OurPERSPECTIVE: Endometrial cancer survivorship study

ISRCTN	ISRCTN97682997
DOI	https://doi.org/10.1186/ISRCTN97682997
Integrated Research Application System (IRAS)	363748
Protocol number	1097
Sponsor	University Hospitals of Leicester NHS Trust
Funder	Leicester, Leicestershire and Rutland Integrated Care Board (LLR ICB)

Submission date: 20/01/2026
Registration date: 28/01/2026
Last edited: 28/01/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Many women live for many years after treatment for endometrial cancer; however, long after treatment has finished, some women continue to experience physical symptoms, emotional concerns, and uncertainty about their health and future. At present, there is limited structured support specifically designed for women who are several years beyond the end of cancer treatment. This study aims to evaluate OurPERSPECTIVE, a structured survivorship programme for women who completed treatment for endometrial cancer at least three years ago. The programme is designed to support wellbeing, help women understand and manage ongoing symptoms, and build confidence in long term health and recovery.

Who can participate?
Women aged 18 years or over who completed primary treatment for endometrial cancer at least three years ago, and who are not receiving active cancer treatment.

What does the study involve?
Participants will be asked to complete questionnaires about their health, well-being, and quality of life at the start of the study and again at 3, 6, and 12 months. Participants will also partake in focus groups to understand, in depth, the barriers and facilitators to participation. Taking part is voluntary, and choosing not to take part will not affect current or future care.

What are the possible benefits and risks of participating?
There are no direct medical benefits from taking part, but participants may find the programme helpful in understanding and managing survivorship issues, and their involvement will help improve future support for women after endometrial cancer. The main risks are minimal and relate to the time required to complete questionnaires or discuss personal experiences, which some women may find upsetting. Participants will be able to skip questions or withdraw at any time.

Where is the study run from?
Leicester Cancer Research Centre, UK

When is the study starting and how long is it expected to run for?
April 2026 to April 2027.

Who is funding the study?
Leicester, Leicestershire and Rutland Integrated Care Board (LLR ICB), UK.

Who is the main contact?
Dr Esther Moss, em321@leicester.ac.uk

Contact information

Dr Esther Moss
Principal investigator, Scientific, Public

Leicester Cancer Research Centre
School of Medical Sciences
University of Leicester
Leicester
LE2 7LX
United Kingdom

Phone	+44 0116 252 5827
Email	em321@leicester.ac.uk

Dr Jatinder Hayre
Public, Scientific

Leicester Cancer Research Centre
School of Medical Sciences
University of Leicester
Leicester
LE2 7LX
United Kingdom

ORCID ID	0000-0003-0473-686X
Phone	+44 0116 252 5827
Email	JSH39@leicester.ac.uk

Study information

Primary study design	Interventional
Allocation	N/A: single arm study
Masking	Open (masking not used)
Control	Uncontrolled
Assignment	Single
Purpose	Prevention, Supportive care
Participant information sheet	48870_PIS_v1.1_30Dec2025.pdf
Scientific title	Feasibility testing of OurPERSPECTIVE: a co-designed survivorship intervention for women following endometrial cancer treatment.
Study acronym	OurPERSPECTIVE
Study objectives	To evaluate the feasibility, acceptability, and preliminary effectiveness of a structured survivorship programme for women 36 months post completion of primary treatment for endometrial cancer, with a focus on quality of life, symptom burden, psychosocial wellbeing, and self management.
Ethics approval(s)	Approved 28/01/2026, West Midlands - Edgbaston Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 0207 104 8000; edgbaston.rec@hra.nhs.uk), ref: 25/WM/0260
Health condition(s) or problem(s) studied	Survivorship and post-treatment health and wellbeing in women following treatment for endometrial cancer.
Intervention	Participants enrolled in the study will take part in OurPERSPECTIVE; a structured survivorship programme designed for women who completed primary treatment for endometrial cancer at least 36 months prior to enrolment. Following consent and baseline assessment, participants will be enrolled into the programme and followed up for a total duration of 12 months. The intervention consists of an eight-week programme, comprising weekly sessions, each lasting approximately 60 minutes. Sessions are delivered in a group-based virtual format using an online platform, allowing participants to take part remotely from their own homes. Each session focuses on a specific survivorship theme: body changes, physical activity, anxiety, fear of recurrence, tiredness, sleep disturbance, and two optional modules: menopause and sexual function. The programme content includes structured educational materials, guided discussion, and reflective activities designed to support self-management skills, confidence, and wellbeing. Participants are provided with a workbook to support engagement during and between sessions. Sessions are delivered by a clinical nurse specialist with experience in cancer survivorship and supportive care. Intervention facilitators have relevant clinical backgrounds and receive training specific to the delivery of the programme to ensure consistency and fidelity. Participants receive the same core content, with opportunities for discussion and reflection, allowing individual experiences to be shared within the group setting. Participant engagement with the programme is monitored through attendance records and completion of session activities. Fidelity of delivery is supported through the use of a structured session guide and facilitator training. Any adaptations made to the intervention during the study will be documented. All participants are asked to complete patient-reported outcome questionnaires at baseline, and again at 3 months, 6 months, and 12 months following enrolment. Participants will also be invited to provide qualitative feedback through focus groups to explore acceptability, barriers, and facilitators to participation. Participants remain free to withdraw from the study at any time without giving a reason, and withdrawal does not affect any current or future clinical care.
Intervention type	Behavioural
Primary outcome measure(s)	Acceptability and Feasibility of the OurPERSPECTIVE survivorship course measured using recruitment rates (proportion of eligible women approached who consent to take part), retention rates (proportion of participants completing the 8-week course), attendance and engagement (number of sessions attended), participant evaluation of the course (questionnaire ratings of usefulness and relevance, and qualitative feedback from focus groups) at either A) mid-week during the intervention for select participants (week 4), or B) upon completion of the entire intervention
Key secondary outcome measure(s)	Recruitment and retention feasibility measured using the proportion of eligible women recruited; proportion completing the intervention; retention at post-intervention assessment; reasons for declining participation; or withdrawal recorded descriptively at baseline, 3 , 6 , and 12 months Questionnaire completion and data quality measured using questionnaire completion rates, item level missingness, and completeness of patient reported outcome measures at baseline, 3 , 6 , and 12 months Psychological wellbeing and emotional distress measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, 3 , 6 , and 12 months General health status and wellbeing measured using the self-reported health status via the 36-Item Short Form Survey (SF-36) and Health-Related Quality of Life (HRQoL) 5-level EQ-5D version (EQ-5D-5L) at baseline, 3 , 6 , and 12 months Participant engagement and acceptability measured using the completion of intervention modules; engagement with programme activities; participant satisfaction and acceptability ratings collected via structured questionnaires at month 3, upon completion of the intervention Barriers and facilitators to participation measured using qualitative feedback on barriers and facilitators to participation, acceptability of study materials, and relevance of course content collected via free text responses or interviews at either A) mid-week during the intervention for select participants (week 4); or B) upon completion of the entire intervention
Completion date	01/04/2027

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	99 Years
Sex	Female
Target sample size at registration	30
Key inclusion criteria	1. Adult women (aged ≥18 years) 2. Histologically confirmed endometrial cancer, treated with curative intent 3. Completed primary treatment (surgery with or without adjuvant radiotherapy and or chemotherapy) 4. Cancer-free and not receiving active anti-cancer treatment at enrolment (excluding maintenance or non-cancer medications) 5. At the survivorship timepoint: 36 months post treatment completion (preferred, consistent with OurPERSPECTIVE specification) 6. Able to provide informed consent 7. Able to participate in the intervention delivery mode (for example, online): access to an internet-enabled device and sufficient digital literacy to engage with materials (with reasonable support as planned) 8. Able to understand study materials in English (or the languages provided, if translated versions are available)
Key exclusion criteria	1. Evidence of recurrent or metastatic endometrial cancer, or undergoing investigation for suspected recurrence at enrolment 2. Currently receiving active anti-cancer treatment for endometrial cancer (for example, chemotherapy, radiotherapy, immunotherapy, targeted therapy), excluding routine surveillance follow-up 3. Less than 36 months since completion of primary endometrial cancer treatment 4. Unable to provide informed consent 5. Insufficient proficiency in the language(s) of the intervention materials to participate meaningfully (unless translated materials and support are available) 6. Severe cognitive impairment or severe mental health presentation that, in the judgement of the clinical or research team, would prevent safe and informed participation (for example, acute psychosis, severe unmanaged depression with marked functional impairment) 7. Medical instability or intercurrent illness that would make participation unsafe or impracticable during the intervention period (for example, current hospital admission, uncontrolled symptoms requiring urgent escalation) 8. Concurrent enrolment in another structured survivorship intervention trial that would materially confound outcomes (case-by-case judgement; observational studies usually permitted) 9. Practical inability to participate in the intervention delivery mode (for example, no access to the necessary device or internet for a digital programme, where no alternative access pathway is provided)
Date of first enrolment	01/04/2026
Date of final enrolment	13/05/2026

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University Hospitals of Leicester NHS Trust

Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
England

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	version 1.1	30/12/2025	27/01/2026	No	Yes
Participant information sheet	Leaflet version 2.0	30/12/2025	27/01/2026	No	Yes
Protocol file	version 1	14/10/2025	27/01/2026	No	No

Additional files

48870_Protocol_v1_14Oct2025.pdf: Protocol file
48870_PIS_v1.1_30Dec2025.pdf: Participant information sheet
48870_PIL_v2.0_30Dec2025.pdf: Leaflet

Editorial Notes

28/01/2026: The following changes were made:
1. The date of first enrolment was changed from 01/02/2026 to 01/04/2026.
2. The date of final enrolment was changed from 31/03/2026 to 13/05/2026.
3. The completion date was changed from 31/03/2027 to 01/04/2027.
4. Final ethics approval date and REC reference added.
27/01/2026: Study's existence confirmed by Health Research Authority (HRA) (UK).