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

NCT02261051 | Withdrawn

• 1 other identifier: 2014-48
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Cancer; Advanced Cancer

Keywords

Palliative Care; Hospice; End of Life; Health Service Utilization; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Patient quality of life

  Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months

• Patient satisfaction

  Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months

• Caregiver burden

  Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months

• Caregiver satisfaction

  Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months

• Patient symptoms

  Collected at baseline and every outpatient oncology clinic visit from enrollment until death from any cause or assessed up to 18 months

Study Arms (1)

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

Interventions

Standard of care OTHER

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

Non-concurrent control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Non-English speaking
• Age \< 18

Sponsors & Collaborators

• Lancaster General Hospital: lead

Study Sites (1)

Lancaster General Ann B. Barshinger Cancer Institute

Lancaster, Pennsylvania, 17604, United States

Location

Related Publications (59)

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Related 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

MeSH Terms

Conditions

Neoplasms; Death; Patient Acceptance of Health Care

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Shanthi Sivendran, MD, MSCR

  Lancaster General Ann B. Barshinger Cancer Institute

  STUDY DIRECTOR

• Randy Oyer, MD

  Lancaster General Ann B. Barshinger Cancer Institute

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 10, 2014
• Study Start: October 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 22, 2016

Record last verified: 2016-04

Locations

US (1)