Impact of Early Radiation Oncology Involvement as Part of a Multidisciplinary Palliative Care Team on Quality of Life Among Diverse Patients with Advanced/Metastatic Malignancies.
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 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 complications related to severe exacerbations in cancer-induced symptoms. This will be assessed by comparing the rates of emergency department visits, hospitalizations, and invasive procedures that patients undergo in each arm. The number of palliative radiation therapy courses and changes in systemic therapy administered to patients in each arm will also be assessed.
3. To determine if early radiation oncology involvement improves other metrics of quality palliative care. This will be assessed by comparing rates of palliative care physician referral, documented advance care planning (based on the percentage of patients in both arms who complete a living will or designate a power of attorney or designate resuscitation preferences in the electronic 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 less before death).
4. To estimate overall survival post-randomization in both arms
5. 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
6. To assess satisfaction with information-giving, availability of care, psychological care, and physical care in patients with advanced cancer using the FAMCARE-P16 questionnaire in each arm
- Rutgers Cancer Institute of New Jersey
- RWJBarnabas Health
- Clara Maass Medical Center
- Jersey City Medical Center, Jersey City
- Newark Beth Israel Medical Center
- Robert Wood Johnson University Hospital, Somerset
- Rutgers Cancer Institute of New Jersey-University Hospital
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. -
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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