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| Name | Class |
|---|---|
| University of Technology, Sydney | OTHER |
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This study aims to explore the perceptions of men with prostate cancer (PCa) and high-risk biochemical recurrence (BCR) regarding the risk of breast-related side effects, including gynaecomastia, from treatment.
This study will inform a set of 'attributes' and their levels that can be used in a later discrete choice experiment (DCE), for which separate ethical approval will be sought, to assess the trade-offs patients are willing to make between breast-related side effects, other quality of life (QOL) impacts and cancer control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A qualitative approach with semi-structured interviews. | Experimental | Through purposive sampling, we plan to conduct interviews with men from two groups: those with high-risk BCR PCa but no ADT+/-ARPI experience, and men with ADT+/-ARPI experience who have experienced breast-related side effects from this treatment. To inform an understanding of how perception of breast-related symptoms might inform treatment preferences, it is important to understand perspectives regarding the hypothetical risk of side-effects as well as those based on actual experience. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semi-structured Interview | Other | this t study will use qualitative methods to explore men's views of gynaecomastia from high-risk BCR PCa treatments (Stage 1) to inform attributes and levels for a later DCE to examine patient treatment preferences (Stage 2). |
| Measure | Description | Time Frame |
|---|---|---|
| Number and content of themes and subthemes describing PCa patients' perceptions of the risk of breast-related side effects, including gynaecomastia, from high-risk BCR PCa treatment. | The outcome will be the set of themes and subthemes identified through qualitative analysis of semi-structured interviews. Interviews will be conducted with three groups: (1) men with high-risk BCR prostate cancer; (2) men with ADT ± ARPI experience; and (3) men who have experienced breast-related side effects from prostate cancer treatment. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number and content of discrete choice experiment (DCE) attributes and their levels, developed to assess the trade-offs patients are willing to make between breast-related side effects, other QoL impacts, and cancer control. | The outcome will be a finalised set of attributes and levels for a DCE. Attributes and levels will be generated through semi-structured qualitative interviews with patients, analysed iteratively across participant groups, and refined with input from an advisory panel. A 'generator developed' approach will then be used to design the final set of attributes and levels for inclusion in the DCE. |
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Inclusion Criteria:
Exclusion Criteria:
• Men receiving psychiatric care as a consequence of their prostate cancer diagnosis or treatment thereof.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kinghorn Cancer Centre | Recruiting | Sydney | New South Wales | 2010 | Australia |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D000230 | Adenocarcinoma |
| D006177 | Gynecomastia |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 12 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |