None listed
Conditions
Brief summary
This study aims to investigate the feasibility and acceptability of patient initiated follow-up (PIFU) following surgery for low risk endometrial cancer. Who is it for? You may be eligible for this study if you are a woman aged 18 years or over who has completed definitive primary surgical treatment for endometrial endometrioid adenocarcinoma, and has been assessed by a gynaecological oncology multidisciplinary team as having low risk disease in whom adjuvant therapy is not indicated. Study details Participants will be randomly allocated to PIFU, or standard of care follow up 6-monthly with the patient's General Practitioner. In the PIFU group, participants will receive an education session at baseline regarding when and how to contact the gynaecologic oncology service. Data will be collected on how many women on PIFU refer themselves back to the clinic. All participants will be followed up at 12 months post-baseline to conduct quality of life measures and cancer recurrence rates will be assessed. It is hoped that findings from this study inform a larger trial in future to assess healthcare costs and long term cancer outcomes associated with PIFU in endometrial cancer.
Interventions
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
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.
Sponsors
King Edward Memorial Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed