Symptom Management, Quality of Life and Satisfaction With Care for Advanced Stage Cancers - Control Arm
NCT ID: NCT02261051
Last Updated: 2016-04-22
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Study Classification
OBSERVATIONAL
Study Start Date
2014-10-31
Study Completion Date
2015-09-30
Brief Summary
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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).
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Detailed Description
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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).
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).
Conditions
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Cancer
Advanced Cancer
Study Design
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Study Time Perspective
PROSPECTIVE
Study Groups
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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).
Standard of care
Intervention Type
OTHER
Patients will be cared for using current standard of care preceding the design and implementation of the LCCM model of care.
Interventions
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Standard of care
Patients will be cared for using current standard of care preceding the design and implementation of the LCCM model of care.
Intervention Type
OTHER
Eligibility Criteria
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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
* Age \< 18
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Lancaster General Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Shanthi Sivendran, MD, MSCR
Role: STUDY_DIRECTOR
Lancaster General Ann B. Barshinger Cancer Institute
Randy Oyer, MD
Role: STUDY_DIRECTOR
Lancaster General Ann B. Barshinger Cancer Institute
Nik Buescher
Role: PRINCIPAL_INVESTIGATOR
Lancaster General Ann B. Barshinger Cancer Institute
Joan Harrold, MD
Role: PRINCIPAL_INVESTIGATOR
Palliative Medicine Consultants
Barbara Martin, PhD
Role: PRINCIPAL_INVESTIGATOR
Lancaster General Research Institute
Kristina Newport, MD
Role: PRINCIPAL_INVESTIGATOR
Palliative Medicine Consultants
Michael Horst, PhD
Role: PRINCIPAL_INVESTIGATOR
Lancaster General Research Institute
Locations
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Lancaster General Ann B. Barshinger Cancer Institute
Lancaster, Pennsylvania, United States
Site Status
Countries
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United States
References
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Related Links
Access external resources that provide additional context or updates about the study.
http://www.cancer.org/acs/groups/content/@research/documents/webcontent/acspc-042151.pdf
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
http://ncccp.cancer.gov/Media/FactSheet.htm
National Community Cancer Centers Program Pilot Fact Sheet, 2007-2010. (n.d.) Retrieved June 16, 2014 from http://ncccp.cancer.gov/Media/FactSheet.htm
Other Identifiers
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2014-48
Identifier Type: -
Identifier Source: org_study_id
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Pilot Study Evaluating the Oncogramme: Analysis of Response to Induction Treatment of Patients With Breast or Ovarian Cancer.
NCT02910622
COMPLETED
Quality of Life in Caregivers of Hospitalized Older Patients With Cancer
NCT01866969
COMPLETED
NA
Second Opinions in Oncology
NCT05102500
COMPLETED
Evaluation of Cancer Care Coordination in the National Cancer Institutes Community Cancer Center Programs
NCT01346280
COMPLETED
Cancer and Sexual Health : Early Information and Sexual Satisfaction of Couples in Oncology
NCT02541162
TERMINATED
NA
Quality of Life in Younger Leukemia and Lymphoma Survivors
NCT00956475
COMPLETED
Patient-Reported Outcome Version of the Common Criteria for Adverse Events
NCT04050072
ACTIVE_NOT_RECRUITING
Quality of Life Among Children and Adolescents With Cancer
NCT00285363
WITHDRAWN
Feasibility and Acceptability of the Remote Oncology Symptom Assessment Application
NCT07218874
RECRUITING
NA
Primary Palliative Care for Patients With Advanced Hematologic Malignancies
NCT02992171
COMPLETED
NA
Comparison of Educational Services and Outcomes for Patients Treated for Childhood Cancer
NCT00178386
COMPLETED
Structured Multidisciplinary Intervention or Standard Medical Care in Improving Quality of Life in Patients Receiving Active Cancer Treatment
NCT01360814
COMPLETED
A Supportive Care Intervention for Older Caregivers of Older Adults with Advanced Cancer
NCT05244915
TERMINATED
NA