Early Radiation Oncology Involvement as Part of a Multidisciplinary Palliative Care Team on Quality of Life Among Diverse Patients with Advanced/Metastatic Malignancies
This phase III trial compares the effect of adding earlier and more regular involvement of radiation oncologists to standard of care versus standard of care alone in improving quality of life in patients with cancer that has spread to other places in the body (metastatic). Cancer can cause a variety of symptoms. These symptoms are often the biggest problem when a cancer has spread to other parts of the body. Radiation therapy may help these symptoms, but radiation oncologists are not often involved early or regularly in the care of patients. Early involvement of radiation oncologists incorporated into the usual care of metastatic cancer may help patients have a better quality of life by reducing symptoms.
Inclusion Criteria
- Age >= 18 years
- Zubrod performance status 0-2
- Pathology-proven cancer, with primary site outside of the central nervous system
- 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
- 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
- Either planned, or actively receiving, systemic therapy (chemotherapy, targeted/biologic therapy, immunotherapy, or hormonal therapy)
- Ability to understand and the willingness to sign a written informed consent document
- 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
- Patients with metastatic solid tumors but life expectancy longer than 24 months will be excluded. This list includes (but is not limited to): * Castrate-sensitive prostate cancer (castrate-resistant prostate cancer are eligible) * Breast cancer responsive to hormonal therapy * Endometrial cancer responsive to hormonal therapy * 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
- 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
- Patients with cancer considered incurable that is locally advanced but non-metastatic
- 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
- 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
- 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
- History of whole brain radiation therapy for brain metastases (patients who underwent one prior treatment with radiosurgery for brain metastases are eligible
- 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
- Pregnant or breastfeeding women; Subjects who are pregnant are excluded from this study because radiation therapy has the potential for teratogenic or abortifacient effects
- Cognitively impaired adults lacking decision-making capacity or unable to consent
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05351294.
Locations matching your search criteria
United States
New Jersey
Belleville
Elizabeth
Jersey City
Livingston
New Brunswick
Newark
Somerville
PRIMARY OBJECTIVE:
I. To determine if the experimental approach of early radiation oncology involvement alongside standard oncologic care will result in higher health related quality of life (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) Quality of Life Questionnaire (QLQ)-C30 questionnaire.
SECONDARY OBJECTIVES:
I. To determine if early radiation oncology involvement improves other more detailed metrics of HRQL.
II. 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).
III. 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).
IV. 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.
V. To assess satisfaction with information-giving, availability of care, psychological care, and physical care in patients with advanced cancer using the FAMCAREP-16 questionnaire in each arm.
VI. To assess caregiver burden using the Montgomery-Borgatta Caregiver Burden Scale.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive usual cancer care for up to 12 months.
ARM II: Patients receive usual cancer care and consultations with a radiation oncologist (RO) for up to 12 months.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationRutgers Cancer Institute of New Jersey
Principal InvestigatorMalcolm David Mattes
- Primary ID002168
- Secondary IDsNCI-2022-02024, Pro2021002435
- ClinicalTrials.gov IDNCT05351294