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NCT Number: NCT07674212

Take5Care+: A Self-management Educational Intervention

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.

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Key information

Conditions

Hematologic Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Take5Care+

Other

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.

Primary outcomes

  1. Feasibility of the intervention

    Time frame: 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.

  2. Qualitative exploration of feasibility of study

    Time frame: 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

Secondary outcomes

  1. Self-reported behaviours of healthy behaviour

    Time frame: 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.

  2. Self-reported health

    Time frame: 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.

  3. Self-reported adherence to Take5Care+ actions

    Time frame: 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.

  4. Subjective perception of health

    Time frame: 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".

  5. Explore perceptions of patients and clinicians

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Jitka Vseteckova

Other

Collaborators

  • Northampton General Hospital NHS Trust

Registry information

Official study title

Take5Care+: A Self-management Educational Intervention to Support the Haematology Patients' Journey Following a Neoplastic Diagnosis.

Acronym: Take5Care+

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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