ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620001149954

Ethics application status

Approved

Date submitted

25/08/2020

Date registered

3/11/2020

Date last updated

3/11/2020

Date data sharing statement initially provided

3/11/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Pilot study to embed electronic Patient Reported Outcome Measures and patient reported experience measures into routine care for patients with Stage III MELanoma (ePROMs-MEL)

Scientific title

Pilot study to embed electronic Patient Reported Outcome Measures and patient reported experience measures into routine care for patients with Stage III MELanoma (ePROMs-MEL)

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1257-2777

Trial acronym

ePROMs-MEL

Linked study record

Not applicable

Health condition

Health condition(s) or problem(s) studied:

Melanoma - Stage III

Psychosocial stress

Quality of life

Mental Health

Condition category

Condition code

Cancer

Malignant melanoma

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will complete PROM questionnaires at their initial recruitment visit (baseline) and at 3-4 monthly intervals over a 12 month period (between 4-5 times). This schedule is designed to coincide with their routine clinical follow-up appointments.
At each visit, all patients will be required to complete two short questionnaires that are used to assess their psychosocial distress and quality of life: 1. the National Comprehensive Cancer Centre (NCCN)’s Distress Thermometer (DT) and Problem List for Patients; and 2. EuroQoL’s EQ-5D-5L and visual analogue scale. Patients who score above the clinical cut off score on these measures (4 or above on DT and 3 or above on any of the five EQ-5D-5L questions), indicating a moderate or higher level of psychosocial distress or moderate quality of life impairment, will then be required to complete an additional three questionnaires: the Melanoma Concerns Questionnaire (MCQ-28), the Depression, Anxiety and Stress Scale (DASS-21) and the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30). These additional questionnaires will provide more detailed information about potential areas of support needs. Completion time for all five questionnaires is expected to be less than 30 minutes.
All questionnaires used in this study have been validated in previous studies. The MCQ-28 is a recently-developed questionnaire which includes some patient-reported experience measures (PREMs) in addition to PROMs. The remaining four questionnaires cover PROMs only.
Data will be collected on time taken to complete questionnaires and on the number of times the questionnaires were completed (out of a maximum of five times). In addition, the
number of questions answered in the second set of three questionnaires (all questions in the first set of two questionnaires are mandatory) will be recorded.

Intervention code [1]

Other interventions

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

To evaluate the feasibility of embedding electronic PROMs into routine care from the perspective of Stage III melanoma patients. This will be assessed by the proportion of patients who complete at least baseline and one other set of PROMs questionnaires, out of a maximum possible five time points. For the intervention to be considered feasible, 60% of participants must complete questionnaires at baseline and at least one other time point.

Timepoint [1]

This outcome will be measured at baseline, 3, 6, 9 and 12 months.

Primary outcome [2]

To evaluate the feasibility of embedding electronic PROMs into routine care from the perspective of the patient's treating clinical team (i.e. surgeons, dermatologists, medical oncologists, psychologists and nurses). This will be assessed by clinician responses to surveys and semi-structured interviews conducted at the end of the study.

Timepoint [2]

This outcome will be measured at 12 months.

Primary outcome [3]

To evaluate the acceptability of embedding electronic PROMs into routine care from the perspective of Stage III melanoma patients. This will be assessed by patient responses to surveys and semi-structured interviews conducted at the end of the study.

Timepoint [3]

This outcome will be measured at 12 months.

Secondary outcome [1]

This is the final primary outcome. To evaluate the acceptability of embedding electronic PROMs into routine care from the perspective of the patient's treating clinical team (i.e. surgeons, dermatologists, medical oncologists, psychologists and nurses). This will be assessed by clinician responses to surveys and semi-structured interviews conducted at the end of the study.

Timepoint [1]

This outcome will be measured at 12 months.

Secondary outcome [2]

To evaluate whether embedding electronic PROMs leads to increase patient referrals. This will be measured by comparison of the number of referrals of patients to support services before and after the intervention. The number of referrals will be assessed via clinic records.

Timepoint [2]

18 months

Secondary outcome [3]

The production of a framework for the data systems required to enable electronic data capture and feedback to clinicians in real-time. This will be assessed by responses from patients and clinicians about the ease of use and relevance of the questionnaire data (through survey and semi-structured interviews).

Timepoint [3]

12 months.

Secondary outcome [4]

NCCN Distress Thermometer and Problem List for Patients outcomes are
Psychosocial distress and five categories of problems: practical, family, emotional, spiritual/religious and physical.

Timepoint [4]