Solid tumor or lymphoma
Conditions
Interventions
The intervention will, in principle, be conducted by patients themselves using the mobile application, with investigators assisting them as needed. 1. GA: Patients will complete the GA on the mobile
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of solid cancer or malignant lymphoma 2. Age >=70 years 3. Scheduled to initiate or change the line of systemic anticancer therapy (chemotherapy, molecularly targeted therapy, or immunotherapy) 4. ECOG Performance Status of 0-2 5. Ability to read, write, and understand Japanese 6. Provision of written informed consent 7. Presence of at least one impaired GA domain at the time of registration
Exclusion criteria
Exclusion criteria: 1. Participation or planned participation in other interventional studies that may interfere with this study (e.g., other psychological or communication support studies, or therapeutic clinical trials) 2. Judged by their attending oncologists to be unsuitable for participation 3. Presence of severe cognitive impairment without a proxy or legal representative
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants in the intervention arm who complete the full intervention program at the first outpatient visit following the initial intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health outcomes: incidence and severity of adverse events assessed by CTCAE and PRO-CTCAE within three months of randomization; proportion of participants who continued treatment as planned for three months; incidence of unscheduled hospital visits or unplanned hospital admissions within three months; functional status assessed by the OARS-IADL questionnaire at baseline and three months; quality of life (QOL) assessed by the EORTC QLQ-C30 at baseline and three months 2. Communication outcomes: communication satisfaction assessed by the CARE-10 at the first outpatient visit following the initial intervention and three months 3. Intermediate outcomes: the number of GAM recommendations implemented by their treating oncologists for participants in both arms within three months 4. Acceptability outcomes: consent rate, perceived usefulness and burden of the mobile application-based intervention program (from both physicians and patients) at the first outpatient visit following the initial intervention | — |
Countries
Japan
Contacts
Public ContactAyumu Matsuoka
National Cancer Center Division of Survivorship Research, Institute for Cancer Control
Outcome results
None listed