A prospective evaluation of the effect of a nurse counsellor on psychological and sexual morbidity in gynaecological cancer patients
| ISRCTN | ISRCTN72407850 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72407850 |
| Protocol serial number | F1005 MAUGHAN R&D |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Northern and Yorkshire (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 19/10/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Karen Maughan
Scientific
Scientific
Northern Gynaecological Oncology Centre
Queen Elizabeth Hospital
Sheriff Hill
Newcastle upon Tyne
NE9 6SX
United Kingdom
| Phone | +44 0191 403 2123 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Psychological sequelae following the diagnosis and treatment of cancer are common. The treatment of gynaecological tumours is however recognised to present particular difficulties in relation to altered fertility, changes in body image and sexual dysfunction. There is evidence to indicate that improvements in sexual function and reduction in psychological morbidity in breast cancer patients can be achieved through counselling. Some previous studies evaluating sexual dysfunction in gynaecological oncology have been flawed due to the failure to use control subjects, the exclusion of partners or the limited duration of follow-up. The Northern Centre for Gynaecological Oncology provides the opportunity to conduct this study due to the centralisation of surgical treatment. The applicant also has the support and supervision of nursing, clinical psychology and medical colleagues, thus providing the skill range necessary to complete the project. Aims : 1. To analyse the impact of surgery for gynaecological cancer on the well being of patients and their lived experience of illness. 2. To identify areas in which nursing practice may be developed across the Primary/Secondary care interface, in relation to the adaptation and rehabilitative process following surgery. 3. To provide clear evidence which demonstrates the benefits of a 'nurse counsellor' for women with gynaecological cancer. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Gynaecological cancer |
| Intervention | Nurse counselling versus standard care. |
| Intervention type | Other |
| Primary outcome measure(s) |
Patient well being, quality of life, sexual functioning. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/07/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Key inclusion criteria | Diagnosed gynaecological cancer having a surgical procedure with curative intent. |
| Key exclusion criteria | Advanced disease/palliative intent. |
| Date of first enrolment | 08/01/1997 |
| Date of final enrolment | 31/07/1998 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Northern Gynaecological Oncology Centre
Newcastle upon Tyne
NE9 6SX
United Kingdom
NE9 6SX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2001 | Yes | No |
