QOL Assessment in Cancer Survivors Integrated Into Routine Clinical Care

Cancer Clinical Trial

Official title:

Quality of Life Assessment in Cancer Survivors Integrated Into Routine Clinical Care Implementation in an Integrated Health System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03835052
• Other study ID #: 2018-0568
• Status: Terminated
• Start date: October 1, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: March 2021
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 500
• Est. completion date: March 30, 2020
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
United States	Geisinger Medical Center	Danville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Geisinger Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Multidisciplinary Cancer Survivorship Clinic Utilization	Patients who have a total score less than 60 on FACT-GP are referred to the Multidisciplinary Cancer Survivorship Clinic for in-person evaluation.	Within 30 days of administration of FACT-GP
Primary	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	Oncology Behavioral Health Referral Follow-up	FACT-GP v.4, Emotional Well-Being Sub-score (EWB) are referred to the Oncology Behavioral Health Service for an evaluation by a PhD behavioral health practitioner.	Within 30 days of administration of FACT-GP
Secondary	Emergency Department utilization, 30 days after completion of SCP	Percentage of patients who present to an Emergency Department as captured in central clinical data architecture	Within 30 days of receipt of Supportive Care Plan