.

Difference in VO2 maximum 30 second intake from beginning of study to end of treatment. Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.

Change in body mass index (function of height and weight) from baseline to end of treatment. Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.

Average change in score of cognitive survey. Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.

61 items where higher scores indicate healthier eating behaviors. Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.

Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.

The ECOS is a validated, 21 item instrument where each question is scored 1-7 and higher scores indicate greater motivation. Average changes will be analyzed using t-tests as well as mixed linear models adjusted for potential confounding factors.

Change in waist and hip circumference ratio from baseline to end of treatment. Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.

Change in total body fat from baseline to end of treatment as measured by whole body dual-energy X-ray absorptiometry scans. Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.

National Cancer Institute (NCI)

Case Comprehensive Cancer Center

Blood and Lymph Conditions

Behaviors and Mental Disorders

Rare Diseases

Leukemia

Hematologic Neoplasms

Acute Disease

Neoplasms by Histologic Type

Hematologic Diseases

Disease Attributes

Quality of Life

Acute Graft Versus Host Disease

Psychotropic Drugs

All Drugs and Chemicals

Patients assigned to the intervention arm will receive 8 - 12 psychotherapy sessions lasting 30 - 60 minutes each, delivered by a trained therapist at our center. Patients will receive specialized symptom control from a nurse/physician team in our Palliative Care Service, when indicated by routine symptom screening.

EASE includes psychotherapeutic (EASE-psy) and physical symptom control (EASE-phys) components.

EASE

Gary Rodin, MD FRCPC

Camilla Zimmermann, MD PhD FRCPC

The purpose of this study is to test the feasibility of an individual psychological and physical symptom intervention, called Emotion And Symptom-focused Engagement (EASE), to reduce traumatic stress and physical symptom burden in individuals newly diagnosed with acute leukemia.

This study involves the pilot-testing of a newly developed, brief manualized individual psychotherapy and physical symptom control intervention, called Emotion And Symptom-focused Engagement (EASE), to reduce traumatic stress and physical symptom burden in individuals newly diagnosed with acute leukemia. The purpose of this study is to conduct a two-arm randomized pilot trial (RPT) to test the feasibility, acceptability, and preliminary efficacy of EASE against usual care (UC) for the reduction of traumatic stress and physical symptom burden in patients with acute leukemia. Usual care for individuals with acute leukemia treated at the Princess Margaret Cancer Centre includes referral for non-standardized, and primarily instrumental, psychosocial care and palliative care service as needed.

The design will be an unblinded RPT consisting of two conditions (EASE and UC), with a baseline assessment and follow-ups at 4, 8, and 12 weeks. The trial will take place at the Princess Margaret Cancer Centre, University Health Network; a comprehensive cancer center in Toronto, Canada. Participants will be newly diagnosed with acute leukemia, within one month of diagnosis and/or admission to hospital for treatment with curative intent.

Emotion And Symptom-focused Engagement (EASE): An Intervention for Individuals With Acute Leukemia

Emotion And Symptom-focused Engagement (EASE): A Randomized Pilot Trial of an Intervention for Individuals With Acute Leukemia

A 30-item reliable and valid self-report measure of traumatic stress symptoms.

A 40-item reliable and valid self-report measure of overall quality of life, including 12 items that assess spiritual well-being, spiritual meaning and peace, and faith.

A 21-item reliable and valid self-report measure of the intensity of depressive symptoms, consistent with the DSM-V criteria for major depressive disorder.

A 9-item reliable and valid self-report measure that assesses pain severity and the impact of pain on daily functioning.

A 32-item reliable and valid self-report inventory assessing the presence and severity of 26 common physical symptoms and 6 psychological symptoms of cancer. The scale has been adapted to reduce burden. A shortened version that omits frequency of symptoms and treatment, and satisfaction with treatment for each symptom was used.

A 16-item reliable and valid self-report measure of attachment security.

A 16-item reliable and valid self-report measure of patient satisfaction with healthcare providers.

A 7-item measure developed for this study to evaluate the extent to which patients felt emotionally supported by the clinical services provided.

A 14-item symptom severity assessment measure adapted for patients with acute leukemia to include prevalent and treatable symptoms in this population: mouth sores, diarrhea, itching, constipation, and insomnia. ESAS-AL was used as a screening tool as part of the clinical intervention, and was added as an outcome later in the trial (13-Apr-2016).

Canadian Cancer Society (CCS)

University Health Network, Toronto

Wounds and Injuries

Trauma and Stressor Related Disorders

Caregiver Burden

Stress, Psychological

Behavioral Symptoms

Mental Disorders

Psychotic Disorders

Participants randomized to the intervention group will receive the EASE intervention and usual care. EASE consists of 8-12 psychotherapeutic sessions (\~30-60 minutes each) delivered by a trained mental health clinician over 12 weeks.

Participants randomized to the control group will receive usual care.

EASE sessions are directed to provide relational support, affect regulation, and problem-solving related to cancer in the child, to changes in spousal, family, and other relationships, and to the burden of multiple individual and family responsibilities.

Lindsay Jibb, RN, PhD

Elham Hashemi, MA

The goal of this two-site phase III randomized controlled trial is to evaluate the effectiveness of a novel psychotherapeutic intervention called Emotion and Symptom-focused Engagement (EASE) in parents caring for a child or adolescent with cancer. The main question it aims to answer is:

- Does EASE reduce traumatic stress symptom severity (primary outcome)?

To do so, researchers will compare parents receiving EASE to usual care. Participants in both groups will complete questionnaires package at enrolment, and 4, 8, and 12 weeks, and 6 months after enrolment. They will also be invited to participate in optional qualitative interviews to better understand their experience.

Quantitative outcome assessors and data analysts will be blinded to participant treatment group. Blinding is not possible for trial participants, intervention providers, or pediatric oncology teams, as assignment cannot be hidden from these individuals.

Emotion and Symptom-Focused Engagement (EASE) for Caregivers

Emotion and Symptom-Focused Engagement (EASE) for Caregivers: A Phase III Randomized Controlled Trial of an Intervention Targeting Traumatic Stress in Parents of Children With Cancer

This will be used to measure caregiver burden.

This will be used to measure perceived social support.

This will be used to measure attachment security.

This will be used to assess expectation of EASE effectiveness in the treatment arm.

This will be used to measure traumatic stress symptoms.

This will be used to measure quality of life.

This will be used to measure depressive symptoms.

This will be used to measure parent capacity to care for their child.

This will be used to measure parent perceived family functioning.

This will be used to measure parent perceived benefit from interaction with clinicians.

This will be used to measure parent satisfaction with care.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Vigorous or Moderate Exercise in Enhancing Active Surveillance in Patients With Localized Prostate Cancer	NCT02179762	Recurrent Prost... Stage I Prostat... Stage IIA Prost... Stage IIB Prost...	moderate exerci... vigorous exerci... questionnaire a... laboratory biom... vigorous exerci... Exercise Logs Adherence Exercise and bo...	18 Years - 75 Years	Case Comprehensive Cancer Center
Emotion And Symptom-focused Engagement (EASE): An Intervention for Individuals With Acute Leukemia	NCT02353559	Acute Leukemia	EASE	18 Years -	University Health Network, Toronto
Vigorous or Moderate Exercise in Enhancing Active Surveillance in Patients With Localized Prostate Cancer	NCT02179762	Recurrent Prost... Stage I Prostat... Stage IIA Prost... Stage IIB Prost...	moderate exerci... vigorous exerci... questionnaire a... laboratory biom... vigorous exerci... Exercise Logs Adherence Exercise and bo...	18 Years - 75 Years	Case Comprehensive Cancer Center
Emotion and Symptom-Focused Engagement (EASE) for Caregivers	NCT06367556	Trauma and Stre... Pediatric Cance... Caregiver Burde...	EASE	18 Years -	University Health Network, Toronto

Spots Global Cancer Trial Database for ease

Every month we try and update this database with for ease 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 ease

Every month we try and update this database with for ease 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 ease 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.