QOL Assessment in Cancer Survivors Integrated Into Routine Clinical Care

Terminated

• Conditions: Cancer

• Registration Number: NCT03835052
• Lead Sponsor: Geisinger Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2019-02-06
• Study First Submitted QC: 2019-02-07
• Study First Posted: 2019-02-08
• Primary Completion: 2020-03-25
• Study Completion: 2020-03-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-31
• Last Update Posted: 2021-04-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survivorship Care Plan (SCP) is completed and given to the patient	Within 12 months of date of diagnosis	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.

Secondary Outcome Measures

Name	Time	Method
Oncology Behavioral Health Referral Follow-up	Within 30 days of administration of FACT-GP	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.
Emergency Department utilization, 30 days after completion of SCP	Within 30 days of receipt of Supportive Care Plan	Percentage of patients who present to an Emergency Department as captured in central clinical data architecture

Trial Locations

Locations (1)

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States