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

ISRCTN	ISRCTN75220876
DOI	https://doi.org/10.1186/ISRCTN75220876
Secondary identifying numbers	11016

Submission date: 28/10/2011
Registration date: 28/10/2011
Last edited: 26/10/2022

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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-comparing-hospital-and-telephone-follow-up-after-treatment-for-womb-cancer-endcat

Contact information

Prof Kinta Beaver
Scientific

Lancashire School of Health
Preston
PR1 2HE
United Kingdom

Phone	+44 (0)1772 89 3715
Email	kbeaver@uclan.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Process of Care
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Other
Participant information sheet	Not available in web format, please contact Kinta Beaver (KBeaver@uclan.ac.uk) to request a patient information sheet
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
Study 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(s)	National Research Ethics Service (NRES) Committee North West Preston, 03/10/2011, REC ref: 11/NW/0648
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 randomised to the control arm (standard care) 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
Primary outcome measure	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 study start date	23/03/2012
Overall study end date	30/06/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Planned Sample Size: 256; UK Sample Size: 256
Total final enrolment	259
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 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

England
United Kingdom

Study participating centre

Lancashire School of Health

Preston
PR1 2HE
United Kingdom

Sponsor information

Lancashire Teaching Hospitals NHS Trust (UK)
Hospital/treatment centre

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

"ROR"	https://ror.org/02j7n9748

Funders

Funder type

Government

Research for Patient Benefit Programme
Government organisation / National government

Alternative name(s): NIHR Research for Patient Benefit Programme, RfPB
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2018		Yes	No
Plain English results			26/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
16/04/2018: Publication reference added.
01/12/2016: No publications found in PubMed, verifying study status with principal investigator.