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Effectiveness and Implementation of 'Supportive and Palliative Care Review Kit in Locations Everywhere' (SPARKLE-2)

2026年7月30日 更新者：National Cancer Centre, Singapore

Effectiveness and Implementation of 'Supportive and Palliative cAre Review Kit in Locations Everywhere' (SPARKLE-2) - A Randomized Controlled Trial

Advanced cancer patients often experience significant physical and emotional symptoms, which can lead to frequent hospital visits and reduced quality of life. Although palliative care can help manage these symptoms and improve well-being, it is often introduced too late.

A proactive symptom monitoring model, SPARKLE-2 aims to identify patients who need palliative care earlier by regularly checking their symptoms using a simple questionnaire. Patients with concerned symptoms will receive timely support from the palliative care team, with the goal of improving their quality of life, reducing unnecessary hospital admissions, and helping more patients receive care in the community rather than in hospital. In the earlier SPARKLE-1 study, it showed the improvement of patients' physical wellbeing. SPARKLE-2 seeks to test the effectiveness among advanced cancer patients with unplanned hospital visits while simultaneously collecting data on real-world implementation.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

To evaluate the effectiveness of SPARKLE-2, we will conduct randomized controlled trial comparing clinical outcomes at 3 months between patients receiving usual care and intervention. For longer-term impact of palliative care, we will also measure patient outcomes at 6, 9, and 12 months. To evaluate ways to improve implementation, the Consolidated Framework for Implementation Research (CFIR) will be used to systematically identify processes that influence implementation outcomes.

The specific aims and hypotheses of this mixed methods study are:

  1. Assess the effectiveness of SPARKLE-2 on health-related quality of life and healthcare utilization among patients with advanced cancer. We hypothesize that the SPARKLE-2 group compared to the usual care group participants will have better health-related quality of life, better health status, earlier palliative care utilisation, and less acute healthcare utilisation.
  2. Assess implementation processes of SPARKLE-2. We will assess acceptability, appropriateness, and feasibility through a structured survey among healthcare providers. Also, we will assess fidelity through completion rate of IPOS screening questionnaires and compliance with clinical response pathways. Implementation costs will be captured from the healthcare system's perspective prospectively using an activity-based costing approach.
  3. Assess contexts and mechanisms that bring about SPARKLE-2 outcomes. We will interview patients, caregivers and healthcare providers who were involved in SPARKLE-2 to explore their perspectives on factors, including facilitators and barriers, that bring about intervention effects.

研究の種類

介入

入学 (推定)

300

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。

研究連絡先

研究連絡先のバックアップ

研究場所

  • シンガポール
      • Singapore、シンガポール、169608
        • Singapore General Hospital
        • コンタクト：
          • Dr Yi ZHOU, MD, MRCP (UK), MMed
      • Singapore、シンガポール、168583
        • National Cancer Centre, Singapore
        • コンタクト：
          • Dr Grace Meijuan YANG, MD, MPH, PhD

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

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Inclusion criteria for patients:

    1. 21 years old or older
    2. Diagnosed of advanced cancer diagnosis, defined as metastatic or recurrent/ progressive Stage III/IV solid tumour
    3. Has an unplanned hospital admission and expected to be discharged home
    4. Able to speak English or Mandarin Chinese or Malay

    5. Able to provide informed consent

      Additional inclusion criteria for patient participants of semi-structured interviews are:

    6. Enrolled in the SPARKLE-2 RCT, whether randomized to the SPARKLE intervention or usual care group and regardless of fidelity to trial procedures.

  • Inclusion criteria for caregivers:

    1. 21 years old or older
    2. Self-endorsing or identified by an enrolled patient as a spouse/partner, relative or friend who knows them well and who provides support due to their cancer
    3. Able to speak English or Mandarin Chinese or Malay
    4. Able to provide informed consent

  • Inclusion criteria for healthcare providers:

    1. 21 years old or older
    2. Healthcare professional who is involved in the clinical care of patients with advanced cancer for at least 50% of their work hours
    3. Able to provide informed consent
    4. Involved in the processes of the SPARKLE-2

Exclusion Criteria:

  • Exclusion criteria for patients:

    1. Assessed by the treating physician as unable to complete study procedures
    2. Unable to complete patient-reported outcome measures

  • Exclusion criteria for caregivers:

    1. Unable to complete interviews

  • Exclusion criteria for healthcare providers:

    1. Healthcare professionals that are not providing care for cancer patients.
    2. Unable to complete interviews

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：SPARKLE-2 Intervention
Participants will receive SPARKLE-2 immediately at bi-weekly interval.
行動：SPARKLE-2

Patients will receive a Short Message Service (SMS) text on their phone every 2 weeks, inviting them to complete a self-reported online six-item Integrated Palliative care Outcome Scale (IPOS) questionnaire over a period of 12 months.

If a patient records higher scores on any IPOS symptom domains, a programme coordinator will then make a phone call to the patient for further assessment of symptoms and concerns identified. If indicated, the programme coordinator would then initiate management of the symptoms and concerns according to structured clinical management protocols.
介入なし：Usual Care
Participants will not receive any study intervention (SPARKLE-2) and will continue to receive their usual care.

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
Quality of life score measured using the Functional Assessment of Chronic Illness Therapy - Palliative (FACIT-Pal)
時間枠：12 weeks.
FACIT-Pal is a 46-item measure with a quality-of-life scale (4 domains: physical, emotional, social, and functional well-being) and a palliative care subscale. It has demonstrated internal consistency, reliability and validity for persons with advanced cancer. Quality of life is scored on a scale of 0 to 184, with higher scores indicating better outcomes.
12 weeks.

二次結果の測定

結果測定
メジャーの説明
時間枠
Quality of life score measured using the Functional Assessment of Chronic Illness Therapy - Palliative (FACIT-Pal)
時間枠：Every 12 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.
The proposed FACIT-Pal assessment schedule is to evaluate longitudinal changes in quality of life over time.
Every 12 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.
Palliative care concerns measured using the Integrated Palliative Care Outcomes Scale (IPOS)
時間枠：Every 2 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.
IPOS is a brief measure of palliative care problems, covering physical and psychological symptoms, social and spiritual issues, communication, information needs, and practical concerns. Each item is rated on a Likert scale of 0 to 4. Higher scores indicate that symptoms and concerns affect the person more. IPOS has been translated to Chinese and validated in Singapore.
Every 2 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.
Health states measured using the EuroQOL Group 5-Dimension Health-related Quality of Life Measurement (EQ-5D-5L)
時間枠：Baseline, 12 weeks, 18 weeks, 27 weeks, and 48 weeks.
EQ-5D-5L contains a 5-item descriptive system measuring 5 dimensions: mobility, self-care, usual activities, pain/ discomfort, anxiety/ depression; a visual analogue scale measuring overall health status. The tool has been validated in Singapore.
Baseline, 12 weeks, 18 weeks, 27 weeks, and 48 weeks.
Acute healthcare utilization.
時間枠：Baseline until death or end of the study, up to 48 weeks.
Frequency of Emergency Department (ED) visits.
Baseline until death or end of the study, up to 48 weeks.
Inpatient healthcare utilization and the intervention's impact on inpatient healthcare utilization.
時間枠：Baseline until death or end of the study, up to 48 weeks.
Number of hospital admissions.
Baseline until death or end of the study, up to 48 weeks.
Healthcare expenditure associated with patient care and the economic impact on intervention.
時間枠：Baseline until death or end of the study, up to 48 weeks.
Total hospital charges.
Baseline until death or end of the study, up to 48 weeks.

その他の成果指標

結果測定
メジャーの説明
時間枠
Appropriateness and feasibility
時間枠：Up to 48 weeks.
To explore perspectives on factors, including facilitators and barriers among patients, caregivers and healthcare workers. Semi-structured interviews conducted using an interview guide developed based on the Consolidated Framework for Implementation Research (CFIR).
Up to 48 weeks.
Implementation cost
時間枠：Up to 48 weeks.
Process maps and project records detailing key intervention activities to elucidate cost of involved personnel and resources through a time-tracking system and an activity-based costing approach.
Up to 48 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。

スポンサー

National Cancer Centre, Singapore

捜査官

  • スタディチェア：Grace Meijuan YANG, MD, MPH, PhD、National Cancer Centre, Singapore

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

便利なリンク

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 (推定)

2026年8月1日

一次修了 (推定)

2029年3月31日

研究の完了 (推定)

2029年3月31日

試験登録日

最初に提出

2026年7月30日

QC基準を満たした最初の提出物

2026年7月30日

最初の投稿 (実際)

2026年8月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月4日

QC基準を満たした最後の更新が送信されました

2026年7月30日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 2026-0459

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個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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