Technology-Enhanced Palliative Care for Advanced Cancer Patients

February 13, 2024 updated by: M.D. Anderson Cancer Center

Technology-Enhanced Palliative Care for Cancer Patients

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

119

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I (standard symptom management)
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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Interview
Participate in interview
Other: Palliative Therapy
Receive standard symptom management by palliative care team
Other Names:
  • Symptom Management
  • Comfort Care
  • Palliative Care
  • Palliative Treatment
  • PA-Palliative Therapy
  • palliation
  • Palliative
  • Symptoms Management
Other: Palliative Therapy
Receive provider initiated remote contact
Other Names:
  • Symptom Management
  • Comfort Care
  • Palliative Care
  • Palliative Treatment
  • PA-Palliative Therapy
  • palliation
  • Palliative
  • Symptoms Management
Experimental: Arm II (weekly provider-initiated remote contact)
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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Interview
Participate in interview
Other: Questionnaire Administration
Complete questionnaire
Other: Palliative Therapy
Receive standard symptom management by palliative care team
Other Names:
  • Symptom Management
  • Comfort Care
  • Palliative Care
  • Palliative Treatment
  • PA-Palliative Therapy
  • palliation
  • Palliative
  • Symptoms Management
Other: Palliative Therapy
Receive provider initiated remote contact
Other Names:
  • Symptom Management
  • Comfort Care
  • Palliative Care
  • Palliative Treatment
  • PA-Palliative Therapy
  • palliation
  • Palliative
  • Symptoms Management
Experimental: Arm III (weekly provider-initiated remote contact)
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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Interview
Participate in interview
Other: Questionnaire Administration
Complete questionnaire
Other: Palliative Therapy
Receive standard symptom management by palliative care team
Other Names:
  • Symptom Management
  • Comfort Care
  • Palliative Care
  • Palliative Treatment
  • PA-Palliative Therapy
  • palliation
  • Palliative
  • Symptoms Management
Other: Palliative Therapy
Receive provider initiated remote contact
Other Names:
  • Symptom Management
  • Comfort Care
  • Palliative Care
  • Palliative Treatment
  • PA-Palliative Therapy
  • palliation
  • Palliative
  • Symptoms Management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 2 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: David Hui, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2020

Primary Completion (Estimated)

May 7, 2024

Study Completion (Estimated)

May 7, 2024

Study Registration Dates

First Submitted

October 7, 2020

First Submitted That Met QC Criteria

July 26, 2021

First Posted (Actual)

August 4, 2021

Study Record Updates

Last Update Posted (Estimated)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2019-1052 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2020-07465 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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