Quality of LifeNCT00895388
Effects of Structured Rehabilitation Program on Quality of Life in Rectal Cancer Patients- a Randomized Controlled Trial
A study testing Structured Rehabilitation program in people with Quality of Life and Sexual Function, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
Quality of life after rectal surgery is reported to be impaired. Side effects of surgery and/or neoadjuvant treatment as functional disturbances like sexual dysfunction, urinary incontinence, anal incontinence or stoma problems are commonly experienced. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Sexual Function, Urinary Incontinence
- What is being tested?
- Structured Rehabilitation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNorway
- Study dates
- May 2009to 2 Dec 2019
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Rectal cancer Surgically treated for rectal cancer Informed concent Included in national guidelines for surveillance of rectal cancer patients
Who cannot join
- Older than 75 years Mentally or physically not able to participate Non curative surgical treatment
Trial locations and contacts
1 site in 1 country.
Norway1 site
Dep. of gastrointestinal surgery, University Hospital of North Norway
Tromsø, N-9037
About this study
Official title: Effects of Structured Rehabilitation Program on Quality of Life After Surgical Treatment for Rectal Cancer- a Randomized Controlled Clinical Trial
Quality of life after rectal surgery is reported to be impaired. Side effects of surgery and/or neoadjuvant treatment as functional disturbances like sexual dysfunction, urinary incontinence, anal incontinence or stoma problems are commonly experienced. The investigators hypotheses is that structured rehabilitation program addressing these problems will improve quality of life. A RCT are performed in order to document the effects of the rehabilitation.
- Being tested
- Structured Rehabilitation program
- Keywords
- Urinary function, Anal function
- Medical subject headings
- Urinary Incontinence, Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Rehabilitation programBehavioural
Questionnaire send by post at 3, 6, 12, 18 and 24 months after operation
| Study group | Role | What they receive |
|---|---|---|
| Structured Rehabilitation program | Other | Not described Receives: Behavioral: Structured Rehabilitation program |
| Controls | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (EORTC QLQ-C30, EORTC QLQ-CR38)
Measured: Baseline, 3, 6, 12,18 and 24 months postoperative.
Quality of LIfe (EQ 5D)
Measured: Baseline, 3,6,12, 18 and 24.
Secondary outcomes (3)
St Marks incontinence
Measured: Baseline, 3, 12 and 24
ICIQ sexual function
Measured: baseline, 3,12 and 24
ICIQ Urinary function Short form
Measured: baseline,3, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startMay 2009
- Primary completionNov 2019
- Study completion2 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Nord
- Responsible party
- Sponsor
- Investigators
- Rolv-Ole Lindsetmo, MD, Phd, Mph, Study director, Dep of gastrointestinal surgery, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895388
- Sponsor's protocol ID
- P REK NORD 105/2007
- Status last verified
- Nov 2011
- First submitted
- 7 May 2009
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes