Technology-Enhanced Palliative Care for Cancer Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Advanced Malignant Solid Neoplasm
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 119
- Locations
- 1
- Primary Endpoint
- Change in global distress score (GDS)
- Status
- Active, not recruiting
- Last Updated
- 6 months ago
Overview
Brief Summary
This trial investigates technology-enhanced palliative care for patients in phase I trials with cancer that has spread to other places in the body (advanced). The goal of this study is to learn if the technology-enhanced palliative care symptom-monitoring program, when combined with in-person clinic visits and standard remote care visits (by phone or video call), helps increase quality of life and care for patients with advanced cancer participating in phase 1 immunotherapy trials.
Detailed Description
PRIMARY OBJECTIVE: I. To assess the effect size of each palliative care intervention technology-enhanced palliative care, standard palliative care \[SPC\]) on the symptom burden of patients prior to or while on a phase I trial. SECONDARY OBJECTIVES: I To estimate the effect size of each palliative care intervention (TEC, SPC) on symptom burden over a 12-week period of a phase I trial. II. To estimate the effect size of each palliative care intervention (TEC, SPC) on clinical outcomes at 6 months post-enrollment. III. To qualitatively assess patients' and caregivers' perceptions of receiving each TEC-based palliative care (PC) Intervention. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I: Patients receive standard symptom management by palliative care team once every 4 weeks for 12 weeks. Patients and caregivers also may participate in an interview with supportive care nurse over 30-45 minutes during week 8. ARM II: Patients in Phase I immunotherapy trials will receive in-person clinic visits or standard remote care encounters at least once every 4 weeks and the e-ESAS and PC provider-initiated remote contact every week. Patients and caregivers may participate in an interview with supportive care nurse over 330-45 minutes during week 8. ARM III: Patients in Phase I non-immunotherapy clinical trials will receive in-person clinic visits or standard remote care encounters at least once every 4 weeks and the e-ESAS and PC provider-initiated remote contact once a week. In all 3 arms, follow-up communication will occur as deemed necessary by the PC team. Patients and caregivers may participate in an interview with supportive care nurse over 30-45 minutes during week 8.
Investigators
Eligibility Criteria
Inclusion Criteria
- •PATIENT: Diagnosis of advanced solid tumor
- •PATIENT: Oncologic plan for a phase I trial
- •PATIENT: High symptom burden (defined as a score of \>= 4 on at least 1 Edmonton Symptom Assessment Scale \[ESAS\] symptom, AND a global distress score \[GDS\] of \>= 20)
- •PATIENT: Reliable telephone and internet access
- •PATIENT: Able to communicate verbally in English and provide informed consent
- •CAREGIVER: Able to communicate verbally in English and provide informed consent
- •CAREGIVER: Reliable telephone and internet access
Exclusion Criteria
- •PATIENT: Low symptom burden defined as scores \< 4 on all ESAS symptoms OR GDS \< 20
- •PATIENT: Delirium (i.e. Memorial Delirium Assessment Scale \> 8)
- •PATIENT: No reliable telephone or internet access
- •CAREGIVER: Refusal to participate in this study
- •CAREGIVER: No reliable telephone or internet access
Outcomes
Primary Outcomes
Change in global distress score (GDS)
Time Frame: Baseline to 2 weeks
Will consist of paired t-tests for the global distress score (GDS, calculated as a sum of 9 physical and psychosocial ESAS items, scored from 0-90 in which a range over 35 indicates high distress) between baseline and 2 weeks if the Edmonton Symptom Assessment Scale (ESAS) scores are approximately normally distributed. If the data are clearly not normally distributed will conduct Wilcoxon signed rank tests.
Secondary Outcomes
- Effect size of each palliative care (PC) intervention, utilizing FAMCARE-P-13 (PRO tool assessing patient satisfaction with outpatient palliative oncology care).(At 6 months after enrollment)
- Patients' and caregivers' perceptions of receiving each technology-enhanced palliative care intervention(Up to 12 weeks on phase I trial)
- Effect size of palliative care (PC) intervention, utilizing Global Distress Score (GDS) derived from Edmonton Symptom Assessment Scale (ESAS).(At 6 months after enrollment)