Prostate Cancer (Adenocarcinoma)
Conditions
Keywords
gynaecomastia, prostate cancer, LHRH, testosterone, breast, estrogen
Brief summary
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.
Detailed description
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.
Interventions
OTHERSemi-structured Interview
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).
Sponsors
St Vincent's Hospital, Sydney
University of Technology, Sydney
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men with high-risk BCR PCa but no ADT+/-ARPI experience. * Men with ADT+/-ARPI experience who have experienced breast-related side effects from this treatment.
Exclusion criteria
• Men receiving psychiatric care as a consequence of their prostate cancer diagnosis or treatment thereof.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 12 months | 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. |
Countries
Australia
Outcome results
None listed