A randomised trial of Telehealth intervention for patient’s post-Hematopoietic Stem Cell Transplant (post-HSCT)

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2015
INTERVENTION: 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. CONDITION: Blood Cancer ; This will be assessed through the 6minute walk test, Sit to stand test and grip strength test. ; 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 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. PRIMARY OUTCOME: To determine if an Internet‐based supervised physical and psychological exercise programme with post‐training reinforcement will improve physical fitness at 3 months post‐intervention compared to standard care post‐HSCT. SECONDARY OUTCOME: To ascertain the impact of the training programme on the protein and gene expression levels of response biomarkers such as neuroendocrine hormones, inflammatory cytokines To evaluate the composite effect of the program on functional and psychological wellbeing at 6 and 12 months post‐intervention ; This will be assessed through the questionnaires 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 To evaluate the composite effect of the programme on measures of quality of life (QOL), at 6 and 12 months post‐intervention. ; This will be assessed through the questionnaires 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 ; To evaluate the composite health outcomes of the program of allogeneic compared to autologous HSCT recipients, assessed through the questionnaires 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. Also through the physical measures of the 6minute walk test, Sit to stand test, grip strength test and anthropometric measures (BMI & waist circumference).
Epistemonikos ID: 0deef6b84ecd6588422cf713871746449c1a02a4
First added on: Aug 23, 2024