None listed
Conditions
Brief summary
There is a lack of expert health services for transplant survivors outside the capitals. Various approaches can be utilised to overcome some of these issues. The current solutions include regular dispatch of healthcare professionals to rural centres and ad hoc phone enquiries/consultations. There are a number of difficulties with this, so a pilot study was conducted to see the effectiveness of a health service delivered by qualified staff to improve the patient’s physical and mental wellbeing through web-based technology. The pilot study showed some positive results, and thus we are now proposing this randomised control trial, to be able to compare the difference between standard care and this intervention over time. The use of a standard care control group as a comparison is particularly important, as post-transplant patients will gradually improve over time. The hypothesis is that delivery of home based health services i.e. supervised exercise and stress management with reinforcement strategy via multi-media technology will improve QOL and functional outcomes of patients following HSCT compared to standard care.
Interventions
All patients will participate in a half-day (2.5-3 hours) face-to-face orientation session, including familiarisation with their program materials, procedures, and requirements. Intervention subjects will have the same half-day orientation with the addition of education into the training program and its associated materials. This session will also involve patients completing a number of written and physical assessments to obtain a baseline assessment. These include: *Anthropometric measures (BMI & waist circumference), 6-Minute Walk test, 1km Walk Test, Grip Strength Measurement, Sit-to- stand Test (STS), International Physical Activity Questionnaire (IPAQ). *HADS, DASS-21, Pittsburgh Sleep Quality Index, Godin-Shephard Leisure Time index, Functional Assessment of Cancer Therapy (FACT)-BMT, Functional Assessment of Cancer Therapy- Fatigue (FACT-F), Karnofsky Performance Scale, Health Resource Utilization form, EQ-5D-5L. Intervention arm: For patients randomised to the intervention group, they will be given an orientation session, internet-based training and have reinforcement sessions. The orientation session will involve an introduction to mindfulness-based stress reduction (MBSR) and exercise techniques. Baseline physical and psychological measures will be conducted during this session. Trial materials including a CD or USB with voice-recordings of guided mindfulness tracks for MBSR skill practice, and resistance bands for exercise practice, will be provided. A training and information booklet that includes information on skills, exercises, assessments and goals, practice logs, and appointment schedules will be supplied. Internet-based Training: Each patient will undergo 6 weekly one-to-one sessions with each of the exercise and stress management trainers via the internet (through Skype), for approximately 1hr. Training sessions will be conducted with appropriately trained staff members, such as a psychologist, and an exercise physiologist. During the stress management sessions, common manifestations of anxiety and current cognitive and behavioural coping methods, and the use of stress management techniques to improve well-being will be discussed. Following MBSR methods, participants will be trained in grounding and mindfulness strategies, and a guided mindfulness practice may be included in each session. Training will be individualised to the patient, depending on their skill level and needs. The exercise training will be comprised of moderate to high intensity aerobic and resistance exercises and stretching. The target during cardio-vascular exercise is to reach 50-75% of predicted heart rate reserve, and resistance/strength training with the target of 65–80% of one-repetition maximum (1-RM) as defined by the Rating of Perceived Exertion (RPE) scale (aiming to train at moderate-to-high intensities: between ratings of 11 and 15 on the RPE). Training will be adapted to the participant’s initial fitness level, and gradually increase in intensity and duration. For both exercise and stress management skill practice, patients will complete training logs in order to keep track of their progress, and will be provided with recommendations for regular practice, during and at the end of the supervised training period. Reinforcement Phase for Intervention arm: Commencing at 3 months post the internet based training period, patients will have a monthly Skype appointment with a trainer/s for three months. This aims to strengthen behavioural change in the long-term using methods found to facilitate long-term behavioural change by identifying values-based goals and attempting to resolve ambivalence and using motivational interviewing techniques. These techniques have been found to have sustained efficacy in promoting health behaviours in a cost effective manner. Patients will be reminded of their initial goals (GAS/ SMART goals), discussing adherence using a training diary, structured problem solving and value-based goal setting, to increase their abilities to meet their training goals. Setting SMART goals and a goal attainment scale (GAS) will also function as an objective end point measurement. Sustainability of outcomes will be assessed at 12 and 18 months after the supervised training period.
Sponsors
Study design
Eligibility
Inclusion criteria
Had an Allogeneic or Autologous Haematological Stem Cell Transplant - Male or Female - Age range: 18 to 75 - Patient is at least 6 months post-transplant. - Willingness to give written informed consent and willingness to participate in, and comply with the study. - Possesses and is able to use a computer or a tablet with Internet connection
Exclusion criteria
Patient has severe Graft Versus Host Disease or other medical issues that require regular clinic visits - Patient has physical or mental impediments which renders them unable to carry out the programs or assessment tasks, - Patient has cardiac disease including arrhythmia - Patient is deemed unfit for this study by the patient’s haematologist. - Participants who fall in the severe or extremely severe range on psychological screening measures of anxiety and depression - Participants with a history of a psychological illness or other condition which may interfere with their ability or limit their capacity to understand the requirements of the study.