Table 1.
Study phase | Hospital or homea | Hospital or homea | Home-based assessments | ||
Time-point description | Screening visita (V1) | Check-in visita (V2) | Baseline visita (V3) | Follow-up visita (V4) | 12-week follow-up visit (V5) |
Week | –8 to 0 weeks | –2 to 0 weeks | 0 week | 1 to 12 weeks | 12 weeks (V5: –3 to + 7 days) |
Method of the visits | In-person | In-person | Zoom call | Weekly call | Zoom call |
Consent, review of inclusion or exclusion criteria | ✓a |
|
|
|
|
Demographic and contact information | ✓a |
|
|
|
|
Medical history review | ✓a |
|
|
|
|
Medication inventory | ✓ a |
|
✓ |
|
✓ |
Release of medical records authorizations form | ✓a |
|
|
|
|
Depression questionnaire using CES-Db | ✓a |
|
|
|
|
Short physical performance battery test | ✓a |
|
|
|
|
Pregnancy test |
|
✓ |
|
✓c |
|
Randomization |
|
✓ |
|
|
|
Distribute TheraBand |
|
✓ |
|
|
|
Distribute or collect tablets and pre-addressed return package |
|
✓ |
|
|
✓ |
Update of medical history |
|
|
✓ |
|
✓ |
MOCA/BLINDd |
|
|
✓ |
|
✓ |
Quality of life questionnaire—EQ-5D-5L version (via app) |
|
|
✓ |
|
✓ |
Timed up and go (via app) |
|
|
✓ |
|
✓ |
30 second sit to stand test (via app) |
|
|
|
|
|
4 stage balance test (via app) |
|
|
|
|
|
Collection of adverse experiences | ✓ a |
|
✓ | ✓ | ✓ |
ECOGe/WHOf/Zubrod Scale |
|
|
✓ |
|
✓ |
aScreening visit (V1) and check-in visit (V2) may be scheduled on the same day for those patients recruited after hospital discharge.
bCES-D: Center for Epidemiologic Studies Depression Scale.
cWe will send urine pregnancy tests every month for participants to complete at home. Pregnancy status will also be reassessed during the weekly calls.
dMOCA/Blind: Montreal Cognitive Assessment.
eECOG: Eastern Cooperative Oncology Group.
fWHO: World Health Organization.