Skin and Connective Tissue Diseases

Symptoms and General Pathology

All Conditions

Alopecia

Alopecia Areata

Hypotrichosis

Hair Diseases

Skin Diseases

Pathological Conditions, Anatomical

Antihypertensive Agents

Vasodilator Agents

All Drugs and Chemicals

Minoxidil

Patients receive oral minoxidil at a dose of 0.01 (\<40kg) and 0.02 (≥40kg) mg/kg/day for 8 months

Patient receive placebo for 4 months followed by oral minoxidil for 4 months

minoxidil at a dose of 0.01 (\<40kg) and 0.02 (≥40kg) mg/kg/day

Oral Minoxidil

Placebo

Alina Markova, MD

Danielle Friedman, MD

This study will test whether minoxidil taken by mouth (oral minoxidil) can improve hair loss caused by cancer treatment in children and young adults. In addition, the researchers will test the safety of oral minoxidil, and see if the study drug causes few or mild side effects in participants. Other purposes of this study include looking at whether participants are able to follow their study drug dosing schedules, and how oral minoxidil affects participants' quality of life.

A Study of Oral Minoxidil to Treat Hair Loss in Children, Teens, and Young Adults Who Are Cancer Survivors

A Pilot Study of Oral Minoxidil for the Treatment of Persistent Hair Loss in Pediatric, Adolescent, and Young Adult Cancer Survivors

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

as assessed by Hairmetrix allows trichoscopy (dermoscopic imaging of the scalp and hair) in real time. It requires no special scalp or hair preparation and allows fully automated unclipped analysis, producing measurements.

Memorial Sloan Kettering Cancer Center

Ten AYA survivors will be recruited to participate in the expanded 12-week text messaging intervention.

text messaging intervention

Mark C Garcia, MD

Adolescents and young adults (AYA) survivors of childhood cancer receive inadequate surveillance for treatment-related late effects. This study evaluates the acceptability and feasibility of a mobile phone messaging intervention targeting behavior changes related to receiving survivorship care among AYA survivors.

Content from an existing text-messaging survivorship education intervention will be adapted to a novel text-messaging platform, Chorus. Ten AYA survivors will be recruited to participate in the expanded 12-week text messaging intervention. In-depth interviews will be conducted with each participant during the study, and a focus group with all participants will be conducted at the end of the study. Qualitative analysis will determine areas for improvement in the text messaging intervention in order to ensure acceptability and feasibility in AYA survivors. The text messaging intervention on Chorus will be adapted to better suit the needs of AYA survivors based on the results of the qualitative analysis. Mobile phone interventions offer a cost-effective, age-appropriate approach to AYA survivorship care education. If effective, the text-messaging intervention will be evaluated in a randomized, controlled pilot trial to improve rates of survivorship care and clinical outcomes for AYA survivors.

Aim 1: To adapt and enhance an existing text messaging intervention to an expanded two-way multi-media mobile phone messaging platform (Chorus) that will improve knowledge regarding the risk of late effects among AYA survivors, intent to seek recommended survivorship care, and completion of standard survivorship care goals. a. both two-way text messaging to improve Children?s Oncology Group (COG) survivorship guideline adherence b. web-based educational content for survivors of key survivorship messages regarding risk for late effects and need for ongoing survivorship care c. Monthly peer navigation phone calls to address barriers and promote retention d. utilization of pre and post-test questionnaires for participants to access and complete within the Chorus platform Aim 2: To test the acceptability and feasibility of the expanded mobile phone intervention content to improve messaging and strategies for survivorship care using qualitative methodologies and applying the Technology Acceptance Model (TAM) within a sample of AYA survivors. a. perceived usefulness of the text messaging system b. perceived ease of use of the text messaging system c. effect of the text messaging system on health-related behavior intent

A Mobile Phone Intervention to Promote Adherence to Survivorship Care Among Adolescent and Young Adult Cancer Survivors

Acceptability and feasibility of an expanded mobile phone intervention as assessed by key informant interview questions and a focus group discussion developed based on the Technology Acceptance Model: (a) perceived usefulness of the text messaging system for completing ASAP goals, (b) perceived ease of use of the text messaging system for completing ASAP goals, and (c) effect of the text messaging system on intent to complete ASAP goals. The assessment will be qualitative only.

The Technology Acceptance Model (TAM) evaluates how likely a user of new technology will accept and continue to use the new technology. TAM posits that if the technology is perceived as useful, easy to use, and increases intent to use - then the technology is more likely to be accepted. Interview questions and focus group discussion points will ask about these criteria. If responses satisfy the TAM criteria, this supports mobile phone intervention as acceptable and feasible for use in AYA cancer survivors.

Themes for refinement of the text messaging intervention as assessed by key informant interview questions designed to elicit feedback on features of the mobile phone intervention that could improve knowledge regarding risk for late effects and intent to seek survivorship care.

Hypothetical example: Collectively, participants believed that the intervention's incorporation of weblinks and phone numbers to community resources clarified their risk for late effects as a cancer survivor.

Key informant interviews with YA survivors regarding their experience during the mobile phone intervention will identify themes from which the mobile phone intervention will be refined in order to improve its potential impact on the completion of participants' Adolescent and Young Adult Survivorship Action Plan (ASAP) goals.

Theoretical example: Collectively, participants believed the appointment reminders provided by the mobile phone intervention made it more likely for them to attend their survivorship care clinic appointment and, thus, complete their ASAP goal (adherence to survivorship care).

Jonsson Comprehensive Cancer Center

Childhood cancer survivors treated with DOX and/or VCR with evidence of BD on DVSS

Childhood cancer survivors treated with DOX and/or VCR without evidence of BD on DVSS

A noninvasive urodynamics is a simple test used to evaluate urinary flow.

Non-invasive Urodynamic Test (niUDS)

Urine proteomics is a powerful platform to identify urinary excreted proteins and peptides in different stages of disease or therapy and to determine their quantity, functions, and interaction.

Urinary proteomic screen

The Dysfunctional Voiding Symptom Score provides accurate and objective grading of voiding behaviors of children.

Dysfunctional Voiding Symptom Score Survey (DVSS)

Gemma Beltran

Nicholas Cost, MD

The over-arching aim of this study is to evaluate the effects of two specific anti-cancer chemotherapies, vincristine and doxorubicin, on bladder function and urine composition.

The over-arching aim of this study is to evaluate the effects of two specific anti-cancer chemotherapies, vincristine and doxorubicin, on bladder function and urine composition. The global hypothesis is that childhood cancer survivors with prior exposure to systemic vincristine (VCR) and/or doxorubicin (DOX) report an increased incidence of bladder dysfunction (BD) symptoms on the Dysfunctional Voiding Symptom Score (DVSS) survey. We expect to observe differences in non-invasive urodynamic (niUDS) testing between childhood cancer survivors with BD symptoms on the DVSS versus those without BD symptoms on DVSS. We also expect to observe statistically significant differences in the urinary levels of known urinary biomarkers of BD (NGF, ATP and BDNF) of patients with evidence of BD compared to those without BD on the DVSS. We also expect to observe rational differences in the urinary proteome of patients between those with and without BD.

Study groups and sub-groups will be assigned by gender

Impact of Chemotherapy on Urinary Biomarkers and Non-Invasive Urodynamics in Children

Patient Data will be shared after written request to study PI and after approval by local IRB and study committee

a. Patterns will be scored by blinded reviewers b. Will calculate an Inter-rater Kappa correlation co-efficient i. Utilize consensus review for discrepancies between reviewers and between the patient's 1st/2nd niUDS for the final assignment ii. Will calculate an intra-test reliability (compare correlation between 1st and 2nd patter) c. Chi-square test to compare proportions of non-normal vs. normal pattern type i. Group 1a vs. 2a ii. Group 1b vs. 2b d. Sample Size Calculation: Based on published data of niUDS patterns in children with normal bladder function, we expect 15% of those children in Group 2 to have non-normal niUDS patterns. We hypothesize that 40% of children in Group 1 to have non-normal niUDS patterns. 38 subjects in each gender sub-group provide 80% power to detect this 25% difference with an one-sided chi-square test with an alpha of 0.05.

a. Will use an "average PVR" between the 1st/2nd niUDS for the analysis b. Chi-square test to compare proportions of elevated PVR i. Group 1a vs. 2a ii. Group 1b vs. 2b c. Sample Size Calculation: Based on published data of PVR in children with normal bladder function, we expect 1.5% of those children in Group 2 to have elevated PVR. We hypothesize that 25% of children in Group 1 to have an elevated PVR. 21 subjects in each gender sub-group provide 80% power to detect this 23.5% difference with an one-sided chi-square test with an alpha of 0.05.

a. Will use the average of the two Qmax between the 1st/2nd flow rate for the analysis b. Two group t-test for comparing continuous variables (Qmax) i. Group 1a vs. 2a ii. Group 1b vs. 2b c. Sample Size Calculation: 38 subjects in Group 1a and 2a provide 80% power to detect an effect size of 0.7 (mean difference divided by the common standard deviation) using a 2-sided two-group test with an alpha of 0.05. if the outcome is not normally distributed, transformation will be carried out so the distribution will be approximately normal. This power calculation also applies to the comparison between Group 1b vs 2b

a. Will use the average of the two Qavg between the 1st/2nd flow rate for the analysis b. Two group ttest for comparing continuous variables (Qavg) i. Group 1a vs. 2a ii. Group 1b vs. 2b c. See the power calculation in 3c.

1. Compare urinary biomarker levels between groups i. ATP, BDNF, NGF ii. Two-group t-test for comparing continuous variables

1. Group 1 vs. 2
2. Sub-analysis

   1. Group 1a vs. 2a
   2. Group 1b vs. 2b The sample size calculation in 1d can apply to each biomarker. Based on published data in other populations with BD, for NGF, ATP and BDNF, we hypothesize to detect a difference of these urinary biomarkers 2x higher in Group 2 (Elevated DVSS scores) vs. Group 1 (Normal DVSS scores).

A mixed effects model will be used to estimate and compare a biomarker expression between the two groups by incorporating the individual measurements on each subject into the model, where gender and group assignment will be the predictor. Interaction term between group and gender will be considered to study the effect modification by gender on a biomarker if possible.

National Cancer Institute (NCI)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Children's Hospital Colorado

University of Colorado, Denver

The study plans to recruit 30 childhood cancer survivors and a parent/legal guardian for each survivor. Participants will be provided with a Fitbit Inspire HR wearable device to record their step counts for two weeks pre-intervention, and over the six-month follow-up period (3-month intervention and 3month follow-up).

Fitbit Inspire HR

Patient-Reported Outcomes Measurement Information System (PROMIS)

Questionaires

This study will test whether a game-based exercise plan can help increase the level of physical activity in childhood cancer survivors. The game-based exercise plan will involve participation by both a childhood cancer survivor and his/her parent or caregiver. This study will also look at whether the game-based exercise plan improves childhood cancer survivors' quality of life.

Game-Based Physical Activity in Childhood Cancer Survivors

Assessing a Game-Based Physical Activity Intervention in Childhood Cancer Survivors: The STEP UP for FAMILIES Pilot Study

(i.e., all four responses on the AIM rates as either a 4 or 5 on a 5-point Likert scale of acceptability);

Sohn Conference Foundation

Participants will be prompted to complete questionnaires.

Mobile Health is a multi-featured app designed to enable participants to self-record and track their health and wellness. Participations will set up a profile and complete questionnaires. The app also records the amount of time and features of programs accessed.

Mobile Health App

Kathy Ruble, RN, PhD

The purpose of this research study is to understand if a mobile app is useful to assist young adult female survivors of childhood cancer in the self-management of survivorship-related needs.

Survivorship related needs include managing lingering symptoms from treatment, how to keep a healthy lifestyle, social and medical issues, as well as other needs. The mobile health app that will be used in this study is the Health Storylines TM app developed by Self Care Catalysts Inc. The app can be used for an unlimited amount of time over nine months, which is how long the study will be conducted. The use of the Health Storylines TM app in this study is investigational.

Participation in this study starts with setting up a study specific profile on the app and entering information including email address, age, ethnicity/race, cancer diagnosis, as well as other optional information for the profile (example health goals or current health conditions). Participants will then be prompted by the app to complete three questionnaires about their ability to self-manage their survivorship-related needs, their perception of their survivorship-related illness symptoms and perceived health related quality of life. They will be prompted on the app to complete these questionnaires again at the 3, 6 and 9 month intervals of using the app. It will take about 20 minutes to complete the questionnaires at each measurement time. The only additional information that will be reported from the app for the study is the amount of time and features of programs accessed during the study period.

This project is a longitudinal one-group pilot study evaluating the use of a Mobile Health (mHealth) app intervention. This study will examine: 1) the amount/type of usage, 2 ) compliance with study evaluations and 3) the association of this mHealth app use with perceived self-efficacy in managing survivorship related needs, perceived health illness and health related quality of life. The study period will be nine months, with four measurement points to assess the study's outcomes: baseline, three, six, and nine months post initiation of the mHealth app.

Assessing the Acceptability of the Use of a Mobile Health App Among Young Adult Female Survivors of Childhood Cancer

Assessing the Acceptability of the Use of a Mobile Health App Among Young Adult Female Survivors of Childhood Cancer: A Feasibility Study

Assess the feasibility of the mHealth app as measured by tracking all activities of the patient-centered mHealth health tracking app, Health StorylinesTM, in young adult female survivors

Assess the adherence to study procedures including baseline and follow-up assessments as measured by completion rates of required tasks

Determine the association between the amount of usage (in minutes), the frequency of usage number of times accessed) of the Health StorylinesTM mhealth app, and self-efficacy in young adult female survivors of childhood cancer.

Determine the association between the amount of usage (in minutes), the frequency of usage number of times accessed) of the Health StorylinesTM mhealth app and health related quality of life in young adult female survivors of childhood cancer

Determine the association between the amount of usage (in minutes), the frequency of usage number of times accessed) of the Health StorylinesTM mhealth app and perceived illness in young adult female survivors of childhood cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Oral Minoxidil to Treat Hair Loss in Children, Teens, and Young Adults Who Are Cancer Survivors	NCT05778825	Survivors of Ch... Alopecia	Oral Minoxidil Placebo	6 Years - 18 Years	Memorial Sloan Kettering Cancer Center
A Mobile Phone Intervention to Promote Adherence to Survivorship Care Among Adolescent and Young Adult Cancer Survivors	NCT05000359	Survivors of Ch...	text messaging ...	18 Years - 39 Years	Jonsson Comprehensive Cancer Center
Impact of Chemotherapy on Urinary Biomarkers and Non-Invasive Urodynamics in Children	NCT04993859	Survivors of Ch... Bladder Dysfunc...	Non-invasive Ur... Urinary proteom... Dysfunctional V...	5 Years - 10 Years	University of Colorado, Denver
A Study of Oral Minoxidil to Treat Hair Loss in Children, Teens, and Young Adults Who Are Cancer Survivors	NCT05778825	Survivors of Ch... Alopecia	Oral Minoxidil Placebo	6 Years - 18 Years	Memorial Sloan Kettering Cancer Center
Game-Based Physical Activity in Childhood Cancer Survivors	NCT04266080	Survivors of Ch...	Fitbit Inspire ... Questionaires	10 Years - 16 Years	Memorial Sloan Kettering Cancer Center
Assessing the Acceptability of the Use of a Mobile Health App Among Young Adult Female Survivors of Childhood Cancer	NCT03242200	Childhood Cance...	Mobile Health A...	18 Years - 30 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Game-Based Physical Activity in Childhood Cancer Survivors	NCT04266080	Survivors of Ch...	Fitbit Inspire ... Questionaires	10 Years - 16 Years	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for survivors of childhood cancer