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Take5Care+: A Self-management Educational Intervention (Take5Care+)

23. Juni 2026 aktualisiert von: 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:

  1. 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:

  2. 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
  3. 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

20

Phase

  • Unzutreffend

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Sonstiges: Take5Care+
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Feasibility of the intervention
Zeitfenster: From beginning of study (0 weeks) until data collection is completed (up to 10 months)
  • % of patients who are recruited from possible participant pool (anonymous) during recruitment period (recruitment numbers = number of participants/number of total participants)
  • % of patients who withdraw from study via study log (study attrition = number of withdrawals/number of total participants who consent into study)
  • % of patients who withdraw from survey during survey completion (survey attrition = number of incomplete surveys/number of times survey is started) All data is secondary data and will not require participant input.
From beginning of study (0 weeks) until data collection is completed (up to 10 months)
Qualitative exploration of feasibility of study
Zeitfenster: Directly after participant completes the intervention (at 4 weeks)
  • Optional semi-structured interviews with participants, analysed using thematic analysis
  • Qualitative interviews with healthcare professionals, analysed using thematic analysis
Directly after participant completes the intervention (at 4 weeks)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Self-reported behaviours of healthy behaviour
Zeitfenster: 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
Zeitfenster: 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:

  • Physical component summary score ranging from 0 - 100
  • Mental component summary score ranging from 0 - 100 The measures will be 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 adherence to Take5Care+ actions
Zeitfenster: 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
Zeitfenster: Survey 1 will be at 0 weeks, survey 2 will be at 4 weeks and survey 3 will be at 16 weeks
  • Perceived control over health
  • Perceived knowledge of how to maintain health
  • Perceived ability to manage health Participants will be asked to rate themselves on statements relating to the concept above on a 7-point Likert scale ranging from "Strongly disagree" to "Strongly agree".
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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Jitka Vseteckova

Mitarbeiter

Northampton General Hospital NHS Trust

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. März 2027

Studienabschluss (Geschätzt)

1. Oktober 2027

Studienanmeldedaten

Zuerst eingereicht

16. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. Juni 2026

Zuerst gepostet (Tatsächlich)

29. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • OpenU
  • IRAS ID 368667 (Andere Kennung: HRA and Health and Care Research Wales (HCRW))

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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