A Pilot Study of Structured Palliative Care for Patients Enrolled on Phase I Clinical Trials
2019年4月22日 更新者：Case Comprehensive Cancer Center
The goal of this research study is to find out if providing patients who are enrolled in phase 1 clinical trials with structured supportive care will enable them to continue in the Phase 1 trial longer and improve their quality of life by reducing or treating side effects and by providing emotional and social support to the patient and family.
The structured supportive or palliative care intervention will be provided by a team of trained specialists which include doctors, nurses, social workers and spiritual care providers.
The supportive care team will provide treatment to address symptoms, such as pain or anxiety, caused by the cancer itself or from the treatment.
The team can make referrals to other specialists.
Such as psychologists or nutritionist, if needed, and can help arrange for services to address home care needs.
調査の概要
詳細な説明
Primary Objective(s): To assess symptoms, adverse events, duration on study, reason for study discontinuation, and quality of life among patients participating in phase I clinical trials who receive structured palliative care, and those who receive standard supportive care. Duration on study will serve as the primary objective for sample size determination.
Secondary Objective(s):
1. To describe the quantity (e.g. hours), type, and cost of palliative care personnel services used by patients and caregivers receiving structured palliative care.
Exploratory:
- To compare adverse event profiles, duration on study, and quality of life between patients who receive structured palliative care and those receiving standard supportive care.
- To compare caregiver burden and quality of life between the study arms.
研究の種類
介入
入学 (実際)
132
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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Ohio
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Cleveland、Ohio、アメリカ、44106
- Case Comprehensive Cancer 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
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Patient Inclusion Criteria:
- Patients must be enrolled in a Phase 1 clinical trial and be within 2 weeks of starting the experimental therapy or intervention.
- Patients are eligible to enroll on this study with or without the enrollment of their caregiver.
Patient Exclusion Criteria:
- Patients diagnosed with a hematologic malignancy.
Caregiver Inclusion Criteria:
- Any caregiver is considered eligible for this study; The caregiver is the person identified by the patient as the one who provides the most regular physical and/or emotional support.
- Caregivers must be willing to complete surveys at baseline and on monthly basis.
Caregiver Exclusion Criteria:
- Caregivers who are solely professional, paid caregivers
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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アクティブコンパレータ：Standard Supportive Care
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Supportive care for the patient and caregiver will be provided by the treating oncologist.
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実験的：Structured Supportive Care
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Supportive care for the patient and caregiver will be provided by the outpatient palliative care team which includes clinicians with specialized palliative care training, social workers, spiritual care specialists and mental health clinical nurse specialist.
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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 |
|---|---|---|
|
Average total MSAS score
時間枠：Up to 6 months
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Assessment of patient burden
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Up to 6 months
|
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Average total FACT-G score
時間枠：Up to 6 months
|
Measure patient quality of life
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Up to 6 months
|
|
Reason for study discontinuation (Patient reported outcome)
時間枠：Up to 6 months
|
Measure of central tendency for why patients discontinued the phase I study.
Patient reported outcomes for reason for study discontinuation will be qualitatively assessed
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Up to 6 months
|
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Duration on Study
時間枠：Up to 6 months
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Measure of central tendency of the duration patients were on the phase I study.
Duration on study will serve as the primary objective for sample size determination
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Up to 6 months
|
|
Adverse events
時間枠：Up to 6 months
|
Measure of central tendency of adverse events.
AE will be described and further categorized as modifiable (primary symptom experience) and non-modifiable (laboratory abnormalities).
The influence of adverse events on study outcomes particularly duration on study and reason for study discontinuation will be assessed.
An exploratory weighted adverse event score will be calculated using the equation: adverse event score = ∑ (NAE * GAE) where N denotes the adverse event number, G denotes grade, AE denotes adverse event.
These scores will be compared between study arms
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Up to 6 months
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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 |
|---|---|---|
|
Mean number of hours of palliative care services
時間枠：Up to 6 months
|
Mean number of hours utilized by patients and caregivers who received structured palliative care.
This analysis will be descriptive, reporting measures of central tendency
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Up to 6 months
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Type of palliative care services
時間枠：Up to 6 months
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Measure of central tendency for the type of palliative care services utilized by patients and caregivers who received structured palliative care.
This analysis will be descriptive, reporting measures of central tendency
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Up to 6 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Frequency of adverse events of patients receiving structured and usual supportive care
時間枠：Up to 6 months
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Up to 6 months
|
|
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Average days on study
時間枠：Up to 6 months
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Up to 6 months
|
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Change in FACT-G score
時間枠：From baseline to last contact, up to 6 months
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Change in patient symptom burden when compared to baseline between patients who received structured palliative care and those who received standard supportive care
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From baseline to last contact, up to 6 months
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Change in MSAS score
時間枠：From baseline to last contact, up to 6 months
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Change in quality of life when compared to baseline between patients who received structured palliative care and those who received standard supportive care
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From baseline to last contact, up to 6 months
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Change in CRA score
時間枠：From baseline to last contact, up to 6 months
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Change in caregiver burden when compared to baseline between those who received structured palliative care and those who received standard supportive care
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From baseline to last contact, up to 6 months
|
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Change in QOLLTI-F score
時間枠：From baseline to last contact, up to 6 months
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Change in caregiver quality of life as assessed through change in QOLLTI-F score when compared to baseline between those who received structured palliative care and those who received standard supportive care
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From baseline to last contact, up to 6 months
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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：Michelle Treasure, MD、Metrohealth Medical Center and Case Comprehensive Cancer Center
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
2015年10月25日
一次修了 (実際)
2019年1月10日
研究の完了 (実際)
2019年1月10日
試験登録日
最初に提出
2015年9月4日
QC基準を満たした最初の提出物
2015年9月4日
最初の投稿 (見積もり)
2015年9月7日
学習記録の更新
投稿された最後の更新 (実際)
2019年4月23日
QC基準を満たした最後の更新が送信されました
2019年4月22日
最終確認日
2019年4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。
癌の臨床試験
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
Standard supportive careの臨床試験
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Compedica IncProfessional Education and Research Institute募集
-
Saint-Joseph University完了
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DeRoyal Industries, Inc.Lincoln Memorial University完了皮膚感作 | 機械的、熱的、および放射線刺激に対する皮膚反応アメリカ
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George Washington UniversityPatient-Centered Outcomes Research Institute; University of Bristol; West Virginia University...まだ募集していません
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Fred Hutchinson Cancer CenterNational Institute on Drug Abuse (NIDA)完了
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University of PittsburghShadyside Hospital Foundation完了
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University of Oxford完了
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Medical University of South CarolinaIcahn School of Medicine at Mount Sinai完了