Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Childhood Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Lymphosarcoma

In the treatment group, the child will receive the VR-based curriculum in addition to receiving the devices to use for 8 weeks.

In the control group, the child will still receive the devices to use for 8 weeks, but will not have the VR-based curriculum.

Rather than rely on mere exposure to devices, participants in the treatment group will receive a curriculum that integrates the devices into traditional content delivered through the after school program.

Virtual reality curriculum

Children will be able to use the same devices but will not have access to a curriculum that integrates the devices with traditional content delivered through the after school program.

No Virtual reality curriculum

Sun Joo Ahn, PhD

Kyle Johnsen, PhD

Lemuel LaRoche

This pilot study aims to leverage VR's capacity to easily replicate content and allow for multiple users to share the same space and engage in activities as if they're meeting in person. Integrating VR into afterschool programs will allow youth to receive more consistent programming content, even when they are unable to travel to the physical location for the in-person meetings.

This pilot study aims to leverage VR's capacity to easily replicate content and allow for multiple users to share the same space and engage in activities as if they're meeting in person. Integrating VR into afterschool programs will allow youth to receive more consistent programming content, even when they are unable to travel to the physical location for the in-person meetings. It will also empower youth to engage with the afterschool program at their own pace by providing a safe space to learn and practice their socioemotional skills. Implemented at scale, these benefits of a VR-integrated afterschool program will be able to address the issues of health inequity head on by expanding access to high quality afterschool content without incurring high operating costs. The results from this pilot study will provide a critical foundation to apply for an extramurally funded clinical trial to demonstrate the efficacy of a VR-integrated afterschool program on youth mental wellbeing.

Aim 1: Determine feasibility of a VR-integrated afterschool program where youth can access the VR content on their own at home.

Aim 2: Test the hypothesis that complementing the in-person afterschool program with VR will increase a) engagement and b) socioemotional competencies in youth.

Aim 3: Test the hypothesis that youth will demonstrate better mental wellbeing when the in-person afterschool program is complemented with VR.

Participants will be masked to which study condition they are assigned to.

Positive Youth Development in the Metaverse

Positive Youth Development in the Metaverse - Development of a Virtual Reality Afterschool Program for Middle Childhood Youth

De-identified data used in published analyses will be made available upon request to other researchers with a verified scientific purpose, guarantee that they will store the data securely, not share the data further, not attempt to use the data to determine the identities of research participants, and reference the source of the data in any resulting publications. Intellectual property rights to all software applications and hardware products will be maintained by the University of Georgia.

Early Adolescent Temperament Questionnaire-Revised ( 1-Almost always untrue, 2-Usually untrue, 3-Sometimes true, sometimes untrue, 4-Usually true, 5-Almost always true)

Strengths and Difficulties Questionnaire (Not true = 0, Somewhat true = 1, Certainly true = 2)

Number of hours of programming delivered for both in-person and VR

University of Georgia

Associate Professor

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Ethanol

Personalized self-management training using RISE (Re-Invent, Integrate, Strengthen, Expand) program.

Along with patient education and internalization of self-determination, the RISE intervention focuses on replacing unhealthy habits with health-promoting habits. Ongoing practice and guidance in generating and enacting SMART (specific, measurable, achievable, realistic, and time-bound) health goals is the centerpiece of the RISE intervention. Working one-on-one with the PI, participants will set goals and develop practical strategies to establish sustainable healthy behavior (HB) change. Motivational interviewing, cognitive behavioral therapy, and patient education will accompany intensive collaborative problem-solving and creation of accountability structures to create lasting change. The 6-week intervention includes 2 in-person visits and 4 videoconference sessions.

RISE Personalized Self-Managament Training (PSMT)

Participants randomized to the control condition will receive 6 standardized sessions from one of the OT interveners, matched to the PSMT for setting. At these visits, participants will be presented with slides containing pre-specified, standardized didactic content about the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) healthy behavior recommendations (HBRs). We hypothesize that these visits will control for the effect of research participation and increased knowledge about HBRs, and that simply providing standardized didactic content as an intervention modality without any personalization will have negligible effects on participants' healthy behaviors (HBs), self-efficacy, or quality of life. Content will follow the WCRF/AICR HBRs. Weeks 1-2 will focus on physical activity; weeks 3-4 will focus on diet and alcohol, and weeks 5-6 will focus on weight management and generalized strategies for HB change.

Standardized Self-Managament Training (SSMT)

Clinical Trial Recruitment Navigator

Ana Martin, MD

Andrew Hendifar, MD, MPH

Jun Gong, MD

Stephen Freedland, MD

Pamela Roberts, PhD

Sarah Salvy, PhD

Patricia Thompson, PhD

Arash Asher, MD

Philip Chang, MD

LJ Amaral, MS, RD, CSO

Alix G Sleight, PhD, OTD, MPH, OTR/L

This is a Phase 2 prospective, randomized, controlled, double-arm study to assess personalized self-management training (PSMT) intervention efficacy and patient experiences compared to standardized self-management training (SSMT). A total of 120 colorectal cancer (CRC) patients will be enrolled and randomized 1:1 to complete a 6-week self-management training program (either PSMT or SSMT) to be carried out by licensed occupational therapists with doctoral training.

This study aims to examine whether PSMT is more effective in increasing adherence to healthy behavior recommendations compared to SSMT in CRC patients.

Personalized Self-Management Training Compared to Standardized Self-Management Training in Colorectal Cancer Patients.

IIT2023-04-SLEIGHT-RISE-PSMT: A Prospective, Randomized, Controlled, Double-Arm Study of RISE (Re-Invent, Integrate, Strengthen, Expand) Personalized Self-Management Training (PSMT) Compared to Standardized Self-Management Training (SSMT) in Colorectal Cancer (CRC) Patients

Outcome measures contributing to each component of WCRF/AICR Healthy Behavior Adherence scale will be collected from baseline and end-of-study visits (Session 6 and Follow-up). The WCRF/AICR scale comprises of 7 categories with each category given a score for non-/low adherence, moderate/some adherence, or full adherence to each HBR. Total value ranges from 0 to 7 points, with a higher score indicating better adherence. HBR items include body composition, physical activity, diet, and alcohol use.

Responses to this questionnaire will be collected at Baseline (Session 1), End of Study Week 6 (Session 6), and Follow-up 6 Weeks Post-Session 6. The questionnaire asks the subject to rate their confidence levels in managing various situations, problems, and events. There are a total of 4 questions, and each question is answered on a scale of 1-4 where higher scores indicate the highest level of confidence. Total value ranges from 4 to 20, with a higher score indicating higher self-efficacy or highest level of confidence.

Responses will be collected at Baseline (Session 1), End of Study Week 6 (Session 6), and Follow-up Visit (6 weeks post Session 6).The questionnaire includes the following components to assess subject's rating on their global physical and mental health: 6 questions are each answered on a scale of 1-5 where higher scoores indicate excellent health, 1 question is answered on a scale of 1-5 where higher scores indicate being able to completely carry out everyday physical activities, and the last 3 questions are answered on a scale of 1-5 where higher scores indicate less frequency or no occurences of fatigue, pain, or emotional problems.

To assess percent change across the various component scores on the WCRF/AICR, the WCRF/AICR will be collected at Screening, Baseline (Session 1) unless screening visit was \<30 days ago, End of Study Week 6 (Session 6), and Follow-up Visit (6 weeks Post Session 6).

National Institutes of Health (NIH)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Alix G. Sleight, PhD

Associate Professor, Department of Physical Medicine and Rehabilitation

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Anne Tjønneland, MD PhD DMSc

Lars Kayser, MD PhD

This is an ethnographic study to investigate the competences and preferences in everyday living of men with prostate cancer, using participant observation and semi-structured interviews.

The study will work as the need assessment part of the emil project, which aims to design, develop, implement and evaluate a digital service to support a healthy lifestyle among men with prostate cancer.

Data was collected between June 2015 and April 2016. The data set included 4 parts; introducing interviews, participant observation, concluding interviews and questionnaires.

The introducing interview is conducted as a semi-structured interview with an interview guide. An informal approach is chosen to help along the report needed for the participant observation. The interview is recorded.

During participant observations, the participant is accompanied by the researcher, as he goes about his daily life. The researcher is participating in his activities to the extend it is possible, carrying out spontaneous informal interviews along the way taking cues from the situation, as is inherent to the participation of the researcher during participant observations. Field jottings are done discretely, during breaks in the observation or afterwards, on dictaphone or computer, in order to keep the relation informal, and not redirect the attention to the fact that they were being observed.

The concluding interview is performed as a natural ending of the collaboration between researcher and participant. It is performed as a semi-structured interview with an interview guide, and the central point is to confirm and elaborate on findings of the observation. The interview is recorded.

Pictures are taken of relevant artefacts or sceneries through all visits between participant and researcher, with the consent of the participants. Pictures are a part of the dataset on equal terms with observational notes and interview transcriptions.

In the questionnaire, baseline information such as educational level and self-rated health is gathered along with measurement of eHealth literacy (eHLQ) and health literacy (HLQ), both multidimensional validated psychometric instruments with seven and nine dimensions respectively, in order to relate the demography of this first study to the later studies of the emil project. The questionnaire is not used in the analysis of this study.

All data is collected before beginning familiarization and analysis of data.

Data analysis and interpretation The data set is analyzed using an inductive thematic analysis as described by Braun and Clarke (2006). All interviews and observations are conducted by the first author. Interviews, both introducing and concluding, are transcribed verbatim except for parts not included in the dataset, such as parts where the formal information about the study is given and written consent obtained or parts where practical arrangements are made.

All observational data are written together in one document from each visit. All pictures are included in the dataset. Familiarization with the data will be by listening and relistenning, reading and rereading through the dataset.

The thematic analysis will be performed by coding, processing and interpretation of data using the qualitative research software Nvivo11. Codes are re-read, discussed in the research group, re-coded and themed as outlined by the phases of Braun and Clarke, ending up with a thematic map.

Ethnographic Study of the Everyday Life of Men With Prostate Cancer, Focusing on Diet, Activities and Digital Behavior

Digitally Supporting Lifestyle Changes in Men With Prostate Cancer, Based on Characteristics and Needs - Part 1: Ethnographic Study of the Everyday Life of Men With Prostate Cancer, Focusing on Diet, Activities and Digital Behavior

It is a priority to protect the privacy of participant according to research ethics guidelines and GDPR. Participant data will only be shared in anonymized form and only in the extend demanded by a journal.

Factors will be identified by using Thematic analysis (Braun and Clarke, 2006) of ethnographic data, including interview transcriptions, observational notes, pictures and artefacts from the participant observation. All themes are based on identified categories and coding of observations, and are confirmed by supporting quotes.

The primary outcomes will be obtained in a way that it can inform the design process in the second study of the emil-project.

Digital capabilities and attitude will be examined as a specific part of the Thematic analysis (Braun and Clarke, 2006) of ethnographic data, including interview transcriptions, observational notes, pictures and artefacts from the participant observation. All themes are based on identified categories and coding of observations, and are confirmed by supporting quotes.

eHealth literacy evaluated by use of the eHealth Literacy questionnaire (eHLQ) and findings related to observed digital behavior.

University of Copenhagen

TrygFonden, Denmark

Danish Cancer Society

Ph.d. fellow, MD

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Breast cancer survivors will receive general information on how to adopt healthy lifestyle behaviors.

Motivational Interviewing

The control group of breast cancer survivors will receive counseling on how to increase their level of physical activity.

Counseling

Paul B. Jacobsen, Ph.D.

The purpose of this study is to find out if a counseling program the investigators have developed can help breast cancer survivors adopt a healthier lifestyle.

Participants will be randomly assigned to one of two groups. One group of breast cancer survivors will receive general information on how to adopt healthy lifestyle behaviors. The other group of breast cancer survivors will receive counseling on how to increase their level of physical activity.

Participants will have three consultations with a health counselor. The first two consultations will take place in-person and the third consultation will take place via telephone. Participants will also be asked to complete questionnaires assessing their physical and mental well-being, their dietary habits, and their physical activity habits at four time-points: in-person during their first study visit, via mail or through an online survey 6 weeks later, in-person 12 weeks later, and via mail or through an online survey 24 weeks later. Additionally, during their first study visit and 12 weeks later, their level of aerobic fitness will be tested by having participants walk a long hallway for six minutes.

Promoting a Healthier Lifestyle Among Breast Cancer Survivors

Motivational Interviewing to Promote Physical Activity in Breast Cancer Survivors

The primary objective of this study is to evaluate the efficacy of a brief Motivational Interviewing (MI) based intervention, relative to a time and attention control intervention (healthy lifestyle counseling), in promoting physical activity among early-stage breast cancer survivors who are physically inactive but are contemplating increasing their level of physical activity.

The secondary objectives of this study are (1) to examine the impact of the MI intervention on depressive symptoms, fatigue, vigor, and aerobic fitness; and

(2) to explore whether the degree of change in physical activity acts as a mediator of the expected benefits of the MI intervention on depressive symptoms, fatigue, vigor, and aerobic fitness.

United States Department of Defense

H. Lee Moffitt Cancer Center and Research Institute

Men with a history of prostate cancer invited to participate in design-workshops , interviews or usabilitytesting.

The emil project aims to design, develop, implement and evaluate a digital service to support a healthy lifestyle among men with prostate cancer.

In this second study, men with a history of prostate cancer are invited to participate in the scoping and design of a digital platform, through three iterations of workshops and individual interviews, which includes prototyping and other ideation processes.

Finally, the men with a history of prostate cancer will be involved in the usability testing of the design, to ensure a platform fit for use by the intended users.

In this user-driven study, the methods will be workshops, interviews, usability testing and a concluding proof of concept testing.

Workshops constitutes the bigger part of the user-driven design and ideation in this project. In workshops a group of people will generate a synergy that opens up for new ideas in a framed setting. The workshop format uses methods such as affinity diagrams; innovation jams; and ideation guided through artefacts such as Lego or paper cuts, with the researcher as the facilitator. After analysing the outcome of each design iteration, the findings will be incorporated into the design and focus the planning of the succeeding workshops in an iterative process.

The usability of the design will be tested in between workshops in interviews. The test will be performed by think aloud testing with the current prototype, recording for data collection and researchers in the room to observe, facilitate and probe for reflection.

For a more elaborate usability testing to conclude the design phase, a proof of concept will be performed. In this living lab scenario, the tool will be used at home by end-users in the intended way. Issues with technical functionality, user interphase, data management and workflow will surface and can be corrected during the proof of concept, thus consolidating the service before the feasibility study. Data collection from this part of the study will be by ongoing dialogue with participants, by e-mail and telephone.

To provide the broadest possible foundation for recruitment in terms of diversity in lifestyle and socioeconomic status, invitation to the study is done by mail directly to a randomly chosen group of men with prostate cancer.

All iterations will be based on the results of the previous. The first iteration is based on the ethnographic input from the first study.

All participants in study 2 will be met with a baseline questionnaire to evaluate digital readiness and e-health literacy and adjust participant configuration to ensure diversity. The questionnaire include self-reported educational level, health issues, treatments, diet, physical activity level and other lifestyle factors as well as eHLQ as part of the READHY questionnaire toolkit. The 13 dimensions of READHY comes from heiQ, HLQ and eHLQ, and work as a multidimensional validated robust psychometric instrument evaluation and can be used in combination to describe user's health technology readiness level and degree of enablement.

Each activity of the user-driven design process will be documented in a report, that will serve as the data foundation for a scientific publication.

Designing a Digital Tool to Support Healthy Lifestyle in Men With Prostate Cancer

Digitally Supporting Lifestyle Changes in Men With Prostate Cancer - Part 2: User-driven Design and Development of a Digital Tool to Support Healthy Lifestyle in Men With Prostate Cancer Based on an Ethnographic Study of the Target Group

The primary outcome is a design product which supports men in their everyday life to have a healthy lifestyle through digital means.

A process of 3 iterations of workshops and individual interviews produces data in the form of notes, sketches, pictures, recordings and prototype-products. By iterative analysis and confirmation and ideation in the following iteration, the primary outcome of this process is the design of a digital health service intervention to support men with prostate cancer in a healthy lifestyle.

Analysis of digital capabilities and attitude of the participants, from notes, sketches, pictures, recordings and prototype-products of the workshops and interviews.

Wireframe and mockup of the intervention, illustrated in the mockup-design tool Mockingbot (mockingbot.com).

Analysis of feedback from a beta-testing of the intervention design. Data collected via e-mail and telephone dialogue with the testers.

Principal Investigator

People who have undergone colorectal cancer screening will be given training on colorectal cancer prevention. Training will be carried out face to face and individually. The training will take approximately 25-30 minutes.

Individuals in this group will be screened for colorectal cancer. However, this group will not be given any training on cancer prevention.

Individuals in this group will be trained on acquiring healthy lifestyle behaviors to protect against colorectal cancer. Training will be individual, face-to-face and in the form of question and answer. At the end of the training, training brochures prepared by the researchers after taking expert opinions will be distributed to the participants. The training will take approximately 25-30 minutes. The training will take place in the training hall at the family health center.

Education

Hilal Kartal

Hilal K KARTAL, PhD student

The aim of this study is to examine the effect of the education given to individuals undergoing colorectal cancer screening on their attitudes, beliefs and healthy lifestyle behaviors.

This study was planned to be conducted as a prospective randomized controlled study in a family health center in Istanbul. The universe of the research; The sample of individuals registered to the family health center will consist of a total of 70 individuals who meet the inclusion criteria for the study.

Patient Diagnosis Form, Colorectal Cancer Screening Attitude Belief Scale, Healthy Lifestyle Behavior Scale II will be used to collect data. Data will be collected at the first encounter, 1 month later, 3 months later, pre-test and post-test. In the research, individuals will be divided into two groups: intervention (n = 35) and control (n = 35). Training will be provided to the intervention group.

Randomized controlled ( experimental and control group)

Effects of Education After Colorectal Cancer Screening

The Effect of Education Given to Individuals Undergoing Colorectal Cancer Screening on Attitudes, Beliefs and Healthy Lifestyle Behaviors

Scale; It consists of five subscales: relevance and consistency, perception of sensitivity, response effectiveness, cancer anxiety, and social influence. There are 16 items in the scale. The scale is in 5-point Likert style and the answer options for each item are; It is evaluated as "strongly disagree" (1 point), "disagree" (2 points), "don't know" (3 points), "agree" (4 points) and "strongly agree" (5 points).

The scale consists of 52 items and six factors. These; health responsibility, physical activity, nutrition, spiritual development, interpersonal relationships and stress management. Scale rating is 4-point Likert type. Expressions such as never (1), sometimes (2), often (3), regularly (4) are accepted. The lowest score that can be obtained from the entire scale is 52 and the highest score is 208.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Positive Youth Development in the Metaverse	NCT05858593	Healthy Healthy Lifesty... Childhood ALL Behavior, Child	Virtual reality... No Virtual real...	9 Years -	University of Georgia
Personalized Self-Management Training Compared to Standardized Self-Management Training in Colorectal Cancer Patients.	NCT05984589	Colorectal Canc... Healthy Lifesty... Behavior, Healt... Health Behavior	RISE Personaliz... Standardized Se...	18 Years -	Cedars-Sinai Medical Center
Ethnographic Study of the Everyday Life of Men With Prostate Cancer, Focusing on Diet, Activities and Digital Behavior	NCT03692585	Prostate Cancer Computer Litera... Health Behavior		40 Years -	Danish Cancer Society
Promoting a Healthier Lifestyle Among Breast Cancer Survivors	NCT01419613	Breast Cancer	Motivational In... Counseling	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Promoting a Healthier Lifestyle Among Breast Cancer Survivors	NCT01419613	Breast Cancer	Motivational In... Counseling	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Designing a Digital Tool to Support Healthy Lifestyle in Men With Prostate Cancer	NCT03692000	Health Literacy Computer Litera... Prostate Cancer		50 Years -	Danish Cancer Society
Effects of Education After Colorectal Cancer Screening	NCT06311565	Healthy Lifesty... Education	Education	50 Years - 70 Years	Istanbul Saglik Bilimleri University
Personalized Self-Management Training Compared to Standardized Self-Management Training in Colorectal Cancer Patients.	NCT05984589	Colorectal Canc... Healthy Lifesty... Behavior, Healt... Health Behavior	RISE Personaliz... Standardized Se...	18 Years -	Cedars-Sinai Medical Center

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