Cancer Clinical Trial
Official title:
Pelvic Radiation Injuries After Cancer Treatment: Symptoms, Quality of Life and Experiences Before, Along and After Hyperbaric Oxygenation Treatment
NCT number | NCT03570229 |
Other study ID # | 01012018 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 31, 2018 |
Est. completion date | December 31, 2022 |
Verified date | December 2023 |
Source | University of Bergen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Osteoradionecrosis, dermal soft tissue necrosis, radiation cystitis, proctitis and sexual dysfunctions are well-known late-effects after radiation for cancer in the pelvic area, negatively affecting the survivors' quality of life (QOL) and psychosocial wellbeing. Increasing evidence and clinical practice support the use of hyperbaric oxygen treatment (HBOT) as an effective treatment in a variety of radiation injuries, but this is still a field with limited research and knowledge. Especially, there is a knowledge gap on how late radiation tissue injury (LRTI) influences cancer survivors' QOL and psychosocial health in a longitudinal perspective (before, along and after HBOT), as well as the patients' knowledge, expectation and experience from this treatment. This study aims to improve knowledge on these issues.
Status | Completed |
Enrollment | 137 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. pelvic radiation injury after intended curative radiation therapy for pelvic cancer (prostate, gynecological, and urological and bowel cancers), 2. = 6 months from finished radiation therapy 3. referred to the unit for hyperbaric oxgen treatment (HBOT) 4. aged = 18 years. Exclusion Criteria: 1. severe physical and/or mental co-morbidity representing a contraindication for HBOT 2. insufficient cognitive or language skills to answer study questionnaires and perform interviews. |
Country | Name | City | State |
---|---|---|---|
Norway | University of Bergen/Haukeland University Hospital | Bergen | Hordaland |
Lead Sponsor | Collaborator |
---|---|
University of Bergen | Haukeland University Hospital |
Norway,
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* Note: There are 34 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Quality of life after HBO-therapy | Self reported quality of life scale, European Organization for Research and Treatment of Cancer (EORTC QLQ C30) scale, 30 questions, 4-point Likert scale 0-3 for 28 items, 0-6 for two items, total score 0-100 (100=highest level of functioning/ best score) | Change from baseline (T1) to 30 weeks (T7, 6 months after end of HBO-therapy) | |
Secondary | Long-term change in Quality of life | Self reported quality of life scale, European Organization for Research and Treatment of Cancer (EORTC QLQ C30) scale, 30 questions, 4-point Likert scale 0-3 for 28 items, 0-6 for two items, total score 0-100 (100=highest level of functioning/ best score) | Change from baseline (T1) to 58 weeks (T8, 1 year after end of HBO-therapy) | |
Secondary | Change in Late radiation tissue injury symptoms after HBO-therapy | Expanded Prostate Cancer Index (EPIC) questionnaire, urinary (12 items) and bowel (14 items) subscores, 3- to 5-point Likert scale, sum-score 0-100 (0=worst symptoms) | Change from baseline (T1) to 30 weeks (T7, 6 months after end of HBO-therapy) | |
Secondary | Time to improvement in Late radiation tissue injury symptoms | Expanded Prostate Cancer Index (EPIC) questionnaire, urinary (12 items) and bowel (14 items) subscores, 3- to 5-point Likert scale, sum-score 0-100 (0=worst symptoms), improvement defined as a higher score of at least 0,5 standard deviations based on the study population | Time from baseline (T1) to significant improvement (at least 0,5 SD) up to 30 weeks (T7) after end of HBO-therapy | |
Secondary | Satisfaction With Care | Total score of EORTC in-PATSAT 32 (European Organization of Research and Treatment of Cancer, In-patient satisfaction With care), 32 questions, 5-point Likert scale, total score 0-100, higher score = more satisfied with care | T3 (after 6 weeks) |
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