NCT04882111

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P75+ for early_phase_1 cancer

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 11, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

November 11, 2021

Status Verified

November 1, 2021

Enrollment Period

1.1 years

First QC Date

November 3, 2020

Last Update Submit

November 10, 2021

Conditions

Cancer

Keywords

Palliative

Outcome Measures

Primary Outcomes (1)

  • Subject retention

    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.

    Two Years

Secondary Outcomes (2)

  • Qualitative interviews of ALIGN participants

    1.5 years

  • Qualitative interviews of SNF staff

    1.5 years

Other Outcomes (6)

  • Advanced Illness Coordinating Care Survey

    Baseline and 60 days

  • Goal alignment measurement

    Baseline and 60 days

  • FACIT-Pal

    Baseline and 60 days

  • +3 more other outcomes

Study Arms (1)

Discharged Cancer Patients

EXPERIMENTAL

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.

Behavioral: ALIGN

Interventions

ALIGNBEHAVIORAL

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.

Discharged Cancer Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage II - IV solid tumor malignancy
  • Discharging from an acute care hospital to a SNF in the metro Denver area
  • Decisional capacity to consent
  • English speaking
  • (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)

You may not qualify if:

  • \. Discharging with hospice as their goal of care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Related Publications (2)

  • 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.

    PMID: 38563805DERIVED

  • 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.

    PMID: 36409676DERIVED

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2020

First Posted

May 11, 2021

Study Start

September 28, 2020

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

November 11, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)