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Trial registered on ANZCTR


Registration number
ACTRN12619001143112
Ethics application status
Approved
Date submitted
3/07/2019
Date registered
16/08/2019
Date last updated
16/08/2019
Date data sharing statement initially provided
16/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cancer-Related Fatigue: A combined Physical Activity and Mindfulness program
Scientific title
Cancer survivors experiencing Cancer-Related Fatigue: A feasibility study evaluating a combined Physical Activity and Mindfulness program
Secondary ID [1] 297804 0
None
Universal Trial Number (UTN)
Trial acronym
ZENERGISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer Related Fatigue 312168 0
Condition category
Condition code
Cancer 310715 310715 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 314046 0
Lifestyle
Intervention code [2] 314047 0
Behaviour
Intervention code [3] 314087 0
Treatment: Other
Comparator / control treatment

None for feasibility study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319563 0
Primary endpoint: Proportion of patients completing the combined intervention, with feasibility cut off at 6/10 patients.
Timepoint [1] 319563 0
Participants will be assessed at baseline (T1) and immediately after the intervention at 12 weeks (T2)
Secondary outcome [1] 368678 0
Fatigue severity as per Fatigue Symptom Inventory (FSI)
Timepoint [1] 368678 0
Participants will be assessed at baseline (T1) and immediately after the intervention at 12 weeks (T2)
Secondary outcome [2] 372958 0
Self-efficacy as per Perceived Self-efficacy for Fatigue Self-management (PSEFSM)
Timepoint [2] 372958 0
Participants will be assessed at baseline (T1) and immediately after the intervention at 12 weeks (T2)
Secondary outcome [3] 372959 0
Mindfulness measure using Mindful Attention Awareness Scale (MAAS)
Timepoint [3] 372959 0
Participants will be assessed at baseline (T1) and immediately after the intervention at 12 weeks (T2)
Secondary outcome [4] 372960 0
Measure of depression, anxiety and tension/stress using Depression Anxiety and Stress Scale-21 (DASS-21)
Timepoint [4] 372960 0
Participants will be assessed at baseline (T1) and immediately after the intervention at 12 weeks (T2)
Secondary outcome [5] 372961 0
Composite item assessing sleep duration and quality: using items from the one item from the Pittsburgh Sleep Quality Index (PSQI) and the 4-item Patient Reported Outcomes Measurement Information System (PROMIS) sleep disturbance scale.
Timepoint [5] 372961 0
Participants will be assessed at baseline (T1) and immediately after the intervention at 12 weeks (T2)
Secondary outcome [6] 372962 0
Exercise capacity using Six Minute Walk Test (6-MWT)
Timepoint [6] 372962 0
Participants will be assessed at baseline (T1) and immediately after the intervention at 12 weeks (T2)
Secondary outcome [7] 372963 0
Measure of exercise capacity and range using Godin-Shephard Leisure-Time Exercise Questionnaire (LTEQ) questionnaire
Timepoint [7] 372963 0
Participants will be assessed at baseline (T1) and immediately after the intervention at 12 weeks (T2)
Secondary outcome [8] 373649 0
Functional Assessment of Cancer Therapy-Fatigue (FACT-F) fatigue subscale
Timepoint [8] 373649 0
Participants will be assessed at baseline (T1) and immediately after the intervention at 12 weeks (T2)
Secondary outcome [9] 373650 0
Patient weight (kilograms) using digital stand-on scale. (Brand of scale: Tanita)
Timepoint [9] 373650 0
Participants will be assessed at baseline (T1) and immediately after the intervention at 12 weeks (T2)
Secondary outcome [10] 373651 0
Patient height (metres) using stadiometer
Timepoint [10] 373651 0
Participants will be assessed at baseline (T1) and immediately after the intervention at 12 weeks (T2)
Secondary outcome [11] 373652 0
Heart Rate Reserve (HRR or HRreserve): this is calculated by ([HR.sub.max]- [HR.sub.rest]), where [HR.sub.rest] is resting heart rate. Heart rate is measured using heart rate monitors and manual radial pulse techniques.
Timepoint [11] 373652 0
Participants will be assessed at baseline (T1) and immediately after the intervention at 12 weeks (T2)
Secondary outcome [12] 373653 0
Patient Body Mass Index (weight divided by square of height)
Timepoint [12] 373653 0
Participants will be assessed at baseline (T1) and immediately after the intervention at 12 weeks (T2)
Secondary outcome [13] 373655 0
Godin-Shephard Leisure-Time Exercise Questionnaire (LTEQ) questionnaire
Timepoint [13] 373655 0
Participants will be assessed at baseline (T1) and immediately after the intervention at 12 weeks (T2)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This is a pilot study testing feasibility of combined intervention to review outcomes and inform protocol accordingly.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Ten (10) patients would be required for the feasibility study, with targeted adherence rate to the combined intervention a priori set at 60%.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/04/2019
Date of last participant enrolment
Anticipated
30/01/2020
Actual
Date of last data collection
Anticipated
1/06/2020
Actual
Sample size
Target
10
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13483 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 26098 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 302330 0
Hospital
Name [1] 302330 0
Concord Repatriation General Hospital
Country [1] 302330 0
Australia
Primary sponsor type
Hospital
Name
Concord Cancer Centre Research Grant
Address
Concord Repatriation General Hospital. Hospital Road, Concord West, NSW 2139
Country
Australia
Secondary sponsor category [1] 302210 0
Charities/Societies/Foundations
Name [1] 302210 0
International Association for the Study of Lung Cancer (IASLC) Foundation
Address [1] 302210 0
13100 East Colfax Ave., Unit 10, Aurora, Colorado 80011, USA
Country [1] 302210 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303001 0
by Concord Repatriation General Hospital (CRGH) Human Research Ethics Committee (HREC)
Ethics committee address [1] 303001 0
Concord Repatriation General Hospital, Hospital Road, Concord West NSW 2139
Ethics committee country [1] 303001 0
Australia
Date submitted for ethics approval [1] 303001 0
26/11/2018
Approval date [1] 303001 0
11/02/2019
Ethics approval number [1] 303001 0
HREC/18/CRGH/296

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92134 0
Dr Ashanya Malalasekera
Address 92134 0
Concord Cancer Centre, Department of Medical Oncology, Concord Repatriation General Hospital, Hospital Road, Concord West, NSW 2139
Country 92134 0
Australia
Phone 92134 0
+612 9767 6354
Fax 92134 0
+612 9767 5764
Email 92134 0
Ashanya.Malalasekera@health.nsw.gov.au
Contact person for public queries
Name 92135 0
Ms Kim Kerin-Ayres
Address 92135 0
Concord Cancer Centre, Department of Medical Oncology, Concord Repatriation General Hospital, Hospital Road, Concord West, NSW 2139
Country 92135 0
Australia
Phone 92135 0
+612 9767 8031
Fax 92135 0
+612 9767 7934
Email 92135 0
Anne.Warby@sydney.edu.au
Contact person for scientific queries
Name 92136 0
Dr Ashanya Malalasekera
Address 92136 0
Concord Cancer Centre, Department of Medical Oncology, Concord Repatriation General Hospital, Hospital Road, Concord West, NSW 2139
Country 92136 0
Australia
Phone 92136 0
+612 9767 6354
Fax 92136 0
+612 9767 5764
Email 92136 0
Ashanya.Malalasekera@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1724Study protocol  Ashanya.Malalasekera@health.nsw.gov.au



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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