Clinical trial · Interventional
Improving Cancer Outcomes Through Personalized Care Planning and Symptom Management.
Improving Cancer Outcomes Through Personalized Care Planning and Symptom Managment
NCT04772118CI-TRIAL-00055998completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This Study is a case control Study conducted with 100 patients with a solid tumor cancer diagnosis (lung, breast, or gynecologic cancer). Records of 50 patients who received treatment plans as standard of care will be abstracted for control data. 50 patients undergoing cancer treatment will receive a treatment plan and report symptoms using Carevive PROmPT™.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carevive PROmpt™ | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Outcomes for Primary Aim 1 - 50 intervention participants with a diagnosis for lung, breast or ovarian cancer measuring the prevalence and severity of 18 different symptoms reported from home over 3 months.
- timeFrame
- 10 months
- description
- Aim 1 is to compare treatment side effect frequency and intensity and patient treatment adherence between Intervention and Control subjects. Data collection for this Aim includes side effect frequency and intensity and time on treatment. Patients in the intervention arm will complete the Core Assessment prior to enrollment as standard of care. They will be enrolled to use the Carevive PROmpt™ platform to access from home. Patients will be instructed to report symptoms once a week between clinic visits. Outcomes measures for this Aim are the prevalence and severity of symptoms in each group, adherence to symptom reporting from home in intervention participants, and time on treatment from enrollment to 3 months after enrollment. Prevalence will be determined by the number of symptom alerts per patient over 3 months/ Severity will be determined by the number of mild, moderate, severe, and very severe over 3 months.
Secondary outcomes (2)
- measure
- Outcomes for Secondary Aim 2 - 50 intervention patients will complete the Patient Satisfaction Survey at the 3month timepoint to measure satisfaction with treatment decision and care experience.
- timeFrame
- 10 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All participants must be 18 years of age or older. * Subject participants must have a diagnosis of a breast, lung, or gynecologic cancer. * Patients must have completed their navigation visit and received a Treatment Care Plan. * Subjects must be able to complete on-line surveys using a cell phone, tablet, or computer. * Subjects must be starting or receiving treatment. * All participants must be able to understand English. Exclusion Criteria: * Any patient who cannot understand written or spoken English. * Any patient without the ability to complete on-line surveys using a cell phone, tablet, or computer. * Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).
References
Publications (0)
Data not yet available
No reference posted for this study.