. 2022 Nov 9;17(11):e0276063.

doi: 10.1371/journal.pone.0276063. eCollection 2022.

Experiences of participants in a clinical trial of a novel radioactive treatment for advanced prostate cancer: A nested, qualitative longitudinal study

Bianca Viljoen^{1

2}, Michael S Hofman^{3

4}, Suzanne K Chambers^{2

5

6

7}, Jeff Dunn^{2

6}, Haryana M Dhillon⁸, Ian D Davis^{9

10}, Nicholas Ralph^{1

2}

Affiliations

¹ School of Nursing & Midwifery, University of Southern Queensland, Toowoomba, Queensland, Australia.
² Centre for Health Research, University of Southern Queensland, Springfield, Queensland, Australia.
³ Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC), Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, Australia.
⁴ Sir Peter MacCallum Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia.
⁵ Faculty of Health Sciences, Australian Catholic University, Brisbane, Queensland, Australia.
⁶ Prostate Cancer Foundation of Australia, Sydney, New South Wales, Australia.
⁷ Exercise Medicine Research Institute, Edith Cowan University, Perth, Western Australia, Australia.
⁸ Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), School of Psychology, Faculty of Science, The University of Sydney, Sydney, Victoria, Australia.
⁹ Eastern Health Clinical School, Monash University, Melbourne, Victoria, Australia.
¹⁰ Department of Medical Oncology, Eastern Health, Melbourne, Victoria, Australia.

PMID: 36350899
PMCID: PMC9645653
DOI: 10.1371/journal.pone.0276063

Experiences of participants in a clinical trial of a novel radioactive treatment for advanced prostate cancer: A nested, qualitative longitudinal study

Bianca Viljoen et al. PLoS One. 2022.

. 2022 Nov 9;17(11):e0276063.

doi: 10.1371/journal.pone.0276063. eCollection 2022.

Authors

Bianca Viljoen^{1

2}, Michael S Hofman^{3

4}, Suzanne K Chambers^{2

5

6

7}, Jeff Dunn^{2

6}, Haryana M Dhillon⁸, Ian D Davis^{9

10}, Nicholas Ralph^{1

2}

Affiliations

¹ School of Nursing & Midwifery, University of Southern Queensland, Toowoomba, Queensland, Australia.
² Centre for Health Research, University of Southern Queensland, Springfield, Queensland, Australia.
³ Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC), Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, Australia.
⁴ Sir Peter MacCallum Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia.
⁵ Faculty of Health Sciences, Australian Catholic University, Brisbane, Queensland, Australia.
⁶ Prostate Cancer Foundation of Australia, Sydney, New South Wales, Australia.
⁷ Exercise Medicine Research Institute, Edith Cowan University, Perth, Western Australia, Australia.
⁸ Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), School of Psychology, Faculty of Science, The University of Sydney, Sydney, Victoria, Australia.
⁹ Eastern Health Clinical School, Monash University, Melbourne, Victoria, Australia.
¹⁰ Department of Medical Oncology, Eastern Health, Melbourne, Victoria, Australia.

PMID: 36350899
PMCID: PMC9645653
DOI: 10.1371/journal.pone.0276063

Abstract

Objectives: Qualitative studies nested within clinical trials can provide insight into the treatment experience, how this evolves over time and where improved supportive care is required. The purpose of this qualitative study is to describe the lived experiences of men with advanced prostate cancer participating in the TheraP trial; a randomised trial of 177Lu-PSMA-617 compared with cabazitaxel chemotherapy.

Methods: Fifteen men with advanced prostate cancer were recruited from the TheraP clinical trial with interviews conducted at three timepoints during the trial. An interpretative phenomenological approach was used, and interviews analysed using thematic analysis. This research paper reports the results from the mid-point, conclusion and follow up interviews, focusing specifically on participants' experiences of trial participation.

Results: Three themes were identified representing the lived experiences of men with advanced prostate cancer participating in the TheraP trial: (1) facing limited options; (2) anticipating outcomes and (3) coping with health changes.

Conclusions: Men who enrol in clinical trial of anti-neoplastic treatments for prostate cancer need targeted psychological and supportive care that includes attention to unique aspects of the experience of having prostate cancer and being in a clinical trial. As part of their trial experience, men with advanced prostate cancer need to be regularly assessed for survivorship needs, fully informed, supported and referred to services for regular care and support across the trajectory of their disease.

Trial registration: NCT03392428. Registered on 8 January 2018 (ANZUP1603).

Copyright: © 2022 Viljoen et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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Conflict of interest statement

The authors declare there are no competing interests.

Figures

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References

1. World Health Organisation. Clinical Trials 2020 Available from: https://www.who.int/topics/clinical_trials/en/.
1. Teo MY, Rathkopf DE, Kantoff P. Treatment of Advanced Prostate Cancer. Annual review of medicine. 2019;70:479–99. doi: 10.1146/annurev-med-051517-011947 - DOI - PMC - PubMed
1. Hofman MS, Emmett L, Sandhu S, Iravani A, Joshua AM, Goh JC, et al.. [177Lu] Lu-PSMA-617 versus cabazitaxel in patients with metastatic castration-resistant prostate cancer (TheraP): a randomised, open-label, phase 2 trial. The Lancet. 2021;397(10276):797–804. doi: 10.1016/S0140-6736(21)00237-3 - DOI - PubMed
1. Viljoen B, Hofman MS, Chambers SK, Dunn J, Dhillon H, Davis ID, et al.. Advanced prostate cancer experimental radioactive treatment—clinical trial decision making: patient experiences. BMJ Supportive & Palliative Care. 2021:bmjspcare-2021-002994. doi: 10.1136/bmjspcare-2021-002994 - DOI - PubMed
1. Bill-Axelson A, Garmo H, Lambe M, Bratt O, Adolfsson J, Nyberg U, et al.. Suicide risk in men with prostate-specific antigen-detected early prostate cancer: a nationwide population-based cohort study from PCBaSe Sweden. European urology. 2010;57(3):390–5. doi: 10.1016/j.eururo.2009.10.035 - DOI - PubMed

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Experiences of participants in a clinical trial of a novel radioactive treatment for advanced prostate cancer: A nested, qualitative longitudinal study

Affiliations

Experiences of participants in a clinical trial of a novel radioactive treatment for advanced prostate cancer: A nested, qualitative longitudinal study

Authors

Affiliations

Abstract

Conflict of interest statement

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References

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Associated data

LinkOut - more resources

Full Text Sources

Medical

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