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Does a multimodal pre-habilitation intervention give better functional and quality of life outcomes than usual care in men choosing radical prostatectomy for localised prostate cancer?

Does a multimodal pre-habilitation intervention give better functional and quality of life outcomes than usual care in men choosing radical prostatectomy for localised prostate cancer? A Pilot Randomised Control Trial (RCT)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000477820
Acronym
Prostate Cancer Prehabilitation Trial
Enrollment
40
Registered
2021-04-21
Start date
2021-05-03
Completion date
2021-07-26
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to test the implementation of a model of supportive care involving multidisciplinary pre-habilitation interventions for men affected by prostate cancer choosing radical prostatectomy (and if applicable, their partner/spouse). This study aims to improve couples' psychological adjustment and supportive self-management prior to radical cancer surgery. Who is it for? Men (18 years and over) with newly diagnosed localised prostate cancer opting for radical prostatectomy (and, if applicable, their partner/spouse). Study details: Participants in this study will be randomly allocated into one of two groups. One group will receive standard care currently available at their clinical site (provision of oral and written information and the contact details of a prostate cancer specialist nurse for additional support if required). The other group will undergo the pre-habilitation multimodal model of supportive care, which involves: informational materials, pelvic floor muscle training, an evidence based self-management seminar, tailored exercise programme and tailored sexual well-being information. It is anticipated that the outcomes of this study will drive forward service improvements, produce information to help patients and their families and help clinical teams choose the most appropriate model of supportive care.

Interventions

20 patients (18 years and over) with newly diagnosed localised prostate cancer, opting for radical prostatectomy (and their partner/spouse), will be randomly allocated to the pre-habilitation multimodal supportive care intervention, which will comprise five main components: (1) Informational Materials Participants will be provided with a custom-made evidence based self-management booklet that will include: how to self-care; managing side-effects of radical prostatectomy; nutrition and exercise;

20 patients (18 years and over) with newly diagnosed localised prostate cancer, opting for radical prostatectomy (and their partner/spouse), will be randomly allocated to the pre-habilitation multimodal supportive care intervention, which will comprise five main components: (1) Informational Materials Participants will be provided with a custom-made evidence based self-management booklet that will include: how to self-care; managing side-effects of radical prostatectomy; nutrition and exercise; relationships and sexual well-being; healthy lifestyle approaches; and community-based support resources. Once off written booklet. (2) Pelvic Floor Muscle Training (PFMT) Participants will be provided with a pelvic floor exercise program tailored to the pathophysiology of post prostatectomy incontinence. Education will include: anatomy; how to correctly contract the pelvic floor muscles without using accessory muscles. The Prostate Cancer Specialist Nurse will assess the correctness of their contraction using a mirror and palpation as biofeedback. Men will be taught how to functionally contract the pelvic floor before any changes in abdominal pressure to condition the pelvic floor to their adapted role post-surgery. Once mastered, the PFMT will be incorporated into the physical exercise programme. Once off session and re-visited at each visit with the specialist nurse session. (3) Evidence-Based Self-Management Seminar The self-management seminar will include: introduction to radical prostatectomy and side-effects; self-managing physical side-effects; education on good bladder and bowel habits; emotions and mental changes; body image, sexual dysfunction and relationships; Mediterranean diet and lifestyle advice; exercise; finance and benefits; relaxation and stress management; sign-posting to community based services; and an open question session with a specialist nurse. One session for 120-minute session. (4) Physical Exercise Programme Participants will be provided a physical exercise programme, which will be tailored to individual exercise abilities and existing co-morbidities. In keeping with “one size does not fit all approach” exercise programmes will include: circuit class-based activities, walking and home exercises. Frequency of physical exercise programme session will be at the time of recruitment, one week prior to surgery, six- and 12-weeks post-surgery. The progression of increase in exercise will be informed on individual physical assessment with the exercise physiologist in cancer care. (5) Sexual Pre-habilitation The man and his partner/spouse (where applicable) will meet with his responsible clinician to discuss realistic goals and expectations for the recovery of sexual function and plan an individualised pre-habilitation plan prior to radical prostatectomy. In line with anecdotal evidence participants will use sildenafil or tadalafil tablets (50mg and 10mg respectively) and/or vacuum therapy at night for 7-10 days prior to radical prostatectomy (unless there are medical contraindications to PDE5i administration) and men will be encouraged to maintain a normal sexual life before their operation. Once off session and re-visited at each visit with the specialist nurse session

Sponsors

University of Canberra
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

I. Age (18 years and older), patients (and, if applicable, their partner/spouse) newly diagnosed with localised PCa II. confirmed by pathological and radiological diagnosis of prostate cancer III. choosing radical prostatectomy IV. self-assessed written and verbal English proficiency V. able to provide written informed consent.

Exclusion criteria

I. Salvage radical prostatectomy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026