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COVID-19 Pandemic Impact on Patients With Cancer - a Danish Survey (COPICADS)

2021年7月21日 更新者:Stefan Starup Jeppesen、Odense University Hospital

The outbreak of coronavirus was categorized as a global pandemic in March 2020. The Danish government recommends social distancing during the COVID-19 pandemic. Long-term social distancing and fear of disease can lead to anxiety, depression and the feeling of loneliness. All these factors might affect the quality of life (QoL).

The aim of this study is to investigate the overall QoL for patients with cancer during the COVID-19 pandemic with special focus on emotional functioning.

調査の概要

状態

完了

条件

詳細な説明

Since the detection of the novel coronavirus also called COVID-19 in December 2019 it has affected many people worldwide. The outbreak of coronavirus was categorized as a global pandemic in March 2020.

The focus of the Danish health care system is on patients infected with COVID-19. In order to limit the spread of this disease, the Danish government recommends social distancing during the COVID-19 pandemic. Unfortunately, long-term social distancing and fear of disease can lead to anxiety, depression and the feeling of loneliness. All these factors might affect the quality of life (QoL). The fear of the COVID-19 among the Danish population is thought to be high since cancer referrals to the departments have decreased markedly during the pandemic - probably because people avoid appointments at the hospital or general practitioner.

A population that may be seriously impacted by the COVID-19 disease is the group of patients with cancer. Patients with cancer are in a high risk of serious illness of infections because the cancer and antineoplastic treatment often weaken the immune system. However, no reports are available regarding higher incidence of COVID-19 in patients with cancer. The patients with cancer might be practicing social distancing even more than the general population and the well-being for this group of patients may be even more affected by the COVID-19 disease.

In Denmark, during the coronavirus outbreak different treatment guidelines have been conducted to minimize the risk of infection with the COVID-19 virus, but also the impact of pandemic on the cancer treatment and follow-up program. Also European recommendations have been conducted to help clinicians deal with various aspects of cancer care. Immunotherapy for patients with cancer can be changed from a 3 week schedule to 6 week schedule and many palliative radiation treatments can be changed from a schedule of 10 fractions to 5 fractions. Furthermore it is recommended by the European societies of medical oncology and radiation oncology to avoid hospital appointments for patients with cancer. In follow-up programmes outpatient clinic visits can be done over the phone or may even be postponed.

Avoiding exposure to the COVID-19 virus can be essential for patients with cancer. The new pandemic situation can cause serious concerns for this group of patients. Many visits at the oncological outpatient clinics are being cancelled or appointments are done by phone to avoid as many contacts to the health system as possible. The lack of face-to-face contact to the staff at the Departments of Oncology might cause worries and anxiety for the patients and their relatives, because of the risk of less detailed information regarding side effects of treatment as well as cancer related symptoms. Patients may also worry that their antineoplastic treatment will be discontinued or changed due to reduction of visits at the outpatient clinics. Overall the QoL can be affected for patients with cancer. A structured and unified approach to COVID-19 prevention and care specific to cancer patients and cancer centers is highly needed. Many of the initiatives to avoid face-to-face contact during the COVID-19 pandemic e.g. telephonic or web-technology contacts for consultation may continue in the time after the COVID-19 pandemic. It is therefore of interest to explore the patients' QoL and to investigate their satisfaction with cancer treatment and follow-up during the COVID-19 pandemic.

研究の種類

観察的

入学 (実際)

6810

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

      • Odense C、デンマーク、5000
        • Department of Oncology, Odense University Hospital
    • Region Of Southern Denmark
      • Odense、Region Of Southern Denmark、デンマーク、5000
        • Department of Haemotology, Odense University 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~125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

サンプリング方法

確率サンプル

調査対象母集団

Patients are recruited at the Department of Oncology and the Department of Haemotology, Odense University Hospital, Denmark.

Patients are either receiving cancer treatment or in follow-up for a cancer diagnosis

説明

Inclusion Criteria:

  • Patients with cancer
  • Patients who are receiving cancer treatment or patients in follow-up for a cancer diagnosis
  • Age 18+

Exclusion Criteria:

  • Patients without "eBoks" - a secure electronic mailbox used to receive digital mail from the private sector

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

コホートと介入

グループ/コホート
介入・治療
Patients with cancer
Survey
Patients will be sent a survey incl. EORTC QLQ-C30

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
Overall Quality of Life
時間枠:One measurement of EORTC QLQ-C30 and a survey created for the purpose will be performed through study completion, an average of 1 months

EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30 (Quality of Life Questionnaire core 30) - The QLQ-C30 is a standardized cancer-specific 30-itemed instrument. Scores are transformed linearly to a zero to 100 scale. A higher score on the functional scale and the global Health related Quality of Life indicates better functioning.

In the current study, the items addressing global quality of life and health: "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" will be used to get a pure expression of QoL.

The EORTC QLQ-C30 scores in this study will be compared with QoL for Danish Cancer patients in the period before COVID-19 (https://www.cancer.dk/dyn/resources/File/file/3/8373/1574778638/kraeftens-bekaempelses-barometerundersoegelse-2019.pdf). Results on overall QoL is listed on page 36.

One measurement of EORTC QLQ-C30 and a survey created for the purpose will be performed through study completion, an average of 1 months

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。

スポンサー

捜査官

  • 主任研究者:Stefan S Jeppesen, MD, PhD、Odense University Hospital

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)

2020年5月14日

一次修了 (実際)

2020年7月21日

研究の完了 (実際)

2021年7月21日

試験登録日

最初に提出

2020年5月12日

QC基準を満たした最初の提出物

2020年5月14日

最初の投稿 (実際)

2020年5月15日

学習記録の更新

投稿された最後の更新 (実際)

2021年7月28日

QC基準を満たした最後の更新が送信されました

2021年7月21日

最終確認日

2021年7月1日

詳しくは

本研究に関する用語

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?

未定

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

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 Center
    National 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

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