Treatments for uro-gynaecological problems and patient self-reports v1
Research type
Research Study
Full title
Relationship between treatments for uro-gynecological problems and patient-reported values, psychological states, and quality of life
IRAS ID
130775
Contact name
Phil Reed
Contact email
Sponsor organisation
Swansea University: Department of Research and Innovation
Research summary
The research aims to assess the relationship between treatments for a range of uro-gynaecological problems (pelvic floor dysfunction, cancers) and patient-reported values, paychological states, and quality of life.
The impact of treatments on the patients’ health outcomes will be measured, using specific uro-gynaecological outcome measures (for either pelvic floor dysfunction or cancer), and patient-reported measures of general health and quality of life. Patients’ psychological states and values will be measured by validated self-report instruments for these areas.
Researchers will obtain consent for participation from patients. Following consent, baseline measures will be taken at the patients’ routine appointment about 4-weeks prior to undergoing treatment (e.g., surgery or physiotherapy for pelvic floor dysfunction, or surgery for a uro-gynaecology cancer). These measures will be the routinely-collected physical data obtained by medical staff, and patient-reported measures of their general health (GHQ-28), psychological state (HADS; PVQ-II), and quality of life (EuroQual-5D, WHOQoL-BREF, QRS, EORTC QLQ-C30). These questionnaires should take about 30 minutes to complete, in total.
The patients will then undergo their treatment (physiotherapy programme or surgery), which will not be affected in any way by this research.
About four weeks post-treatment, patients will receive their usual appointment, and routinely-colleced physical data will be obtained by medical staff, and patients will complete the measures as described above.
With the patient’s consent, the above evaluation will be repeated at every follow-up appointment that the patient has (i.e. after 3-months, and then at yearly intervals, for 5 years).
The impact of treatments on objective routine health measures taken by medical staff, and on patient-reported measures of health, quality of life, personal values, and psychological functioning, will be documented at each measurement point. Additionally, relationships between psychological states/values and both objective- and subjective-ratings of how treatments have impacted the patients will be established.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
13/EM/0314
Date of REC Opinion
2 Aug 2013
REC opinion
Further Information Favourable Opinion