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Hematologic NeoplasmsTake5Care+NCT07674212

Take5Care+: A Self-management Educational Intervention

A study testing Take5Care+ in people with Hematologic Neoplasms, run by Jitka Vseteckova.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hematologic Neoplasms
What is being tested?
Take5Care+
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
Jul 2026to Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 17Show fewer
  • 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.

About this study

Official title: 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.

Read more

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.
Being tested
Take5Care+
Keywords
hematologic neoplasms, pilot intervention, feasibility study
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07674212
Study groupRoleWhat they receive
Take5Care+ treatmentExperimentalNewly 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.
Receives: Other: Take5Care+

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of the intervention

    • % 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.

    Measured: From beginning of study (0 weeks) until data collection is completed (up to 10 months)

  2. Qualitative exploration of feasibility of study

    • Optional semi-structured interviews with participants, analysed using thematic analysis
    • Qualitative interviews with healthcare professionals, analysed using thematic analysis

    Measured: Directly after participant completes the intervention (at 4 weeks)

Secondary outcomes (5)

  1. Self-reported behaviours of healthy behaviour

    • 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.

    Measured: Survey 1 will be at 0 weeks, survey 2 will be at 4 weeks and survey 3 will be at 16 weeks

  2. Self-reported health

    • 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.

    Measured: Survey 1 will be at 0 weeks, survey 2 will be at 4 weeks and survey 3 will be at 16 weeks

  3. Self-reported adherence to Take5Care+ actions

    • 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.

    Measured: Survey 2 will be at 4 weeks and Survey 3 at 16 weeks.

  4. Subjective perception of health

    • 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".

    Measured: Survey 1 will be at 0 weeks, survey 2 will be at 4 weeks and survey 3 will be at 16 weeks

  5. Explore perceptions of patients and clinicians

    Thematic analysis of perceptions of participation, barriers and facilitators via semi-structured interviews with patients (optional) and clinicians

    Measured: Directly after the intervention (at 4 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionMar 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07674212
Sponsor's protocol ID
OpenU
Other IDs
IRAS ID 368667
Acronym
Take5Care+
Status last verified
Jun 2026
First submitted
16 Jun 2026
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Take5Care+ in people with Hematologic Neoplasms, run by Jitka Vseteckova.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the intervention (time frame: From beginning of study (0 weeks) until data collection is completed (up to 10 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07674212.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

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