Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
F1005 MAUGHAN R&D
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Gynaecological cancer
Intervention
Nurse counselling versus standard care.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Patient well being, quality of life, sexual functioning.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
08/01/1997
Overall trial end date
31/07/1998
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Diagnosed gynaecological cancer having a surgical procedure with curative intent.
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Advanced disease/palliative intent.
Recruitment start date
08/01/1997
Recruitment end date
31/07/1998
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Northern Gynaecological Oncology Centre
Newcastle upon Tyne
NE9 6SX
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11820343
Publication citations
-
Results
Maughan K, Clarke C, The effect of a clinical nurse specialist in gynaecological oncology on quality of life and sexuality., J Clin Nurs, 2001, 10, 2, 221-229.