Staying Strong and Healthy During Androgen Deprivation Therapy (ADT) for Men
2021年2月15日 更新者：University of Kansas Medical Center
The purpose of this study is to learn if lifestyle changes and counseling along with standard medical care, compared to standard medical care alone, can prevent heart problems and diabetes in men who are receiving ADT for prostate cancer treatment.
調査の概要
状態
完了
条件
詳細な説明
Prostate cancer is a very treatable cancer but those treatments can have long-lasting effects. A kind of hormone therapy called Androgen Deprivation Therapy (ADT) is often used along with other treatments like radiation and has been shown to improve survival. However, ADT can have negative effects especially on the heart and metabolism (the body's system for using and storing energy).
Participation in this study will last for up to 12 months. The study is looking at two different approaches to treating men who are undergoing ADT:
- Staying Strong & Healthy Intervention + Usual Care
- Usual Care
All participants will have blood drawn and be asked questions about how they are feeling during their participation. The men in the Staying Strong & Healthy Intervention group will also take part in a diet and exercise program and receive counseling from a member of the study team.
研究の種類
介入
入学 (実際)
38
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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California
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Los Angeles、California、アメリカ、90095
- University of California, Los Angeles
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Kansas
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Kansas City、Kansas、アメリカ、66160
- University of Kansas Medical Center
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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
21年歳以上 (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
男
説明
Inclusion Criteria:
- Diagnosed with prostate cancer
- Starting or have started ADT (oral or injection) for prostate cancer treatment within the last 3 months
- Re-initiating ADT after being on holiday for longer than their ADT dosage (e.g. If the man's dosage is every six months and he has been off ADT for more than six he is eligible);
- Able to speak and read in English or Spanish
- Reachable consistently by telephone
- Able to travel to KUMC
Exclusion Criteria:
- Not diagnosed with prostate cancer
- Not receiving or planning to receive ADT for prostate cancer treatment within the last three months
- Initiating ADT for prostate cancer prior to the previous 3 months or are not on ADT holiday
- Not able to speak and read in English or Spanish
- Not reachable consistently by telephone
- Not able to travel to the study site for data collection
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 |
|---|---|
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実験的：Staying Strong & Healthy Intervention (SS&H)
Participants will take part in a 6-month exercise program and diet and nutrition coaching program.
Also part of this arm is a nutritional and lifestyle counseling program to be lead by a member of the study team.
Participants will also receive the usual care they would normally receive if not taking part in this study.
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Participants will have a personal training session at the first visit.
A member of the study team will discuss strength training and cardiovascular workouts for them to complete over the first 6 months of the study.
A member of the study team will then talk with the participant every week for the first 3 months and monthly afterwards until month 6.
Participants will be sent exercise videos and be given recommendations for the exercise program via phone calls and will be tailored to the individual.
Videos and recommendations will be sent directly to the participant's smartphone.
Diet and nutrition coaching session with an overview of resources on the smartphone.
Over the first 6 months, participants will receive healthy recipes and nutritional information on the smartphone.
Participants will receive the usual care for men undergoing ADT.
This includes monitoring blood work and answering questions about how they are feeling.
Participants will be directed to the IMPACT website for education materials on prostate cancer.
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アクティブコンパレータ：Usual Care with Attention (UCA)
Participants will receive the usual care they would normally receive if not taking part in this study.
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Participants will receive the usual care for men undergoing ADT.
This includes monitoring blood work and answering questions about how they are feeling.
Participants will be directed to the IMPACT website for education materials on prostate cancer.
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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 |
時間枠 |
|---|---|
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Change in LDL
時間枠：Change from Baseline to Month 12
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Change from Baseline to Month 12
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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 Body Mass Index (BMI)
時間枠：Change from Baseline to Month 6
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Change from Baseline to Month 6
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Change in Body Mass Index (BMI)
時間枠：Change from Baseline to Month 12
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Change from Baseline to Month 12
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Change in Lipid Profile
時間枠：Change from Baseline to Month 6
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Change from Baseline to Month 6
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Change in Lipid Profile
時間枠：Change from Baseline to Month 12
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Change from Baseline to Month 12
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Change in Waist/Hip Circumference
時間枠：Change from Baseline to Month 6
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Change from Baseline to Month 6
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Change in Waist/Hip Circumference
時間枠：Change from Baseline to Month 12
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Change from Baseline to Month 12
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Change in Glucose
時間枠：Change from Baseline to Month 6
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Change from Baseline to Month 6
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Change in Glucose
時間枠：Change from Baseline to Month 12
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Change from Baseline to Month 12
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Change in Health Related Quality
時間枠：Change from Baseline to Month 6
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Quality of life will be measured using the SF-12 and Expanded Prostate Cancer Index Composite.
The two are scored together and result in a composite score.
Scores can range from 0-100.
The higher the score the better the quality of life.
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Change from Baseline to Month 6
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Change in Health Related Quality
時間枠：Change from Baseline to Month 12
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Quality of life will be measured using the SF-12 and Expanded Prostate Cancer Index Composite.
The two are scored together and result in a composite score.
Scores can range from 0-100.
The higher the score the better the quality of life.
|
Change from Baseline to Month 12
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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。
捜査官
- 主任研究者：Sally Maliski, PhD, RN, FAAN、University of Kansas Medical Center
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3月7日
一次修了 (実際)
2020年7月1日
研究の完了 (実際)
2020年7月31日
試験登録日
最初に提出
2016年11月17日
QC基準を満たした最初の提出物
2016年11月17日
最初の投稿 (見積もり)
2016年11月21日
学習記録の更新
投稿された最後の更新 (実際)
2021年2月17日
QC基準を満たした最後の更新が送信されました
2021年2月15日
最終確認日
2021年2月1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。
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