Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Arm A will receive print educational materials about the benefits of exercise and diet for men with prostate cancer, with recommendations geared at men living with prostate cancer, mailed around the date of surgery. They also receive a 10-week text messaging program focused on recovery after radical prostatectomy surgery.

Arm B receives the following: Arm A material plus access to an online portal with additional educational materials to help improve exercise habits and various tools, such as the ability to track exercise; additional educational print materials on exercise; additional text messages over 2 years that supports healthy exercise habits; and a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with an exercise coach over 2 years.

Arm C receives the following: Arm A material plus access to an online portal with additional educational materials to help improve diet habits and various tools, such as the ability to track diet; additional educational print materials on diet; additional text messages over 2 years that supports healthy diet habits; and a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with a diet coach over 2 years.

Arm D receives the following: Arm A material plus access to an online portal with additional educational materials to help improve exercise and diet habits and various tools, such as the ability to track exercise and diet; additional educational print materials on exercise and diet; additional text messages over 2 years that supports healthy exercise and diet habits; a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with an exercise coach over 2 years; and a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with a diet coach over 2 years.

Behavioral program provides access to educational materials + clinical texting program (Arm A) + participant portal, text messaging, and coaching (Arms B-D)

Exercise and Diet

Stacey A Kenfield, DSc

The Prostate 8-II study is a randomized controlled trial of testing different combinations of educational and supportive tools related to diet and exercise to evaluate biological, clinical, and quality of life outcomes in men choosing radical prostatectomy as treatment for prostate cancer.

This is a PI initiated, randomized controlled trial of four exercise and diet interventions among men opting for radical prostatectomy for prostate cancer.

The Prostate 8-II study enrolls men up to 8 weeks prior to surgery and participants remain on study for 24 cycles after surgery (1 cycle=28 days). After obtaining written informed consent, enrolled subjects will be scheduled for the baseline assessments. All participants will receive Group A educational materials and tools, but these will be distributed at different times based on group assignment. The other 3 groups will receive different combinations of exercise (Group B), diet (Group C) and exercise and diet (Group D) tools. Men in all arms will be asked to complete questionnaires at baseline, pre-surgery, and at cycles 6,12, \& 24 post-surgery, and complete blood and urine collection, diet recall, and accelerometer measurement at select time points. Specimens from biopsy and radical prostatectomy will be reviewed by the investigators' collaborator, GenomeDx, for RNA characterization and assessment of the genomic risk scores. Participants will be followed for 30 days after completion of the 2-year 24-cycle intervention period or removal from the study, or until death, whichever occurs first for any treatment-related adverse events. Following the completion of the intervention, participant's treatment and disease status will be collected on a yearly basis, for 3 more years.

Diet and Exercise Interventions Among Men With Prostate Cancer (Prostate 8-II)

A Randomized Controlled Trial of Diet & Exercise Interventions Among Men With Prostate Cancer - II (Prostate 8-II)

Detectable PSA will be defined based on current practice at the time of analysis. Point estimate and 95% confidence interval of the proportion of detectable PSA at 6 months and 2 years post-surgery for each group will be reported. In addition, Pearson's Chi-square test will be used to test if there are differences in the proportion of detectable PSA at least 6 weeks post-surgery among the groups. If there is a significant difference observed, a 2-sample proportion test to compare Groups B, C, and D, separately, with Group A and one another for each post-intervention time point will be performed. Point estimates and 95% confidence intervals of the recurrence proportion will be obtained for each group

Risk of cancer recurrence (based on current practice) measured using standard criteria using a log- rank test to evaluate the time to recurrence among groups, and multivariate Cox proportional hazards regression to obtain a hazard ratio for the time to recurrence

Effect of intervention on changes in mRNA expression patterns using the 1.4 million marker Affymetrix 1.0 Human Exon Array, in formalin-fixed paraffin-embedded (FFPE) prostate biopsy and prostatectomy tissue to determine which genes are differentially expressed from biopsy to RP within each group. If the expression is significantly different in at least one of the groups, the change of RNA expression level will be compared among all groups by ANOVA. If there is a significant difference observed, we will perform pairwise comparisons among the groups. Multiple testing adjustment will be done by controlling false discovery rate

Assessment of genomic classifiers, using the 1.4 million marker Affymetrix 1.0 Human Exon Array, in FFPE (formalin-fixed paraffin embedded) prostate biopsy and radical prostatectomy tissue. Each score ranges from 0 to 100 and can be interpreted as a probability of progression. The 2-sample proportion test will be used to compare the proportion of reduction in the genomic score between Groups B, C, and D, separately with Group A first. Significant mean changes in the Decipher score will be tested using Analysis of Variance (ANOVA). If there is a significant difference observed, pairwise comparisons among the groups will be performed. A regression model will be built using an indicator for group and stratification factors such as age at diagnosis and surgical parameters (e.g., CAPRA-S) which have been determined to be potential covariates.

The EPIC-26 will be used to determine the impact of quality of life issues on the sexual function domain. Response options for each EPIC item form a Likert scale, and the raw score of each item is then transformed linearly to a 0-100 scale. Multiple items are combined and then averaged to form the domain scores and total score at each time point also ranging from 0-100, with higher scores representing better health related quality of life (HRQOL).

The EPIC-26 will be used to determine the impact of quality of life issues on the urinary function domain. Response options for each EPIC item form a Likert scale, and the raw score of each item is then transformed linearly to a 0-100 scale. Multiple items are combined and then averaged to form the domain scores and total score at each time point also ranging from 0-100, with higher scores representing better health related quality of life (HRQOL).

General anxiety items usually has five response options ranging in value from one to five with a higher value indicating a greater degree of anxiety. The total raw score is the sum the values of the response to each question, and then converted to a scaled T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.

Memorial Anxiety Scale for Prostate Cancer (MAX-PC) - 18 items assessing prostate cancer anxiety, PSA anxiety, and fear of recurrence; range 0-54; smaller number is better.

General depression items usually has five response options ranging in value from one to five with a higher value indicating a greater degree of depression. The total raw score is the sum the values of the response to each question, and then converted to a scaled T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.

The SF-12 is a 12-item questionnaire used to assess generic health outcomes from the patient's perspective. The SF-12 consists of a subset of 12 items from the SF-36® Health Survey (SF-36) and measures two composite outcomes assessing mental health composite score (MCS) and physical health composite scores (PCS). The PCS \& MCS are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The absolute change in item score by group from baseline up to 12 months was used to assess the quality of life/psychosocial impact on the patients with a larger scores indicating a greater degree of change on physical and mental health.

Patients will wear an Actigraph GT3X+ accelerometer on their wrist for 7 consecutive days to measure physical activity

The Godin-Shephard Leisure-Time Physical Activity Questionnaire measures the frequency and duration of various types of physical activity (strenuous, moderate, light) and each is weighted by multiplying the frequency by a corresponding multiplier (x9, x5, x3 respectively) during a typical 7-Day period. The weekly leisure activity score = (9 × Strenuous) + (5 × Moderate) + (3 × Light). A score of 24 units or more indicates a status of "Active", 14 - 23 units "Moderately Active" and \< 14 units "Insufficiently Active/Sedentary".

The FFQ is a self-administered questionnaire to assess intake of various nutrients. Nutrient intakes are computed by assigning a daily frequency weight

Two online 24-hour diet recalls as recommended by the National Cancer Institute's Diet Assessment Primer

Various metrics for study feasibility (e.g., text message, portal, and coaching use) will be measured over time. Study acceptability will be evaluated by survey and in a subset, by phone interview. Descriptive data of these metrics across arms will be reported

Confidence scores in adopting dietary and physical activity behaviors at for each group using descriptive statistics, such as means, medians, and interquartile range will be reported using descriptive statistics.

In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality

Social support will be measured using published measures from University of California, San Diego (http://sallis.ucsd.edu/measure_socialsupport.html

National Cancer Institute (NCI)

University of California, San Francisco

Participants in the intervention arm will receive the standard surgical teaching while in the operating room (master-apprentice model (MAM)), plus the intervention of reviewing the recorded video with the surgical coach after performing their first attempt at laparoscopic closure of the vaginal vault.

Participants in the control arm will receive the standard surgical teaching while in the operating room (master-apprentice model-(MAM)).

The coaching session will follow the Wisconsin Coaching Framework (Greenberg 2015). The surgical coaching session will last at maximum 30 minutes and will occur within 1-2 week following the procedure. The surgical coaching session will occur over Zoom. The second attempt will occur within 1 week following the coaching session.

Video-based coaching

Standard surgical teaching that conventionally occurs in the operating room follows a master-apprentice model (MAM).

Standard surgical teaching (master-apprentice model - (MAM))

Brenna Swift

Danielle Vicus, MD

Evan Tannenbaum, MD, MSc

Stephane Laframboise, MD

This multi-centre, randomized controlled trial aims to assess the role of video-based coaching (VBC) in residency education in gynecologic and gynecologic oncology surgery. It involves a trainee and a surgical coach, who together review a recording of the trainee performing a surgical skill or procedure and coaching is provided for skill improvement. Resident performance will be evaluated using a standardized scoring scale by two experienced surgeons before and after the intervention and compared to the control group receiving the standard surgical teaching curriculum.

Achieving technical excellence is a core component of surgical training. Historically, a combination of didactic teaching, surgical simulation and the master-apprentice model (MAM) were the cornerstone of surgical education. With restrictions on resident duty hours and operating time with the COVID-19 pandemic and a shift to competency-based medical education, there is an opportunity to transform surgical education and improve educational efficiency. The purpose of this study is to assess the effect of video-based coaching (VBC) on resident skill acquisition in laparoscopic suturing of the vaginal vault at the time of laparoscopic hysterectomy.

Participants will include year 3 to 5 Obstetrics and Gynecology residents completing gynecology and gynecologic oncology rotations at the study sites. Participants will be randomized to the control (standard surgical curriculum) and intervention (standard curriculum and VBC) arms on the day of the first attempt. The effectiveness of VBC will be measured by the difference in baseline and post-intervention standardized blinded score between the intervention and control group during laparoscopic closure of the vaginal cuff.

All residents will be video recorded performing laparoscopic closure of the vaginal cuff at the time of hysterectomy using video recording built into the laparoscopic equipment in the operating rooms. Residents in the control group will receive standard surgical teaching (MAM), then they will be video-recorded performing the skill at their second attempt. Residents in the intervention group will receive the standard surgical teaching plus the intervention of reviewing the recorded video with the surgical coach at the end of the procedure (MAM plus VBC). The surgical coach will provide specific personalized feedback on performance and suggestions for improvement following the Wisconsin Coaching Framework during their coaching session. Participants will then be recorded on their subsequent attempt.

All raw video footage will be edited to include only the relevant portion of the film. This will facilitate the assessment process (i.e., the assessors will view only the relevant footage). The edited video segments for both groups on both attempts will be scored independently using the validated surgical assessment tool by two blinded, experienced gynecologic laparoscopists to evaluate surgical performance (blinded to attempt number and randomization group). The average score between both assessors will be used for statistical analysis. The effectiveness of VBC will be evaluated by comparing the difference in assessment scores between the baseline and post-intervention scores between the control and intervention groups.

Participants will be randomized to the intervention (video-based coaching plus standard surgical teaching following the master-apprentice model) or the control (standard surgical teaching following the master-apprentice model)

Due to the nature of the intervention, the participants and the surgical coach will not be blinded. The participants will be informed of their assignment after completing the first attempt. The staff surgeon in the operating room for each attempt will be blinded. The experienced laparoscopists who will be scoring the videos will be blinded to the group allocation and the attempt number.

Video-based Coaching (VBC) in Gynecologic Surgery

A Multicentre, Randomized Controlled Trial to Assess Video-based Feedback for Surgical Coaching in Gynecology and Gynecologic Oncology

The modified OSATS score is a standardized rubric for assessing technical skills

Desirability of the intervention will be evaluated based on the proportion of eligible residents who enrol in the study (number enrolled/number eligible).

Participants in the intervention arm will complete a surgical coachee questionnaire to determine if the participants in the intervention arm found the coaching experience to be useful for developing their surgical skills.

Surgical coach will complete a questionnaire immediately after the coaching activity, which will collect time for video-editing, time for coaching session and receptivity of the participant to coaching

The intraclass correlation coefficient (ICC) between the two score for each video will be calculated

Sunnybrook Health Sciences Centre

University Health Network, Toronto

Mount Sinai Hospital, Canada

Assistant Professor, Obstetrician/Gynecologist

Symptoms and General Pathology

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Musculoskeletal Diseases

Heart and Blood Diseases

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Rare Diseases

Syndrome

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Noonan Syndrome

Costello Syndrome

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Congenital Abnormalities

Craniofacial Abnormalities

Musculoskeletal Abnormalities

Heart Defects, Congenital

Cardiovascular Abnormalities

Heart Diseases

Connective Tissue Diseases

Abnormalities, Multiple

Quality of Life

Neurofibromatosis

Neurofibromatosis Type 1

Cardiofaciocutaneous Syndrome

Legius Syndrome

Participants will begin their 1-week baseline EMA data collection period and then take part in intervention procedures immediately after enrollment to assess feasibility and acceptability.

Participants will begin their 1-week baseline EMA data collection period immediately after randomization and will begin receiving the 8-week intervention at the end of this week/beginning of the next week (depending on participant schedule).

After an initial 1-week baseline period for EMA data collection and 8 weeks of maintaining their usual routine (wait list period), participants will begin receiving the 8-week intervention.

8 weeks of maintaining usual routine followed by 8-week intervention that emphasizes mindfulness, acceptance, perspective taking, and values-based actions.

Waitlist

8-week intervention that emphasizes mindfulness, acceptance, perspective taking, and values-based actions.

ACT Intervention

Staci M Peron, Ph.D.

Staci Peron, Ph.D.

Background:

RASopathies are a group of genetic diseases that affect a child s development. They cause physical, cognitive, and behavioral symptoms. Caring for a child with a RASopathy can be stressful. Acceptance and Commitment Therapy (ACT) is a therapy that helps people become more aware and accepting of difficult thoughts and feelings. ACT has been found to be helpful for parents with high parenting stress.

Objective:

To find out if Acceptance and Commitment Therapy (ACT) can help caregivers of children with a RASopathy better cope with parenting stress.

Eligibility:

People aged 18 years or older who care for a child (younger than 18 years) with a RASopathy. The child must live with the caregiver at least 50% of the time.

Design:

The study is fully remote. Participants need a mobile device that can play audio and video and connect to the internet. They can borrow an iPod if needed.

Participants will download a free app called MetricWire. They will use this app to watch videos and answer questions.

The first 8 participants will be in a pilot study. They will receive the ACT intervention starting the first week after they begin the study.

After the pilot study, we will start a new phase called the randomized trial. In this phase, participants will have a 50-50 chance of being in the group that will start the intervention right away or the group that will start the intervention after about 2 months.

Participants will fill out surveys on 5 random days each week. These surveys have 7 questions and take about 2 minutes. They will also fill out 3 longer questionnaires: once before ACT begins, once just after the 8-week study period, and once about 3 months later. Questions will cover topics including:

Parenting stress

Life satisfaction

Self-compassion

Uncomfortable feelings and thoughts

Mindfulness

Participants will take part in an 8-week ACT intervention. They will have one 75-minute session with an ACT coach in the first week.

Participants will watch 9- to 17-minute videos each week. The videos talk about how to practice ACT techniques to cope with parenting stress.

Participants will have 20- to 30-minute coaching sessions in weeks 3 and 6. The coach will help them practice exercises and work through any problems.

Background:

* RASopathies are a group of neurodevelopmental genetic conditions caused by mutations affecting components within the RAS-map kinase (RAS-MAPK) cellular signaling pathway.
* Caregivers of children with a RASopathy are faced with numerous challenges related to the physical, cognitive, and behavioral symptoms associated with their child s condition.
* The use of virtual interventions has been increasing over the past decade, which increase accessibility and are especially critical during times of physical distancing, such as due to COVID-19.
* Similarly, Ecological Momentary Assessments (EMA) are being utilized more frequently in order to maximize ecological validity of results and minimize recall bias.
* To our knowledge, no psychological interventions have been investigated targeting parenting stress among caregivers of a child with a RASopathy.

Primary Objectives:

* Internal Pilot Study: To assess the feasibility (e.g., enrollment and attrition) and acceptability (e.g., satisfaction) of an Acceptance and Commitment Therapy (ACT) coping intervention on parenting stress for caregivers of a child with a RASopathy
* Randomized Controlled Trial (RCT): To compare Parental Stress Scale (PSS) changes from baseline to 8 weeks between the Immediate Intervention Arm and the Waitlist Control Arm

Eligibility:

* Caregiver (parent or legal guardian) of a child (\< 18 years) residing with them at least 50% of the time who has a diagnosis of RASopathy syndrome including NF1, Noonan Syndrome, Legius Syndrome, Cardiofaciocutaneous (CFC) syndrome, and Costello Syndrome, or another RASopathy
* Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access) or be willing to use an iPod provided by the study team
* Must score a 15 or higher total score on modified questions from the PSS to indicate at least a moderate level of parenting stress
* Ability to read and speak English

Design:

* This is an 8-week psychological intervention study that has two phases: the first, an internal pilot study, will enroll an initial, small cohort of caregivers (n = 8), all of whom will participate in the ACT intervention. (COMPLETE)
* Due to the success of the internal pilot study (with specific benchmarks met), the second phase of this study will be an RCT comparing participants who receive the intervention immediately (Immediate Intervention Arm) with those in a control group (Waitlist Control Arm). Participants randomized to the Waitlist Control Arm will cross over to receive the intervention after the waitlist period.
* The intervention for the RCT phase involves a baseline 90-minute coaching session and two follow-up coaching sessions with a therapist over video chat, followed by weekly prerecorded video modules that the participants can view at their convenience over the following 8 weeks.
* Participants will complete measures of parenting stress, mindfulness, psychological flexibility, self-compassion, and perceptions of child well-being at baseline, the 8-week post-intervention assessment, and a 3-month follow-up assessment. Additionally, the study will use EMA whereby questions will be sent electronically at random times and days (once a day at varying times on 5 days a week) during weeks 0-8 (the first week will serve as baseline data for comparison) for the Immediate Intervention Arm and weeks 0-18 for the Waitlist Control Arm using the Catalyst mobile applicatioon by MetricWire software.
* We plan to enroll 8 participants in the internal pilot phase and 56 participants in the RCT phase to account for the potential attrition of two caregivers from the intervention, for a total accrual target of 64 evaluable participants.

Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Randomized Controlled Trial

Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Phase III Randomized Controlled Trial

.All IPD recorded in the medical record will be shared with intramural investigators upon request.

Feasibility defined by compliance with viewing \>50% of the weekly videos (proposed target rate of 5 out of 8 videos watched; must watch at least 80% of each video), and 70% of participants attending both coaching sessions 2 and 3. Acceptability defined by descriptive data per caregiver reports of satisfaction on the Study Satisfaction survey (mean of questions 1-7 and 9).

RCT: Mean scores on the Parental Stress Scale (PSS) will be compared from pre- to post-intervention (baseline to 8 weeks between the immediate intervention arm and the wait list control arm.

Feasibility defined by compliance with daily surveys (target rate of 30 out of 40 surveys (75%) completed on average by each participant). Acceptability defined by post-intervention participant reports of satisfaction with completing daily EMA ratings on the Study Satisfaction survey.

We will examine pre- to post-intervention changes in scores on measures of psychological flexibility (MPFI-SF), self-compassion (SCS-SF), experiential avoidance (BEAQ), depression (PROMIS Depression 8a) and child affect (PROMIS Positive Affect Scale).

We will look for a significant indirect association between treatment arm assignment and pre- to post-intervention PSS changes via psychological flexibility as measured by the BEAQ.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Diet and Exercise Interventions Among Men With Prostate Cancer (Prostate 8-II)	NCT03999151	Prostate Cancer	Exercise and Di...	18 Years -	University of California, San Francisco
Video-based Coaching (VBC) in Gynecologic Surgery	NCT05086783	Education Surgery Gynecologic Can...	Video-based coa... Standard surgic...	-	Mount Sinai Hospital, Canada
Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Randomized Controlled Trial	NCT05361811	Neurofibromatos... Noonan Syndrome Legius Syndrome Cardiofaciocuta... Costello Syndro...	Waitlist ACT Interventio...	18 Years -	National Institutes of Health Clinical Center (CC)
Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Randomized Controlled Trial	NCT05361811	Neurofibromatos... Noonan Syndrome Legius Syndrome Cardiofaciocuta... Costello Syndro...	Waitlist ACT Interventio...	18 Years -	National Institutes of Health Clinical Center (CC)
Diet and Exercise Interventions Among Men With Prostate Cancer (Prostate 8-II)	NCT03999151	Prostate Cancer	Exercise and Di...	18 Years -	University of California, San Francisco

Spots Global Cancer Trial Database for coach

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

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