Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001329459
Ethics application status
Approved
Date submitted
20/09/2016
Date registered
23/09/2016
Date last updated
1/12/2020
Date data sharing statement initially provided
25/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
EXERCISE THERAPY: Counteracting mental health issues in men with prostate cancer through exercise
Scientific title
EXERCISE THERAPY: Counteracting mental health issues in men with prostate cancer through exercise
Secondary ID [1] 289639 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 299431 0
Mental Health 299432 0
Condition category
Condition code
Cancer 299412 299412 0 0
Prostate
Mental Health 300222 300222 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The physical exercise intervention will involve a 3-month, group-based, supervised exercise program delivered in community fitness centres/gyms in Victoria. Prior to commencing the program, each participant will receive a consultation with an exercise physiologists (EP) in order to individualise the exercise prescription to their specific needs according to their prostate cancer and general health history, physical abilities and personal preferences. A combination of aerobic (e.g. walking, jogging, cycling) and resistance (i.e. lifting weights) exercise will be undertaken 3 times per week. Specifically, the aerobic exercise component will include 20 to 30 minutes of moderate to vigorous intensity cardiovascular exercise (~60-85% of estimated maximum heart rate) using a variety of modes such as walking or jogging on a treadmill, cycling or rowing on a stationary ergometer. Participants will be encouraged to undertake additional home-based aerobic exercise with the goal of achieving a total of at least 150 minutes of moderate to vigorous intensity aerobic exercise each week. The resistance exercise component will involve 6-8 exercises that target the major upper and lower body muscle groups. Intensity will be manipulated from 6-12 repetition maximum (RM; i.e. the maximal weight that can be lifted 6 to 12 times which is equivalent to ~60-85% of 1RM) using 1-4 sets per exercise. Exercise prescription will be progressive and modified according to individual response. Exercise sessions will take approximately 60 minutes and will be supervised by an experienced EP. Compliance and attendance (including the reason for any missed sessions) will be tracked throughout the program by the EP.
Intervention code [1] 295253 0
Lifestyle
Comparator / control treatment
The control group will maintain usual care for a 3-month period and will then be offered participation in the supervised exercise program at the completion of the 3-month period. Usual care involves standard medical care. Thus patients may be referred to a mental health care service (helpline, support group, psychologist/psychiatrist, medication).
Control group
Active

Outcomes
Primary outcome [1] 298879 0
Psychological Distress as determined by the Brief Symptom Inventory-18 (cancer-specific)
Timepoint [1] 298879 0
Baseline (0 months), post-intervention (3 months) and 3-month follow-up (6 months)
Primary outcome [2] 299694 0
Psychological Distress as determined by the Hospital Anxiety and Depression Scale (generic)
Timepoint [2] 299694 0
Baseline (0 months), post-intervention (3 months) and 3-month follow-up (6 months)
Primary outcome [3] 299695 0
Psychological Distress as determined by the Male Depression Risk Scale (gender specific)
Timepoint [3] 299695 0
Baseline (0 months), post-intervention (3 months) and 3-month follow-up (6 months)
Secondary outcome [1] 325517 0
Psychological Supportive Care Needs as determined by the Supportive Care Needs Survey
Timepoint [1] 325517 0
Baseline (0 months), post-intervention (3 months) and 3-month follow-up (6 months)
Secondary outcome [2] 325518 0
Quality of Life as determined by the Medical Outcomes Short Form 36 (SF-36)
Timepoint [2] 325518 0
Baseline (0 months), post-intervention (3 months) and 3-month follow-up (6 months)
Secondary outcome [3] 325519 0
Fatigue as determined by the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire (FACIT-F)
Timepoint [3] 325519 0
Baseline (0 months), post-intervention (3 months) and 3-month follow-up (6 months)
Secondary outcome [4] 325520 0
Sleep Quality as determined by the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [4] 325520 0
Baseline (0 months), post-intervention (3 months) and 3-month follow-up (6 months)
Secondary outcome [5] 325521 0
Physical Fitness as determined by the 6 minute walk test (aerobic capacity) and leg press one repetition maximum test (muscular strength)
Timepoint [5] 325521 0
Baseline (0 months), post-intervention (3 months) and 3-month follow-up (6 months)
Secondary outcome [6] 325522 0
Physical Activity Levels as determined by a tri-axial accelerometer activity monitor (ActiGraph GT3X+) and the Godin Leisure-Time Exercise Questionnaire (self-reported)
Timepoint [6] 325522 0
Baseline (0 months), post-intervention (3 months) and 3-month follow-up (6 months)
Secondary outcome [7] 325523 0
Body Composition (regional and whole body lean mass and fat mass) as determined by dual-energy X-ray absorptiometry scans
Timepoint [7] 325523 0
Baseline (0 months), post-intervention (3 months) and 3-month follow-up (6 months)
Secondary outcome [8] 325524 0
Masculine Self-Esteem as determined by the Masculine in Chronic Disease Inventory (MCD-I)
Timepoint [8] 325524 0
Baseline (0 months), post-intervention (3 months) and 3-month follow-up (6 months)
Secondary outcome [9] 325525 0
Cost-effectiveness using the ACE-Prevention methodology and involving the Client Service Receipt Inventory (CSRI) and Quality adjusted life years (QALY)
Timepoint [9] 325525 0
Baseline (0 months), post-intervention (3 months) and 3-month follow-up (6 months)
Secondary outcome [10] 325526 0
Attitudes Towards the use of Exercise for Managing Distress determined by semi-structured interviews
Timepoint [10] 325526 0
Baseline (0 months) and post-intervention (3 months)
Secondary outcome [11] 325528 0
Safety as determined by the incidence and severity of adverse events (e.g. muscle pulls or strains, falls, abnormal blood pressure, fainting, light-headedness, muscle cramps or strain, nausea, and in very rare cases heart rhythm disturbances or heart attack (risk is 1 in 49,565 patient training hours in cardiac rehabilitation)). The incidence and severity of any adverse events will be monitored and reported throughout the study by the supervising exercise physiologist. Additionally, participants will self-report incidence and severity of any adverse events using a weekly log and custom questionnaire administered after the intervention and follow-up periods.
Timepoint [11] 325528 0
From baseline until completion of follow-up (6 months).
Secondary outcome [12] 327869 0
Psychological Distress as determined by the Distress Thermometer (further primary outcome)
Timepoint [12] 327869 0
Baseline (0 months), post-intervention (3 months) and 3-month follow-up (6 months)
Secondary outcome [13] 327870 0
Psychological Distress as determined by the Kessler Psychological Distress Scale (further primary outcome)
Timepoint [13] 327870 0
Baseline (0 months), post-intervention (3 months) and 3-month follow-up (6 months)

Eligibility
Key inclusion criteria
1) psychological distress as defined by a distress thermometer score of =>4
2) physician consent
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1) acute illness or any musculoskeletal, cardiovascular or neurological disorder that could inhibit exercise or put participants at risk from exercising
2) unable to read and speak English

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)
Central randomisation by computer. Written informed consent will be required prior to any testing or randomisation. Participants who dropout prior to completing baseline testing will not be randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by a randomisation table created by a computer sequence. Randomisation is at the level of the individual patient and will be stratified by 1) psychological distress level (<moderate=) as assessed by the Kessler Psychological Distress Scale; 2) current use of antidepressant and/or anti-anxiety medication (yes/no); 3) currently accessing psychological services (yes/no); 4) prostate cancer stage (localised and locally advanced/metastatic); and 5) currently receiving prostate cancer treatment (yes/no).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/09/2017
Actual
19/10/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
53
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8891 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 8892 0
Goulburn Valley Health - Shepparton campus - Shepparton
Recruitment hospital [3] 8893 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [4] 8894 0
Peter MacCallum Cancer Centre - Melbourne

Funding & Sponsors
Funding source category [1] 294020 0
University
Name [1] 294020 0
Australian Catholic University
Country [1] 294020 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
ACU Mary MacKillop Institute for Health Research
Level 5, 215 Spring Street
Melbourne, VIC 3000
Country
Australia
Secondary sponsor category [1] 292840 0
Individual
Name [1] 292840 0
A/Prof Prue Cormie
Address [1] 292840 0
ACU Mary MacKillop Institute for Health Research
Level 5, 215 Spring Street
Melbourne, VIC 3000
Country [1] 292840 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295432 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 295432 0
Australian Catholic University
40 Edward Street
North Sydney
NSW 2060
Ethics committee country [1] 295432 0
Australia
Date submitted for ethics approval [1] 295432 0
21/09/2016
Approval date [1] 295432 0
07/12/2016
Ethics approval number [1] 295432 0
2016-229H
Ethics committee name [2] 298482 0
St Vincent's Hospital Melbourne HREC
Ethics committee address [2] 298482 0
41 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [2] 298482 0
Australia
Date submitted for ethics approval [2] 298482 0
08/02/2017
Approval date [2] 298482 0
25/05/2017
Ethics approval number [2] 298482 0
HREC/17/SVHM/31

Summary
Brief summary
The objective of this study is to explore the efficacy of a targeted exercise intervention as a mental health care service for prostate cancer patients. In particular the aim is to a)examine whether a tailored exercise intervention can help manage psychological distress in men with prostate cancer and b) evaluate the cost-effectiveness of the program to promote mental health in men with prostate cancer. Who is it for? You may be eligible to join if you are a male aged 18 years and over and experiencing psychological distress after a prostate cancer diagnosis. Trial details: Participants in this study will be randomly (by chance) divided into two groups. Participants in one group (i.e. Exercise intervention group) will attend a 3 month physical exercise intervention program that involves resistance (i.e. lifting weights) and aerobic exercise (e.g. walking, jogging, cycling) undertaken 3 times per week at various community based fitness centres/gyms throughout Melbourne . Exercise sessions will take approximately 60 minutes and will be conducted in small groups under the supervision of an accredited exercise physiologist. Participants in the second group (i.e. Usual care) will maintain usual care for 6 months and will then be offered the exercise intervention. All participants will be required to complete a number of questionnaires at baseline, 3 months and 6 months, in order to assess mental health and quality of life. They will also undergo fitness tests and dual-energy X-ray absorptiometry (DEXA) scans to evaluate changes in physical fitness levels and body composition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67290 0
A/Prof Prue Cormie
Address 67290 0
Australian Catholic University
Mary MacKillop Institute for Health Research
Level 5, 215 Spring Street
Melbourne VIC 3000
Country 67290 0
Australia
Phone 67290 0
+61 (0)3 9230 8242
Fax 67290 0
Email 67290 0
[email protected]
Contact person for public queries
Name 67291 0
A/Prof Prue Cormie
Address 67291 0
Australian Catholic University
Mary MacKillop Institute for Health Research
Level 5, 215 Spring Street
Melbourne VIC 3000
Country 67291 0
Australia
Phone 67291 0
+61 (0)3 9230 8242
Fax 67291 0
Email 67291 0
[email protected]
Contact person for scientific queries
Name 67292 0
A/Prof Prue Cormie
Address 67292 0
Australian Catholic University
Mary MacKillop Institute for Health Research
Level 5, 215 Spring Street
Melbourne VIC 3000
Country 67292 0
Australia
Phone 67292 0
+61 (0)3 9230 8242
Fax 67292 0
Email 67292 0
[email protected]

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


What supporting documents are/will be available?

No Supporting Document Provided



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.