Recruiting

Palliative Care

Sponsor:

Good Samaritan Hospital Medical Center, New York

Code:

NCT05947695

Conditions

Solid Tumor, Adult

Metastasis

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Palliative and Survivorship Care Model

Study Details

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.

Conditions

Solid Tumor, Adult

Metastasis

Study ID

NCT05947695

Start date

Mar 2, 2023

Status verified date

Sep, 2023

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention

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.

active comparator: Standard of Care

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.

Interventions

Palliative and Survivorship Care Model

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

Primary outcome measure

  • participant reported symptom burden [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Johnny Kao, MD

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

LuAnn Rowland, MS RN

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

Locations

Good Samaritan University Hospital

Recruiting

West Islip, New York, United States, 11795

Contacts

Johnny Kao, MD

631-376-4047johnny.kao@chsli.org

LuAnn Rowland, MS, RN

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

More Information

Sponsor

Good Samaritan Hospital Medical Center, New York

Last update posted

Sep 13, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Good Samaritan Hospital Medical Center, New York on 2023-09-13.