None listed
Conditions
Brief summary
The study is evaluating whether exercise aids in the management of sexual dysfunction and explores if an integrated treatment model incorporating pharmacological, exercise and psychosexual therapies maximises improvement in sexual 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; have had prior and/or current treatment for prostate cancer including prostatectomy, radiotherapy or androgen deprivation therapy; and 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). Trial details. Participants in this study will be randomly (by chance) divided into one of three groups. Participants in one group (i.e. Exercise intervention group) will attend a 6 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 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. Participants in the second group (i.e. Exercise and psychosexual intervention group) will also undergo the exercise intervention described above as well as attend a single, 60 minute, one-on-one psycho-educational session with their exercise physiologist and receive a self-management kit that addresses psychological and sexual well-being. Participants in the third group (i.e. Usual care – delayed intervention group) will maintain usual care for 6 months before receiving the intervention – half will receive the intervention provided to the Exercise Group, and half will receive the intervention provided to the Exercise and Psychosexual Intervention Group.
Interventions
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 describ
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.
Sponsors
Edith Cowan University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
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)
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.
Outcome results
None listed