Assessment of Early Radiation Oncology Involvement Alongside Standard Oncologic Care in the Managemet

Phase 3

Recruiting

• Conditions: Radiation Therapy; Metastatic Cancer
• Interventions: Combination Product: Early Radiation Oncology Involvement Alongside Standard Oncologic Care; Other: Questionnaires

• Registration Number: NCT05351294
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

To determine if the experimental approach of early radiation oncology involvement alongside standard oncologic care will result in higher HRQL at 6 months compared to the control arm receiving standard oncologic care alone, based on the global subscale score of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire.

Detailed Description

Primary Objective To determine if the experimental approach of early radiation oncology involvement alongside standard oncologic care will result in higher HRQL at 6 months compared to the control arm receiving standard oncologic care alone, based on the global subscale score of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire. Secondary Objectives

1. To determine if early radiation oncology involvement improves other more detailed metrics of HRQL. This will be assessed using each of the 5 domains of the EORTC QLQ-C30 (physical, role, cognitive, emotional, social), each of the 5 dimensions of the EuroQol (EQ) 5D-5L (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and the health index score and EQ visual analogue scale. If there are significant differences in the primary endpoint, then a cost-utility analysis will be conducted using a Markov model and the EQ-5D-5L index scores.

2. To determine if early radiation oncology involvement will reduce the incidence of severe exacerbations/crises in cancer-induced symptoms (excluding systemic therapy-induced side effects), according to the number of emergency department visits and hospitalizations (total number of occurrences, and days admitted). These findings will be reported in the context of the number of palliative radiation therapy (PRT) courses and other invasive procedures that patients undergo, toxicities from those treatments, duration of time to initiation of tumor-directed treatment for exacerbation in symptoms, number of different lines of systemic therapy administered, and overall survival of each patient.

3. To determine if early radiation oncology involvement improves other metrics of quality palliative care across the disease trajectory, as assessed by rates of early Palliative and Supportive Care (PSC) referral alongside standard oncologic care, documented advance care planning (based on the percentage of patients in both arms who complete a living will, and designate a power of attorney and resuscitation preferences in the medical record), hospice referral prior to death, and aggressiveness of care within 14 days of death (defined as meetings any of the following three criteria: chemotherapy, radiation, or surgery within 14 days before death, no hospice care, or admission to hospice 3 days or fewer before death).

4. To assess patient/caregiver perceptions of prognosis, goals of treatment, and quality of communication with oncologists through the use of the Prognosis and Treatment Perceptions Questionnaire (PTPQ) in each arm

5. To assess satisfaction with information-giving, availability of care, psychological care, and physical care in patients with advanced cancer using the FAMCAREP16 questionnaire in each arm

6. To assess caregiver burden using the Montgomery-Borgatta Caregiver Burden Scale.

Study Timeline

• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-04-27
• Study First Posted: 2022-04-28
• Study Start: 2023-07-13
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-29
• Primary Completion: 2025-12-16
• Study Completion: 2025-12-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

The inclusion criteria for this study are as follows:

1. Age ≥ 18 years
2. Zubrod performance status 0-2
3. Pathology-proven cancer, with primary site outside of the central nervous system
4. Clinical (based on physical exam or imaging) or pathological diagnosis of metastatic disease, for which curative intent treatment is not feasible and treatment goals are palliative. Both patients with newly diagnosed metastatic disease, and those who have a metastatic relapse after prior curative-intent treatment for their malignancy, are eligible.
5. Estimated life expectancy 6-24 months. Guidelines for estimating life expectancy will be based on best available evidence, based primarily on tumor type, systemic therapy used and its expected outcome, line of systemic therapy, and in some cases patients' initial response to systemic therapy, along with the enrolling medical oncologist's judgement.
6. Either planned, or actively receiving, systemic therapy (chemotherapy, targeted/biologic therapy, immunotherapy, or hormonal therapy)
7. Ability to understand and the willingness to sign a written informed consent document
8. If a patient is actively participating in another clinical trial utilizing an investigation agent, they are still eligible for participation in this study unless radiation therapy is explicitly not allowed in that trial.

Exclusion Criteria

The exclusion criteria for this study are as follows:

1. Patients with metastatic solid tumors but life expectancy longer than 24 months will be excluded. This list includes (but is not limited to):

   1. Castrate-sensitive prostate cancer (castrate-resistant prostate cancer are eligible)
   2. Breast cancer responsive to hormonal therapy
   3. Endometrial cancer responsive to hormonal therapy
   4. Patients receiving first line systemic therapy, for whom median progression-free survival is greater than 6 months, and response to therapy has not been assessed yet.

2. Patients considered metastatic only due to pleural or peritoneal metastases without metastases to any other organ are excluded since palliative radiation therapy is less commonly used in these cases.

3. Patients with cancer considered incurable that is locally advanced but nonmetastatic.

4. Patients with leukemia or primary central nervous system cancers will be excluded since these patients less commonly are treated with palliative radiation therapy. Patients with lymphoma and multiple myeloma are eligible if they meet the other eligibility criteria.

5. Any patient for whom standard-of-care radiation oncology referral would be immediately indicated for palliative radiation therapy. The purpose of this is to ensure that patients in the control arm will not have a detriment in their care by not seeing a radiation oncologist at enrollment,

6. In order to avoid bias from prior standard-of-care radiation oncology involvement, patients will also be excluded if they are undergoing active follow-up with a radiation oncologist after prior palliative radiation therapy.

7. History of whole brain radiation therapy for brain metastases (patients who underwent one prior treatment with radiosurgery for brain metastases are eligible)

8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, adrenal insufficiency, chronic liver disease, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

9. Pregnant or breastfeeding women; Subjects who are pregnant are excluded from this study because radiation therapy has the potential for teratogenic or abortifacient effects.

10. Cognitively impaired adults lacking decision-making capacity or unable to consent. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Early Radiation Oncology Involvement Alongside Standard Oncologic Care	Patients enrolled in Arm 2 will also be seen be a radiation oncologist during the course of the study. The RO will review the patient's most recently completed EQ 5D-5L questionnaires and perform a complete History and Physical evaluation to determine if there is any immediate role for PRT. Based on the patient's type of cancer and areas of spread, the RO will also discuss types of symptoms that could develop in the future, and give instructions and educational materials to the patient so he/she can better identify those symptoms early on.
Arm 1	Questionnaires	All enrolled patients will receive standard oncologic care at the discretion of the treating physicians, but will also complete the EORTC QLQ-C30, EQ-5D-5L, PTPQ, FAMCARE-P16 at baseline before randomization. Follow-up assessment using EORTC QLQ-C30, PTPQ, FAMCARE-P16 will occur every 3 months, and using EQ-5D-5L will occur every 1 month, for a total of 12 months. These will be administered during standard-of-care clinic or infusion center visits.

Primary Outcome Measures

Name	Time	Method
Measure of Health-related quality of life (HRQL) at six months	At Six Months	To see if early radiation oncology involvement alongside standard oncologic care will result in higher Health-related quality of life (HRQL) at six months compared to the control arm receiving standard oncologic care alone, based on the global subscale score of the European Organization for Research and Treatment of Cancer(EORTC) QLQ-C30 questionnaire.

Secondary Outcome Measures

Name	Time	Method
Health Index Score	12 months	To measure the degree of severity or damage incurred by an organ or tissue.
Levels of HRQL	12 Months	To measure health-related quality of life (HRQL), by seeing if early radiation oncology involvement improves other more detailed metrics of HRQL.

Trial Locations

Locations (5)

Rutgers Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States

RWJBarnabas Health Jersey City Medical Center; 🇺🇸 Jersey City, New Jersey, United States

RWJBarnabas Health - Newark Beth Israel Medical Center; 🇺🇸 Newark, New Jersey, United States

Malcolm David Mattes, MD; 🇺🇸 Newark, New Jersey, United States

RWJBarnabas Health - Robert Wood Johnson University Hospital; 🇺🇸 Somerset, New Jersey, United States