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

Cancer Clinical Trial

— LCCM-Control  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02261051
• Other study ID #: 2014-48
• Status: Recruiting
• Phase: N/A
• First received: September 29, 2014
• Last updated: October 13, 2014
• Start date: October 2014
• Est. completion date: October 2016

Study information

• Verified date: October 2014
• Source: Lancaster General Hospital
• Contact: Shanthi Sivendran, MD, MSCR
• Phone: 717-544-3600
• Email: ssivendran2[@]lghealth.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: October 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Advanced Cancer
• Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Lancaster General Ann B. Barshinger Cancer Institute	Lancaster	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Lancaster General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (59)

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* Note: There are 59 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of patients' ED visits and hospitalizations	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	No
Secondary	Patient quality of life	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	No
Secondary	Patient satisfaction	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	No
Secondary	Caregiver burden	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	No
Secondary	Caregiver satisfaction	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	No
Secondary	Patient symptoms	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	No

External Links

•   Cancer Facts and Figures 2014. (n.d.). Retrieved May 21, 2014, from http://www.cancer.org/acs/groups/content/@research/documents/webcontent/acspc-042151.pdf
•   National Community Cancer Centers Program Pilot Fact Sheet, 2007-2010. (n.d.) Retrieved June 16, 2014 from http://ncccp.cancer.gov/Media/FactSheet.htm
•   The Dartmouth Atlas of Health Care. (2010). Retrieved May 21, 2014, from www.darthmouth.org/keyissues/issues.aspx?con=294