Quality of Life Clinical Trial
Official title:
Effects of Structured Rehabilitation Program on Quality of Life After Surgical Treatment for Rectal Cancer- a Randomized Controlled Clinical Trial
Verified date | November 2011 |
Source | University Hospital of North Norway |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2, 2019 |
Est. primary completion date | November 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Rectal cancer Surgically treated for rectal cancer Informed concent Included in national guidelines for surveillance of rectal cancer patients Exclusion Criteria: - Older than 75 years Mentally or physically not able to participate Non curative surgical treatment |
Country | Name | City | State |
---|---|---|---|
Norway | Dep. of gastrointestinal surgery, University Hospital of North Norway | Tromsø |
Lead Sponsor | Collaborator |
---|---|
University Hospital of North Norway | Helse Nord |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of Life (EORTC QLQ-C30, EORTC QLQ-CR38) | Baseline, 3, 6, 12,18 and 24 months postoperative. | ||
Primary | Quality of LIfe (EQ 5D) | Baseline, 3,6,12, 18 and 24. | ||
Secondary | St Marks incontinence | Baseline, 3, 12 and 24 | ||
Secondary | ICIQ sexual function | baseline, 3,12 and 24 | ||
Secondary | ICIQ Urinary function Short form | baseline,3, 12 and 24 months |
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