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| ID | Type | Description | Link |
|---|---|---|---|
| IRAS ID 368667 | Other Identifier | HRA and Health and Care Research Wales (HCRW) |
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| Name | Class |
|---|---|
| Northampton General Hospital NHS Trust | OTHER |
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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:
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:
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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Take5Care+ treatment | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the intervention |
| From beginning of study (0 weeks) until data collection is completed (up to 10 months) |
| Qualitative exploration of feasibility of study |
| Directly after participant completes the intervention (at 4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Survey 1 will be at 0 weeks, survey 2 will be at 4 weeks and survey 3 will be at 16 weeks |
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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:
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:
Concurrent active malignancy requiring systemic therapy.
Any other condition that, in the investigator's judgement, would compromise safe participation.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 8, 2026 | Jun 16, 2026 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 7, 2026 | Jun 16, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Self-reported health | • Self-reported health as measured by SF-12, transformed into two scores:
| 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 | • 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 |
| 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 | 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) |