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Trial registered on ANZCTR


Registration number
ACTRN12613001179729
Ethics application status
Approved
Date submitted
25/10/2013
Date registered
28/10/2013
Date last updated
3/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving sexual health in men with prostate cancer through exercise and psychosexual therapies
Scientific title
Improving sexual health in men with prostate cancer: randomised controlled trial of exercise and psychosexual therapies
Secondary ID [1] 283454 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 290377 0
Sexual Dysfunction 290378 0
Condition category
Condition code
Cancer 290768 290768 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
EXERCISE INTERVENTION
The physical exercise intervention program will include 6 months of resistance (i.e. lifting weights) and aerobic exercise (e.g. walking, jogging, cycling) undertaken 3 times per week in an exercise clinic. Exercise sessions will take approximately 60 minutes and will be conducted in small groups under the supervision of an accredited exercise physiologist.

EXERCISE + PSYCHOSEXUAL INTERVENTION
This intervention program will involve the same exercise intervention as described above as well as a brief psychosexual self-management intervention that addresses psychological and sexual well-being. Participants will attend a single, 60 minute, one-on-one psycho-educational session with their exercise physiologist and receive a self-management kit. Specifically, the education session addresses: stress management; problem solving coping for treatment challenges; and goal setting for sexual rehabilitation. This session will occur during the week prior to initiating the exercise program. The self-management kit includes: a published self-help book for men with prostate cancer and their partners; study specific tip sheets about treatments for erectile dysfunction and goal setting for sexual rehabilitation; a progress journal-diary; and audio resources for stress management.
Intervention code [1] 288171 0
Lifestyle
Comparator / control treatment
USUAL CARE, DELAYED INTERVENTION GROUP:
The control group will maintain usual care for 6 months and then will receive the interventions (half to receive the Exercise Intervention and half the Exercise + Psychosexual Intervention). Usual care may involve no intervention/medication for sexual dysfunction but standard medical care of erectile dysfunction may include the use of phosphodiesterase-5 inhibitor drugs (e.g. viagra), vacuum constriction devices, penile injections with intracavernosal vasodialators, and/or penile implant surgery at the discretion of the patient.
Control group
Active

Outcomes
Primary outcome [1] 290761 0
Sexual Health as determined by the International Index of Erectile Functioning questionnaire.
Timepoint [1] 290761 0
Baseline (0 months), post-intervention (6 months) and follow-up (18 months)
Primary outcome [2] 290762 0
Sexual health as determined by the Expanded Prostate Cancer Index Composite questionnaire.
Timepoint [2] 290762 0
Baseline (0 months), post-intervention (6 months) and follow-up (18 months)
Primary outcome [3] 290763 0
Sexual health as determined by European Organisation for Research and Treatment of Cancer prostate cancer specific questionnaire.
Timepoint [3] 290763 0
Baseline (0 months), post-intervention (6 months) and follow-up (18 months)
Secondary outcome [1] 305208 0
Sexual self-confidence as determined by the Short Form Psychological and Interpersonal Relationship Scale
Timepoint [1] 305208 0
Baseline (0 months), post-intervention (6 months) and follow-up (18 months)
Secondary outcome [2] 305209 0
Masculine self-esteem as determined by the Masculine Self-Esteem Scale.
Timepoint [2] 305209 0
Baseline (0 months), post-intervention (6 months) and follow-up (18 months)
Secondary outcome [3] 305210 0
Utilisation of sexual aids as determined by a scale assessing whether participants have sought medical assistance for sexual dysfunction. All treatments will be documented and the impact of these treatments rated.
Timepoint [3] 305210 0
Baseline (0 months), post-intervention (6 months) and follow-up (18 months)
Secondary outcome [4] 305211 0
Relationship satisfaction as determined by the Dyadic Adjustment Scale.
Timepoint [4] 305211 0
Baseline (0 months), post-intervention (6 months) and follow-up (18 months)
Secondary outcome [5] 305212 0
Sexual supportive care needs as determined by the Supportive Care Needs Survey.
Timepoint [5] 305212 0
Baseline (0 months), post-intervention (6 months) and follow-up (18 months)
Secondary outcome [6] 305213 0
Quality of life as determined by the Medical Outcomes Short Form 36.
Timepoint [6] 305213 0
Baseline (0 months), post-intervention (6 months) and follow-up (18 months)
Secondary outcome [7] 305214 0
Psychological distress as determined by the Brief Symptom Inventory-18.
Timepoint [7] 305214 0
Baseline (0 months), post-intervention (6 months) and follow-up (18 months)
Secondary outcome [8] 305215 0
Fatigue as determined by the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire.
Timepoint [8] 305215 0
Baseline (0 months), post-intervention (6 months) and follow-up (18 months)
Secondary outcome [9] 305216 0
Whole body and regional fat and lean mass as determined by Dual Energy X-Ray Absorptiometry.
Timepoint [9] 305216 0
Baseline (0 months), post-intervention (6 months) and follow-up (18 months)
Secondary outcome [10] 305217 0
Body image as determined by the Body Image Scale.
Timepoint [10] 305217 0
Baseline (0 months), post-intervention (6 months) and follow-up (18 months)
Secondary outcome [11] 305218 0
Physical function as determined by 400-m walk (aerobic capacity), one repetition maximum in the leg press and chest press (muscular strength), repeated chair rise (muscular power), usual and fast pace 6-m walk (ambulation), and backwards tandem 6-m walk (balance).
Timepoint [11] 305218 0
Baseline (0 months), post-intervention (6 months) and follow-up (18 months)
Secondary outcome [12] 305219 0
Testosterone, C-reactive protein and Prostate Specific Antigen as determined by a blood sample.
Timepoint [12] 305219 0
Baseline (0 months), post-intervention (6 months) and follow-up (18 months)
Secondary outcome [13] 305220 0
Physical activity levels as determined by an accelerometer activity monitor worn for 7 days.
Timepoint [13] 305220 0
Baseline (0 months), post-intervention (6 months) and follow-up (18 months)

Eligibility
Key inclusion criteria
1. Prior and/or current treatment for prostate cancer including prostatectomy, radiotherapy or androgen deprivation therapy
2. Being concerned about sexual health (as assessed by International Index of Erectile Functioning overall satisfaction score and/or Expanded Prostate Cancer Index Composite sexual bother score)
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Non-nerve sparing prostatectomy
2. Greater than 6 months since prostatectomy or completion of radiotherapy or androgen deprivation therapy
3. Incontinent defined as requiring the use of more than 1 pad in a 24-hour period
4. Already performing regular exercise defined as undertaking structured aerobic or resistance training two or more times per week within the past 3 months
5. Acute illness or any musculoskeletal, cardiovascular or neurological disorder that could inhibit exercise or put participants at risk from exercising
6. 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) age (less than 60 years/greater than or equal to 60 years); 2) current sexual activity level (no/minor-moderate); 3) previous prostatectomy (yes/no); 4) previous radiotherapy (yes/no); and 5) previous/current androgen deprivation therapy (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
The three groups of participants receive different interventions during the same time span of the study, however the usual care delayed intervention group receive the interventions after 6 months of usual care.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data from our previous study in prostate cancer patients indicates that the standard deviation for change in our primary outcome of sexual health equates to ~22 points. We observed the mean change after the intervention to differ between exercise and usual care groups by ~11 points. There is no available evidence comparing changes in sexual health between exercise and psychosexual interventions. However, data from previous psychosexual interventions in prostate cancer patients indicates changes of a moderate standardised effect (d = 0.5) in sexual health following the psycho-educational interventions. We have based sample size calculations on the assumption that there will be an additive effect of exercise and psychosexual therapies. A priori, 64 participants per group will be required to achieve 80% power at an alpha level of 0.05 (two tailed), and to demonstrate a difference between the three groups in sexual health at the end of the intervention. Previous experience in exercise and psychosexual therapy trials indicates an attrition rate of up to 20% over the intervention period. Therefore, to adequately ensure that we have sufficient participant numbers at the end of the intervention, 240 participants will be randomised to the study arms.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA

Funding & Sponsors
Funding source category [1] 288170 0
Government body
Name [1] 288170 0
National Health and Medical Research Council
Country [1] 288170 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
ECU Health and Wellness Institute
270 Joondalup Drive
Joondalup, WA 6027
Country
Australia
Secondary sponsor category [1] 286891 0
Individual
Name [1] 286891 0
Dr Prue Cormie
Address [1] 286891 0
ECU Health and Wellness Institute
Edith Cowan University
270 Joondalup Drive
Joondalup, WA 6027
Country [1] 286891 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290084 0
Human Research Ethics Committee
Ethics committee address [1] 290084 0
Ethics committee country [1] 290084 0
Australia
Date submitted for ethics approval [1] 290084 0
25/10/2013
Approval date [1] 290084 0
10/04/2014
Ethics approval number [1] 290084 0
10643

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

Contacts
Principal investigator
Name 43862 0
Dr Prue Cormie
Address 43862 0
ECU Health and Wellness Institute
Edith Cowan University
270 Joondalup Drive
Joondalup, WA 6027
Country 43862 0
Australia
Phone 43862 0
+61 8 6304 3418
Fax 43862 0
Email 43862 0
p.comie@ecu.edu.au
Contact person for public queries
Name 43863 0
Prue Cormie
Address 43863 0
ECU Health and Wellness Institute
Edith Cowan University
270 Joondalup Drive
Joondalup, WA 6027
Country 43863 0
Australia
Phone 43863 0
+61 8 6304 3418
Fax 43863 0
Email 43863 0
p.comie@ecu.edu.au
Contact person for scientific queries
Name 43864 0
Prue Cormie
Address 43864 0
ECU Health and Wellness Institute
Edith Cowan University
270 Joondalup Drive
Joondalup, WA 6027
Country 43864 0
Australia
Phone 43864 0
+61 8 6304 3418
Fax 43864 0
Email 43864 0
p.comie@ecu.edu.au

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
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Documents added automatically
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