Improvement of Information to Cancer Patients' Caregivers
2019年1月18日 更新者：Mogens Groenvold、Bispebjerg Hospital
Improvement of Information to Cancer Patients' Caregivers: a Randomised Intervention Study
The purpose of this study is to investigate whether a systematic early assessment of uncovered needs for information, supplemented by an interview about the needs with the patient's nurse who seeks to provide the information requested, will improve the caregivers' and the patients' satisfaction with information and communication and potentially also decrease anxiety and depression.
調査の概要
研究の種類
介入
入学 (実際)
211
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
-
-
-
Herlev、デンマーク、2730
- Department of Oncology, Herlev Hospital
-
-
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
いいえ
受講資格のある性別
全て
説明
Patient Inclusion Criteria:
- Cancer patient
- Newly refered to (i.e., this is the patient's first visit in) Department of Oncology, Herlev Hospital, in order to start medical treatment (e.g. chemotherapy)
- Written informed consent
Caregiver Inclusion Criteria:
- Attends the first visit in the Department of Oncology with the patient
- Has lacked information about at least one of the 13 aspects of information asked about in the questionnaire
- Written informed consent
Exclusion Criteria:
- Patient and/or caregiver do not understand Danish well enough to participate in the study
- The patient has an expected survival of less than six months
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：ヘルスサービス研究
- 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 |
|---|---|
|
実験的：Immediate intervention
Immediately after enrollment in the project, caregivers and patients receive the intervention
|
The intervention consists of an interview about the caregiver's responses (baseline measurement) to a list about 'lack of information' within 13 areas.
For each area, the patient's nurse will enquire about what information is requested by the caregiver and the patient.
Subsequently, the nurse provides the requested information.
She may involve the doctor and arrange follow-up visits or phone calls until the need is covered
|
|
他の：Delayed intervention (3 weeks later)
This group receives the same intervention as in the experimental group, but after the outcome assessment at 2 weeks
|
The intervention consists of an interview about the caregiver's responses (baseline measurement) to a list about 'lack of information' within 13 areas.
For each area, the patient's nurse will enquire about what information is requested by the caregiver and the patient.
Subsequently, the nurse provides the requested information.
She may involve the doctor and arrange follow-up visits or phone calls until the need is covered
|
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 |
|---|---|---|
|
Satisfaction with information from health care professionals
時間枠：Change from baseline (enrollment) at 2 weeks
|
Measure: The "Cancer Caregiving Tasks, Consequences and Needs Questionnaire" (CaTCoN) item 24
|
Change from baseline (enrollment) at 2 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Satisfaction with information from health care professionals
時間枠：Change from baseline (enrollment) at 2 weeks
|
Measure: CaTCoN subscale "Lack of information from health care professionals" (revised version)
|
Change from baseline (enrollment) at 2 weeks
|
|
Satisfaction with communication with health care professionals
時間枠：Change from baseline (enrollment) at 2 weeks
|
Measure: CaTCoN subscale "Problems with the quality of information and communication from health care professionals"
|
Change from baseline (enrollment) at 2 weeks
|
|
Satisfaction with support from health care professionals
時間枠：Change from baseline (enrollment) at 2 weeks
|
Measures: CaTCoN subscale "Lack of attention from health care professionals on the caregivers' wellbeing"
|
Change from baseline (enrollment) at 2 weeks
|
|
Satisfaction with support from health care professionals
時間枠：Change from baseline (enrollment) at 2 weeks
|
Measures: CaTCoN subscale "Need for help from health care professionals"
|
Change from baseline (enrollment) at 2 weeks
|
|
Anxiety and depression
時間枠：Change from baseline (enrollment) at 2 weeks
|
Measure: The Hospital Anxiety and Depression Scale (HADS)
|
Change from baseline (enrollment) at 2 weeks
|
|
Fulfillment of needs
時間枠：Change from baseline (enrollment) at 2 weeks
|
Measure: Family Inventory of Needs (FIN)
|
Change from baseline (enrollment) at 2 weeks
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The time spent on information as reported by health care professionals
時間枠：Weeks 0-6 from baseline
|
Investigated in focus group interviews with the health care professionals
|
Weeks 0-6 from baseline
|
|
Satisfaction with information from health care professionals
時間枠：Change from baseline (enrollment) at 12 weeks
|
Measure: CaTCoN item 24
|
Change from baseline (enrollment) at 12 weeks
|
|
Satisfaction with information from health care professionals
時間枠：Change from baseline (enrollment) at 12 weeks
|
Measure: CaTCoN subscale "Lack of information from health care professionals" (revised version)
|
Change from baseline (enrollment) at 12 weeks
|
|
Satisfaction with communication with health care professionals
時間枠：Change from baseline (enrollment) at 12 weeks
|
Measure: CaTCoN subscale "Problems with the quality of information and communication from health care professionals"
|
Change from baseline (enrollment) at 12 weeks
|
|
Satisfaction with support from health care professionals
時間枠：Change from baseline (enrollment) at 12 weeks
|
Measures: CaTCoN subscale "Lack of attention from health care professionals on the caregivers' wellbeing"
|
Change from baseline (enrollment) at 12 weeks
|
|
Satisfaction with support from health care professionals
時間枠：Change from baseline (enrollment) at 12 weeks
|
Measures: CaTCoN subscale "Need for help from health care professionals"
|
Change from baseline (enrollment) at 12 weeks
|
|
Anxiety and depression
時間枠：Change from baseline (enrollment) at 12 weeks
|
Measure: The Hospital Anxiety and Depression Scale (HADS)
|
Change from baseline (enrollment) at 12 weeks
|
|
Fulfillment of needs
時間枠：Change from baseline (enrollment) at 12 weeks
|
Measure: Family Inventory of Needs (FIN)
|
Change from baseline (enrollment) at 12 weeks
|
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。
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。
一般刊行物
- Lund L, Ross L, Petersen MA, Groenvold M. The interaction between informal cancer caregivers and health care professionals: a survey of caregivers' experiences of problems and unmet needs. Support Care Cancer. 2015 Jun;23(6):1719-33. doi: 10.1007/s00520-014-2529-0. Epub 2014 Nov 29.
- Lund L, Ross L, Groenvold M. The initial development of the 'Cancer Caregiving Tasks, Consequences and Needs Questionnaire' (CaTCoN). Acta Oncol. 2012 Nov;51(8):1009-19. doi: 10.3109/0284186X.2012.681697. Epub 2012 May 8.
- Lund L, Ross L, Petersen MA, Groenvold M. The validity and reliability of the 'Cancer Caregiving Tasks, Consequences and Needs Questionnaire' (CaTCoN). Acta Oncol. 2014 Jul;53(7):966-74. doi: 10.3109/0284186X.2014.888496. Epub 2014 Mar 16.
- Lund L, Ross L, Petersen MA, Sengelov L, Groenvold M. Improving information to caregivers of cancer patients: the Herlev Hospital Empowerment of Relatives through More and Earlier information Supply (HERMES) randomized controlled trial. Support Care Cancer. 2020 Feb;28(2):939-950. doi: 10.1007/s00520-019-04900-3. Epub 2019 Jun 8.
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4月1日
一次修了 (実際)
2016年5月1日
研究の完了 (実際)
2016年8月1日
試験登録日
最初に提出
2015年1月29日
QC基準を満たした最初の提出物
2015年3月2日
最初の投稿 (見積もり)
2015年3月5日
学習記録の更新
投稿された最後の更新 (実際)
2019年1月22日
QC基準を満たした最後の更新が送信されました
2019年1月18日
最終確認日
2019年1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。