NCT01038271CompletedNot Applicable
A Randomized, Controlled Trial of Integrated vs. Standard Palliative Care in Patients With Advanced NSCLC
Massachusetts General Hospital1 site in 1 country151 target enrollmentStarted: May 1, 2006Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 151
- Locations
- 1
- Primary Endpoint
- Assess the impact of early integration with palliative care on QOL in patients with advanced NSCLC.
Study Overview
Brief Summary
The main purpose of this study is to compare two types of treatment-standard palliative care (which usually is given towards the end of life) and integrated palliative care (which is given soon after diagnosis) to see which is better for improving quality of life of participants with advanced non-small cell lung cancer. Palliative care is care that tries to lessen the symptoms of a disease. Although many people with advanced lung cancer receive palliative care or hospice toward the end of their disease, the entire course of their disease is often complicated by physical and emotional difficulties. Palliative care may be useful when it is started soon after diagnosis.
Detailed Description
- Participants with advanced small-cell lung cancer, will be asked to fill out some quality of life questionnaires that help to measure their quality of life (QOL), mood and understanding of their illness. They will also be asked to identify an important person in their life, either a relative or friend, who they count on for help and support. The research staff will contact that individual and ask them to if they want to participate in the caregiver part of this study.
- Lung cancer participants will then be randomized into one of the two study groups: integrated palliative care or standard palliative care.
- Participants assigned to the Standard palliative care group will be referred to the Palliative Care Team at their doctor's or their request at any time. At that time the Palliative Care Team (PCT) will follow and treat the participant as they would any other cancer patient. Research staff will request the participant to fill out QOL, mood & illness understanding questionnaires about 12, 18 and 24 weeks after they sign the consent form. Their caregiver will be asked to fill out the FamCare form at 12, 18 and 24 weeks.
- Participants assigned to the Integrated Palliative Care group will have an appointment with the Palliative Care Team within 3 weeks of being randomized. The palliative care physician will formulate a care plan based on the participant's and caregiver's issues and needs. The PCT will meet with the participant on a regular basis, a minimum of every 6 weeks. These visits wil vary with the participant's needs and may include individual or group meetings with the physicians, nurse practitioners, social workers or chaplains. Research staff will ask you to fill out QOL, mood & illness understanding questionnaires about 12, 18 and 24 weeks after they sign the consent form. Their caregiver will be asked to fill out the FamCare form at 12, 18 and 24 weeks.
- Participants will be in this research study for about 24 weeks or 6 months. After this 6 month period is over, care by the Palliative Care Team my continue but the participants will not be asked to fill out more questionnaires.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically or cytologically confirmed incurable NSCLC, stage IIIB with a pleural or pericardial effusion or stage IV
- •Performance status 0-2
- •Diagnosis of advanced NSCLC within the previous eight weeks
- •Ability to read and respond to questions in English
- •Permission of attending physician
Exclusion Criteria
- •Prior chemotherapy for metastatic disease
- •Existence of other co-morbid disease, which in the opinion of the investigator prohibits participation in the protocol
Arms & Interventions
Standard Palliative Care Group
Active Comparator
Intervention: Standard Palliative Care Group (Other)
Integrated Palliative Care Group
Active Comparator
Intervention: Integrated Palliative Care Intervention (Other)
Outcomes
Primary Outcomes
Assess the impact of early integration with palliative care on QOL in patients with advanced NSCLC.
Time Frame: 3 years
Secondary Outcomes
- Compare outpatient code status documentation between study arms.(3 years)
- Assess the impact of early integration with palliative care on family caregiver satisfaction, mood, and QOL both during care and after death.(3 years)
- Compare hospice referrals and length of stay on hospice between study arms.(3 years)
- Assess the impact of early integration with palliative care on mood and illness understanding.(3 years)
- Compare the percentage of patients on each arm who received chemotherapy within one month of death.(3 years)
- Determine the amount of time palliative care devotes to illness understanding, symptom management, decision-making, and coping with an illness in the outpatient setting.(3 years)
- Health Care Costs(After death)
Investigators
Jennifer Temel, MD
Thoracic Oncology
Massachusetts General Hospital
Study Sites (1)
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