Quality of Life and Hyperbaric Treatment

Background:
Osteoradionecrosis, dermal soft tissue necrosis, radiation cystitis, proctitis, and sexual dysfunctions are well-known late effects following pelvic cancer radiation, negatively impacting survivors' quality of life (QOL) and psychosocial wellbeing. While there is increasing evidence supporting the efficacy of HBOT in treating various radiation injuries, there remains limited research and knowledge in this field. Particularly, there is a knowledge gap regarding how LRTI influences cancer survivors' QOL and psychosocial health before, during, and after HBOT, as well as the patients' knowledge, expectations, and experiences with this form of treatment.

Purpose:
The overarching goal of this study is to enhance the understanding of LRTI and HBOT. Specifically, the study aims to achieve three main goals:

1. To enhance understanding of how QOL and psychosocial health are affected in pelvic cancer survivors with LRTI and how these may change due to HBOT.
2. To gather information about patients' knowledge and expectations concerning HBOT, as well as their experiences and satisfaction with care during HBOT.
3. To improve knowledge regarding the time frame of changes in LRTI symptoms and patients' long-term QOL, psychosocial health, and LRTI after completing HBOT.

Design and Methods:
This is a mixed-methods study with a prospective longitudinal embedded design. Quantitative data are collected at eight timepoints: at baseline of HBOT (T1), after three weeks (T2, in the middle of HBOT), after six weeks (T3, end of HBOT), and subsequently at 6 (T4), 12 (T5), 18 (T6), 24 (T7), and 52 (T8) weeks after completing HBOT. Qualitative data are collected through in-depth interviews at T1, T3, and T8 to elaborate on patients' experiences.

Study Participants:
Participants are recruited from all patients with pelvic radiation injury undergoing HBOT at the Section for Hyperbaric Medicine (SHM) at Haukeland University Hospital in Bergen, the Norwegian National Center for planned HBOT. Inclusion criteria include pelvic radiation injury after intended curative radiation for pelvic cancer (prostate, gynecological, urological, and bowel cancers), ≥ 6 months from finished radiation, referral to the unit for HBOT, and age ≥ 18 years.

Data Collection:
The following quantitative and qualitative data are collected:

Photo:

Centre for crisis psychology

Time Frame:
The study commenced in 2019, and data collection concluded in December 2022. It includes 137 pelvic cancer survivors, and the research team is currently working on papers based on the collected data.

Project Management:
This collaborative study involves the Section for Hyperbaric Medicine (SHM), Department of Occupational Medicine (DOM) at Haukeland University Hospital in Bergen, Norway, and the Center for Crisis Psychology (CCP), Faculty of Psychology, University of Bergen (UiB). The research group is led by Professor May Aa. Hauken (CCP) as the project manager, with contributions from PhD/MD Bernd Mueller (SMH) and RN/Msc/PhD candidate Grete K. Velure (SHM). Research assistants RN Synnøve Andersen and RN Tone Merete Jansen are also part of the team. An Advisory Board (AB) has been established to provide input and quality assurance throughout the project:

Photo:

Centre for crisis psychology

Ethical Approval:
The study has received approval from the Regional Committee for Medical and Health Research Ethics (2018/706) and is registered in ClinTrials.gov (NCT03570229).

Results:
Several papers and a doctoral thesis have been published based on the study's findings, covering topics such as patients' experiences with pelvic radiation injuries, symptom burden, psychological distress, health-related quality of life, and sexual health in cancer survivors with pelvic radiation injuries:

• Velure GK, Müller B, Aa. Hauken M. Experiences of patients with pelvic radiation injuries after cancer treatment undergoing hyperbaric oxygen therapy: A phenomenological-hermeneutical study. Nordic Journal of Nursing Research. 2021;41(3):131-139. https://journals.sagepub.com/doi/full/10.1177/2057158521994405
• Velure GK, Muller B, Hauken MA. Symptom burden, psychological distress, and health-related quality of life in cancer survivors with pelvic late radiation tissue injuries. Support Care Cancer. Mar 2022;30(3):2477-2486. https://pubmed.ncbi.nlm.nih.gov/34779920/
• Velure GK, Muller B, Hauken MA. Symptom burden and health-related quality of life six months after hyperbaric oxygen therapy in cancer survivors with pelvic radiation injuries. Support Care Cancer. Jul 2022;30(7):5703-5711. https://pubmed.ncbi.nlm.nih.gov/35320424/
• Velure, G. Symptom burden and health-related quality of life in cancer survivors undergoing hyperbaric oxygen therapy for pelvic late radiation tissue injuries: A mixed-methods study. Doctoral thesis, Center for Crisis Psychology, 2022. https://hdl.handle.net/11250/3012644
• Hauken MA, Velure GK, Muller B, Sekse RJT. Sexual Health and Quality of Life in Cancer Survivors with Pelvic Radiation Injuries. Cancer Nurs. Jul 14 2023. https://pubmed.ncbi.nlm.nih.gov/37449715/
• Hauken MA, Gjesdal,R., Velure, G., Müller, B., Sekse, RJT: Sexual Health following Hyperbaric Oxygen Treatment for Pelvic Late Radiation Tissue Injuries. Submitted

Hauken, MA, Velure, G., Muller, B. «I have to plan everything»- a mixed method study of cancer survivors’ quality of life and experiences of living with pelvic radiation injuries. In production.