ALIGN Intervention in Patients With Advanced Cancer Discharging to a SNF

Early Phase 1

Completed

• Conditions: Cancer
• Interventions: Behavioral: ALIGN

• Registration Number: NCT04882111
• Lead Sponsor: University of Colorado, Denver

Brief Summary

This is a single arm, pre-post, pilot study assessing the feasibility and acceptability of the ALIGN intervention in metastatic adult cancer patients discharging to local area SNFs.

Detailed Description

A novel approach for delivering high quality palliative care for cancer patients discharging to a skilled nursing facility (SNF) is critically needed. This investigator plans to test a palliative care social work led intervention called ALIGN (Assessing and Listening to Individual Goals and Needs) that aims to define patient and caregiver goals, facilitate communication between patients and their care teams, and develop a patient-centered plan that accompanies the patient across all future health system transitions. The central hypothesis is that implementation of ALIGN is feasible and acceptable for cancer patients and their caregivers and SNF staff.

Study Timeline

• Study Start: 2020-09-28
• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2021-05-05
• Study First Posted: 2021-05-11
• Status Verified: 2021-11
• Primary Completion: 2021-11-01
• Study Completion: 2021-11-01
• Last Update Submitted: 2021-11-10
• Last Update Posted: 2021-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Stage II - IV solid tumor malignancy
2. Discharging from an acute care hospital to a SNF in the metro Denver area
3. Decisional capacity to consent
4. English speaking
5. (During COVID requirements) Either internet access through a computer, tablet, or smartphone OR cellular service with adequate allowance of cellular minutes to allow virtual visits (by participant's assessment)

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Exclusion Criteria

1. Discharging with hospice as their goal of care

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Discharged Cancer Patients	ALIGN	25 patients, adults ≥ 18, with stage II - IV solid tumor malignancy discharging from an acute care hospital to a SNF in the metro Denver area who have decisional capacity to consent and are English speaking.

Primary Outcome Measures

Name	Time	Method
Subject retention	Two Years	This investigator anticipates the study to be feasible if enrollment and retention rates of patients and caregivers are within 60% of the goal and if, of those enrolled, 70% of patients and caregivers complete the intervention.

Secondary Outcome Measures

Name	Time	Method
Qualitative interviews of ALIGN participants	1.5 years	Study staff will conduct individual semi-structured interviews with 15 patients and 15 caregivers who receive the ALIGN intervention.
Qualitative interviews of SNF staff	1.5 years	Exit interviews will be conducted with 10 SNF front line staff (social worker, medical director, care manager, director of nursing) from SNF's that had 2 or more patients that received the intervention.

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States