Infections

All Conditions

Virus Diseases

All Drugs and Chemicals

Vaccines

After completing the pre-test survey, participants from all intervention groups will receive the written information. Subsequently, they will be randomly assigned to one of the intervention groups. The K-Talk group will receive a series of weekly storytelling videos, and access to the chatbot via the web-based platform KakaoTalk for 3 months.

After completing the pre-test survey, participants from all intervention groups will receive the written information. Subsequently, they will be randomly assigned to one of the intervention groups. The storytelling intervention group will only be exposed to periodic release of stories via email for 3 months.

After completing the pre-test survey, participants from all intervention groups will receive the written information. Subsequently, they will be randomly assigned to one of the intervention groups. The K-Bot group will only interact with the chatbot via the web-based platform or KakaoTalk for 3 months.

This group will only be exposed to written, didactic HPV education materials after the pre-test.

The K-Talk intervention group receives a combination of a storytelling intervention and an artificial intelligence chatbot (K-Bot) education.

K-Talk Intervention (Storytelling and K-Bot)

The storytelling intervention features 12 authentic stories from young Korean immigrants and Americans. Each video is about 3 minutes long and includes stories from 1st, 1.5, and 2nd generation young Korean individuals, highlighting their perceptions of HPV and HPV vaccines, and their experiences with HPV vaccination.

Storytelling Intervention

The K-Bot intervention is a conversational and button-based artificial intelligence Chatbot that is available in both English and Korean.

K-Bot Intervention

The written information provided includes the Centers for Disease Control and Prevention's (CDC) details on HPV and HPV vaccines.

Written Information

Minjin Kim, PhD., RN

Minjin Kim

The goal of this clinical trial is to test the feasibility, acceptability, and preliminary efficacy of a storytelling video-based intervention using AI chatbot technology (K-Talk) to promote HPV vaccination behavior among Korean Americans aged 18 to 45.

The main questions this study aims to answer are:

* Is the K-Talk intervention feasible for use among Korean Americans aged 18 to 45?
* Is the K-Talk intervention acceptable to the target population?
* What is the preliminary efficacy of the K-Talk intervention in promoting HPV vaccination uptake?

Participants will be Korean Americans aged 18 to 45 who are at risk for HPV infection. Participants will be asked to complete a baseline survey and then will be "randomized" into one of four groups: Group 1 (chatbot + storytelling intervention), Group 2 (chatbot only), Group 3 (storytelling only), and Group 4 will be only exposed to written didactic HPV education materials. All groups will receive written didactic HPV education materials. Researchers will compare how Group 1, a combination of AI Chatbot and storytelling intervention is more effective than other intervention groups in promoting HPV vaccination uptake among underserved, hard-to-reach Korean Americans.

The objective of this study is to conduct a pilot Multiphase Optimization Strategy trial (MOST) to evaluate the acceptability, feasibility, and preliminary efficacy of K-Talk as an intervention to improve HPV vaccination initiation and completion among Korean American men and women. K-Talk is a user-centered intervention that combines AI chatbot technology with storytelling to enhance health communication, foster connection, and provide accurate advice related to HPV vaccination. The study design follows an optimization phase of the MOST, utilizing a 2 x 2 factorial design with two factors (storytelling and chatbot) and two levels (Yes/On and No/Off). The study aims to recruit a total of 160 participants, with 40 participants assigned to each experimental condition. The sample will consist of 80 males and 80 females who are eligible for participation in factorial experimentation using the MOST design. Interested individuals will undergo an online eligibility screening survey. If eligible for the study, participants will receive an online survey link containing informed consent, a baseline survey, written HPV information, and random assignment to an intervention group.

Participants will be randomized to one of four experimental conditions using a 2x2 factorial design with two factors (Storytelling and Chatbot) and two levels (Yes/On and No/Off). Acceptability and feasibility outcomes include recruitment/retention rates, obtaining photographic documentation, and perceived satisfaction with the intervention.

Qualtrics is an online survey software used by researchers. It can randomly assign participants to different groups without revealing the assignments to participants or researchers, blinding them to the assignment. This ensures unbiased treatment and assessment of participants.

Let's K-Talk - HPV Study for Ethnic Koreans

Let's K-Talk: A Storytelling Intervention Leveraging Chatbot Technology to Prevent HPV and HPV Associated Cancers for Ethnic Koreans Living in the U.S.

Sharing only aggregated data will be presented in a summary format without any identifying information about individual participants.

Participants who received at least one dose of HPV vaccine at 3-month

Participants who received at least one dose of HPV vaccine at 6-month

Participants who received at least one dose of HPV vaccine at 12-month

Higher scores represent better knowledge.

Higher scores indicate higher risk perceptions about HPV and STI

Two questions will be used to assess participants' intention to receive HPV vaccines: "Do you intend to get the HPV vaccine?" and "How likely is it that you will get an HPV vaccine in the next 3 months?"

University of Cincinnati

Assistant Professor

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Written Information Prescription Technology

Written Information Prescription Technology Coaching

Receive written information on diet and exercise relevant to older men with prostate cancer

Participants receive tailored exercise prescription and tailored diet recommendations

Prescription

Participants receive motivational text messages and can electronically log and track their exercise and diet habits

Technology

Participants receive access to an exercise and diet coach to provide advice by phone and/or email

Coaching

Kerri Winters-Stone

This pilot clinical trial studies how well the True NTH Community of Wellness internet-based exercise and diet support works in improving diet and exercise habits in prostate cancer survivors. Internet-based exercise and diet support may help better control treatment-related side effects and symptoms, better overall quality of life, and lower risk factors associated with cancer progression.

PRIMARY OBJECTIVES:

I. To determine the feasibility and acceptability of the Community of Wellness web portal among prostate cancer survivors by conducting a randomized controlled study comparing four levels of web-based content and interaction with participants.

SECONDARY OBJECTIVES:

I. To compare efficacy of four levels of web-based content in the Community of Wellness web portal in a pilot randomized controlled trial on exercise and dietary habits, self-efficacy for behavior change, motivation for exercise, and changes in treatment-related side effects.

OUTLINE: Patients are assigned to 1 of 4 groups.

GROUP I: Patients receive "Written Information" which includes access to the TrueNTH open access portal that provides basic written information about exercise and diet.

GROUP II: Patients receive access to "Written Information + Prescription", including written information plus additional an exercise prescription and tailored diet recommendations.

GROUP III: Patients receive access to "Written Information + Prescription + Technology", including written information, exercise prescription + diet recommendation and additional technology components. Patients complete diet and exercise behavior logs and receive educational and motivational text messages about healthy diet and exercise habits.

GROUP IV: Patients receive access to "Written Information + Prescription + Technology + Coaching" and receive written information, exercise prescription + diet recommendation, technology support and a 30-minute (each) diet and exercise consultation plus the ability to receive ongoing advice from coaches via the web portal.

After completion of intervention, patients are followed up at 3 months.

Internet-Based Exercise and Diet Support in Prostate Cancer Survivors

True NTH Community of Wellness Internet-Based Exercise and Diet Support for Prostate Cancer Survivors

Measured as ability to recruit target sample size within one year

Measured as the % of men who complete post-intervention and follow-up measures out of the total # of men enrolled

Measured as the # of times that a man visits the portal over three months

CHAMPS estimates total weekly energy expenditure (in kilocalories per week) from low to vigorous intensity physical activities for older adults.

This 132-item survey assesses dietary intake over the past month in categories from "never or less than once per month" to "6 or more times per day" and supports examining major food and nutrient categories of the U.S. diet.

A 6-item measure of Self-efficacy for Exercise will be used. Summed scores range from 6-30, and higher scores indicate higher self-efficacy.

This 5-question measure asks the person to select one description, from a choice of five, which describes his current activity behavior.

The Charlson Comorbidity Index is a weighted index to predict mortality. Scores range from 0-37, with higher scores indicating more chronic medical conditions.

Diet self-efficacy will be measured by having participants rate their confidence in performing each recommended task (e.g., two more servings of cooked tomatoes per week) using a Likert scale.

This self-report questionnaire assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score.

MAX-PC is an 18 item scale to facilitate the identification and assessment of men with prostate cancer-related anxiety. This scale consists of three subscales that measure general prostate cancer anxiety, anxiety related to prostate specific antigen (PSA) levels in particular, and fear of recurrence.

PROMIS - Fatigue evaluates self-reported symptoms of fatigue, from mild subjective feelings of tiredness to an overwhelming sense of exhaustion over the past seven days.

BREQ2 measures the continuum of behavioral regulation in exercise psychology research. This questionnaire concerns the reasons why a person exercises regularly, works out, or engages in other such physical activities. It is structured so that it asks one question and provides responses that represent external regulation, introjected regulation, identified regulation, and intrinsic motivation.

EORTC QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients and has five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease. Scores range from 0-100, with higher functional scale scores indicating a higher level of healthy functioning while a higher score for a symptom scale represents a higher level of symptomatology or problems.

Movember Foundation

OHSU Knight Cancer Institute

Principal Investigator

Behaviors and Mental Disorders

Anxiety Disorders

Uterine Cervical Neoplasms

Mental Disorders

Psychotic Disorders

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Group of participants to whom the information is given through an audiovisual medium.

Group of participants to whom the information is given through the writing that is available on the website of the health organization.

The information provided to this group is in audiovisual format. This information is what has been designed with the aim of reducing the level of anxiety of patients who participate in cervical cancer screening.

Audiovisual information

The information provided to this group is in written format. This information is what is distributed to patients in the midwife's consultation and is available on the website of the health organization (Osakidetza)

Written information

David Del Valle, MD

When participating in population-based screening for cervical cancer, women experience great anxiety during the weeks of waiting since they learn that they have an altered screening result until the colposcopy is performed. In this study we want to verify how anxiety decreases when the information is improved and an audiovisual support is added when giving it.

This study is designed as a double-blind clinical trial. Candidate patients for this study are women referred to a colposcopy consultation after an altered result of the screening test. Those women who have previously been in the colposcopy consultation or have had this test performed in a private center are excluded.

The initial recruitment is done by telephone. If they accept, they are given an appointment at the hospital one day where, after being informed again and signing the informed consent, they are randomized and assigned a group. There are 2 groups, in one they receive an envelope with the information in writing that was created in Osakidetza and is available on the website of said organization, and the other group receives a sheet with the links to the videos created for this study in the same envelope. In this way, both groups assume that they are receiving information and we avoid bias. The principal investigator is the one who carries out this phase and distributes the envelopes, but is unaware of their contents. Previously, a collaborator fills in the envelopes according to the randomization code and indicates outside the envelope the order in which they should be delivered. Only she knows the randomization code and she will not reveal it until the end of the study.

To analyze the level of anxiety, the participants will fill out 2 scales before receiving the information, and they will return them on the day of the colposcopy before performing it. The scales used are the Spielberger´s State-trait anxiety inventory (STAI) and the Cohen´s PerceivedStress Scale 14 (PSS14). The STAI scale has 40 items, scored from 0 (never) to 3 (very much) points. The final result can range between 0 and 60, higher scores are related to a higher level of anxiety. The PSS14 scale consists of 14 items with a five-point scale response format (0 is never and 4 is very often). The scale scores from 0 to 56; higher scores indicate higher perceived stress.

It will also be analyzed whether the waiting time until the colposcopy and the level of academic studies influence the level of anxiety. And the perception of the colposcopy will be analyzed, with the VAS scale, according to their level of anxiety and the way they received the information.

Clinical trial on quality of life where there are 2 groups. After signing the informed consents and completing the anxiety surveys, each participant is randomized and given the corresponding envelope.

The randomization code is only known to a collaborator who fills the envelopes according to said code. The envelopes are distributed in order of arrival at the study, the researcher in charge of distributing them and recording the information does not know the randomization code. At the end of the study and registering all the data, the collaborator who has the code will deliver it to the principal investigator of the study.

In all the envelopes there is some type of information so that the patients are also blind. The experimental group is given a sheet with the links to the videos and the other group is given written information, which is available on the health organization's website. In this way, no group feels that it does not receive information and we control said bias.

This clinical trial is aimed at all people with a cervix, regardless of the gender that represents them. Although the vast majority are women, men with a cervix can participate.

Impact of the Different Information Channels in Reducing Anxiety in Participants of Cervical Cancer Screening

Audiovisual Informative Project for the Participants of the Cervical Cancer Screening in Osakidetza

Change in the level of anxiety according to the information format Compare the level of anxiety between who have the information in audiovisual format and who have the traditional model in written format. For the analysis we will use the STAI (described in Study description).

The analysis of the results will be done by comparing the basic situation of each participant and the response to the same survey after having the information provided. On the other hand, the results of the surveys between both randomized groups will be compared after having access to the information studied.

Change in the level of anxiety according to the information format Compare the level of anxiety between who have the information in audiovisual format and who have the traditional model in written format. For the analysis we will use the PSS14 (described in Study description).

The analysis of the results will be done by comparing the basic situation of each participant and the response to the same survey after having the information provided. On the other hand, the results of the surveys between both randomized groups will be compared after having access to the information studied.

In this secondary objective, we analyze whether the waiting time from the day the patient knows that she has an altered test until the day of the colposcopy influences the level of anxiety. Generally, the patient has to wait from 2 to 6 weeks from being notified of the altered result until the colposcopy. We are going to group the patients into 3 groups (from 0 to 2 weeks of waiting, from 2 to 4 weeks and from 4 to 6 weeks of waiting) and we will compare the results of the STAI scale to see if this factor is significant in their perception of emotional stress.

In this secondary objective, we analyze whether the waiting time from the day the patient knows that she has an altered test until the day of the colposcopy influences the level of anxiety. Generally, the patient has to wait from 2 to 6 weeks from being notified of the altered result until the colposcopy. We are going to group the patients into 3 groups (from 0 to 2 weeks of waiting, from 2 to 4 weeks and from 4 to 6 weeks of waiting) and we will compare the results of the PSS14 scale to see if this factor is significant in their perception of emotional stress.

The level of anxiety obtained through the STAI scale score will be stratified in the 6 educational level categories (none, primary, secondary, high school, university or professional training) to see if there are significant differences between them.

The level of anxiety obtained through the PSS14 scale score will be stratified in the 6 educational level categories (none, primary, secondary, high school, university or professional training) to see if there are significant differences between them.

We are going to analyze the pain perceived during the colposcopy, using the VAS scale (Visual Analogue Scale of pain) and we will compare them according to the level of anxiety detected in the STAI scale. We want to determine whether the perception of pain worsens at a higher level of anxiety.

We are going to analyze the pain perceived during the colposcopy, using the VAS scale (Visual Analogue Scale of pain) and we will compare them according to the level of anxiety detected in the PSS14 scale. We want to determine whether the perception of pain worsens at a higher level of anxiety.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Let's K-Talk - HPV Study for Ethnic Koreans	NCT05884697	Human Papilloma... Papillomavirus ...	K-Talk Interven... Storytelling In... K-Bot Intervent... Written Informa...	18 Years - 45 Years	University of Cincinnati
Internet-Based Exercise and Diet Support in Prostate Cancer Survivors	NCT03406013	Cancer Survivor Prostate Carcin...	Written Informa... Prescription Technology Coaching	18 Years -	OHSU Knight Cancer Institute
Impact of the Different Information Channels in Reducing Anxiety in Participants of Cervical Cancer Screening	NCT05622760	Uterine Cervica... Early Detection... Anxiety Clinical Trial	Audiovisual inf... Written informa...	25 Years - 65 Years	Biogipuzkoa Health Research Institute

Spots Global Cancer Trial Database for written information