N/A
N=1,197
Electronic Patient Reporting of Symptoms During Cancer Treatment
Metastatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03249090 ↗Enrolled (actual)
1,197
Serious AEs
—
Results posted
Jan 2025
Primary outcome: Primary: Overall Survival — 42.0; 43.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Patient Self-Reporting of Symptoms (Other); Usual Care Delivery (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Alliance Foundation Trials, LLC.
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
42.0; 43.5 | — |
| SECONDARY Physical Functioning |
227; 195; 133; 147; 162; 202 | — |
| SECONDARY Symptom Control |
195; 158; 199; 215; 123; 170 | — |
| SECONDARY Health-related Quality of Life |
191; 154; 199; 229; 127; 160 | — |
| SECONDARY Patient Satisfaction/Communication |
480; 472; 359; 365; 353; 387 | — |
| SECONDARY Emergency Department Utilization |
315; 273; 278; 325 | — |
Summary
The current study is designed to test nationally whether patients' outcomes and utilization of services can be improved through symptom monitoring via patient-reported outcomes between visits.
Eligibility Criteria
Inclusion Criteria
- Adults (21+) with metastatic cancer of any type (EXCEPT leukemia or indolent [slow growing] lymphoma)
- Receiving outpatient systemic cancer treatment for non-curative/palliative intent, including chemotherapy, targeted therapy, or immunotherapy.
- Enrolled at any point in their treatment trajectory, meaning during any line of treatment, and at any point during a course or cycle of treatment.
- Can understand English, Spanish, and/or Mandarin Chinese.
Exclusion Criteria
- Cognitive deficits that would preclude understanding of consent form and/or questionnaires.
- Current participation in a therapeutic clinical trial (because these often involve PRO questionnaires and intensive monitoring).
- Patients being treated with curative intent (e.g., adjuvant chemotherapy for breast, lung, or ovarian cancer; primary curative therapy for testis cancer or lymphoma).
- Receiving hormonal therapy only (e.g., tamoxifen or aromatase inhibitors in breast cancer; androgen deprivation therapy in prostate cancer; or octreotide in neuroendocrine cancers)
- Indolent lymphomas (due to their prolonged time courses that may be minimally symptomatic).
- Leukemias (time courses inconsistent with other tumor types in chronic and acute leukemias).
- Does not understand English, Spanish, or Mandarin Chinese.
Data sourced from ClinicalTrials.gov (NCT03249090). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.