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

23 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

20

Phase

  • N'est pas applicable

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Feasibility of the intervention
Délai: 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
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Self-reported behaviours of healthy behaviour
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Jitka Vseteckova

Collaborateurs

Northampton General Hospital NHS Trust

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

1 mars 2027

Achèvement de l'étude (Estimé)

1 octobre 2027

Dates d'inscription aux études

Première soumission

16 juin 2026

Première soumission répondant aux critères de contrôle qualité

23 juin 2026

Première publication (Réel)

29 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

29 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • OpenU
  • IRAS ID 368667 (Autre identifiant: HRA and Health and Care Research Wales (HCRW))

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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