Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001120561p
Ethics application status
Submitted, not yet approved
Date submitted
20/08/2024
Date registered
17/09/2024
Date last updated
17/09/2024
Date data sharing statement initially provided
17/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient Initiated Follow Up (PIFU) in Endometrial Cancer (PECAN) – a Randomised Pilot Feasibility Study
Scientific title
Patient Initiated Follow Up (PIFU) in Endometrial Cancer (PECAN) – a Randomised Pilot Feasibility Study
Secondary ID [1] 312796 0
None
Universal Trial Number (UTN)
None
Trial acronym
PECAN
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Endometrial cancer 334859 0
Condition category
Condition code
Cancer 331412 331412 0 0
Womb (Uterine or endometrial cancer)
Public Health 331542 331542 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The experimental intervention is patient initiated follow-up (PIFU).

Participants will be randomised and allocated to either patient initiated follow-up (PIFU) or to standard general practitioner (GP) follow-up (regular 6-monthly visits with their GP).

Participants allocated to the PIFU arm will not have to attend follow-up appointments or their general practitioner for an examination every few months. Instead, they will receive education about symptoms to look out for, which may suggest that their endometrial cancer could have returned (for example, vaginal bleeding).

The Education will be provided by a Research Nurse during one 30 minutes session provided either face-to-face or by telephone one-on-one. Written information about symptoms of endometrial cancer recurrence developed specifically for this study will be provided to participants at this education session by a Research Nurse. Attendance at this education session will be mandatory for study enrolment. The 'teach back' technique will be used to ensure that participants have understood the information. Participants will be asked by the Research Nurse to repeat back the information they have received in their own words.

If participants allocated to the PIFU arm do have any symptoms or are concerned they will be asked to contact the gynaecological cancer clinic and will be offered an urgent clinic appointment.

Participants will be asked to complete three questionnaires about your health and quality of life on two separate occasions.
1. At the beginning of the study, after they have been allocated to either the PIFU group or to the standard GP follow-up group.
2. After 12 months, at the end of the study.

The qualitative sub-study will be 'opt-in' and involve interviews exploring participant experiences of participating in PIFU to explore their views on the acceptability of the intervention. The interviews will be semi-structured and conducted by a psychology researcher at the Psycho-oncology Co-operative Research Group (PoCoG) based at the University of Sydney. The approximate duration of interviews will be 45 minutes. Approximately 20 participants in the PFU arm will be asked to participate. Interviews will be audio-recorded and transcribed. The coding of the interviews will be conducted by a single researcher; a second researcher will conduct an independent audit to confirm that the analysis was systematic and transparent and that the resulting themes are credible. NVivo qualitative data management software will facilitate the organisation and thematic analysis.
Intervention code [1] 329321 0
Treatment: Other
Comparator / control treatment
Participants allocated to the control arm will receive standard of care follow up that involved 6-monthly follow-up visits with their GP. These visits involve review of symptoms and physical examination. Patients will also receive education to seek review outside of planned follow up schedule if any new symptoms or concerns,

Participants allocated to the PIFU arm will not receive follow-up as this is the intervention.
Control group
Active

Outcomes
Primary outcome [1] 339159 0
The proportion of eligible patients who enrol in the PECAN pilot study
Timepoint [1] 339159 0
At completion of the recruitment period
Primary outcome [2] 339285 0
Acceptability
Timepoint [2] 339285 0
12 months
Secondary outcome [1] 438823 0
The proportion of patients randomised to PIFU who self-refer back to the gynaecologic oncology clinic.
Timepoint [1] 438823 0
Participants will be followed until 12 months post-baseline. The proportion of patients who self-refer back to the gynaecologic oncology clinic will be assessed at the end of the study.
Secondary outcome [2] 438824 0
Fear of Cancer Recurrence
Timepoint [2] 438824 0
Baseline and 12 months post-baseline
Secondary outcome [3] 438825 0
Cancer recurrence
Timepoint [3] 438825 0
12 months post-baseline
Secondary outcome [4] 439367 0
Quality of life
Timepoint [4] 439367 0
Baseline and 12 months post-baseline
Secondary outcome [5] 439368 0
Endometrial Cancer Specific Quality of Life
Timepoint [5] 439368 0
Baseline and 12 months post-baseline

Eligibility
Key inclusion criteria
1. Women who have completed definitive primary surgical treatment for endometrial endometrioid adenocarcinoma
2. Women who are assessed by a gynaecological oncology multidisciplinary team as having low risk disease in whom adjuvant therapy is not indicated
3. Patients who are clinically well, have no side effects needing ongoing intervention or management, and are not on any active treatment or enrolled in any clinical trials
4. Patients who can access the gynaecological oncology team while undergoing PIFU (access to phone / internet / transport if needed)
5. Non-English-speaking patients with access to interpreter services, and where PROMS are available in the appropriate language, and with capacity to consent to enrol in the trial
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Non-endometrioid histology
2. Not able to engage with PIFU
3. Stage 1B
4. Grade 3
5. p53 abnormal tumours
6. Extensive LVSI

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centralised randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is a pilot study. Analyses will be descriptive.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
30/01/2026
Actual
Date of last data collection
Anticipated
26/02/2027
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 26968 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 43043 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 317227 0
Charities/Societies/Foundations
Name [1] 317227 0
Australia and New Zealand Gynaecological Oncology Group (ANZGOG)
Country [1] 317227 0
Australia
Funding source category [2] 317228 0
Charities/Societies/Foundations
Name [2] 317228 0
Australasian Society of Gynaecological Oncologists
Country [2] 317228 0
Australia
Primary sponsor type
Hospital
Name
King Edward Memorial Hospital
Address
Country
Australia
Secondary sponsor category [1] 319506 0
None
Name [1] 319506 0
None
Address [1] 319506 0
Country [1] 319506 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315964 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 315964 0
Ethics committee country [1] 315964 0
Australia
Date submitted for ethics approval [1] 315964 0
03/09/2024
Approval date [1] 315964 0
Ethics approval number [1] 315964 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136366 0
A/Prof Emma Allanson
Address 136366 0
Western Australia Gynaecological Cancer Service, King Edward Memorial Hospital, 374 Bagot Road, Subiaco, WA 6008
Country 136366 0
Australia
Phone 136366 0
+61 8 6458 1164
Fax 136366 0
Email 136366 0
emma.allanson@health.wa.gov.au
Contact person for public queries
Name 136367 0
A/Professor Emma Allanson
Address 136367 0
Western Australia Gynaecological Cancer Service, King Edward Memorial Hospital, 374 Bagot Road, Subiaco, WA 6008
Country 136367 0
Australia
Phone 136367 0
+61 8 6458 1164
Fax 136367 0
Email 136367 0
emma.allanson@health.wa.gov.au
Contact person for scientific queries
Name 136368 0
A/Professor Emma Allanson
Address 136368 0
Western Australia Gynaecological Cancer Service, King Edward Memorial Hospital, 374 Bagot Road, Subiaco, WA 6008
Country 136368 0
Australia
Phone 136368 0
+61 8 6458 2222
Fax 136368 0
Email 136368 0
emma.allanson@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24154Informed consent form    388327-(Uploaded-03-09-2024-15-40-20)-PECAN PICF 20 August 2024.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.