Take5Care+: A Self-management Educational Intervention
ConditionHematologic Neoplasms
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJitka Vseteckova
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older.
Have been diagnosed within the last 3 months with one of the eligible conditions listed in Table 1.
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Take5Care+
Other interventionNewly 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Take5Care+ treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
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
Time frame
Directly after participant completes the intervention (at 4 weeks)Secondary outcomes
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.
Time frame
Survey 1 will be at 0 weeks, survey 2 will be at 4 weeks and survey 3 will be at 16 weeks2
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.
Time frame
Survey 1 will be at 0 weeks, survey 2 will be at 4 weeks and survey 3 will be at 16 weeks3
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.
Time frame
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".
Time frame
Survey 1 will be at 0 weeks, survey 2 will be at 4 weeks and survey 3 will be at 16 weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jitka Vseteckova
Lead sponsor
Open University
Sponsor institution
Northampton General Hospital NHS Trust
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: