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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Structured Rehabilitation Program on Quality of Life After Surgical Treatment for Rectal Cancer- a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT00895388
- Acronym / sponsor ID
- P REK NORD 105/2007
- Keywords
- Urinary function, Anal function
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Helse Nord
- Study start
- May 2009
- Primary completion
- Nov 2019 (actual)
- Study completion
- 2 Dec 2019 (actual)
- First posted
- 8 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Rehabilitation program | Other | Behavioral: Structured Rehabilitation program |
| Controls | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Rectal cancer Surgically treated for rectal cancer Informed concent Included in national guidelines for surveillance of rectal cancer patients
Key exclusion criteria (1 listed)
- Older than 75 years Mentally or physically not able to participate Non curative surgical treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Rehabilitation programQuestionnaire send by post at 3, 6, 12, 18 and 24 months after operation | Behavioural | Structured Rehabilitation program |
Primary outcome
Quality of Life (EORTC QLQ-C30, EORTC QLQ-CR38)
Time frame: Baseline, 3, 6, 12,18 and 24 months postoperative.
Quality of LIfe (EQ 5D)
Time frame: Baseline, 3,6,12, 18 and 24.
3 secondary outcomes
St Marks incontinence
Time frame: Baseline, 3, 12 and 24
ICIQ sexual function
Time frame: baseline, 3,12 and 24
ICIQ Urinary function Short form
Time frame: baseline,3, 12 and 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolv-Ole Lindsetmo, MD, Phd, Mph study director
Dep of gastrointestinal surgery, University Hospital of North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (EORTC QLQ-C30, EORTC QLQ-CR38) (time frame: Baseline, 3, 6, 12,18 and 24 months postoperative.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.