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

23 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

20

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Feasibility of the intervention
Tijdsspanne: 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
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Self-reported behaviours of healthy behaviour
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Jitka Vseteckova

Medewerkers

Northampton General Hospital NHS Trust

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 maart 2027

Studie voltooiing (Geschat)

1 oktober 2027

Studieregistratiedata

Eerst ingediend

16 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

23 juni 2026

Eerst geplaatst (Werkelijk)

29 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

23 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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