None listed
Conditions
Brief summary
The purpose of this study is to determine whether integrative approaches of exercise and psychosocial interventions may best address the needs of cancer survivors experiencing Cancer-Related Fatigue. Who is it for? You may be eligible for this study if you are aged 18 or over, have a fatigue score of greater than or equal to 4/10 and have completed definitive primary adjuvant cancer treatment (surgery and chemotherapy, targeted therapy and/or radiotherapy) for early stage cancer, within the previous 6–60 months, with no evidence of recurrence. Participants will be randomised to either a 12-week combined program of Physical Activity (PA) and standard Mindfulness Based Stress Reduction (MBSR), or PA alone. All sessions are delivered via Zoom by an Accredited Exercise Physiologist and Clinical Psychologist. The exercise will involve aerobic exercise (walking, cycling in the gym) or resistance training (weights). The mindfulness will involve group discussion, mindfulness practice, meditation and gentle yoga. Sessions will be in a group format. The mindfulness session is scheduled to occur after one of the Exercise sessions, for a total combined session of 3 hours. All sessions will be a group activity. You will be given resources to use at home, to help you practice. These resources may include: - handouts / audiorecording guides relating to mindfulness technique and practice (which you may keep) - wearable technology, such as a fitbit (which would be on loan from Concord Cancer Centre) - activity log for you to record your home practice Before and after the trial, participants will answer questionnaires about their quality of life, fatigue, fear of recurrence, sleep duration/quality, depression, physical fitness and patient experience. It is hoped this study will help improve Cancer related fatigue in cancer survivors, including their quality of life.
Interventions
The intervention will be combined Mindfulness Based Stress Reduction (MBSR) and Physical Activity (PA). For both interventions, participants will be prescribed home-based activity.
The intervention will be fully delivered online.
The PA intervention will comprise group aerobic and resistance graded exercise sessions supervised by an Accredited Exercise Physiologist (AEP): 1 x 1-hour session per week for 12 weeks, with extra phone support for the first 6 weeks. Group sizes are between 5-8 parti
The intervention will be combined Mindfulness Based Stress Reduction (MBSR) and Physical Activity (PA). For both interventions, participants will be prescribed home-based activity. The intervention will be fully delivered online. The PA intervention will comprise group aerobic and resistance graded exercise sessions supervised by an Accredited Exercise Physiologist (AEP): 1 x 1-hour session per week for 12 weeks, with extra phone support for the first 6 weeks. Group sizes are between 5-8 participants per group. To enhance self efficacy, in the first 2 weeks of the program, the training intensity and volume is low to ensure participants are able to complete the training and thus perceive a mastery experience. The intervention will be delivered in a group format to enable peer support. Encouragement and feedback will be provided throughout each supervised session to improve self confidence and facilitate active self management by setting personal training goals and monitoring training progress using exercise logs. Activity pacing strategies will aim to encourage participants to avoid exacerbations of fatigue by planning their daily and weekly schedules of activity. Details of PA prescription: - Aerobic exercise: Increasing duration and intensity. Weeks 1-4: 65% HRmax; 45% VO2 max; RPE 12; Weeks 5-8: 65%-85% HRmax; RPE 15, Weeks 8-12: 65%-85% HRmax; RPE 15. Exercises may consist of step, walking, marching etc. - Resistance exercise: Increasing RPE 9-15. Examples of exercise: Major muscle groups of the upper and lower body. Exercises may consist of body weight, dumbbells, resistance bands, cables machines. Specific exercises selected due to musculoskeletal limitations identified by the AEP and patient-specific ability. - Phone support: individualised support will be scheduled between the AEP and participant once weekly, preferably within 48-72 hours after the supervised exercise session. Duration of contact will be approximately 15-30 minutes per participant and via telehealth/email/other (according to resources and participant preference). The principle is to encourage behavioural change and provide support; no exercise prescription will be given during this interaction. Content will be semi-structured and cover program goals, feedback, health behaviours, reinforce success and identify benefits. The psychosocial intervention will be standardised MBSR, delivered in live group sessions, conducted by a Clinical Psychologist, starting on Week 1 and conducted, if possible, on the same day as PA. Group sizes are between 5-8 participants per group. The MBSR program will comprise 1 x 2-hour session per week, for a total of 8 weeks, with an intense retreat scheduled towards the end of the program. Live sessions will be facilitated with slide sets with links to short videos, interactive activities and opportunity for group/individual debrief. Home-based practice supplements will include weekly formal, informal everyday handouts / practice logs and audiorecordings. These will be adapted at the therapist’s discretion, based on the curriculum by Kabat-Zinn and other certified sources. They will be available in paper and electronic formats, to provide patients with options. The course outline is as follows: Week 1 Introduction to MBSR Week 2 Stress and Automatic Pilot Week 3 Mind, Breath, Body Week 4 Responding rather than Reacting Week 5 Stepping Back from Thoughts and Feelings Week 6 Bringing Awareness to Times of Difficulty Week 7 Mindfulness in Relationships Week 8 Keeping Up your Mindfulness Practice Intense Retreat: 5-6 hour one-off, live group session conducted by 2 x Clinical Psychologists towards the end of the program to consolidate learnings. Teachings will be facilitated by slide sets and will comprise of a mix of: Stretch/Mindful Walking, sitting meditation, mindful daily activities, chair yoga and group/individual debriefs. Informal practice will be no more than 10 minutes per week and optional (completed at the participant's own discretion). Formal practice will be between 30-60mins per week
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males or females with screening CRF score >/= 4/10 i.e., moderate or severe fatigue 2. Age >/= 18 years 3. Completed definitive primary adjuvant cancer treatment (surgery and/or chemotherapy, targeted therapy, radiation therapy) for early stage solid organ malignancy, within the previous 6–60 months, with no evidence of recurrence. Patients stable on endocrine therapy for >/= 2 months are eligible. 4. No evidence of recurrent measurable disease according to RECIST 1.1. 5. Adequate bone marrow (Hb > 80g/L), liver, renal, cardiac and thyroid function, as per clinical discretion. 6. Study treatment both planned and able to start within 14 days of randomisation (for the Phase 2 study). 7. Willing and able to comply with all study requirements, including treatment (e.g. willing to engage in physical activity), timing and/or nature of required assessments 13. Signed, written informed consent
Exclusion criteria
1. Severe and/or uncontrolled specific comorbidities (e.g. severe insomnia, anaemia, thyroid dysfunction, cardiovascular disease, asthma) as per clinical discretion 2. Severe and/or uncontrolled cognitive impairment, intellectual impairment, substance abuse and / or mental illness as per clinical discretion (including major depression, severe anxiety, Post Traumatic Stress Disorder) impacting capacity 3. Primary spoken language is language other than English, limiting ability to engage in group sessions 4. Life expectancy of less than 12 months 5. History of another malignancy within 5 years prior to registration; patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder at any time are eligible. 6. Concurrent illness or condition, including severe infection, that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
Outcome results
None listed