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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-07465 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2019-1052 | Other Identifier | M D Anderson Cancer Center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (standard symptom management) | Active Comparator | 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. |
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| Arm II (weekly provider-initiated remote contact) | Experimental | 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 30-45 minutes during week 8. |
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| Arm III (weekly provider-initiated remote contact) | Experimental | 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. Patients and caregivers may participate in an interview with supportive care nurse over 30-45 minutes during week 8. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interview | Other | Participate in interview |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in global distress score (GDS) | 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. | Baseline to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effect size of each palliative care (PC) intervention, utilizing FAMCARE-P-13 (PRO tool assessing patient satisfaction with outpatient palliative oncology care). | We will measure incremental change in the scores of patient satisfaction using FAMCARE-P13 from the baseline values. We also will measure the change in the scores every 4 weeks from the baseline score at time-point T0 to the 12 study weeks: weeks 4 (T4), 8 (T8), and 12 (T12). We will additionally measure at 6 months after enrollment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Hui | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 22, 2021 | Oct 23, 2024 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 1, 2026 |
| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| D010166 | Palliative Care |
| D000070659 | Patient Comfort |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Palliative Therapy | Other | Receive standard symptom management by palliative care team |
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| Palliative Therapy | Other | Receive provider initiated remote contact |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Complete questionnaire |
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| At 6 months after enrollment |
| Effect size of palliative care (PC) intervention, utilizing Global Distress Score (GDS) derived from Edmonton Symptom Assessment Scale (ESAS). | We will measure incremental change in the scores for GDS using ESAS, a validated score of overall symptom intensity and burden derived from the ESAS. The GDS (range 0-90) is comprised of 9 symptoms: (1) the six physical ESAS symptoms (pain, fatigue, nausea, drowsiness, appetite, shortness of breath), (2) the two psychosocial symptoms (depression, anxiety), and (3) overall sense of wellbeing.. We also will measure the change in the scores every 4 weeks from the baseline score at time-point T0 to the 12 study weeks: weeks 4 (T4), 8 (T8), and 12 (T12). We will additionally measure at 6 months after enrollment. | At 6 months after enrollment |
| Patients' and caregivers' perceptions of receiving each technology-enhanced palliative care intervention | We will use semi-structured interviews with patients and caregivers to assess patients and caregivers' perceptions of TEC to understand the value of PC provider-initiated contact between clinic visits | Up to 12 weeks on phase I trial |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |