Early Palliative Care with Standard Care or Standard Care Alone in Improving Quality of Life of Patients with Incurable Lung or Non-colorectal Gastrointestinal Cancer and Their Family Caregivers

Status: Closed to Accrual

Description

This randomized phase III trial studies how well early palliative care integrated with standard care works compared with standard care alone in improving the quality of life of patients with lung or non-colorectal gastrointestinal cancer that cannot be cured and their family caregivers. Palliative care focuses on improving the quality of life for patients with advanced diseases and their family members by providing support for relief of physical symptoms, emotional and psychological support, and counseling. Patients who receive palliative care along with their regular care at an earlier time in their disease may experience fewer emotional and physical issues from their cancer. This may also improve the quality of life of family caregivers.

Eligibility Criteria

Inclusion Criteria

  • PATIENT: Confirmed incurable lung cancer (non-small cell lung cancer [NSCLC], small cell lung cancer, or mesothelioma) or non-colorectal gastrointestinal (GI) cancer (esophageal, gastric, hepatic, biliary, or pancreatic or GI unknown primary) not being treated with curative intent
  • PATIENT: Informed of diagnosis of incurable disease within the previous 8 weeks
  • PATIENT: Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • PATIENT: Ability to read and respond to questions in English or able to complete questions with minimal assistance required from an interpreter or family member
  • PATIENT: Planning to receive all medical care for cancer at the enrolling institution
  • PATIENT: Participants must be under the care of an oncologist (who does not practice as a palliative care physician for that patient), but their current plan may or may not include chemotherapy or other forms of tumor-directed therapies
  • CAREGIVER: Relative or friend who is identified by the patient participant who plans to regularly accompany the patient to the majority of their clinic visits
  • CAREGIVER: Family caregiver must live with the patient or have in-person contact with him or her at least twice per week
  • CAREGIVER: Ability to read and respond to questions in English or able to complete questions with minimal assistance required from an interpreter or family member

Locations & Contacts

See trial information on ClinicalTrials.gov for a list of participating sites.

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine the efficacy of early integrated palliative care (PC) on patient reported quality-of-life (QOL) at 12 weeks using the Functional Assessment of Cancer Therapy (FACT) in patients with newly diagnosed incurable lung or non-colorectal gastrointestinal cancer.

SECONDARY OBJECTIVES:

I. To determine the efficacy of early integrated palliative care (PC) on other patient reported outcomes in patients with newly diagnosed incurable lung or non-colorectal gastrointestinal cancer, by assessing the endpoints detailed.

II. To determine the efficacy of early integrated palliative care (PC) on family caregiver reported outcomes in those with newly diagnosed incurable lung or non-colorectal gastrointestinal cancer, by assessing the endpoints detailed.

III. To assess the impact of early, integrated PC on quality of end-of-life (EOL) care and resource utilization in patients with newly diagnosed incurable lung or non-colorectal gastrointestinal cancer by assessing the endpoints detailed.

IV. To determine concordance between patient and family caregiver report of prognosis/curability.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (EARLY PALLIATIVE CARE): Patients receive standard oncology care and early integrated palliative care comprising clinic visits (or phone calls if visits are not feasible) at baseline and as needed or at least every 4 weeks throughout the patient’s life.

ARM II (STANDARD ONCOLOGY CARE): Patients receive standard oncology care.

After completion of study, patients are followed up every 4 months from week 24 to up to 3 years.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Supportive care

Lead Organization

Lead Organization
Alliance for Clinical Trials in Oncology

Principal Investigator
Jennifer Gold Temel

Trial IDs

Primary ID A221303
Secondary IDs NCI-2014-01943
Clinicaltrials.gov ID NCT02349412