Набор скоро начнётся NCT07655557

Sexual Health Communication Skills Training Intervention for Patients With Prostate Cancer

Без фазы С лечением Prostate Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Starting the Conversation (STC), Time and Attention.
Кому может быть актуально: Состояния в реестре: Prostate Cancer. Базовые параметры: от 18 лет · Мужчины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Pilot Testing a Sexual Health Communication Skills Training Intervention for Patients With Prostate Cancer

Обзор

This is a pilot randomized controlled trial of a sexual health communication skills training multimedia intervention (Starting the Conversation \[STC\] adapted for patients with prostate cancer \[PCa\]) to improve patients' ability to communicate with providers about their sexual health concerns during PCa care compared to a time and attention control arm.

Подробное описание

The investigators will conduct a pilot RCT of STC adapted for PCa with 100 patients randomly assigned to the intervention or control arm in a 1:1 ratio. Primary feasibility outcomes are clinical trial metrics and feasibility, acceptability, and appropriateness of STC. Primary efficacy outcomes are self-efficacy for sexual health communication with providers and rates of sexual health communication with providers. Secondary efficacy outcomes are sexual health outcomes (use of therapies for sexual dysfunction, sexual activity, and sexual satisfaction). Measures of efficacy will be compared between the intervention and control groups.

Вмешательства

Поведенческое Starting the Conversation (STC)
20-minute slideshow, 5-page workbook, 2-page supportive care resource guide focused on sexual health and teaching communication skills to help patients with prostate cancer discuss their sexual health concerns with their healthcare providers.
Поведенческое Time and Attention
2-page supportive care resource guide, as well as a 20-minute video slideshow and 5-page pamphlet on diet, sleep, and exercise for patients with prostate cancer.

Первичные конечные точки

Eligibility rate [Срок оценки: Baseline]
Enrollment rate [Срок оценки: Baseline]
Retention rate [Срок оценки: Up to Month 2 Follow-Up]
Assessment process [Срок оценки: Up to Month 2 Follow-Up]
Feasibility of Intervention Measure (FIM) [Срок оценки: Post-Appointment (Day 1)]
Acceptability of Intervention Measure (AIM) [Срок оценки: Post-Appointment (Day 1)]
Intervention Appropriateness Measure (IAM) [Срок оценки: Post-Appointment (Day 1)]
Number of patients who raised a sexual health topic during clinic visit [Срок оценки: Post-Appointment (Day 1)]
Number of patients who discussed sexual health concerns during clinic visit [Срок оценки: Post-Appointment (Day 1)]
Number of patients who asked a sexual health question during clinic visit [Срок оценки: Post-Appointment (Day 1)]

Вторичные конечные точки (1)

PROMIS Sexual Function and Satisfaction Measure (PROMIS SexFS v2.0) [Срок оценки: Baseline, Post-Appointment (Day 1), Month 2 Follow-Up]

Критерии участия

Критерии включения

Adult male with PCa at least 18 years of age
Speak English
Reside in the U.S.
Have internet/web access, and
Report current bother due to sexual dysfunction
Capacity and willingness to provide consent
Have an appointment with a PCa provider at NYU Langone Health during the study accrual period