Sexual Health Communication Skills Training Intervention for Patients With Prostate Cancer
2026年6月29日 更新者：NYU Langone Health
Pilot Testing a Sexual Health Communication Skills Training Intervention for Patients With Prostate Cancer
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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
100
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Natasha Gupta, MD
- 電話番号：646-501-2599
- メール：Natasha.gupta@nyulangone.org
研究場所
-
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New York
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New York、New York、アメリカ、10016
- NYU Langone Health
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- Individual with impaired decision-making capacity.
- Participation in another part of this study (prior aim)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Exposure to STC Intervention
Participants will receive a multimedia intervention focused on teaching communication skills to help patients with prostate cancer discuss their sexual health concerns with their healthcare providers.
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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.
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|
アクティブコンパレータ：Control Arm
The control arm will be exposed to a 2-page supportive care resource guide, as well as a video slideshow and pamphlet on diet, sleep, and exercise for patients with prostate cancer.
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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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Eligibility rate
時間枠：Baseline
|
Proportion of screened individuals who are eligible
|
Baseline
|
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Enrollment rate
時間枠：Baseline
|
Proportion of eligible individuals who enroll
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Baseline
|
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Retention rate
時間枠：Up to Month 2 Follow-Up
|
Proportion of enrolled participants who are not lost to follow-up
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Up to Month 2 Follow-Up
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Assessment process
時間枠：Up to Month 2 Follow-Up
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Proportion of participants who completed intervention and assessments
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Up to Month 2 Follow-Up
|
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Feasibility of Intervention Measure (FIM)
時間枠：Post-Appointment (Day 1)
|
FIM is a validated 4-item scale designed to evaluate whether a specific intervention or practice can be successfully implemented and carried out within a given setting.
Each item is rated on a scale from 1-5; the total score is the average of the responses and ranges from 1-5; higher scores indicate greater feasibility.
|
Post-Appointment (Day 1)
|
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Acceptability of Intervention Measure (AIM)
時間枠：Post-Appointment (Day 1)
|
AIM is a validated 4-item scale used in implementation research to assess stakeholders' perception that a new program, treatment, or practice is agreeable and satisfactory.
Each item is rated on a scale from 1-5; the total score is the average of the responses and ranges from 1-5; a higher overall average indicates a greater level of acceptability for the intervention.
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Post-Appointment (Day 1)
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Intervention Appropriateness Measure (IAM)
時間枠：Post-Appointment (Day 1)
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The Intervention Appropriateness Measure (IAM) is a validated, 4-item tool used in implementation science to assess the perceived fit, relevance, and suitability of an intervention.
Each item is rated on scale from 1-5; the total score is the average of responses and ranges from 1-5; higher scores indicate greater appropriateness.
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Post-Appointment (Day 1)
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Number of patients who raised a sexual health topic during clinic visit
時間枠：Post-Appointment (Day 1)
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Post-Appointment (Day 1)
|
|
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Number of patients who discussed sexual health concerns during clinic visit
時間枠：Post-Appointment (Day 1)
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Post-Appointment (Day 1)
|
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Number of patients who asked a sexual health question during clinic visit
時間枠：Post-Appointment (Day 1)
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Post-Appointment (Day 1)
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Self Efficacy - Talking about Sexual Health
時間枠：Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
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Self-efficacy for talking about sexual health with a healthcare provider, scored from 0-10.
Higher scores indicate greater self-efficacy.
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Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
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Self Efficacy - Asking about Sexual Health
時間枠：Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
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Self-efficacy for asking a healthcare provider about sexual health, scored from 0-10.
Higher scores indicate greater self-efficacy.
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Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
PROMIS Sexual Function and Satisfaction Measure (PROMIS SexFS v2.0)
時間枠：Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
|
Questions from the domains of 1) engagement in sexual activity and 2) use of therapeutic aids for sexual activity will be converted into dichotomous variables; proportions will be evaluated at each time point as well as over time using a Z-test for differences in proportions between groups; higher scores indicate greater sexual function and satisfaction.
The domain of global satisfaction with sex life will be assessed as the change over time and compared between groups using two-sample t-tests.
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Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Natasha Gupta, MD、NYU Langone Health
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月1日
一次修了 (推定)
2028年10月31日
研究の完了 (推定)
2028年10月31日
試験登録日
最初に提出
2026年6月11日
QC基準を満たした最初の提出物
2026年6月11日
最初の投稿 (実際)
2026年6月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月1日
QC基準を満たした最後の更新が送信されました
2026年6月29日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 26-00587
- K08CA293275 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health.
Datasets that can be shared will be deposited in open ICPSR.
The protocol and statistical analysis plan will be posted on Clinicaltrials.gov
only as required by federal regulation or supporting awards and agreements.
IPD 共有時間枠
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD 共有アクセス基準
Datasets that can be shared will be deposited in open ICPSR.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。