Clinical trial NCT04989556: Technology-Enhanced Palliative Care for Advanced Cancer Patients
Official title: Technology-Enhanced Palliative Care for Cancer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Advanced Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in global distress score (GDS)
timeFrame: Baseline to 2 weeks
Secondary outcomes:
measure: Effect size of each palliative care (PC) intervention, utilizing FAMCARE-P-13 (PRO tool assessing patient satisfaction with outpatient palliative oncology care).
timeFrame: At 6 months after enrollment
measure: Effect size of palliative care (PC) intervention, utilizing Global Distress Score (GDS) derived from Edmonton Symptom Assessment Scale (ESAS).
timeFrame: At 6 months after enrollment
measure: Patients' and caregivers' perceptions of receiving each technology-enhanced palliative care intervention
timeFrame: Up to 12 weeks on phase I trial
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: David Hui
role: PRINCIPAL_INVESTIGATOR
References: