Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04647474 |
| Other study ID # |
284473 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 15, 2021 |
| Est. completion date |
March 29, 2023 |
Study information
| Verified date |
May 2023 |
| Source |
King's College London |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The complex relationship that exists between physical and mental health in prostate cancer is
increasingly being understood. Psychiatric symptoms are common in this group and have
important consequences for the quality of life and cancer outcomes for patients with prostate
cancer. However, less is understood about the severity of disease and which patient factors
and treatment options are risk factors for developing problems. Additionally, the impact
these conditions have on problems such as urinary incontinence or sexual function is less
well understood. The investigators anticipate that different patient characteristics and
treatment options increase an individuals risk of developing problems after a prostate cancer
diagnosis. Therefore, this study aims to further investigate these specific factors to
improve follow up care in patients with prostate cancer.
This observational study will follow up newly diagnosed prostate cancer patients for a period
of 12 months to evaluate these outcomes. Participants will be identified across seven
hospitals in London and South England. After being recruited participants will be invited to
undergo repeated online or postal questionnaires at baseline, 3, 6, 9 and 12 months. These
will assess depressive and anxiety symptom load, body image issues, fear of recurrence,
masculinity perception and functional symptoms (including urinary, bowel and sexual symptoms)
load.
Analysis of these findings will allow for identification of 1) Which subgroups of patients
appear to have worse mental wellbeing and quality of life outcomes, and 2) How mental health
issues impact functional outcomes. This will provide important information for guiding future
research within the subject area and further inform clinicians about these issues.
Description:
Prostate cancer represents a large proportion of global cancer incidence, accounting for
13.5% of all male cancers. However, with high survival rates, which are still improving,
there is growing acceptance that living longer does not always equate to living well. The
mental health aspect of the disease is unfortunately sometimes neglected with research
focusing on the physical symptoms after disease much more prominent and frequently conducted.
Previous research has already demonstrated that mental health issues are common in patient
with prostate cancer, however, less is known about which patients are at greater risk of
developing problems after being diagnosed with prostate cancer. Additionally, the association
between mental health conditions and what are called 'functional outcomes' (i.e. bladder,
bowel and sexual function) after treatment are less well understood. A greater knowledge of
these factors can help clinicians to make better assessments of patients and also will help
the future development of additional tools which are able to help with diagnosis in future.
With these factors in mind the primary aims of the research study is :
1. To evaluate the association between prostate cancer patients undergoing different
treatments and overall mental wellbeing in the initial cancer follow-up stage.
The secondary aims of the study are to:
1. Identify high risk time-frames post diagnosis for worsening of mental wellbeing
2. Assess the impact of depressive and anxiety symptoms on functional, clinical and other
mental wellbeing outcomes.
3. Explore patient and cancer related factors conferring a risk for the development of
significant mental wellbeing problems.
The investigators hypothesis is that prostate cancer patients experience a high psychological
symptom load in the initial follow up period after diagnosis. Additionally, based on previous
prostate cancer and mental health research the investigators hypothesise that certain
subgroups (e.g. certain treatment or patient groups) are at increased risk of developing
significant psychological symptoms.
To explore these aims and hypothesis the investigators will conduct a questionnaire based,
longitudinal and observational cohort study of participants recently diagnosed with prostate
cancer. There is no interventional element to the study. The investigators will identify
newly diagnosed patients, who have not yet received treatment from multiple hospital sites in
London and the South East of England. This will include patients allocated to surgery,
radiotherapy, surveillance or hormone therapy depending on prostate cancer characteristics.
Participants will be identified by the clinical team during the hospital outpatient
appointment, with contact details taken at this stage. The investigators are aiming to
recruit 300 participants for this study based on power calculations (80% power with 0.05
significance) for the primary outcomes taking into account a maximum drop out rate of 25%.
Following identification, screening and consenting for inclusion into the study participants
will begin data collection through serial questionnaires. Participants will have the option
of either undergoing postal or electronic follow up, depending on preference. Questionnaires
will include numerous validated measures to evaluate mental and social wellbeing as well as
functional symptoms of disease/treatment including bladder, bowel and sexual function as per
the outcome measures described.
Collection of data will occur at set intervals for the duration of the study and will include
the same questionnaire being filled at the beginning of the study, 3, 6, 9 and 12 months.
Additionally, at the outset of the study some further information will be asked from the
participant including demographics and previous medical or psychiatric history. The research
team will in addition collect data from the medical files at the beginning of the study about
the cancer characteristics and then again at the end of the study at 12 months. At 12 months
participants will complete the study and data analysis along the primary and secondary
outcome measures will be conducted once all participants have completed this.
