Clinical trial NCT02261051: Symptom Management, Quality of Life and Satisfaction With Care for Advanced Stage Cancers - Control Arm
Official title: Symptom Management, Quality of Life and Satisfaction With Care for Advanced Stage Cancers - Control Arm
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cancer
Advanced Cancer
Keywords: Palliative Care
Hospice
End of Life
Health Service Utilization
Quality of Life
Lead sponsor: Lancaster General Hospital
Sponsor class: OTHER
First posted: 2014-10-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our study population includes patients newly diagnosed with a solid tumor-type cancer that is considered either advanced and unresectable or metastatic. Patients also will be at least 18 years of age and English-speaking.

Brief summary: Symptom Management, Quality of Life and Satisfaction with Care for Advanced Stage Cancers is the first part of a two part study (The Lancaster Cancer Care Model (LCCM) - Non-Concurrent Control Study). The primary aim of the study is to compare the proportion of advanced cancer patients who have a hospitalization or emergency department visit in the last 6 months of life before and after implementation of a new care model that provides more comprehensive symptom management and supportive care, including earlier referral to palliative care. The secondary comparative aim is to assess measures of quality of life and satisfaction in both groups. This current study is to collect data on the control group only. After system redesign, we will open an intervention arm study to collect data after implementation of the new care model (about 18-24 months from start of control phase).

Detailed description: Symptom Management, Quality of Life and Satisfaction with Care for Advanced Stage Cancers is the first part of a two part study (The Lancaster Cancer Care Model (LCCM) - Non-Concurrent Control Study) that was submitted to the National Cancer Institute (NCI) for funding. A decision on funding the full study should be forthcoming in the early part of 2015. The primary aim of the study is to compare the proportion of advanced cancer patients who have a hospitalization or emergency department visit in the last 6 months of life before and after implementation of a new care model that provides more comprehensive symptom management and supportive care, including earlier referral to palliative care. The secondary comparative aim is to assess measures of quality of life and satisfaction in both groups. To accomplish the aims of the study by the end of the funding period, we propose to begin data collection in advance of a funding decision. Should the study not receive funding, the data collected will be used to inform decisions regarding other funding applications and/or implementation of program changes at the Ann B. Barshinger Cancer Institute. Data collection does not represent more than minimal risk for the patients enrolled.

This protocol is for the first phase of the study, which is the enrollment and collection of data on the control group, to serve as the baseline for comparison regarding hospitalizations, ED visits, quality of life, and patient and family satisfaction. To achieve sufficient number of subjects and observed deaths in the control group, we are targeting the start of enrollment and data collection in this group during the third quarter of 2014. If the project is funded, the intervention and enrollment in the intervention group are targeted to start in the second quarter of 2016. Background and study aims are presented for the entire project to provide context, but the intent of this application is only for approval of the enrollment and data collection on the control subjects (which contributes to aims 2 and 3 of the larger project). A second protocol would be presented for review and approval at the start of the intervention if the project funding is granted.

In phase one of the project, subjects would be approached and consented at the point of a determination/diagnosis of advanced cancer and followed until the end of life or the start of the intervention period in the 2nd quarter of 2016 (whichever comes first) per protocol.

This current study is to collect data on the control group only. After system redesign, we will open an intervention arm study to collect data after implementation of the new care model (about 18-24 months from start of control phase).

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed with a solid tumor-type cancer that is considered either advanced and unresectable or metastatic

Exclusion Criteria:

* Non-English speaking
* Age \< 18

Primary outcomes:
measure: Frequency of patients' ED visits and hospitalizations
timeFrame: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
Secondary outcomes:
measure: Patient quality of life
timeFrame: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
measure: Patient satisfaction
timeFrame: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
measure: Caregiver burden
timeFrame: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
measure: Caregiver satisfaction
timeFrame: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
measure: Patient symptoms
timeFrame: Collected at baseline and every outpatient oncology clinic visit from enrollment until death from any cause or assessed up to 18 months
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Lancaster General Ann B. Barshinger Cancer Institute
state: Pennsylvania
Study officials:
affiliation: Lancaster General Ann B. Barshinger Cancer Institute
name: Shanthi Sivendran, MD, MSCR
role: STUDY_DIRECTOR
affiliation: Lancaster General Ann B. Barshinger Cancer Institute
name: Randy Oyer, MD
role: STUDY_DIRECTOR
affiliation: Lancaster General Ann B. Barshinger Cancer Institute
name: Nik Buescher
role: PRINCIPAL_INVESTIGATOR
affiliation: Palliative Medicine Consultants
name: Joan Harrold, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Research Institute
name: Barbara Martin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Palliative Medicine Consultants
name: Kristina Newport, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Research Institute
name: Michael Horst, PhD
role: PRINCIPAL_INVESTIGATOR
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