None listed
Conditions
Brief summary
The goal of this innovative trial is to test a multidisciplinary home based package of exercise, patient self-management and motivational strategies aimed at improving functional exercise capacity in people with inoperable non-small cell lung cancer (NSCLC). Who is it for? You may be eligible to join this study if you are aged 18 years or above, have a confirmed diagnosis of inoperable NSCLC, are scheduled to receive treatment other than surgery (radiotherapy, chemotherapy, targeted therapy), and do not regularly partake in exercise. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive the intervention package, which comprises 1) a home-based, eight week exercise program including resistance exercises and a walking program and 2) disease self-management education including symptom management and promotion of exercise adherence using behaviour modification strategies with phone follow up. Participants in this group will receive a 1 hour initial home visit from a physiotherapist together with weekly telephone follow-up calls from both the physiotherapist and nurse and up to 2 further physiotherapy home visits if needed. Participants in the second group will receive usual care, which includes 2 booklets: on lung cancer diagnosis and treatment and exercise for people living with cancer produced by Cancer Council Victoria. All participants will undergo assessments of functional exercise capacity, and complete a number of questionnaires at baseline, 9 weeks and 6 months in order to assess quality of life, survival and resource use. This research is clinically based, relevant and aimed at improving the quality of survival of people with NSCLC. The research is designed to be clinically feasible and cost-effective and has the capacity to be widely disseminated and adopted into practice guidelines in this large and vulnerable group.
Interventions
In addition to usual care, participants will receive a structured multidisciplinary intervention including a personalised aerobic and resistance exercise program, goal setting and follow up in one to one phone and home visit consultations and symptom self-care education as outlined below. The aim is to increase general physical function levels, adherence with exercises through behaviour change and symptom management support. The initial physiotherapy session will be performed in the participant’
In addition to usual care, participants will receive a structured multidisciplinary intervention including a personalised aerobic and resistance exercise program, goal setting and follow up in one to one phone and home visit consultations and symptom self-care education as outlined below. The aim is to increase general physical function levels, adherence with exercises through behaviour change and symptom management support. The initial physiotherapy session will be performed in the participant’s home, followed by weekly, scripted telephone contact to monitor exercise adherence and progress exercises and up to 2 additional home visits as required. Participants will also receive weekly nursing telephone intervention to monitor symptoms and provide self-care education. At the completion of the eight week home based program, a maintenance exercise program will be prescribed for each participant individually, with monthly physiotherapy telephone contact to monitor adherence and progress to the final 6 month time point. Physical intervention: Will include both aerobic and resistance exercise training. Exercise intensity for each participant will be guided using a modified Borg Scale for perceived exertion/breathlessness (scale 0-10) aiming for exercise to be performed in the range of 4-5 (somewhat strong exertion). This will permit prescription of the same relative intensity across participants and allow participants to guide and monitor their own exercise effort to minimise likelihood of the exercises being too strenuous. Partners/carers will be encouraged to motivate participants as well as participate in the exercises, diary entry and measurement sessions. Participants will be taught all exercises by trained physiotherapists at an initial one hour face-to-face session. The resistance exercise package will incorporate upper and lower limb exercises performed in the participant’s home using hand weights. Functional exercises, easy to perform at home, will also be included to assist in strength training (eg; step ups, sit to stand). Exercise dosage will be prescribed following an initial 10RM. With participants completing up to 80% of their 10RM and 2-3 sets of each exercise. Resistance exercises will be performed at least three days per week for 20 minutes and logged into activity diaries. Participants will be provided with a smartphone during the 8-week program and will receive one SMS reminder per day to act as a prompt to complete their exercise regime. They will also be able to use the smartphone to monitor their daily physical activity (steps taken and distance walked). Participants will be provided with a resistance exercise DVD and encourage to view this weekly to remind them of the accurate performance of each exercise. The aerobic component will consist of prescribed walking exercise. The aim of the walking program will be to progress to walking for a minimum of 150 minutes in total per week at a moderate intensity, as recommended by the guidelines for lung cancer. Walking may be undertaken in bouts of 10 minutes or in one block of 30mins or more. Defined, individualized outdoor physical activity will be prescribed to each subject by the physiotherapist and monitored using a combination of mapping and GPS software. Safety: Participants will be advised not to start exercising if they have a fever (>38 degrees Celsius), or have any new onset chest pain and will be provided with a contact number to ring if they or their partner/carer are concerned. They will be advised to stop exercising if they experience any new chest pains or are too breathless to be able to speak. Participants will be encourage to record details of daily aerobic and resistance exercises into an exercise diary. Symptom management and behaviour change support sessions: The model used for behaviour change support is the Health Change Australia Model of Behaviour Change. The aim is to build motivation and self-efficacy by identifying and addressing individual barriers to the recommended resistance training and cardiovascular exercise goals and thus initiate and sustain new physical activity behaviours. The physiotherapist will use the behaviour change model to establish the motivation level to participate and set individualised participant goals. Self-care requirements will be assessed at each 15 minute, scripted nursing telephone session where the nurse will use the validated Edmonton symptom assessment system to identify areas of individual unmet physical and emotional need. The aim of the initial nursing intervention session is to ensure symptoms that might interfere with exercise are addressed. Evidence based self-management information for specific symptoms will be provided to patients during these sessions. In addition, patients will be referred for further assessment and treatment by the medical team if more severe uncontrolled symptoms or side-effects are identified.
Sponsors
Professor Linda Denehy
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria: Eligible patients will have a histologically confirmed diagnosis of inoperable, NSCLC; be scheduled to receive treatment other than surgery (radiotherapy, chemotherapy, targeted therapy); be aged 18 years or older; be able to read and write English; have an Eastern Co-operative Oncology Group performance status of 0-2 and Clinical Frailty Scale score of less than 7 at study entry; have a physician rated estimated life expectancy of greater than or equal to 6 months; have primary attending oncologist approval; have been sedentary in the past month (i.e., patients not performing regular exercise on at least 5 days a week, for at least 30 minutes each session, at a moderate or vigorous intensity for the past month).
Exclusion criteria
Patients will be excluded if they have: pelvic or lower limb bony metastases, an unstable psychiatric or cognitive disorder; presence of a concurrent, actively treated other malignancy or history of other malignancy treated within the past one year (or three if treatment within the vicinity of the lung fields eg. radiotherapy for breast or oesophageal cancer), other than non-melanoma skin cancer or in-situ melanoma, or have any other comorbidities preventing participation in a land based exercise program.
Outcome results
None listed