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ID
Source
Brief title
Health condition
polycythaemia vera (PV), essential trombocytose (ET) en Primary myelofibrosis (PMF)
Sponsors and support
Intervention
Outcome measures
Primary outcome
fatigue (Multidemensional Fatigue Inventory), achieving personal goal(s) measured with a subscale of the EORTC QLQ-30
Secondary outcome
quality of life (EORTC QLQ-30), lifestyle behaviours (BRAVO quickscan)
Background summary
myeloproliferative illnesses are also called myeloproliferative neoplasmata (MPN). Patients often report fatigue and weight loss and suffer from splenomegaly. Because of its multi-dimensional approach, lifestyle coaching seems a applicable intervention to improve fatigue and quality of life in MPN patients. This intervention has nog been studied previously in these patients.
The aim of this study is to determine the effect of lifestyle coaching on fatigue and quality of life in MPN patients. In this study, part of the MPN patient treated in the Martini Hospital will receive this intervention.
The study will be a randomised trial with a waiting list control groep; half of the participants start immediately, and half of the participants start after six months.
The study population will comprise 46 MPN patients aged 18 years or older, who received the diagnosis MPN at least 12 months ago.
The interventions will be lifestyle coaching built on the model of positieve health, in which the patient sets his/her own goals with respect to six dimensions. This trajects consists of two phaese: An active phase of three months with active support and treatment of a lifestyle coach. The lifestyle coach will provide personalised support to facilitate patient's behavioural changes that lead to improved lifestyle. The patient will be guided to set his own 'SMART' goals and consecutive actions. Secondly there wille be a passive phase of 9 months, during which the patient can call the lifelstyle coach for help without a pre-set programme initiated by the coach. During the whole trajectory. the coach uses techniques of 'motivational intervieweing'.
Main study parameters/endpoints:
- Fatigue(MFI) measured after 3 and 12 months
- Achieving personal goals
Study objective
Lifestyle coaching will lead to reduced fatigue and improved quality of life
Study design
Both primary and secondary outcomes will be measured by validated questionnaires at 3 and 12 months follow-up. Follow up will be completed in all participants 2 years after starting the study, which will be in april 2022. In septermber 2022 data will be analysed and results presented.
Intervention
leefstile coaching
Inclusion criteria
Treated at the outpatient clinic in the Martini Hospital, diagnosed at least one year before informed consent.
Aged 18 years or above
Exclusion criteria
Insufficient capability to read or speak Dutch.
Psychological or cognitive problems that make it impossible to provide informed consent
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9242 |
| CCMO | NL75048.042.20 |