Table 2 Summary of findings for the 14 methodological issues addressed in feasibility research

1

Did the feasibility/pilot study allow a sample size calculation for the main trial?

The pilot data provided valuable information related to the participant’s satisfaction and quality of care of the novel ANP-led integrated oncology setting. In the absence of an active comparator in the pilot trial, summaries of these instruments will be compared to equivalent summaries coming from patients receiving usual care, to inform the definitive trial of a sensible effect size to be considered in the sample size calculations

The EQ5D and the EORTC-OUT-PATSAT7 questionnaires were well accepted, demonstrated by high percentage of completion. Furthermore, the intervention in a future trial would be delivered in community-based clusters defined by the centres delivering the treatment. Through the involvement in the pilot study, and in communication with ANP-led oncology clinics similar to the one participating in the feasibility trial, members of the team obtained important information regarding the potential number of clusters and average cluster size (number of participants per cluster) for a future trial. This information will be very relevant when planning the sample size of the main cluster randomised clinical trial

2

What factors influenced eligibility and what proportion of those approached were eligible?

The major constraint on eligibility was the availability of the intervention setting, which was limited to 2 half-days per week

All of those eligible were approached

Of the entire OAM clinic workload of 67 participants, 37 (55%) had assessments appropriate for days the intervention setting was available

Of these 37, all (100%) were approached about participation

3

Was recruitment successful?

Yes, recruitment was successful

37 of 37 patients deemed eligible recruited

4

Did eligible participants consent?

Yes, all eligible participants consented

37 of 37 patients deemed eligible consented

5

Were participants successfully randomized and did randomization yield equality in groups?

This was a single-arm study (all participants received the intervention), and so randomisation was not relevant

Not applicable

6

Were blinding procedures adequate?

This was a single arm study (all participants received the intervention) and so blinding procedures were not relevant

Not applicable

7

Did participants adhere to the intervention?

Clinic attendance was high with no attrition other than completion of OAM course or disease progression on treatment

Referrals by the wider multi-disciplinary team to the ANP continued during the study indicating that staff adhered to the referral process

152 assessments were performed on the 37 participants (101 face-to-face; 51 virtual). 2 assessments were missed by the patient as they had forgotten about the appointment, but they were rescheduled and attended with 7 days

Staff referral of patients to the clinic matched usual care, at approximately 3 patients per month

8

Was the intervention acceptable to the participants?

Participants and staff both reacted positively to the intervention

Utilising the EORTC-OUT-PATSAT7 instrument, participants assessments of convenience, transition, and continuity of care were all at the top of the potential range, indicating very high levels of satisfaction with the intervention

The 3 items rating staff acceptability of the intervention were all highly scored

9

Was it possible to calculate intervention costs and duration?

The methods developed and implemented for the health economics analysis proved feasible

See Table 7 for total intervention costs for the intervention, and Table 8 for patient resource use estimates at follow-up

10

Were outcome assessments completed?

Both participant and staff completion of outcome measures were very high

Full outcome measure data is available for 35 of the 37 participants (94.6%). Only 2 participants could not complete data collection due to disease progression/being unwell

The staff satisfaction questionnaire was completed by 74.1% of staff members solicited (n = 23)

11

Were outcomes measured those that were the most appropriate outcomes?

Outcome measures were appropriate though high scores may suggest additional more sensitive measures may be required for a full trial

The EORTC-OUT-PATSAT7 instrument was deemed appropriate based on the clinical expertise of the research team, and the high completion rates suggest it was appropriate for participants in this study

The EQ-5D-5L has been generally accepted as suitable for use in oncology research and no issues were encountered in the current study

12

Was retention to the study good?

All participants were retained within the study

No participants actively withdrew consent to participation. However, disease progression did impact upon data collection

13

Were the logistics of running a multicentre trial assessed?

This was a single-centre study, and so assessing the logistics of a multicentre trial was not possible

Not applicable

14

Did all components of the protocol work together?

The intervention components worked together as planned. Integrated care in a community location was provided to participants smoothly within existing oncology care

Judgement of the research team, combined with the lack of any problems with the intervention itself