NCT05351294

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

Assessment of Early Radiation Oncology Involvement Alongside Standard Oncologic Care in the Management of Metastatic Malignancies

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Radiation Therapy
• Metastatic Cancer

Interventions

Type	Name	Description
OTHER	Questionnaires	All patients in Arm 2 will be seen and treated by one of three ROs with an interest in participating in this study, who will be trained by the PI to perform these visits reproducibly and with rigor. These will all be "regular" ROs, who like most ROs administer a mix of curative and PRT in their clinical practice; like most cancer centers, there are no ROs who formally subspecialize in PRT at our institution. Notably, patients in Arm 1 (control arm) will always have standard-of-care RO referral available for consideration of PRT if needed for symptom relief. However, patients in Arm 1 will be seen by other ROs without any specific training for this study. Any courses of PRT administered in either arm are at the discretion of the treating RO in terms of the timing, dose, fractionation, and treatment technique.
COMBINATION_PRODUCT	Early Radiation Oncology Involvement Alongside Standard Oncologic Care	Early Radiation Oncology Involvement Alongside Standard Oncologic Care

Timeline

• Start date: 2023-07-13
• Primary completion: 2026-12-30
• Completion: 2027-12-30
• First posted: 2022-04-28
• Last updated: 2026-01-07

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study