Clinical Nurse Specialist Led Early Palliative Survivorship Care for Patients With Advanced Cancer
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ClinicalTrials.gov Identifier: NCT05947695 |
Recruitment Status :
Recruiting
First Posted : July 17, 2023
Last Update Posted : September 13, 2023
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Condition or disease | Intervention/treatment | Phase |
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Solid Tumor, Adult Metastasis | Behavioral: Palliative and Survivorship Care Model | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | A Randomized Controlled Trial of Clinical Nurse Specialist Led Early Palliative Survivorship Care for Patients With Advanced Cancer |
Actual Study Start Date : | March 2, 2023 |
Estimated Primary Completion Date : | March 2026 |
Estimated Study Completion Date : | March 2029 |
Arm | Intervention/treatment |
---|---|
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.
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Behavioral: 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. |
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.
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Behavioral: 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. |
- participant reported symptom burden [ Time Frame: 24 months ]The Edmonton Symptom Assessment System- Revised (ESAS-r) will be used to measure patient reported symptom burden
- participant reported quality of life [ Time Frame: 24 months ]Updated NCCN Distress Thermometer Problem List for Patients will be used to measure participant reported quality of life
- participant reported distress [ Time Frame: 24 months ]Updated NCCN Distress Thermometer will be used to measure participant reported distress
- participant overall survival [ Time Frame: 60 months ]Measured as survival at 60 months
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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05947695
Contact: Johnny Kao, MD | 631-376-4047 | Johnny.Kao@chsli.org | |
Contact: LuAnn Rowland, MS RN | 631-376-4047 | luann.rowland@chsli.org |
United States, New York | |
Good Samaritan University Hospital | Recruiting |
West Islip, New York, United States, 11795 | |
Contact: Johnny Kao, MD 631-376-4047 johnny.kao@chsli.org | |
Contact: LuAnn Rowland, MS, RN (631) 376-4047 luann.rowland@chsli.org |
Study Chair: | Johnny Kao, MD | Good Samaritan University Hospital |
Responsible Party: | Patricia Eckardt, Research Scientist, Good Samaritan Hospital Medical Center, New York |
ClinicalTrials.gov Identifier: | NCT05947695 |
Other Study ID Numbers: |
IRB# 22-009 |
First Posted: | July 17, 2023 Key Record Dates |
Last Update Posted: | September 13, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | IPD will not be shared. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Neoplasm Metastasis Neoplastic Processes Neoplasms Pathologic Processes |