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Trial registered on ANZCTR


Registration number
ACTRN12616000176460
Ethics application status
Approved
Date submitted
19/01/2016
Date registered
11/02/2016
Date last updated
30/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of exercise intervention on improving psychological effects in prostate cancer patients
Scientific title
Effectiveness of exercise intervention on improving psychological effects in prostate cancer patients
Secondary ID [1] 288353 0
Nil known
Universal Trial Number (UTN)
U1111-1178-6979
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 297338 0
anxiety 297339 0
depression 297381 0
distress 297382 0
fatigue 297383 0
Condition category
Condition code
Cancer 297537 297537 0 0
Prostate
Mental Health 297567 297567 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two arms in intervention group:
Arm 1: Group exercise
Arm 2: Individual exercise
Both arms will be subjected to identical exercise interventions which
is Moderate to vigorous physical Activity (MVPA); 60 minutes of MVPA, 3 days per week until completion of radiation treatment but no more than eight (8) months.


They will start the exercise program within a month of hormone injection.
Aerobic training target will be 60-85% maximum heart rate and will be calculated for each participant from estimated maximum heart rate minus age. Resistance training intensity will be manipulated from 6-12 RM, using 1-4 sets per exercise to support strength gains.

Exercise sessions involve aerobic/light impact activity and resistance/light impact activity. The program will alternate each week.

Week 1:
*2 sessions of aerobic/light impact activity
*1 session of resistance/light impact activity

Week 2:
*1 session of aerobic/light impact activity
*2 sessions of resistance/light impact activity

The exercise sessions will be performed and supervised by an accredited Exercise physiologist for both arms.

In arm 1 (group) will have 2-10 participants.

The exercise physiologist will monitor adherence by registering attendance for each session.
Intervention code [1] 293656 0
Treatment: Other
Comparator / control treatment
Control arm: No exercise program
Control group
Active

Outcomes
Primary outcome [1] 297092 0
SF-36 Quality of Life Questionnaire
Timepoint [1] 297092 0
Pre - within one month of hormone injection
Post - in their final week of radiotherapy treatment
Primary outcome [2] 297096 0
Exercise assessment completed by exercise physiologist
Cardiovascular fitness is measured using the 6minute walking test.
Timepoint [2] 297096 0
Pre assessment - completed within one month of hormone injection
Post assessment - completed in their final week of radiation therapy treatment
Secondary outcome [1] 320013 0
Prostate distress screening questionnaire to assess psychological distress/ fatigue
Journal title: The validity of the distress therometer in prostate cancer populations
Authors: Suzanne K. Chambers et al
Timepoint [1] 320013 0
Pre - questionnaire to be completed within a month of hormone injection
Secondary outcome [2] 320020 0
Post intervention interview to collect data to identify what aspect provides greater support exercise alone or group exercise.
Timepoint [2] 320020 0
End of radiation treatment

Eligibility
Key inclusion criteria
* Newly diagnosed localised prostate cancer
* All participants to be able to walk 400 meters completed at pre-assessment by exercise physiologist
* Provide written consent
* Able to start exercise program within one month of Eligard hormone treatment
* Obtain medical clearance prior to participating in the intervention
All participants must be scheduled to undergo radiotherapy in combination with Eligard hormone treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Advanced or metastatic prostate cancer
* Unable to walk 400m unassisted
* Have musculoskeletal, cardiovascular and/or neurological disorders that could inhibit them from exercising (determined by patient’s physician)
* Cognitive impaired

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)
Allocations are placed into a sealed opaque envelope by an independent person.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
There will be a person independent of the study that will be generating the randomisation list using an online randomisation program.
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
Basic descriptive statistics will be performed using Statistics Package for the Social Sciences (SPSS Version 22) to provide an overview of all results. Physiological parameters pre and post assessment are predominantly continuous numerical data and be analysed using repeated measures ANOVA. The primary outcome measure will be analysed using the program provided with the SF-36, version 2 by the distributor.

A qualitative content analysis of the interview transcripts will be performed. After collecting the data from interviews which will be recorded, transcribed and then analysed using Thematic analysis. The coding and theme development will be directed by the content of the data.

Sample size calculation using the mental component summary (MCS) score of the SF-36

Using the results of Moinpour et al (2012) for the standard deviation of 12.91 and anticipating a relevant difference of 10% between the groups:

Analysis: comparison of difference between the mean MCS of the groups using an independent t-test at 5% significance

N = 2 x K (sd/difference in means)2
N = 39 per arm

Sample size method of Trent RDSU Ref (Wharrad, H et al 2007)

To account for attrition of patients during the study additional patients will be recruited until the final sample size for analysis in each arm is 39 patients. Based on previous exercise studies we anticipate an attrition rate of up to 20% (Cormie, P et al (2014) and Cormie, P et al (2015).

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
16/11/2015
Date of last participant enrolment
Anticipated
31/12/2017
Actual
7/03/2017
Date of last data collection
Anticipated
Actual
24/08/2017
Sample size
Target
117
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5088 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 12549 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 292710 0
Hospital
Name [1] 292710 0
Townsville Hospital and Health Service
Country [1] 292710 0
Australia
Funding source category [2] 292711 0
Commercial sector/Industry
Name [2] 292711 0
TOLMAR
Country [2] 292711 0
Australia
Primary sponsor type
Hospital
Name
Townsville Hospital and Health Service
Address
100 Angus Smith Drive
Douglas, QLD 4814
Country
Australia
Secondary sponsor category [1] 291444 0
None
Name [1] 291444 0
none
Address [1] 291444 0
none
Country [1] 291444 0
Other collaborator category [1] 278778 0
University
Name [1] 278778 0
James Cook University
Address [1] 278778 0
1 James Cook Drive, Townsville Queensland 4811
Country [1] 278778 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294197 0
Townsville Hospital and Hospital Service Human Research and Ethics Committee EC00183
Ethics committee address [1] 294197 0
100 Angus Smith Drive
Douglas QLD 4814
Ethics committee country [1] 294197 0
Australia
Date submitted for ethics approval [1] 294197 0
20/01/2015
Approval date [1] 294197 0
01/06/2015
Ethics approval number [1] 294197 0
HREC/15/QTHS/5

Summary
Brief summary
The primary purpose of this exercise study (in collaboration with JCU) is to investigate if regular physical activity in a group or individually improves the psychological effects whilst on hormone and radiation treatment. We aim to recruit 117 patients. The exercise program will be conducted by the exercise physiologists at the JCU clinic.

Who is it for?
You may be eligible to participate in this study if you have been recently diagnosed with localised prostate cancer, for which you have been scheduled to begin a combination of radiotherapy and Eligard hormone treatment. You must not have commenced Eligard hormone treatment more than one month previously.

Study details:
Participants enrolled in this study will be randomly allocated (by chance) to one of three groups.
*The first group involves completing a group exercise program.
*Participants allocated to the second group will complete an individual exercise program.
*Participants allocated to the third group will not complete any exercise program, but will simply continue with their cancer treatment as normal.

Participants allocated to either of the first two groups, i.e. the exercise program groups, will complete a 60 minute training session either as part of a group or on their own, three times per week for the duration of their hormone and radiotherapy treatment, or for a maximum of eight months.

Exercise sessions involve aerobic/light impact activity and resistance/light impact activity. The program will alternate each week.

Week 1:
*2 sessions of aerobic/light impact activity
*1 session of resistance/light impact activity

Week 2:
*1 session of aerobic/light impact activity
*2 sessions of resistance/light impact activity

Researchers will assess the efficacy of the exercise programs using questionnaires, s fitness test before starting the program and after finishing the program, and through a brief 15 minute interview with participants at the end of their radiation treatment. It is hoped that the findings from this trial will provide further information on the benefits of exercise during treatment for prostate cancer, and on which format of exercise is preferable and most beneficial for patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62854 0
Mrs Hana Grigg
Address 62854 0
The Townsville Hospital and Health Service
100 Angus Smith Drive, Douglas QLD 4814
Country 62854 0
Australia
Phone 62854 0
+61 7 44 33 4324
Fax 62854 0
Email 62854 0
[email protected]
Contact person for public queries
Name 62855 0
Elderene Brostrom
Address 62855 0
The Townsville Hospital and Health Service
100 Angus Smith Drive, Douglas QLD 4814
Country 62855 0
Australia
Phone 62855 0
+61 7 44 33 3702
Fax 62855 0
Email 62855 0
[email protected]
Contact person for scientific queries
Name 62856 0
Tilley Pain
Address 62856 0
The Townsville Hospital and Health Service
100 Angus Smith Drive, Douglas QLD 4814
Country 62856 0
Australia
Phone 62856 0
+61 7 44334154
Fax 62856 0
Email 62856 0
[email protected]

No information has been provided regarding IPD availability


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.