Study assessing the impact of depression and anxiety on prostate cancer patients' quality of life
| ISRCTN | ISRCTN79584810 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79584810 |
| Secondary identifying numbers | REC ref: 05/Q2403/8 |
- Submission date
- 02/07/2021
- Registration date
- 27/07/2021
- Last edited
- 27/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
Prostate cancer is the most common male cancer. Hormone therapy, in form of testosterone deprivation, plays an important role in the treatment of both early and metastatic prostate cancer. However, the hormonal treatment of prostate cancer is associated with significant psychological illness. The extent, severity and the natural course of the psychological side effects have not been well studied. This study aims to evaluate the psychological effects of hormonal treatment using questionnaires and scales. This study also aims to validate the ‘ageing male symptoms scale’ in prostate cancer patients on hormonal treatment.
Who can participate?
Male patients on hormone therapy for prostate cancer
What does the study involve?
Psychological side effects and symptoms are assessed using questionnaires. Before they begin their hormone treatment, participants will be given a complete physical examination and their medical history will be taken. Participants complete questionnaires and undergo a full physical examination during and after hormone therapy. Blood samples (about two tablespoons per visit) will also be taken. Many of these blood tests would have been routinely done as part of follow up visits.
What are the possible benefits and risks of participating?
There is no intended clinical benefit. It is hoped that the information from this study will benefit other patients with prostate cancer in the future. There are no expected risks. The main possible disadvantage would be the time involved in completing the questionnaires.
Where is the study run from?
Nottingham University Hospital NHS Trust (UK)
When is the study starting and how long is it expected to run for?
June 2002 to December 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Santhanam Sundar
Santhanam.Sundar@nuh.nhs.uk
Contact information
Scientific
Dept of Oncology
Nottingham University Hospital NHS Trust
Nottingham
NG5 1PB
United Kingdom
 ORCID ID |
0000-0003-0850-5161 |
|---|---|
| Phone | +44 (0)1159691169 |
| sundar@oncology.org |
Study information
| Study design | Prospective observational longitudinal single-centre study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | 40116_PIS.doc |
| Scientific title | Prospective assessment of psychological and vasomotor side effects of testosterone deprivation and assessment of ageing males’ symptoms scale in prostate cancer patients |
| Study acronym | Prostate QOL |
| Study hypothesis | Prospective assessment of psychological and vasomotor side effects of testosterone deprivation and development of an andropause rating scale |
| Ethics approval(s) | Approved 01/03/2005, Nottingham LREC Committee (NHS Nottingham level 3, 1 Standard Court, Park Row, Nottingham, NG1 6GN, UK; +44 (0)115 912 3344 ext 49435; linda.ellis@rushcliffe-pct.nhs.uk), REC ref: 05/Q2403/8 |
| Condition | Prostate cancer |
| Intervention | Patients were administered quality of life (QOL) questionnaires and rating scale questionnaires at specific time points before, during and after completion of hormone therapy. Hormone therapy duration was variable mainly due to baseline clinical features such as Tumour stage, PSA and Pathological features, and in a minority of patients due to subsequently identified clinical need |
| Intervention type | Other |
| Primary outcome measure | Measured before, during and after completion of hormone therapy: 1. Anxiety and depression measured using the Hospital Anxiety and Depression Scale 2. Severity of symptoms related to aging measured using the Aging Males’ Symptoms (AMS) scale 3. Quality of life measured using the EORTC QLQ-C30 questionnaire 4. Symptoms measured using the non-specific symptom (NSS) checklist 5. Health anxiety measured using the Whiteley Index 6. Erectile dysunction measured using an abridged version of the IIEF SCALE |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/06/2002 |
| Overall study end date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 150 |
| Total final enrolment | 150 |
| Participant inclusion criteria | 1. Patients with prostate cancer starting LHRH agonist therapy, irrespective of stage 2. Ability to give informed consent 3. Performance status 0-2 4. Life expectancy should be more than 6 months |
| Participant exclusion criteria | 1. Past or present history of psychiatric problem 2. If a patient scores greater than 11 on the baseline Hospital and Anxiety Scale they will be offered anti-depressant drug treatment and/or a psychiatric referral. In addition they will be asked if they wished to continue in the study. If the patients do not wish to continue at this stage the researchers would not collect any further quality of life information from them 3. Concurrent steroid therapy or treatment with any other antipsychotic/antidepressant/sedative drugs 4. Brain metastases 5. Concurrent radiotherapy 6. Major surgery in last 6 months, e.g. prostatectomy, colectomy etc 7. Major medical illness in last 6 months e.g. pulmonary embolism, myocardial infarction, cerebrovascular accident etc |
| Recruitment start date | 01/03/2005 |
| Recruitment end date | 30/04/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Sponsor information
Hospital/treatment centre
Hucknall Road
Nottingham
NG5 1PB
England
United Kingdom
| Phone | +44 (0)115 9691169 |
|---|---|
| caitlin.todd@nuh.nhs.uk | |
| Website | https://www.nuh.nhs.uk/ |
"ROR" |
https://ror.org/05y3qh794 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Presentation at national and international conferences 2. Peer-reviewed publications |
| IPD sharing plan | The data may be available from Dr Santhanam Sundar (sundar@oncology.org) after the researchers have analysed and published the data in PubMed-listed journals (the main paper and any associated hypothesis-generating papers based on the study data). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 26/07/2021 | No | Yes | ||
| Protocol file | version 3 | 01/06/2009 | 26/07/2021 | No | No |
Additional files
Editorial Notes
26/07/2021: Trial's existence confirmed by Nottingham Research Ethics Committee 1.
