Condition category
Cancer
Date applied
28/10/2011
Date assigned
28/10/2011
Last edited
01/12/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Kinta Beaver

ORCID ID

Contact details

Lancashire School of Health
Preston
PR1 2HE
United Kingdom
+44 1772 89 3715
kbeaver@uclan.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11016

Study information

Scientific title

Comparing hospital and telephone follow up for women treated for endometrial cancer (ENDCAT): ENDometrial CAncer Telephone follow up trial): a randomised controlled trial

Acronym

ENDCAT

Study hypothesis

This study aims to demonstrate that specialist nurses have the skills and expertise to meet the information needs and concerns of women treated for endometrial cancer, with no physical or psychological detriment, by carrying out a randomised controlled trial comparing traditional hospital follow-up with telephone follow-up by specialist gynaecology oncology nurses. In addition, we aim to explore patient views and experiences of receiving telephone follow-up.

This study is a randomised controlled trial (RCT) comparing two forms of service provision: standard hospital outpatient follow-up (control arm) and a telephone intervention administered by specialist gynaecology oncology nurses (intervention arm). Primary outcomes are psychological morbidity and patient satisfaction with information; secondary outcomes are quality of life, patient satisfaction with service, number of referrals, time to detection of recurrent disease and cost effectiveness (efficiency). In addition we will also conduct a qualitative study, using semi-structured interviews, to obtain more in-depth information on patients’ experiences of telephone follow-up and nurse specialist views on positive and negative aspects of delivering the telephone intervention.

Ethics approval

National Research Ethics Service (NRES) Committee North West – Preston. REC reference number : 11/NW/0648, Ethical approval : 03 October 2011

Study design

Randomised; Interventional; Design type: Process of Care

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please contact Kinta Beaver (KBeaver@uclan.ac.uk) to request a patient information sheet

Condition

Topic: National Cancer Research Network; Subtopic: Gynaecological Cancer; Disease: Endometrium

Intervention

The total sample size of 256 includes equal distribution between those randomised to the intervention group (telephone follow-up) and those randomsied to the control arm (standard care)

Telephone follow-up, Telephone follow-up by specialist gynaecology oncology nurses at specified time points using a structured telephone intervention designed to meet information and support needs and promote self management.; Follow Up Length: 24 month(s); Study Entry : Registration and One or More Randomisations

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Psychological Morbidity; Timepoint(s): Baseline (pre-randomisation), 1st scheduled clinic appointment post randomisation

Secondary outcome measures

1. Clinical outcomes (time to detection of recurrence); Timepoint(s): At each telephone/hospital appointment that takes place during study period
2. Efficiency; Timepoint(s): 6 and 12 months post randomisation
3. Patient satisfaction with information; Timepoint(s): Baseline (pre-randomisation), 1st scheduled clinic appointment post randomisation
4. Patient satisfaction with service; Timepoint(s): Baseline (pre-randomisation), 1st scheduled clinic appointment post randomisation
5. Quality of Life; Timepoint(s): Baseline (pre-randomisation), 1st scheduled clinic appointment post randomisation

Overall trial start date

23/03/2012

Overall trial end date

30/06/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Known diagnosis of Stage I endometrial cancer
2. Completed primary treatment (e.g. surgery, radiotherapy, chemotherapy)
3. Attending outpatient clinics for the purposes of routine monitoring and surveillance
4. Access to a telephone
5. No age limitations
Gender = female; Target Gender: Female

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 256; UK Sample Size: 256

Participant exclusion criteria

1. Known diagnosis of stage II, III or IV endometrial cancer
2. Currently receiving active treatment
3. Taking part in clinical trials that have pre-defined follow-up regimes
4. Auditory problems that inhibit the use of the telephone
5. Cannot speak or understand English where no interpreter services are available

Recruitment start date

23/03/2012

Recruitment end date

30/06/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Lancashire School of Health
Preston
PR1 2HE
United Kingdom

Sponsor information

Organisation

Lancashire Teaching Hospitals NHS Trust (UK)

Sponsor details

School of Health
University of Central Lancashire
Brook Building 4th Floor (Room BB 440)
Preston
PR1 2HE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) -Research for Patient Benefit programme

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

Publication citations

Additional files

Editorial Notes

01/12/2016: No publications found in PubMed, verifying study status with principal investigator.