Take5Care+: A Self-management Educational Intervention

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Feasibility of the intervention [Time frame: From beginning of study (0 weeks) until data collection is completed (up to 10 months)]
• Qualitative exploration of feasibility of study [Time frame: Directly after participant completes the intervention (at 4 weeks)]

Secondary outcome measures (5)

• 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 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 adherence to Take5Care+ actions [Time frame: Survey 2 will be at 4 weeks and Survey 3 at 16 weeks.]
• 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]
• Explore perceptions of patients and clinicians [Time frame: Directly after the intervention (at 4 weeks)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07674212 · OpenU · IRAS ID 368667

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗