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A Randomized, Controlled Trial of Integrated vs. Standard Palliative Care in Patients With Advanced NSCLC


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

Thank you

Trial Information

A Randomized, Controlled Trial of Integrated vs. Standard Palliative Care in Patients With Advanced NSCLC


- 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Assess the impact of early integration with palliative care on QOL in patients with advanced NSCLC.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Jennifer Temel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

06-030

NCT ID:

NCT01038271

Start Date:

May 2006

Completion Date:

September 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • palliative care
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617