Technology-Enhanced Palliative Care for Advanced Cancer Patients

Advanced Malignant Solid Neoplasm Clinical Trial

Official title:

Technology-Enhanced Palliative Care for Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04989556
• Other study ID #: 2019-1052
• Secondary ID: NCI-2020-0746520
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 20, 2020
• Est. completion date: May 7, 2024

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 119
• Est. completion date: May 7, 2024
• Est. primary completion date: May 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Malignant Solid Neoplasm

Intervention

Other:
• Interview
Participate in interview
• Palliative Therapy
Receive standard symptom management by palliative care team
• Palliative Therapy
Receive provider initiated remote contact
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Complete questionnaire

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	At 6 months after enrollment
Secondary	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
Secondary	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

External Links

•   University of Texas MD Anderson Cancer Center Website