Primary outcome | ||||||||
Variable | Measures | Participants | Reliability | Validity | E0 | E1 | E2 | E3 |
Fear of cancer recurrence severity | FCRI-SF | Patients | Internal consistency, test–retest17 46 | Concurrent, convergent, discriminant17 46 | ✓ | ✓ | ✓ | ✓ |
Secondary effectiveness outcomes | ||||||||
Variable | Measures | Participants | Reliability | Validity | E0 | E1 | E2 | E3 |
Demographic information | Demographic questionnaire | Patients | N/A | N/A | ✓ | – | – | – |
Fear of cancer recurrence subscales | FCRI | Patients | Internal consistency, test–retest17 46 | Concurrent, convergent, discriminant17 46 | ✓ | ✓ | ✓ | ✓ |
Melanoma-related knowledge | Purpose-designed questionnaire | Patients | N/A | N/A | ✓ | ✓ | ✓ | ✓ |
Depression, anxiety and stress | DASS-21 | Patients | Internal consistency47–51 | Concurrent, convergent, discriminant47–49 | ✓ | ✓ | ✓ | ✓ |
Health-related quality of life | AQOL-8D | Patients | Internal consistency, test–retest52–54 | Concurrent, convergent, discriminant52 54–56 | ✓ | ✓ | ✓ | ✓ |
Secondary implementation outcomes | |||||
Variable | Measures | Participants | I1 | I2 | I3 |
Acceptability | Acceptability of Intervention Measure | Patients* | – | – | – |
Implementation stakeholders | ✓ | ✓ | ✓ | ||
Semistructured interviews | Patients† | – | – | – | |
Expert group discussions | Implementation stakeholders | ✓ | ✓ | ✓ | |
Process data | N/A | ✓ | ✓ | ✓ | |
Appropriateness | Intervention Appropriateness Measure | Patients* | – | – | – |
Implementation stakeholders | ✓ | ✓ | ✓ | ||
Semistructured interviews | Patients† | – | – | – | |
Expert group discussions | Implementation stakeholders | ✓ | ✓ | ✓ | |
Feasibility | Feasibility of Intervention Measure | Implementation stakeholders | ✓ | ✓ | ✓ |
Expert group discussions | Implementation stakeholders | ✓ | ✓ | ✓ | |
Cost | Process data | N/A | ✓ | ✓ | ✓ |
Fidelity | Review of telehealth sessions | Implementation stakeholders | – | – | ✓ |
Sustainability | Expert group discussions | Implementation stakeholders | – | ✓ | ✓ |
E0, baseline; E1, 1-week follow-up; E2, 6-month follow-up; E3, 12-month follow-up.
I1, 3 months pre-implementation; I2, quarterly throughout implementation; I3, 3 months post-implementation.
*Patients will complete the Acceptability of Intervention Measure and Intervention Appropriateness Measure within 1 week of completing their final telehealth session, 6-month and 12-month follow-up.
†Patients will be invited to participate in semistructured interviews within 1 week of completing their final telehealth session.
AQOL-8D, Assessment of Quality of Life–8 Dimensions; DASS-21, Depression, Anxiety and Stress Scales 21-item Short Form; FCRI, Fear of Cancer Recurrence Inventory; FCRI-SF, Fear of Cancer Recurrence Inventory 9-item Short Form; N/A, Not Applicable.