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Technology-Enhanced Palliative Care for Advanced Cancer

N/A
Waitlist Available
Led By Ishwaria M Subbiah
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Caregivers able to communicate verbally in English and provide informed consent
Patients with a diagnosis of advanced solid tumor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months after enrollment
Awards & highlights

Study Summary

This trial is investigating whether technology-enhanced palliative care, when combined with in-person clinic visits and standard remote care visits, can help increase quality of life and care for patients with advanced cancer participating in phase 1 immunotherapy trials.

Who is the study for?
This trial is for English-speaking advanced cancer patients with high symptom burden, who have internet and phone access, and are enrolled in phase I immunotherapy trials. Caregivers must also speak English and have reliable communication means. Patients or caregivers without this access or those with low symptom burden/delirium cannot participate.Check my eligibility
What is being tested?
The study tests a technology-enhanced palliative care program that includes symptom monitoring combined with standard clinic visits and remote care (phone/video). It aims to see if this improves the quality of life for advanced cancer patients in phase I trials.See study design
What are the potential side effects?
Since the interventions involve interviews, assessments, and questionnaires rather than medications, traditional side effects are not expected. However, participants may experience emotional or psychological discomfort discussing their condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can speak English and agree to participate.
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I have been diagnosed with an advanced solid tumor.
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I have severe symptoms and high distress according to the ESAS.
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I can speak English and understand the consent form.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months after enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months after enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in global distress score (GDS)
Secondary outcome measures
Effect size of each palliative care (PC) intervention, utilizing FAMCARE-P-13 (PRO tool assessing patient satisfaction with outpatient palliative oncology care).
Effect size of palliative care (PC) intervention, utilizing Global Distress Score (GDS) derived from Edmonton Symptom Assessment Scale (ESAS).
Patients' and caregivers' perceptions of receiving each technology-enhanced palliative care intervention

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm III (weekly provider-initiated remote contact)Experimental Treatment4 Interventions
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.
Group II: Arm II (weekly provider-initiated remote contact)Experimental Treatment4 Interventions
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.
Group III: Arm I (standard symptom management)Active Control3 Interventions
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.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,964 Previous Clinical Trials
1,804,299 Total Patients Enrolled
Ishwaria M SubbiahPrincipal InvestigatorM.D. Anderson Cancer Center
David HuiPrincipal InvestigatorM.D. Anderson Cancer Center
9 Previous Clinical Trials
1,918 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are taking part in this investigation?

"Affirmative. Clinicaltrials.gov confirms that this trial is actively recruiting and the initial posting date was August 20th, 2020 with a recent update on August 18th 2022. 150 patients are needed from just one medical centre."

Answered by AI

Is there capacity for additional participants to join this trial?

"Affirmative. According to the clinicaltrials.gov website, this medical investigation is actively attempting to recruit patients that commenced on August 20th 2020 and was updated accordingly in 18/08/2022. In total, they are looking for 150 participants at one single site of enrollment."

Answered by AI
~0 spots leftby May 2024