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

Sponsor

Lancaster General Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02261051

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cancer Advanced Cancer	Other: Standard of care

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 Design

Study Type:

Observational

Actual Enrollment :

0 participants

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Frequency of patients' ED visits and hospitalizations [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

Secondary Outcome Measures

Patient quality of life [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)
Patient satisfaction [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)
Caregiver burden [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
Caregiver satisfaction [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)
Patient symptoms [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lancaster General Ann B. Barshinger Cancer Institute	Lancaster	Pennsylvania	United States	17604

Sponsors and Collaborators

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