QOL Assessment in Cancer Survivors Integrated Into Routine Clinical Care

NCT03835052 | Terminated

• 1 other identifier: 2018-0568
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This observational cohort study of patients who received cancer treatment (of any modality) in the last 18 months are evaluated by the use of a validated QOL tool (FACT-GP) and are evaluated via telephone or in person or both. Patients with high-risk for unmet needs or distress as determined by the FACT-GP are referred to an in-person Multidisciplinary Cancer Survivorship Clinic. This is considered standard of care at the investigator's institution and is part of the continuous clinical quality improvement program within the Geisinger Cancer Institute.

Conditions

Cancer

Keywords

Survivorship

Outcome Measures

Primary Outcomes (1)

• Survivorship Care Plan (SCP) is completed and given to the patient

  A completed Survivorship Care Plan (SCP) as defined by the American College of Surgeons, Committee on Cancer (ACS-CoC) is completed by a member of the clinical care team and is provided personally to the patient.

  Within 12 months of date of diagnosis

Secondary Outcomes (2)

• Oncology Behavioral Health Referral Follow-up

  Within 30 days of administration of FACT-GP

• Emergency Department utilization, 30 days after completion of SCP

  Within 30 days of receipt of Supportive Care Plan

Other Outcomes (1)

• Multidisciplinary Cancer Survivorship Clinic Utilization

  Within 30 days of administration of FACT-GP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients meeting criteria identified through the use of analytics querying the central data architecture of health system

You may qualify if:

• Diagnosis of malignancy in the last 18 months, treated with curative intent

You may not qualify if:

• Patients treated with palliative intent, metastatic disease at the time of diagnosis

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Christian S Adonizio, MD

  Geisinger Clinic

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director: Center for Oncology Research and Innovation

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 8, 2019
• Study Start: October 1, 2018
• Primary Completion: March 25, 2020
• Study Completion: March 30, 2020
• Last Updated: April 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)