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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hematologic Neoplasms
• Intervention / Treatment: Other: Take5Care+

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	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
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.	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	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	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)

Collaborators and Investigators

• Sponsor: Jitka Vseteckova
• Collaborators: Northampton General Hospital NHS Trust

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: feasibility study; hematologic neoplasms; pilot intervention
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: OpenU; IRAS ID 368667 (Other Identifier: HRA and Health and Care Research Wales (HCRW))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No