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Completed

NCT Number: NCT01038271

Integrated Versus Standard Palliative Care in Patients With Advanced Non-small Cell Lung Cancer (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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Palliative Care Group

Other

Participant is referred to the Palliative Care Team at any time.

Integrated Palliative Care Intervention

Other

Participant meets with the Palliative Care Team within 3 weeks of being randomized

Primary outcomes

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

    Time frame: 3 years

Secondary outcomes

  1. Assess the impact of early integration with palliative care on mood and illness understanding.

    Time frame: 3 years

  2. 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

  3. Compare hospice referrals and length of stay on hospice between study arms.

    Time frame: 3 years

  4. Compare outpatient code status documentation between study arms.

    Time frame: 3 years

  5. Compare the percentage of patients on each arm who received chemotherapy within one month of death.

    Time frame: 3 years

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • American Society of Clinical Oncology

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2017
First posted
Dec 23, 2009
Registry last updated
Mar 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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