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Completed

NCT Number: NCT04882111

ALIGN Intervention in Patients With Advanced Cancer Discharging to a SNF

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • Discharging with hospice as their goal of care

Treatment and study plan

ALIGN

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.

Primary outcomes

  1. Subject retention

    Time frame: 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 outcomes

  1. Qualitative interviews of ALIGN participants

    Time frame: 1.5 years

    Study staff will conduct individual semi-structured interviews with 15 patients and 15 caregivers who receive the ALIGN intervention.

  2. Qualitative interviews of SNF staff

    Time frame: 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.

Other outcomes

  1. Advanced Illness Coordinating Care Survey

    Time frame: Baseline and 60 days

    A survey of satisfaction with care for patients and caregivers

  2. Goal alignment measurement

    Time frame: Baseline and 60 days

    Patients and providers will be asked a focus of treatment question ("Please select one of the options below that best describes your current focus of treatment") and asked to select from the following options: curative, life prolonging/rehabilitative, or comfort focused. Patients and providers will be asked this question at the beginning and end of the study. We are measuring whether there is increased congruence in the response between patient and providers at the end of the study. If there is increased congruence this suggests that the ALIGN intervention is helping facilitate illness and prognostic understanding.

  3. FACIT-Pal

    Time frame: Baseline and 60 days

    This 39 item questionnaire measures four primary quality of life domains: physical well-being, social/family well-being, emotional well-being, functional well-being, and spiritual well-being. Lower scores indicate lower quality of life.

  4. Advance Care Planning documentation

    Time frame: Baseline and 60 days

    Study staff will collect patient and caregiver reported outcomes (virtually by phone or Zoom) to help guide future estimations of sample size. MDPOA, CPR directive, MOST are documents that communicate end of life wishes for patients and also who they would designate to make medical decisions on their behalf if they are unable to do so themselves. We are measuring completion rates of these documents in patients who participate in the ALIGN intervention. The more patients that have an MDPOA/CPR directives/MOST form completed after the intervention suggests that the ALIGN intervention helps people with advance care planning.

  5. Decision Regret Scale

    Time frame: Baseline and 60 days

    This 5 item scale measures distress or remorse after a health care decision. The minimum score is 0 and the maximum score is 100. A higher score indicates greater regret.

  6. Caregiver Reaction Assessment

    Time frame: Baseline and 60 days

    This is a 24 item instrument designed to measure the reactions of family members to caring for adults with a variety of illness. The instrument focuses on five dimensions: caregiver's esteem, lack of family support, impact on finances, impact on schedule, and impact on health. The minimum score is 0 and the maximum score is 24. A higher score indicates greater caregiver burden.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Icahn School of Medicine at Mount Sinai
  • National Cancer Institute (NCI)

Registry information

Official study title

ALIGN - A Palliative Care Social Work Intervention for Cancer Patients Discharging to a Skilled Nursing Facility

Acronym: ALIGN

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 11, 2021
Registry last updated
Nov 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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