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
Secondary identifying numbers F1005 MAUGHAN R&D
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

Northern Gynaecological Oncology Centre
Queen Elizabeth Hospital
Sheriff Hill
Newcastle upon Tyne
NE9 6SX
United Kingdom

Phone +44 0191 403 2123

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeQuality of life
Scientific title
Study objectivesPsychological 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) studiedGynaecological cancer
InterventionNurse counselling versus standard care.
Intervention typeOther
Primary outcome measurePatient well being, quality of life, sexual functioning.
Secondary outcome measuresNot provided at time of registration
Overall study start date08/01/1997
Completion date31/07/1998

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexFemale
Target number of participantsNot provided at time of registration
Key inclusion criteriaDiagnosed gynaecological cancer having a surgical procedure with curative intent.
Key exclusion criteriaAdvanced disease/palliative intent.
Date of first enrolment08/01/1997
Date of final enrolment31/07/1998

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Northern Gynaecological Oncology Centre
Newcastle upon Tyne
NE9 6SX
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Northern and Yorkshire (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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