Condition category
Cancer
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
19/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Karen Maughan

ORCID ID

Contact details

Northern Gynaecological Oncology Centre
Queen Elizabeth Hospital
Sheriff Hill
Newcastle upon Tyne
NE9 6SX
United Kingdom
+44 0191 403 2123

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11820343

Publication citations

  1. 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.

Additional files

Editorial Notes