Building Caregiver Skills Using a Simulation-based Intervention for Care of Head and Neck Cancer
2019年2月8日 更新者：Case Comprehensive Cancer Center
Building Family Caregiver Skills Using a Simulation-based Intervention for Care of Patients With Head and Neck Cancer
Patients with head and neck cancer and their caregivers face many challenges.
These include learning about cancer and its treatment, coping with symptoms from illness and treatment side effects, making adjustments to usual activities, and managing the emotional effects of having a serious illness.
This study tests whether different forms of education and support can help family caregivers feel better prepared.
To find out if education about caregiving and different kinds of support are effective, this study wants to compare approaches.One group includes caregivers who will receive an education and support program throughout radiation treatment in addition to usual care by their doctors and nurses.
The other group receives an educational booklet about caregiving in addition to usual care by their doctors and nurses.
The caregiver also completes surveys about his or her emotions, distress, confidence as a care giver, and quality of life.
In addition, the study asks the caregiver questions about his or her age, race, ethnicity, marital status, employment status, education, annual household income, and current living arrangements.
This pilot study will only be offered at the Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Main Campus.
調査の概要
詳細な説明
Aim 1: Conduct a pilot test of the effects of a novel caregiver intervention, as compared to a control group, on family caregiver self-efficacy for caregiving, anxiety, depression, and health-related quality of life.
Aim 2: Explore the acceptability of a caregiver intervention that utilizes simulation.
Aim 3: Assess the feasibility of the intervention. Aim 4: Describe the incidence of patient events that may be impacted by caregiver self-efficacy, such as acute care visits, admissions to the hospital, visits to the emergency department, need for fluids in the radiation oncology department, and interrupted treatment course.
研究の種類
介入
入学 (実際)
18
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
- University Hospitals Cleveland Medical Center, 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
Inclusion Criteria:
- family member or friend of an adult patient with a new diagnosis of Stage III - IV cancers of the tongue, gum, oral cavity, nasopharynx, oropharynx, hypopharynx, larynx, or parotid who is receiving radiation therapy for curative intent
- identified by the patient as his/her primary caregiver who is providing daily assistance and/or emotional support
- cognitively intact, as evidenced by orientation to person, place, and time
- ability to speak, read, and comprehend English
Exclusion Criteria:
- Caregivers of patients who are receiving hospice care will be excluded because of the patient's poor prognosis and multiple issues associated with end-of-life care
- Caregivers who are themselves undergoing active cancer treatment will be excluded (hormonal treatment allowed)
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：Intervention Group: Caregiver education
The intervention includes caregivers who will receive an education and support program throughout radiation treatment in addition to usual care by their doctors and nurses.
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The intervention will be delivered by a radiation oncology nurse.
Each of the four in-person sessions consists of approximately 30 minutes of educational content/simulation that addresses a specific caregiving topic and any issues or concerns that the caregiver may be experiencing.
他の名前：
written, qualitative assessments of areas including depression and anxiety, caregiver self-efficacy, care-giver self efficacy for head and neck cancer, health-related quality of life, patient performance status, demographics, and medical history.
A structured series of open-ended questions will be used during a telephone interview with participants at four weeks post radiation treatment.
他の名前：
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アクティブコンパレータ：Control Group: educational booklet
The control group will receive an educational booklet about caregiving in addition to usual care by their doctors and nurses
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written, qualitative assessments of areas including depression and anxiety, caregiver self-efficacy, care-giver self efficacy for head and neck cancer, health-related quality of life, patient performance status, demographics, and medical history.
A structured series of open-ended questions will be used during a telephone interview with participants at four weeks post radiation treatment.
他の名前：
Radiation Oncology Nurse will hand participant the NCI booklet
他の名前：
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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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Average efficacy of caregiving summary score
時間枠：Up to 5 weeks
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Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically.
Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.
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Up to 5 weeks
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Average anxiety summary score
時間枠：Up to 5 weeks
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Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically.
Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.
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Up to 5 weeks
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Average depression summary score
時間枠：Up to 5 weeks
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Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically.
Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.
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Up to 5 weeks
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Average Health Related Quality of Life (HRQOL) summary score
時間枠：Up to 5 weeks
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Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically.
Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.
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Up to 5 weeks
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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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Qualitative assessment of acceptability
時間枠：Up to 5 weeks
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Descriptive statistics will be used to summarize responses to semi-structured interviews
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Up to 5 weeks
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Attrition rate to assess feasibility
時間枠：Up to 5 weeks
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Feasibility will be assessed via attrition and consent rates.
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Up to 5 weeks
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Consent rate to assess feasibility
時間枠：Up to 5 weeks
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Feasibility will be assessed via attrition and consent rates.
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Up to 5 weeks
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Total time for delivering intervention to assess costs
時間枠：Up to 5 weeks
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Time for delivering the intervention will be recorded to aid in assessing costs.
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Up to 5 weeks
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Average missed checklist items to assess integrity of intervention
時間枠：Up to 5 weeks
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Integrity of the intervention will be assessed through monitoring of intervention checklist.
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Up to 5 weeks
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Event rate for patient events
時間枠：Up to 5 weeks
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Describe the average incidence of all patient events that may be impacted by caregiver self-efficacy.
Events may include acute care visits, admission to the hospital, visits to the emergency department, need for fluids in the radiation oncology department, and interrupted treatment course, and others
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Up to 5 weeks
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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：Susan Mazanec, PhD, RN、University Hospitals Cleveland Medical Center, Case Comprehensive Cancer 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)
2015年8月1日
一次修了 (実際)
2018年1月12日
研究の完了 (実際)
2018年1月12日
試験登録日
最初に提出
2015年10月14日
QC基準を満たした最初の提出物
2015年10月14日
最初の投稿 (見積もり)
2015年10月16日
学習記録の更新
投稿された最後の更新 (実際)
2019年2月11日
QC基準を満たした最後の更新が送信されました
2019年2月8日
最終確認日
2019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。
In-person education sessionsの臨床試験
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Washington University School of MedicineUniversity of Colorado, Denver; University of California, Berkeley; University of California,... と他の協力者積極的、募集していない