Could supported weight loss reduce womb cancer surgery complications?

Approved 03/08/2023, Oxford B Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8230; oxfordb.rec@hra.nhs.uk), ref: 23/SC/0223

1. Recruitment rate measured using the number of sites open, the total n participants recruited, and the number of participants recruited per site as documented in the study notes per month at screening.
2. Engagement rate measured using the mean proportion of phone calls answered per participant documented in the study notes throughout the intervention.
3. Adherence rate measured using the proportion of intervention participants with ≥5% weight loss documented in the study notes from baseline to the day of surgery.
4. Retention rate measured using the proportion of participants documented in the study notes as attending their final follow-up (30 days post-operatively)
5. Safety profile measured using related adverse events and expected related and unexpected related serious adverse events documented in the study notes throughout the study.

Current secondary outcome measures as of 30/12/2024:
Morbidity will be assessed from patient records at discharge and 30 days postoperatively using the Clavien-Dindo classification as follows:
1. Any morbidity
2. Morbidity by grade (II, IIIa, IIIb, IVa, IVb)

Oncological outcomes will be assessed from patient records using:
3. Survival (grade V) assessed at 3 years
4. Fitness to receive planned adjuvant therapy assessed at 30 days post postoperatively
5. Recurrence assessed at 3 years
6. New primary/secondary cancer assessed at 3 years

Operative outcomes will be assessed from patient records using:
7. Intraoperative blood loss assessed at discharge
8. Operative time assessed at discharge
9. Conversion to open surgery assessed at discharge
10. Surgical site infection assessed at discharge and 30- days post-operatively
11. Time in the intensive care unit and high-dependency unit assessed at discharge and 30- days post-operatively.
12. Re-operation rates assessed at 30 days post-operatively and 3 years
13. Re-admission rates assessed 30 days post-operatively and 3 years

Hospital stay will be assessed from patient records at discharge and 30 days postoperatively using:
16. Length of hospital stay (fitness to discharge) assessed at discharge.
17. Days alive and out of hospital assessed 30 days post-operatively.

Anthropometry will be assessed by measuring in-person at baseline, on admission, and 30 days postoperatively using:
18. Weight
19. Fat-free mass

Fitness will be assessed by measuring in-person at baseline and 30 days postoperatively using:
20. Time for sit-to-stand test

Health-related quality of life will be self-reported at baseline, 4 days preoperatively, and 30 days postoperatively using:
21. EQ-5D-5L
22. HADS

Endometrial cancer specific health-related quality of life will be self-reported at 30 days postoperatively using:
23. EORTC-QLQ-EN24

Costs and resource use will be assessed from trial records and by self-report using:
24. Intervention costs assessed at the end of intervention.
25. Healthcare resource use questionnaire assessed at baseline, and 30 days post-operatively.
26. QALYs assessed at baseline, and 30 days post-operatively.

27. Adverse events will be self-reported throughout the study

Process outcome measures:

Experience of the intervention will be assessed using:
1. Analysis of qualitative interviews with intervention participants conducted halfway from starting intervention to surgery.
2. Feedback pre-operatively self-reported using a feedback questionnaire at 4 days preoperatively.
3. Feedback post-operatively self-reported using a feedback questionnaire 30 days post-operatively.

Experience of the trial will be assessed using:
4. Feedback post- operatively self-reported using a feedback questionnaire 30 days post-operatively.
5. Interviews with staff conducted throughout the trial.

6. Interviews with next of kin/friends/carers

Control group contamination will be assessed using:
7. Feedback post- operatively self-reported using a feedback questionnaire 30 days post-operatively.

Fidelity of delivery will be assessed using:
8. Observation of consultations throughout the intervention

Barriers to trial enrolment will be assessed using:
9. Reasons for declining participation assessed from patient records at screening

Exploratory (sub-study) – Manchester NHS Foundation Trust only :

Skeletal and lean muscle mass will be assessed at baseline and 2 days preoperatively using:
1. Appendicular skeletal muscle
2. Whole-body lean mass
3. Relative lean mass (%)

Fat mass will be assessed at baseline and 2 days 2 days preoperatively using:
4. Whole body fat mass

Cardiorespiratory fitness will be assessed at baseline and 2 days preoperatively using:
5. V02 peak
6. First ventilatory threshold
7. Distance walked during 6-minute walk test

Bone mineral density will be assessed at baseline and 2 days preoperatively using:
8. Bone density at the (total hip, femoral neck, lumbar spine, whole body)

Previous secondary outcome measures:
Morbidity will be assessed from patient records at discharge and 30 days postoperatively using the Clavien-Dindo classification as follows:
1. Any morbidity
2. Morbidity by grade (II, IIIa, IIIb, IVa, IVb)

Oncological outcomes will be assessed from patient records using:
3. Survival (grade V) assessed at 3 years
4. Fitness to receive planned adjuvant therapy assessed at 30 days post postoperatively
5. Recurrence assessed at 3 years
6. New primary/secondary cancer assessed at 3 years

Operative outcomes will be assessed from patient records using:
7. Intraoperative blood loss assessed at discharge
8. Operative time assessed at discharge
9. Conversion to open surgery assessed at discharge
10. Surgical site infection assessed at discharge and 30- days post-operatively
11. Time in the intensive care unit and high-dependency unit assessed at discharge and 30- days post-operatively.
12. Re-operation rates assessed at 30 days post-operatively and 3 years
13. Re-admission rates assessed 30 days post-operatively and 3 years

Hospital stay will be assessed from patient records at discharge and 30 days postoperatively using:
16. Length of hospital stay (fitness to discharge) assessed at discharge.
17. Days alive and out of hospital assessed 30-days post-operatively.

Anthropometry will be assessed by measuring in-person at baseline, on admission, and 30 days postoperatively using:
18. Weight
19. Fat-free mass

Fitness will be assessed by measuring in-person at baseline and 30 days postoperatively using:
20. Time for sit-to-stand test

Health-related quality of life will be self-reported at baseline, 4 days preoperatively, and 30 days postoperatively using:
21. EQ-5D-5L
22. HADS

Endometrial cancer specific health-related quality of life will be self-reported at 30 days postoperatively using:
23. EORTC-QLQ-EN24

Costs and resource use will be assessed from trial records and by self-report using:
24. Intervention costs assessed at the end of intervention.
25. Healthcare resource use questionnaire assessed at baseline, and 30 days post-operatively.
26. QALYs assessed at baseline, and 30 days post-operatively.

27. Adverse events will be self-reported throughout the study

Process outcome measures:

Experience of the intervention will be assessed using:
1. Analysis of qualitative interviews with intervention participants conducted halfway from starting intervention to surgery.
2. Feedback pre-operatively self-reported using a feedback questionnaire at 4 days preoperatively.
3. Feedback post-operatively self-reported using a feedback questionnaire 30 days post-operatively.

Experience of the trial will be assessed using:
4. Feedback post- operatively self-reported using a feedback questionnaire 30 days post-operatively.
5. Interviews with staff conducted throughout the trial.

Control group contamination will be assessed using:
6. Feedback post- operatively self-reported using a feedback questionnaire 30 days post-operatively.

Fidelity of delivery will be assessed using:
7. Observation of consultations throughout the intervention

Barriers to trial enrolment will be assessed using:
8. Reasons for declining participation assessed from patient records at screening