Take5Care+: A Self-management Educational Intervention

NCT07674212 | Not Yet Recruiting

• 2 other identifiers: OpenUIRAS ID 368667
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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 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. 1.To assess the feasibility of using Take5Care+ with patients newly diagnosed with indolent or chronic haematological malignancies, recruited via hospital departments
2. 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. 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.

Conditions

Hematologic Neoplasms

Keywords

hematologic neoplasms; pilot intervention; feasibility study

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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

  Directly after participant completes the intervention (at 4 weeks)

Secondary Outcomes (5)

• Self-reported behaviours of healthy behaviour

  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

  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

  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

  Directly after the intervention (at 4 weeks)

Study Arms (1)

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.

Other: Take5Care+

Interventions

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.

Take5Care+ treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jitka Vseteckova: lead
• Northampton General Hospital NHS Trust: collaborator

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 29, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 29, 2026

Record last verified: 2026-06