Enhancing Survivorship Care Planning for Patients With Localized Prostate Cancer Using A Couple-focused Web-based Tailored Symptom Self-management Program (SCP)
2020年9月3日 更新者：UNC Lineberger Comprehensive Cancer Center
The purpose of this research study is to examine the feasibility of the enhanced survivorship care plans (ESCPs, regular SCPs with the a web-based couple-focused symptom self-management project (PERC) or National Cancer Institute prostate cancer web links) and to conduct an initial benefit assessment of enhanced survivorship care plans among prostate cancer patients transitioning from active treatment to post-treatment self-management, and their partners.
Participation of this study lasts for about for 16 weeks. Depending on participants' need for information, it takes 10-30 minutes of their time each week to review the information about prostate cancer.
Eligible and consented patients with newly treated localized prostate cancer and your partner (couples) are randomly assigned to the regular survivorship care plan (SCPs) with the NCI website or the enhanced survivorship care plans (SCP plus the web-based prostate cancer education program, PERC) groups. They complete baseline (T1, prior to randomization) and 4-month post-T1 follow-up measures (T2).
調査の概要
詳細な説明
Methods: A two-group randomized controlled pretest-posttest design will be used and collect data at baseline (T1) and 4 months later (T2) among 50 patients completing initial treatment for localized prostate cancer and their partners. First, the investigators will assess the feasibility of ESCP by recruitment, enrollment, and retention rates, program satisfaction with the ESCP, and perceived ease of use of the ESCP. To achieve the secondary aim, the ESCP users will be compared with the standardized SCP users and assess their primary outcomes of QOL (overall, physical, emotional, and social QOL), secondary outcomes (reduction in negative appraisals and improvement in self-efficacy, social support, and health behaviors to manage symptoms), and number of visits to post-treatment care services at T1 and T2. The primary and secondary outcomes are assessed using measurements with sound psychometrical properties. The investigators will use a qualitative and quantitative mixed methods approach to achieve the research aims.
Conclusions: The results from this study will help design a definitive randomized trial to test the efficacy of the ESCPs, a potentially scalable program, to enhance supportive care for prostate cancer patients and their families.
研究の種類
介入
入学 (実際)
124
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。
研究場所
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27559
- University of North Carolina at Chapel Hill
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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
18年～99年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
Eligibility included men who:
- were diagnosed with localized PC;
- were within 16 weeks of completing their initial curative intent treatment [26] at genitourinary and radiation oncology clinics at two comprehensive cancer centers in the U.S southeast;
- were not treated for another cancer in last year; and
- had a partner > 18 years of age not receiving cancer treatment.
Exclusion Criteria:
- Either member of couple unable to speak English
- Unwilling/unable to provide Informed Consent
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：Survivorship Care Plan (SCP)
The SCP group (control) participants were directed to the National Cancer Institute PC website (NCI) (http://www.cancer.gov/types/prostate),
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Participants visit the NCI prostate cancer website in addition to their standardized post-treatment survivorship care
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実験的：Enhanced SCP (ESCP)
ESCP consists of the standard SCP that is enhanced by a couple-focused, tailored mHealth PC education program, the Patient Education Resources for Couples, to improve symptom management at home.
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In addition to their standardized post-treatment survivorship care, participants visit the prostate cancer education resources for couples (PERC) website that was based on scientific evidence and input from stakeholders including PC patients, partners, and cancer care providers.
Participants learn about skills and knowledge about how to enhance their positive appraisals of symptoms and self-efficacy in symptom management through information and skills training, fostering healthy behaviors, and facilitating social support
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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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Percentage of Potentially Eligible Participants Actually Enrolled Into the Study
時間枠：after participants completed baseline survey
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Will evaluate the percentage of patients and partners successfully consented and completing the baseline survey among all people approached for the study
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after participants completed baseline survey
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Percentage of Participants Enrolled Who Remained in the Study and Completed the Post-Intervention Follow-Up Survey
時間枠：during 4-month study period
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Will evaluate the percentage of participants successfully following protocol, defined as completing the Follow-Up survey at the end of the study period among those who have been enrolled into the study (who completed the baseline).
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during 4-month study period
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Percentage of Participants That Used the Web-Based Intervention Sessions That Are Consistent With Patient-Reported Symptoms
時間枠：during 4-month study period
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The usage of Web-Based Intervention Sessions is determined by the percentage of participants who logged into the study website among those who have been randomly assigned to the intervention group.
Patient-Reported Symptoms are determined by patient's responses on their appraisal of prostate cancer symptoms and general symptoms.
1=patient reported the symptom and the symptom webpage reviewed; 0=patient reported the symptom and no related webpage reviewed OR patient did not report the symptom but the webpage reviewed
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during 4-month study period
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Participant Satisfaction Scores
時間枠：at the 4 month followup
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Program satisfaction determined by the 11-item Participant Satisfaction Scale measured the level of program satisfaction.
The first to tenth items ranged from 1=not satisfied to 5=extremely satisfied.
The eleventh item ranged from 1=extremely not to 4=definitely yes.
Higher total score indicates greater program satisfaction
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at the 4 month followup
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Perceived Ease of Use Score
時間枠：at the 4 month followup
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The 16-item Program Usability measures participants' assessment of their agreement with the ease of use of the program in terms of its general features, content, and navigation.
The ranges of the total scores are (3,15), (4,20), (9,45) for general features, content, and navigation, respectively.
The score of individual item ranges from1=strongly disagree to 5=strongly agree.
Higher score indicates greater perceived ease of use.
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at the 4 month followup
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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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Change in FACT-G Scores
時間枠：Baseline upon enrollment, Month 4
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Change in QOL determined using the Functional Assessment of Cancer Therapy General Scale (FACT-G) v.4, a 27-item measure yielding total score and scores for physical, social/family, emotional, and functional well-being of demonstrated reliability, validity, and sensitivity to change.
FACT-G consists of 4 subscales: physical well-being (PWB), functional well-being (FWB), emotional well-being (EWB) and social well-being (SWB).
Scores on the four subscales are summed to produce a total score ranging from 0 to 108 with higher scores indicating better quality of life.
Change from baseline is the post-Baseline values minus the Baseline value.
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Baseline upon enrollment, Month 4
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Change in Appraisal of Prostate Cancer-Specific Symptoms
時間枠：Baseline upon enrollment, Month 4
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The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment.
EPIC will be used to measure change in appraisal of symptoms scores among patients from Baseline (T1) to T2 (4 months post T1).
EPIC contains 26 items within 5 domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal.
Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing opposite results by role: patient with better appraisal of symptoms and partner with worse appraisal of symptoms.
Change from baseline is the post-Baseline values minus the Baseline value.
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Baseline upon enrollment, Month 4
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Change in Appraisal of General Symptoms
時間枠：Baseline upon enrollment, Month 4
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The 19-item Risk for Distress-general symptoms is a subscale of the Risk for Distress Scale.
It measures how much trouble the participant has with the general symptoms such as pain, fatigue, and etc.
The total score ranges between 0 and 38, with higher scores indicating worse appraisal of symptoms.
Change from baseline is the post-Baseline values minus the Baseline value.
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Baseline upon enrollment, Month 4
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Healthcare Utilization Extracted From Electronic Medical Record
時間枠：during the first 10 months after participants completed baseline survey
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The total number of prostate cancer-related followup visits, emergency room use and readmissions.
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during the first 10 months after participants completed baseline survey
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Change in Self-Efficacy Scores From Baseline to 4-Months Post Baseline
時間枠：Baseline upon enrollment, Month 4
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The Lewis Cancer Self-Efficacy used to measure change in participants' feelings of self-efficacy in dealing with the patient's cancer diagnosis and treatment from Baseline (T1) to T2 (4 months post T1).
Participants rate statements about how confident they feel on a scale from 1 to 10, where higher scores indicate higher self-efficacy.
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Baseline upon enrollment, Month 4
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Change in PROMIS Social Support-Informational Support From Baseline to 4-Months Post-Baseline
時間枠：Baseline upon enrollment, Month 4
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The Patient-Reported Outcomes Measurement Information System (PROMIS) Informational Support Short Form 8a will be used to assess changes in patient and partner reported informational support system using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1).
The total score range: 8-40.
Higher scores indicate more informational support.
Change from baseline is the post-Baseline values minus the Baseline value.
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Baseline upon enrollment, Month 4
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Change in PROMIS Social Support-Emotional Support From Baseline to 4-months Post-Baseline
時間枠：Baseline upon enrollment, Month 4
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The PROMIS Emotional Support System-Short Form 8a will be used to assess changes in the self-reported emotional support system of patients and their partners using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1).
The total score range: 8-40.
Higher scores indicate more emotional social support.
Change from baseline is the post-Baseline values minus the Baseline value.
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Baseline upon enrollment, Month 4
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Change in PROMIS Social Support-Instrumental Support From Baseline to 4-months Post-Baseline
時間枠：Baseline upon enrollment, Month 4
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The PROMIS Instrumental Support-Short Form 8a will be used to assess changes in patient and partner reported instrumental support system using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1).
The total score range: 8-40.
Higher scores indicate more instrumental support.
Change from baseline is the post-Baseline values minus the Baseline value.
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Baseline upon enrollment, Month 4
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Change in Dietary Risk Assessment Scores From Baseline to 4-month Post Baseline as Measured by the Health Promoting Lifestyle Profile II
時間枠：Baseline upon enrollment, Month 4
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Change in Dietary Risk Assessment scores used to measure changes in dietary risk from Baseline (T1) to T2 (4 months post T1).
Change from baseline is the post-Baseline values minus the Baseline value.
Participants are asked how often they consume different foods over the past month or week and respond using a Likert Scale ranging from 1=never to 4=routinely.
The total score range: 8-32.
Higher scores indicate better health behaviors in nutrition.
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Baseline upon enrollment, Month 4
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Change in Physical Activity Assessment Scores From Baseline to 4-month Post Baseline as Measured by the Health Promoting Lifestyle Profile II
時間枠：Baseline upon enrollment, Month 4
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Change in Physical Activity Assessment scores used to measure changes in physical activity from Baseline (T1) to T2 (4 months post T1).
Change from baseline is the post-Baseline values minus the Baseline value.
Participants are asked how often they engage in exercises and physical activity over the past month or week and respond using a Likert Scale, ranging from 1=never to 4=routinely.
The total score range: 9-36.
Higher scores indicate better health behaviors in physical activity.
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Baseline upon enrollment, Month 4
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協力者と研究者
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出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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 (実際)
2017年8月3日
一次修了 (実際)
2018年11月30日
研究の完了 (実際)
2019年4月15日
試験登録日
最初に提出
2020年3月28日
QC基準を満たした最初の提出物
2020年4月14日
最初の投稿 (実際)
2020年4月17日
学習記録の更新
投稿された最後の更新 (実際)
2020年9月23日
QC基準を満たした最後の更新が送信されました
2020年9月3日
最終確認日
2020年9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
- LCCC 1619
- 1R21CA212516 (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
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
IPD 共有時間枠
9 to 36 months following publication
IPD 共有アクセス基準
Investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.
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
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