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ALIGN Intervention in Patients With Advanced Cancer Discharging to a SNF

NCT ID: NCT04882111

Last Updated: 2021-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-28

Study Completion Date

2021-11-01

Brief Summary

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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

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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.

Conditions

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Cancer

Keywords

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Palliative

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Discharged Cancer Patients

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.

Group Type EXPERIMENTAL

ALIGN

Intervention Type BEHAVIORAL

The ALIGN intervention was developed by the Holding Group, an independent partnership of palliative care-trained social workers. The intervention is theory driven, patient/caregiver centered, addresses palliative care and psychosocial issues, and integrates with health care teams. Working in collaboration with KPCO and Dr. Stacy Fischer (primary mentor), the Holding Group tested the ALIGN intervention in the LTAC and SNF setting (Preliminary Studies). The Holding Group will be the intervention personnel providing psychosocial care that targets communication, goal alignment, and caregiver support.

Interventions

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ALIGN

The ALIGN intervention was developed by the Holding Group, an independent partnership of palliative care-trained social workers. The intervention is theory driven, patient/caregiver centered, addresses palliative care and psychosocial issues, and integrates with health care teams. Working in collaboration with KPCO and Dr. Stacy Fischer (primary mentor), the Holding Group tested the ALIGN intervention in the LTAC and SNF setting (Preliminary Studies). The Holding Group will be the intervention personnel providing psychosocial care that targets communication, goal alignment, and caregiver support.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Exclusion Criteria

1\. Discharging with hospice as their goal of care
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Colorado Hospital

Aurora, Colorado, United States

Site Status

Countries

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United States

References

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Singh S, Dafoe A, Lahoff D, Tropeano L, Owens B, Nielsen E, Cagle J, Lum HD, Dorsey Holliman B, Fischer S. A Process Evaluation of a Palliative Care Social Work Intervention for Cancer Patients in Skilled Nursing Facilities. J Palliat Med. 2024 Jun;27(6):734-741. doi: 10.1089/jpm.2023.0381. Epub 2024 Apr 2.

Reference Type DERIVED
PMID: 38563805 (View on PubMed)

Singh S, Dafoe A, Lahoff D, Tropeano L, Owens B, Nielsen E, Cagle J, Lum HD, Dorsey Holliman B, Fischer S. Pilot Trial of a Social Work Intervention to Provide Palliative Care for Adults with Cancer in Skilled Nursing Facilities. J Palliat Med. 2023 Apr;26(4):527-538. doi: 10.1089/jpm.2022.0413. Epub 2022 Nov 21.

Reference Type DERIVED
PMID: 36409676 (View on PubMed)

Other Identifiers

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P30CA046934

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-1656.cc

Identifier Type: -

Identifier Source: org_study_id