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 Cancer related fatigue score of greater than or equal to 4/10 and have completed definitive primary adjuvant cancer treatment (surgery, chemotherapy, targeted therapy and/or radiotherapy), within the previous 6–60 months, with no evidence of recurrence. Study details Participants in this study will undergo a 12-week combined program of Physical Activity (PA) and standard Mindfulness Based Stress Reduction (MBSR ) or to the control group with Physical activity only. This will involve coming to the Sydney Survivorship Centre, for two to three sessions a week, regularly for 12 weeks. For the first 6 weeks, the Exercise sessions will be held at 3 different times a week. The mindfulness session is scheduled to occur after one of the Exercise sessions. You may choose which two Exercise sessions are most convenient for you to attend. The exercise will involve aerobic exercise (walking, cycling in the gym) or resistance training (weights). Sessions will be in a small group format and guided face to face by our Exercise Physiologist. You may share the gym with other patients who are not participating in this study. The mindfulness will involve group discussion, mindfulness practice, meditation and gentle yoga. Sessions will be in a group format and will be guided face to face by our Clinical Psychologist. All sessions will be a group activity. You will be given resources to take home, to help you practice. These resources may include: - handouts / 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 All 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)
Standardised Mindfulness Based Stress Reduction (MBSR) intervention program will be used. Implementation of supplementary material will be adapted at the therapist’s discretion, based on certified curriculum and resources.
The MBSR intervention
This intervention will:
1. Be delivered in group face-to-face format by a qualified Clinical Psychologist at the Survivorship Gym, Concord Hospital
The intervention will be combined Mindfulness Based Stress Reduction (MBSR) and Physical Activity (PA) Standardised Mindfulness Based Stress Reduction (MBSR) intervention program will be used. Implementation of supplementary material will be adapted at the therapist’s discretion, based on certified curriculum and resources. The MBSR intervention This intervention will: 1. Be delivered in group face-to-face format by a qualified Clinical Psychologist at the Survivorship Gym, Concord Hospital 2. Start on Week 1 with Physical Activity (PA) and conducted on the same day 3. Comprise 1 x 2-hour sessions per week, for a total of 8 weeks, with an intense retreat in Week 12. 4. Be supplemented by weekly handouts specifically designed for this study and therapist audiotaped recordings for home-based practice. The Physical Activity (PA) intervention All exercise sessions will take place at the Survivorship Gym, Concord Hospital in small groups with a minimum of 1 and maximum of 6 participants, depending on participants’ availability. All sessions will be under the supervision of an accredited exercise physiologist (AEP) experienced in delivering interventions to people with cancer. Participants will receive 2 x 60-minute, group-based exercise sessions for week’s 1-6 and 1 x group-based exercise session for weeks 7-12. A combination of aerobic and resistance exercise will be prescribed. Aerobic exercise will be of light to moderate intensity and will be progressed every 2-4 weeks according to heart rate and/or RPE. Resistance exercises will be progressed every 2 weeks according to RPE. Unsupervised exercise Modality of home exercise will be self selected based on participant preference however, walking is typically the preferred modality of aerobic activity for cancer survivors. From week 3 onwards, participants will be encouraged to increase their exercise duration by up to 20% every 2-3 weeks. Participants may be provided with wearable tech such as fitbits and log book to monitor home exercise. An attendance list will be kept to monitor attendance at all sessions. Patients will be given resources, such as handouts and logs, to take home to guide practice. Patients asked to complete logs of home-based exercise and mindfulness practice, using a personal activity diary. To ensure compliance, records will be monitored and photocopied as source documents by the therapists and/or research assistant. We may also provide wearable technology, such as fitbits on loan from Sydney Survivorship Centre, to provide objective records of biometrics and aid compliance.
Sponsors
Concord Cancer Centre Research Grant
Study design
Allocation
Non-randomised trial
Intervention model
Single group
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 greater than or equal to 4/10 i.e., moderate or severe fatigue 2. Age greater than or equal to 18 yrs 3. Completed definitive primary adjuvant cancer treatment (surgery, chemotherapy, targeted therapy and/or radiotherapy), within the previous 6–60 months, with no evidence of recurrence. Patients stable on endocrine therapy for greater than or equal to 2 months are eligible. 4. No evidence of recurrent measurable disease according to RECIST 1.1. 5. Adequate bone marrow function (Hb greater than 80g/L, platelets greater than 100 x 109/L, ANC greater than 1.5 x 109/L, etc) 6. Adequate liver function (e.g. ALT/AST less than 1.5 x ULN, etc) 7. Adequate renal function (e.g. creatinine clearance greater than 50 ml/min) 8. Adequate cardiac function 9. Adequate thyroid function (TSH 0.4 – 4.0 mU/L) 10. Study treatment both planned and able to start within 14 days of randomisation. 11. Willing and able to comply with all study requirements, including treatment (e.g. willing to engage in physicial activity), timing and/or nature of required assessments 12. Signed, written informed consent
Exclusion criteria
1. Severe specific comorbidities (e.g. severe insomnia, anaemia, thyroid dysfunction, cardiovascular disease, asthma) 2. Severe cognitive impairment as per clinical discretion, intellectual impairment and / or mental illness (major depression and/or severe anxiety, including Post Traumatic Stress Disorder) therefore impacting capacity 3. Non-English Speaking background 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