NCT01401907 · REGISTRY CONDITION SEARCH

Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2023-10-19

The purpose of this study is to compare two types of care - standard oncology care and standard oncology care with early palliative care (started soon after diagnosis) to see which is better for improving the experience of patients and families with advanced lung and non-colorectal GI cancer. The study will use questionnaires to measure patients' and caregivers' quality of life, mood, coping and understanding of their illness.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Functional Assessment of Cancer Therapy (Quality of Life Measure)

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outcome · POSTED

Functional Assessment of Cancer Therapy (Quality of Life Measure)

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outcome · POSTED

Rate of Clinically Significant Depression Symptoms Based on Hospital Anxiety and Depression Scale

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outcome · POSTED

Number and Percentage of Participants Who Reported Goal of Their Cancer Treatment is to Cure Their Cancer

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outcome · POSTED

Family Caregiver Quality of Life as Measured by the SF-36

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outcome · POSTED

Family Caregiver Psychological Distress (Based on the Hospital Anxiety and Depression Scale)

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outcome · POSTED

Number and Percentage of Family Caregivers Who Reported the Goal of Treatment is to Cure Cancer

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outcome · POSTED

Coping (Brief Cope)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Confirmed metastatic lung cancer (NSCLC, small cell lung cancer, and mesothelioma)or non-colorectal GI cancer (esophageal, gastric and hepatobiliary) not being treated with curative intent * Informed of metastatic disease within the previous 8 weeks * No prior therapy for metastatic disease * Able to read questions in English or willing to complete questionnaires with the assistance of an interpreter * Relative or friend of patient who will likely accompany the patient to clinic visits Exclusion Criteria: * Significant psychiatric or other co-morbid disease
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Subjects receive standard of care with early palliative care.
intervention Names
Other: early palliative care
label
Early Palliative Care
type
EXPERIMENTAL
description
Subjects receives standard of care
label
Standard of Care
type
NO_INTERVENTION

interventions

arm Group Labels
Early Palliative Care
description
patient assigned to the intervention will receive early palliative care along with standard oncology care.
name
early palliative care
type
OTHER

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

intervention Model Description

early palliative care

masking Info

masking: SINGLE
who Masked: OUTCOMES_ASSESSOR

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 351
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
The Functional Assessment of Cancer Therapy - General is a quality of life measure with higher scores indicating better quality of life (range 0-108). We are examining the adjusted mean difference from baseline to 12 weeks in this study
measure
Functional Assessment of Cancer Therapy (Quality of Life Measure)
time Frame
12 weeks

secondary Outcomes

description
The Functional Assessment of Cancer Therapy - General is a quality of life measure with higher scores indicating better quality of life (range 0-108). We are examining the adjusted mean difference from baseline to 24 weeks.
measure
Functional Assessment of Cancer Therapy (Quality of Life Measure)
time Frame
24 weeks
description
The hospital anxiety and depression scale examines symptoms of depression and anxiety. We compared rates of clinically significant depression symptoms (using a cut off of 8 on the depression subscale score) between study arms at week-12 and week-24.
measure
Rate of Clinically Significant Depression Symptoms Based on Hospital Anxiety and Depression Scale
time Frame
Week-12 and Week-24
description
We used the response to an item on Perception of Treatment and Prognosis Questionnaire to compare rates of accurate prognostic understanding between study arms. Participants reported their primary goal of their current cancer treatment: 1) to cure my cancer; 2) to lesson my suffering as much as possible; 3) for me and/or my family to be able to keep hoping; 4) to make sure I have done everything; 5) to extend my life as long as possible; 6) to help cancer research. Participants' responses were dichotomized as 1) to cure my cancer vs. all other.
measure
Number and Percentage of Participants Who Reported Goal of Their Cancer Treatment is to Cure Their Cancer
time Frame
Week12 and Week 24
description
The Medical Health Outcomes Survey- Short Form (SF-36) is a measure of QOL. The SF-36 measures eight domains of health-related quality of life: physical functioning, role limitation due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitation due to emotional health, and mental health. The response choices are scored and summed to yield two physical (PCS) and mental (MCS) component summary measures with ranges from 0-100. Higher scores indicate better quality of life. We compared family caregiver PCS and MCS scores between the two study arms at week-12 and week-24 adjusting for baseline scores.
measure
Family Caregiver Quality of Life as Measured by the SF-36
time Frame
Week-12 and Week-24
description
We used the Hospital Anxiety and Depression scale to measure overall psychological distress in family caregivers. The Hospital Anxiety and Depression Scale contains two subscales measuring depression and anxiety respectively. When examined continuously, this scale reflects degree of psychological distress with higher scores indicating more psychological distress (range 0-42). We compared overall psychological distress (HADS-total) among family caregivers between the two study arms
measure
Family Caregiver Psychological Distress (Based on the Hospital Anxiety and Depression Scale)
time Frame
Week 12 and Week 24
description
We used the response to an item on Perception of Treatment and Prognosis Questionnaire to compare rates of accurate prognostic understanding between study arms. Family caregivers reported their primary goal of the current cancer treatment: 1) to cure my cancer; 2) to lesson my suffering as much as possible; 3) for me and/or my family to be able to keep hoping; 4) to make sure I have done everything; 5) to extend my life as long as possible; 6) to help cancer research. Family caregivers' responses were dichotomized as 1) to cure my cancer vs. all other.
measure
Number and Percentage of Family Caregivers Who Reported the Goal of Treatment is to Cure Cancer
time Frame
12 and 24 weeks
description
compare mean change in approach oriented coping from baseline to week-24. Approach oriented coping scale is composed of active coping, positive reframing, and acceptance subscales. Scores range from 0-8 with higher scores indicate higher approach-oriented coping
measure
Coping (Brief Cope)
time Frame
Up to week-24

Full study description

brief Summary: The purpose of this study is to compare two types of care - standard oncology care and standard oncology care with early palliative care (started soon after diagnosis) to see which is better for improving the experience of patients and families with advanced lung and non-colorectal GI cancer. The study will use questionnaires to measure patients' and caregivers' quality of life, mood, coping and understanding of their illness.
detailed Description: Subjects and their caregiver will complete a baseline questionnaire and then be randomized to a study group. Subjects who are randomized to Standard Oncology Care will follow up with their treating oncologist. They will consult with the palliative care team at their request or at the request of the treating oncologist. They will complete questionnaires at 12 weeks and 24 weeks after enrollment. Subjects who are randomized to the Standard Oncology Care with Early Palliative Care will meet with a palliative care clinician at their next medical oncology visit or infusion visit. They will meet with the palliative care clinician at least every three weeks. They will complete questionnaires at 12 and 24 weeks after enrollment.

Source references

references

citation
Hoerger M, Greer JA, Jackson VA, Park ER, Pirl WF, El-Jawahri A, Gallagher ER, Hagan T, Jacobsen J, Perry LM, Temel JS. Defining the Elements of Early Palliative Care That Are Associated With Patient-Reported Outcomes and the Delivery of End-of-Life Care. J Clin Oncol. 2018 Apr 10;36(11):1096-1102. doi: 10.1200/JCO.2017.75.6676. Epub 2018 Feb 23.
pmid
29474102
type
DERIVED
citation
Greer JA, Jacobs JM, El-Jawahri A, Nipp RD, Gallagher ER, Pirl WF, Park ER, Muzikansky A, Jacobsen JC, Jackson VA, Temel JS. Role of Patient Coping Strategies in Understanding the Effects of Early Palliative Care on Quality of Life and Mood. J Clin Oncol. 2018 Jan 1;36(1):53-60. doi: 10.1200/JCO.2017.73.7221. Epub 2017 Nov 15.
pmid
29140772
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice