Take5Care+: A Self-management Educational Intervention (Take5Care+)
2026年6月23日 更新者：Jitka Vseteckova
Take5Care+: A Self-management Educational Intervention to Support the Haematology Patients' Journey Following a Neoplastic Diagnosis.
Patients who are diagnosed with haematological malignancies may feel that they have little or no control over their health which can be distressing. However, a diagnosis can also be the opportunity for a "teachable moment" during which patients are more likely to open to behaviour change, which can positively impact on their health and wellbeing. Take Five to Age Well (Take Five) was designed to empower people to achieve effective, long-term self-management of health by introducing healthy habits in 30 days.
In collaboration with Northampton General Hospital (NGH) the current study will recruit newly diagnosed haematology patients who are either being actively monitored or only on non-intensive treatment to take part in a self-managed behaviour change intervention. This is primarily a feasibility study to inform main trials in the future.
The main aim of the research is:
To assess the feasibility of using Take5Care+ with patients newly diagnosed with indolent or chronic haematological malignancies, recruited via hospital departments
There are also secondary aims, including:
- To assess the impact of participating in Take5Care+ on patients' self-reported health and well-being, healthy behaviours and sense of control, knowledge and management of health
- To explore the perceptions of patients and clinicians about their participation in the Take5Care+ Patients who wish to take part will be asked to fill out a survey at baseline, complete a "challenge" where they commit to a healthy action for 30 days, fill out a second survey immediately after and a third survey three months later. Patients may also consent to participating in an interview post-challenge. Giving consent and completing the baseline survey will take place in NGH but the challenge is self-managed at home and remotely supported. Survey 2, Survey 3 and the optional interviews are also carried out online or over the phone.
調査の概要
研究の種類
介入
入学 (推定)
20
段階
- 適用できない
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:
- 18 years or older.
- Have been diagnosed within the last 3 months with one of the eligible conditions listed in Table 1.
Be managed with either:
- Active monitoring, or
- Non-intensive oral therapy, defined as outpatient oral regimens that do not require inpatient initiation and have lower expected toxicity (e.g., BTK inhibitors, TKIs, interferon, lenalidomide, hydroxycarbamide, low-dose alkylators).
- Have ECOG Performance Status 0-2.
- Be able to give informed consent.
- Be judged suitable for participation by the treating clinician.
Exclusion Criteria:
- Receiving intensive chemotherapy, immunotherapy, IV combination regimens, cellular therapy, radiotherapy or treatments requiring inpatient initiation.
- Received or expected to require regular blood product transfusions
- Life expectancy <12 months.
- Acutely terminal illness.
- ECOG ≥3.
- Cognitive impairment that would prevent the patient from giving informed consent, or reliably completing the daily action and follow-up assessments
- Pregnant or lactating.
- Currently participating in a CTIMP or other behavioural research intervention.
- Age <18.
Unstable, uncontrolled, or severe comorbidities:
- Uncontrolled heart failure, unstable angina, or MI <3 months.
- Stroke/TIA <3 months.
- Severe/unstable COPD or asthma with recent exacerbations.
- Poorly controlled diabetes
- Severe psychiatric illness interfering with participation.
- Concurrent active malignancy requiring systemic therapy.
- Any other condition that, in the investigator's judgement, would compromise safe participation.
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：なし
- 介入モデル：単一グループの割り当て
- 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：Take5Care+ treatment
Newly diagnosed haematology patients will be recruited to take part in a self-managed behaviour change intervention.
Participants commit to a behavioural action (a "healthy habit") from a predetermined list for 30 days.
|
Newly diagnosed haematology patients will be recruited to take part in a self-managed behaviour change intervention.
Participants commit to a behavioural action (a "healthy habit") from a predetermined list for 30 days.
|
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 |
|---|---|---|
|
Feasibility of the intervention
時間枠：From beginning of study (0 weeks) until data collection is completed (up to 10 months)
|
|
From beginning of study (0 weeks) until data collection is completed (up to 10 months)
|
|
Qualitative exploration of feasibility of study
時間枠：Directly after participant completes the intervention (at 4 weeks)
|
|
Directly after participant completes the intervention (at 4 weeks)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Self-reported behaviours of healthy behaviour
時間枠：Survey 1 will be at 0 weeks, survey 2 will be at 4 weeks and survey 3 will be at 16 weeks
|
• Self-reported behaviours that facilitate improved nutrition, hydration, physical activity, cognitive stimulation and social engagement using a 7-point Likert scale ranging from "Never" to "Every day", collected at Survey 1, Survey 2 and Survey 3.
|
Survey 1 will be at 0 weeks, survey 2 will be at 4 weeks and survey 3 will be at 16 weeks
|
|
Self-reported health
時間枠：Survey 1 will be at 0 weeks, survey 2 will be at 4 weeks and survey 3 will be at 16 weeks
|
• Self-reported health as measured by SF-12, transformed into two scores:
|
Survey 1 will be at 0 weeks, survey 2 will be at 4 weeks and survey 3 will be at 16 weeks
|
|
Self-reported adherence to Take5Care+ actions
時間枠：Survey 2 will be at 4 weeks and Survey 3 at 16 weeks.
|
• Participants will be asked how many days a week, on average, they are still doing their chosen action, from 1-7 days. This data will be collected at Survey 2 and Survey 3. |
Survey 2 will be at 4 weeks and Survey 3 at 16 weeks.
|
|
Subjective perception of health
時間枠：Survey 1 will be at 0 weeks, survey 2 will be at 4 weeks and survey 3 will be at 16 weeks
|
|
Survey 1 will be at 0 weeks, survey 2 will be at 4 weeks and survey 3 will be at 16 weeks
|
|
Explore perceptions of patients and clinicians
時間枠：Directly after the intervention (at 4 weeks)
|
Thematic analysis of perceptions of participation, barriers and facilitators via semi-structured interviews with patients (optional) and clinicians
|
Directly after the intervention (at 4 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。
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7月1日
一次修了 (推定)
2027年3月1日
研究の完了 (推定)
2027年10月1日
試験登録日
最初に提出
2026年6月16日
QC基準を満たした最初の提出物
2026年6月23日
最初の投稿 (実際)
2026年6月29日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月29日
QC基準を満たした最後の更新が送信されました
2026年6月23日
最終確認日
2026年6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
- OpenU
- IRAS ID 368667 (その他の識別子：HRA and Health and Care Research Wales (HCRW))
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
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