Technology-Enhanced Palliative Care for Advanced Cancer Patients

Not Applicable

Active, not recruiting

• Conditions: Advanced Malignant Solid Neoplasm
• Interventions: Other: Interview; Other: Palliative Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT04989556
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2020-08-20
• Study First Submitted: 2020-10-07
• Study First Submitted QC: 2021-07-26
• Study First Posted: 2021-08-04
• Status Verified: 2024-09
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26
• Primary Completion: 2026-05-07
• Study Completion: 2026-05-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 119

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (standard symptom management)	Interview	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 (weekly provider-initiated remote contact)	Interview	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.
Arm I (standard symptom management)	Quality-of-Life Assessment	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 (weekly provider-initiated remote contact)	Palliative Therapy	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.
Arm III (weekly provider-initiated remote contact)	Interview	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.
Arm I (standard symptom management)	Palliative Therapy	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 (weekly provider-initiated remote contact)	Quality-of-Life Assessment	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.
Arm II (weekly provider-initiated remote contact)	Questionnaire Administration	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.
Arm III (weekly provider-initiated remote contact)	Quality-of-Life Assessment	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.
Arm III (weekly provider-initiated remote contact)	Palliative Therapy	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.
Arm III (weekly provider-initiated remote contact)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Change in global distress score (GDS)	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 Outcome Measures

Name	Time	Method
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	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.
Patients' and caregivers' perceptions of receiving each technology-enhanced palliative care intervention	Up to 12 weeks on phase I trial	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
Effect size of palliative care (PC) intervention, utilizing Global Distress Score (GDS) derived from Edmonton Symptom Assessment Scale (ESAS).	At 6 months after enrollment	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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States