The Find Your PATHS (Pragmatic Assessment of a Tool to Help Survivors) to Sexual Health and Parenthood Study (PATHS)
Concerns with sexual health and fertility are common among cancer patients, survivors and their partners. Literature reviews suggest that over 60% of survivors have reproductive health problems yet fewer than 20% get professional help. This study will test the uptake, use and effectiveness of online, interactive self-help programs for men and women with cancer. Participants in the study will receive up to 6 months of access to the self-help programs without charge. Navigation through the programs can be personalized by setting goals and following links to the most relevant information. The programs cover all cancer sites and common treatments, explaining sexual and fertility side effects. Programs also include step-by-step cognitive behavioral self-help exercises, guidance on available medical treatment options, decision aids, and video stories with actual survivors as well as vignettes with actors. Information for same-sex couples is included. Programs include suggestions on how partners can work together to cope with sexual or fertility issues.
The primary hypothesis is that participants will report improvements in sexual function and satisfaction from baseline to 3-month follow-up. Secondary hypotheses will investigate whether more extensive use of the program is associated with better outcomes (dose-response effect) and whether the intervention also improves secondary outcomes such as anxiety, depression, relationship satisfaction, and seeking medical help. Analyses from the data will investigate how many people who are informed of the study decide to participate (uptake), as well as how often participants visit the program and which parts are used most. Both the male and female programs have previously been shown to help cancer survivors and partners in published clinical trials.
Participants will be encouraged to invite a sexual partner to join the study, but that will be optional. Partners will be able to be linked for statistical analysis through their unique study identification numbers. Participants' use of the websites will be electronically tracked and compared with questionnaire outcome measures. Outcome measures include online, self-report questionnaires completed at baseline and 3-month follow-up. At 6-month follow-up, participants will complete 2 online ratings of the helpfulness of the programs. Privacy and security are carefully protected. The entire website meets standards for HIPAA (Health Insurance Portability and Accountability Act). Questionnaires are identified with study numbers rather than names or email addresses. Once the study data are analyzed, the list linking participant identifying information (names, email) and study numbers will be destroyed. Any publications resulting from the study will discuss group data and will not contain any information that could be used to identify an individual participant.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Texas
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Houston、Texas、アメリカ、77025
- Will2Love, LLC
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Has had a diagnosis of cancer or is the intimate partner of a cancer patient/survivor
- Has a concern or wants to learn more about cancer-related issues with sexuality or fertility
- Has a way to access the website and questionnaires on the internet
Exclusion Criteria:
- Younger than age 18
- Does not read and understand English well enough to use the website independently
- Does not live in the United States
- Potential participant has already subscribed to the male or female self-help program
研究計画
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:なし
- 介入モデル:単一グループの割り当て
- 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 |
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実験的:Cancer patients, survivors, and partners
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Participants will receive access to the program, which provides: In-depth information specific to cancer sites and treatments, guidance on medical options for cancer-related sex or fertility problems, personalized goal-setting with progress tracking and relapse prevention, self-help exercises on overcoming sexual, relationship, and dating problems, videos of survivors' stories, and video vignettes with actors.
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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 |
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PROMIS® (Patient-Reported Outcomes Measurement Information System) Brief Sexual Profile v2 Male
時間枠:Change from baseline to 3 months post consent
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Construct: Sexual function and satisfaction in men; Total Score Range: 0-33; Higher values represent a better outcome
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Change from baseline to 3 months post consent
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PROMIS® (Patient-Reported Outcomes Measurement Information System) Brief Sexual Profile v2 Female
時間枠:Change from baseline to 3 months post consent
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Construct: Sexual function and satisfaction in women; Total Score Range: 0-49; Higher values represent a better outcome
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Change from baseline to 3 months post consent
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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PROMIS® (Patient-Reported Outcomes Measurement Information System) Brief Anxiety Scale
時間枠:Change from baseline to 3 months post consent
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Construct: General anxiety level; Total Score Range: 0-16; Higher scores represent a worse outcome
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Change from baseline to 3 months post consent
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PROMIS® (Patient-Reported Outcomes Measurement Information System) Brief Depression Scale
時間枠:Change from baseline to 3 months post consent
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Construct: Depressed Mood; Total Score Range: 0-16; Higher scores represent a worse outcome
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Change from baseline to 3 months post consent
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Abbreviated Dyadic Adjustment Scale-4
時間枠:Change from baseline to 3 months post consent
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Construct: Relationship happiness; Total Score Range: 0-21; Higher scores represent a better outcome
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Change from baseline to 3 months post consent
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協力者と研究者
協力者
捜査官
- 主任研究者:Tenbroeck Smith、American Cancer Society, Inc.
- 主任研究者:Leslie Schover、Will2Love, LLC
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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。
Online, interactive self-help programの臨床試験
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Universiti Sultan Zainal Abidin募集