Integrated Versus Standard Palliative Care in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | May 2006 |
| End Date: | January 2017 |
A Randomized, Controlled Trial of Integrated vs. Standard Palliative Care in Patients With Advanced NSCLC
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.
(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.
- 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.
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.
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
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