None listed
Conditions
Brief summary
This study will assess the feasibility (can it be done?) and acceptability (is it a helpful thing to do?) of short electronic surveys called patient reported outcome measures (PROMS) in the ongoing treatment of Stage III melanoma patients. Who is it for? If you are an adult who has been diagnosed with Stage III melanoma (with lymph node involvement) at least 3 months earlier and you are being treated at the Sydney Melanoma Surgical Oncology clinics at either the Royal Prince Alfred Hospital, or the Melanoma Institute of Australia, you may be eligible to participate in this study. Study details Participants enrolled in this study will be asked to complete a series of 2-5 health-related surveys about their quality of life on an iPad prior to their scheduled clinic appointments. Participants will receive instructions on how to complete the surveys, and will be provided with assistance from a nurse or the research project manager as needed. It is anticipated that completion of the surveys will take no more than 30 minutes before each appointment, and participants will be asked to complete either 2 or 5 surveys before 4-5 clinic visits over a 12 month period. At the end of the 12 months, all participants will be asked to complete a short survey and some will be invited to attend a one-on-one study interview with the research project manager to discuss their involvement in the study, and whether they found the surveys helpful in their discussions with their doctors. It is hoped this research may be used to improve health outcomes for patients with Stage III melanoma by highlighting patient-important outcomes following surgery, including symptoms, and quality of life issues that are central to assessing the value of melanoma care from a patient’s perspective.
Interventions
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 Probl
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.
Sponsors
The University of Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient key inclusion criteria: • Adults (over 18) • Diagnosis of Stage III melanoma at least 3 months earlier • Under the care of melanoma clinicians at MIA or RPAH • Sufficient English and cognitive ability to comprehend study materials, provide informed consent and participate in this study Clinician inclusion criteria: • Clinicians currently treating and managing patients with stage III melanoma at Sydney Melanoma Surgical Oncology clinics at MIA or RPAH.
Exclusion criteria
None
Outcome results
None listed