Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001006730
Ethics application status
Approved
Date submitted
19/05/2022
Date registered
18/07/2022
Date last updated
18/07/2022
Date data sharing statement initially provided
18/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The ZENERGISE trial: A trial comparing combined Physical Activity and Mindfulness versus Physical Activity alone, for cancer survivors experiencing Cancer-Related Fatigue
Scientific title
Cancer survivors experiencing Cancer-Related Fatigue: A Randomised Phase 2 study comparing combined Physical Activity and Mindfulness versus Physical Activity alone
Secondary ID [1] 307169 0
None
Universal Trial Number (UTN)
Trial acronym
ZENERGISE
Linked study record
The current study is a follow-up linked to registration record ACTRN12619001143112

Health condition
Health condition(s) or problem(s) studied:
Cancer-Related Fatigue 326376 0
Cancer 326377 0
Condition category
Condition code
Cancer 323671 323671 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). 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
Intervention code [1] 323619 0
Lifestyle
Intervention code [2] 323620 0
Behaviour
Intervention code [3] 323928 0
Treatment: Other
Comparator / control treatment

The same Physical Activity (PA) intervention program described above will be used for the combined intervention program and the ‘PA alone’ arm of the randomised Phase 2 trial.
Control group
Active

Outcomes
Primary outcome [1] 331417 0
Functional Assessment of Cancer Therapy-Fatigue (FACT-F) fatigue subscale, with a Minimal Clinically Important Difference of 3
Timepoint [1] 331417 0
Participants will be assessed at baseline (T1), immediately after the intervention at 12 weeks (T2 - primary timepoint) and 20 weeks (T3). An additional assessment is planned at 6 months post T2 to capture trajectory of expected Cancer Related Fatigue (CRF) levels (T4).
Secondary outcome [1] 409794 0
Fatigue Symptom Inventory (FSI)
Timepoint [1] 409794 0
Participants will be assessed at baseline (T1), immediately after the intervention at 12 weeks (T2) and 20 weeks (T3). An additional assessment is planned at 6 months post T2 to capture trajectory of expected CRF levels (T4).
Secondary outcome [2] 409795 0
Perceived Self-efficacy for Fatigue Self-management (PSEFSM)
Timepoint [2] 409795 0
Participants will be assessed at baseline (T1), immediately after the intervention at 12 weeks (T2) and 20 weeks (T3). An additional assessment is planned at 6 months post T2 to capture trajectory of expected CRF levels (T4).
Secondary outcome [3] 409796 0
Mindful Attention Awareness Scale (MAAS)
Timepoint [3] 409796 0
Participants will be assessed at baseline (T1), immediately after the intervention at 12 weeks (T2) and 20 weeks (T3). An additional assessment is planned at 6 months post T2 to capture trajectory of expected CRF levels (T4).
Secondary outcome [4] 409797 0
Depression Anxiety and Stress Scale (DASS)
Timepoint [4] 409797 0
Participants will be assessed at baseline (T1), immediately after the intervention at 12 weeks (T2) and 20 weeks (T3). An additional assessment is planned at 6 months post T2 to capture trajectory of expected CRF levels (T4).
Secondary outcome [5] 409798 0
Sleep duration: we will use one item from the Pittsburgh Sleep Quality Index (PSQI)63:

"During the past week, how many hours of actual sleep did you get at night? (This may be different than the number of hours you spent in bed.) "
Timepoint [5] 409798 0
Participants will be assessed at baseline (T1), immediately after the intervention at 12 weeks (T2) and 20 weeks (T3). An additional assessment is planned at 6 months post T2 to capture trajectory of expected CRF levels (T4).
Secondary outcome [6] 409799 0
Six Minute Walk Test (6-MWT): The 6-MWT is an exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of cardiopulmonary function, health-related quality of life, maximum exercise capacity, and mortality. The minimal clinically important difference (MCID) for the 6MWT is conservatively estimated to be 54–80 meters using both distributional and discriminative methods. For an individual patient, the 6MWT would need to change by about 86 meters to be statistically confident that there has been a change.
Timepoint [6] 409799 0
Participants will be assessed at baseline (T1), immediately after the intervention at 12 weeks (T2) and 20 weeks (T3). An additional assessment is planned at 6 months post T2 to capture trajectory of expected CRF levels (T4).
Secondary outcome [7] 409800 0
Leisure-Time Exercise Questionnaire (LTEQ)
Timepoint [7] 409800 0
Participants will be assessed at baseline (T1), immediately after the intervention at 12 weeks (T2) and 20 weeks (T3). An additional assessment is planned at 6 months post T2 to capture trajectory of expected CRF levels (T4).
Secondary outcome [8] 409801 0
Semi-structured patient questionnaire designed specifically for this study, assessing a composite of behaviour change, experience and quality of life.
Timepoint [8] 409801 0
Participants will be assessed at baseline (T1), immediately after the intervention at 12 weeks (T2) and 20 weeks (T3). An additional assessment is planned at 6 months post T2 to capture trajectory of expected CRF levels (T4).
Secondary outcome [9] 411485 0
Work Productivity and Activity Impairment (WPAI) using validated questionnaire
Timepoint [9] 411485 0
Participants will be assessed at baseline (T1), immediately after the intervention at 12 weeks (T2) and 20 weeks (T3). An additional assessment is planned at 6 months post T2 to capture trajectory of expected CRF levels (T4).
Secondary outcome [10] 411731 0
Sleep quality: We will use the 4-item Patient Reported Outcomes Measurement Information System (PROMIS) sleep disturbance scale.
Timepoint [10] 411731 0
Participants will be assessed at baseline (T1), immediately after the intervention at 12 weeks (T2) and 20 weeks (T3). An additional assessment is planned at 6 months post T2 to capture trajectory of expected CRF levels (T4).

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis of endpoints:

Descriptive statistics will be calculated and statistical tests (Chi-square for categorical variable and independent samples t-test / Mann-Whitney U test for continuous variable) will be performed on all patients in the feasibility study and to check for differences between the two arms at baseline in the Phase 2 trial. If a significant difference is found, the baseline score will be used as a covariate in further analyses. Analysis of co-variance will be performed to test whether the outcome variables differ between the combined intervention group and PA group, using the baseline level as covariate. Chi-square tests will be used to compare the number of clinically improved patients between the combined intervention group and PA group.

Multivariate analysis:

Intention-to-treat analyses using linear mixed model ANOVA will be performed to test change over time and significance of the difference between combined intervention and PA alone groups. Multiple imputation analysis will be used to handle missing data.
Pre-planned subgroup analyses will be performed according to the following clinical characteristics: cancer type, obesity, age, gender, time since completion of adjuvant treatment (with the exception of adjuvant hormone treatment) and adjuvant hormone treatment.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/07/2022
Actual
Date of last participant enrolment
Anticipated
20/07/2022
Actual
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
65
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22402 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 37567 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 311468 0
Charities/Societies/Foundations
Name [1] 311468 0
International Association for the Study of Lung Cancer (IASLC) Foundation
Country [1] 311468 0
United States of America
Funding source category [2] 311471 0
Hospital
Name [2] 311471 0
Concord Cancer Centre
Country [2] 311471 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Camperdown NSW 2000
Country
Australia
Secondary sponsor category [1] 312869 0
None
Name [1] 312869 0
Address [1] 312869 0
Country [1] 312869 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310937 0
Concord Repatriation General Hospital (CRGH) Human Research Ethics Committee (HREC)
Ethics committee address [1] 310937 0
Ethics committee country [1] 310937 0
Australia
Date submitted for ethics approval [1] 310937 0
11/12/2021
Approval date [1] 310937 0
09/05/2022
Ethics approval number [1] 310937 0
93995

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119418 0
Dr Ashanya Malalasekera
Address 119418 0
Concord Cancer Centre, Concord Repatriation General Hospital, Concrd West NSW 2139
Country 119418 0
Australia
Phone 119418 0
+61 2 97677487
Fax 119418 0
Email 119418 0
[email protected]
Contact person for public queries
Name 119419 0
Ashanya Malalasekera
Address 119419 0
Concord Cancer Centre, Concord Repatriation General Hospital, Concrd West NSW 2139
Country 119419 0
Australia
Phone 119419 0
+61 2 97677487
Fax 119419 0
Email 119419 0
[email protected]
Contact person for scientific queries
Name 119420 0
Ashanya Malalasekera
Address 119420 0
Concord Cancer Centre, Concord Repatriation General Hospital, Concrd West NSW 2139
Country 119420 0
Australia
Phone 119420 0
+61 2 97677487
Fax 119420 0
Email 119420 0
[email protected]

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16142Informed consent form    384090-(Uploaded-19-05-2022-12-06-48)-Study-related document.pdf
16519Clinical study report"ZENERGISE trial and COVID-19 tribulation: a snapshot of progress" - Clinical Oncology Society of Australia (COSA) ASM 2020: Trials in Progress e-poster presentation   384090-(Uploaded-02-07-2022-17-36-06)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.