Take5Care+: A Self-management Educational Intervention (Take5Care+)
2026년 6월 23일 업데이트: Jitka Vseteckova
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:
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.
연구 개요
연구 유형
중재적
등록 (추정된)
20
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Feasibility of the intervention
기간: From beginning of study (0 weeks) until data collection is completed (up to 10 months)
|
|
From beginning of study (0 weeks) until data collection is completed (up to 10 months)
|
|
Qualitative exploration of feasibility of study
기간: Directly after participant completes the intervention (at 4 weeks)
|
|
Directly after participant completes the intervention (at 4 weeks)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Self-reported behaviours of healthy behaviour
기간: Survey 1 will be at 0 weeks, survey 2 will be at 4 weeks and survey 3 will be at 16 weeks
|
• 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
기간: 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 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
기간: Survey 2 will be at 4 weeks and Survey 3 at 16 weeks.
|
• 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
기간: Survey 1 will be at 0 weeks, survey 2 will be at 4 weeks and survey 3 will be at 16 weeks
|
|
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
기간: Directly after the intervention (at 4 weeks)
|
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)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 1일
기본 완료 (추정된)
2027년 3월 1일
연구 완료 (추정된)
2027년 10월 1일
연구 등록 날짜
최초 제출
2026년 6월 16일
QC 기준을 충족하는 최초 제출
2026년 6월 23일
처음 게시됨 (실제)
2026년 6월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 29일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 23일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .