Integrated Versus Standard Palliative Care in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01038271|
Recruitment Status : Completed
First Posted : December 23, 2009
Last Update Posted : March 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Other: Standard Palliative Care Group Other: Integrated Palliative Care Intervention||Not Applicable|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||151 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomized, Controlled Trial of Integrated vs. Standard Palliative Care in Patients With Advanced NSCLC|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||January 2017|
|Active Comparator: Standard Palliative Care Group||
Other: Standard Palliative Care Group
Participant is referred to the Palliative Care Team at any time.
|Active Comparator: Integrated Palliative Care Group||
Other: Integrated Palliative Care Intervention
Participant meets with the Palliative Care Team within 3 weeks of being randomized
- Assess the impact of early integration with palliative care on QOL in patients with advanced NSCLC. [ Time Frame: 3 years ]
- Assess the impact of early integration with palliative care on mood and illness understanding. [ Time Frame: 3 years ]
- Assess the impact of early integration with palliative care on family caregiver satisfaction, mood, and QOL both during care and after death. [ Time Frame: 3 years ]
- Compare hospice referrals and length of stay on hospice between study arms. [ Time Frame: 3 years ]
- Compare outpatient code status documentation between study arms. [ Time Frame: 3 years ]
- Compare the percentage of patients on each arm who received chemotherapy within one month of death. [ Time Frame: 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. [ Time Frame: 3 years ]
- Health Care Costs [ Time Frame: After death ]We will utilize the hospital cost accounting/billing system to determine health care costs as per study arm
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01038271
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Jennifer Temel, MD||Massachusetts General Hospital|