NCT05947695

Brief Summary

The purpose of the randomized control trial is to estimate the effect of an oncology clinical nurse specialist-led early intervention multidisciplinary approach to palliative and survivorship care within two previously identified and validated patient groups having metastatic solid tumor malignancy on patient-reported symptom burden, patient-reported overall quality of life (QOL), distress, and overall survival. The primary hypothesis is that the effect of an oncology clinical nurse specialist- led early intervention multidisciplinary palliative and survivorship care model will be significantly higher, as compared to the standard of care approach to palliative and survivorship care, on the primary endpoint of patient-reported symptom burden for patients with metastatic solid tumor malignancy within favorable and very favorable risk groups. Symptom burden includes pain, tiredness, drowsiness, nausea, lack of appetite, depression, anxiety, shortness of breath, and wellbeing.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
34mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Mar 2023Mar 2029

Study Start

First participant enrolled

March 2, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Expected
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

3 years

First QC Date

March 22, 2023

Last Update Submit

September 11, 2023

Conditions

Solid Tumor, AdultMetastasis

Outcome Measures

Primary Outcomes (1)

  • participant reported symptom burden

    The Edmonton Symptom Assessment System- Revised (ESAS-r) will be used to measure patient reported symptom burden

    24 months

Secondary Outcomes (3)

  • participant reported quality of life

    24 months

  • participant reported distress

    24 months

  • participant overall survival

    60 months

Study Arms (2)

Intervention

EXPERIMENTAL

The oncology nurse-specialist-led multidisciplinary early intervention arm includes standard of care with additional coordination of services, patient education, and referral to treatment and other resources aligned with comprehensive best practice models for multidisciplinary care teams.

Behavioral: Palliative and Survivorship Care Model

Standard of Care

ACTIVE COMPARATOR

The standard of care comparator arm is usual clinical care using NCCN guidelines and evidence-based practice for palliative and survivorship care for patients treated with distant metastases.

Behavioral: Palliative and Survivorship Care Model

Interventions

Palliative and Survivorship Care ModelBEHAVIORAL

The standard of care comparator arm is usual clinical care using NCCN guidelines and evidence-based practice for palliative and survivorship care.

InterventionStandard of Care

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients (21 yrs and over)
  • metastatic solid tumor malignancy with very favorable and favorable prognostic curves
  • under the care of GSUH oncology and radiation oncology clinicians

You may not qualify if:

  • patients with metastatic solid tumor malignancy who are \< 21 yrs of age
  • adult patients with metastatic solid tumor malignancy who are in standard risk and unfavorable prognostic curves
  • patients not under the care of GSUH oncology and radiation oncology clinicians

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Good Samaritan University Hospital

West Islip, New York, 11795, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Johnny Kao, MD

    Good Samaritan University Hospital

    STUDY CHAIR

Central Study Contacts

Johnny Kao, MD

CONTACT

631-376-4047Johnny.Kao@chsli.org

LuAnn Rowland, MS RN

CONTACT

631-376-4047luann.rowland@chsli.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

March 22, 2023

First Posted

July 17, 2023

Study Start

March 2, 2023

Primary Completion

March 1, 2026

Study Completion (Estimated)

March 1, 2029

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

IPD will not be shared.

Locations

US(1)