Symptom Management, Quality of Life and Satisfaction With Care for Advanced Stage Cancers - Control Arm (LCCM-Control)

April 21, 2016 updated by: Lancaster General Hospital
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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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).

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604
        • Lancaster General Ann B. Barshinger Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-concurrent control group

A group of advanced cancer patients who received care at our Center before implementation of the LCCM model. They will receive current standard of care.

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).
Other: Standard of care
Patients will be cared for using current standard of care preceding the design and implementation of the LCCM model of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of patients' ED visits and hospitalizations
Time Frame: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
All cause: ED admission treat and release, ED admission to inpatient visit and direct inpatient admission
Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient quality of life
Time Frame: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
Assessed with FACT-G (Functional Assessment of Cancer-General measure)
Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
Patient satisfaction
Time Frame: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
Assessed with FAMCARE-2 (patient and family satisfaction with care)
Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
Caregiver burden
Time Frame: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
Assessed with BASC (Brief Assessment Scale for Caregivers) Caregiver Burden
Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
Caregiver satisfaction
Time Frame: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
Assessed with FAMCARE-2 (patient and family satisfaction with care)
Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
Patient symptoms
Time Frame: Collected at baseline and every outpatient oncology clinic visit from enrollment until death from any cause or assessed up to 18 months
Assessed with the ESAS-R (Edmonton Symptom Assessment System Revised) and ECOG (Eastern Cooperative Oncology Group) performance status
Collected at baseline and every outpatient oncology clinic visit from enrollment until death from any cause or assessed up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lancaster General Hospital

Investigators

  • Study Director: Shanthi Sivendran, MD, MSCR, Lancaster General Ann B. Barshinger Cancer Institute
  • Study Director: Randy Oyer, MD, Lancaster General Ann B. Barshinger Cancer Institute
  • Principal Investigator: Nik Buescher, Lancaster General Ann B. Barshinger Cancer Institute
  • Principal Investigator: Joan Harrold, MD, Palliative Medicine Consultants
  • Principal Investigator: Barbara Martin, PhD, Lancaster General Research Institute
  • Principal Investigator: Kristina Newport, MD, Palliative Medicine Consultants
  • Principal Investigator: Michael Horst, PhD, Lancaster General Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

September 29, 2014

First Submitted That Met QC Criteria

October 6, 2014

First Posted (ESTIMATE)

October 10, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

April 22, 2016

Last Update Submitted That Met QC Criteria

April 21, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014-48

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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