Table 1.
Investigation schedule.
|
|
Electronic case report form creation | Baseline visit | Follow-up month 1a week 4 (–2 weeks to +2 weeks) | Follow-up month 3 week 12 (–2 weeks to +2 weeks) | Follow-up month 6 week 24 (–2 weeks to +2 weeks) | |
| Prescreening informed consent | ✓ |
|
|
|
|
|
| Screening informed consent |
|
✓ |
|
|
|
|
| Eligibility criteria |
|
✓ |
|
|
|
|
| Clinical datab |
|
✓ | ✓ | ✓ | ✓ | |
| Supportive care resources proposedc |
|
✓ |
|
|
|
|
| Attendance and adoption data to supportive care resources proposedd |
|
|
|
✓ | ✓ | |
| Out of schedule use of hospital services (emergency visits, extra consultations, and hospitalization) |
|
|
|
✓ |
|
|
| Resilience mobile app use datae |
|
✓ | ✓ | ✓ | ✓ | |
| Electronic patient-reported outcomesf | ||||||
|
|
Sociodemographic questionnaire |
|
✓ |
|
|
|
|
|
National Comprehensive Cancer Network’s Distress Thermometer and Problem List |
|
✓ | ✓ | ✓ | ✓ |
|
|
5-level EQ-5D version |
|
✓ | ✓ | ✓ | ✓ |
|
|
MD Anderson Symptom Inventory |
|
✓ | ✓ | ✓ | ✓ |
|
|
Patient Assessment of Chronic Illness Care |
|
|
|
✓ |
|
|
|
Health Literacy Questionnaire |
|
✓ |
|
|
|
|
|
Gustave Roussy vulnerability questionnaireg |
|
✓ |
|
|
|
|
|
30-item European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaireh |
|
✓ |
|
✓ | ✓ |
|
|
Hospital Anxiety and Depression Scalei |
|
✓ |
|
✓ | ✓ |
|
|
Insomnia Severity Index j |
|
✓ |
|
✓ | ✓ |
|
|
22-item European Organization for the Research and Treatment of Cancer Sexual Health Questionnairek |
|
✓ |
|
✓ | ✓ |
|
|
Experience and satisfaction questionnairesl |
|
|
|
✓ |
|
| Qualitative research | ||||||
|
|
Focus groupsm |
|
|
|
✓ |
|
aFor patients included in the immune toxicity management pathway.
bComplete clinical data including type of cancer; stage; prior and ongoing oncological treatments; comorbidities; disease status; description and grading of treatment-related toxicities and its relationship with treatment; treatment discontinuation and reintroduction; supportive care strategies proposed and attendance log to supportive care strategies; and use of hospital services, including emergency visits, extra consultations, and hospitalizations. Oncological scores used for supportive care management included: Geriatric score G8, thrombosis score, nausea, and vomiting score.
cFor the complete list of supportive care resources, refer to Textbox 1.
dIncluding attendance data in all in-person supportive care interventions.
eResilience [29] is a mobile app used in routine care at Gustave Roussy for remote symptom monitoring, patient empowerment, and education. Data on mobile app use, including symptoms reported, alerts generated, and content used, will be evaluated.
fSpecific questionnaires can be added if pertinent to a new pathway.
gSent only for patients participating in the pathway to prevent treatment-related burden (brain, head and neck, thoracic, and neuroendocrine tumors).
hSent only for patients in the pathway for preventing treatment-related burden after breast cancer.
iSent only for patients in the pathway for preventing treatment-related burden after breast cancer or patients referred to supportive care services for emotional distress and anxiety (mindfulness meditation programs, cognitive behavioral therapy, and psychological consultation).
jSent only for patients referred for supportive care strategies for insomnia (cognitive behavioral therapy and mindfulness meditation programs).
kSent only for patients with sexual concerns referred for sexologist consultation.
lThe experience questionnaire will be specific for each supportive care intervention.
mFocus groups with participants of each supportive care intervention.