An Early Phase 1 interventional study of ALIGN in Cancer, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-11.
Sponsored by University of Colorado, Denver · Early Phase 1, Interventional, and Health services research
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.
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.
University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
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.
Time frame: Two Years
Qualitative interviews of ALIGN participants
Study staff will conduct individual semi-structured interviews with 15 patients and 15 caregivers who receive the ALIGN intervention.
Time frame: 1.5 years
Qualitative interviews of SNF staff
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.
Time frame: 1.5 years
Advanced Illness Coordinating Care Survey
A survey of satisfaction with care for patients and caregivers
Time frame: Baseline and 60 days
Goal alignment measurement
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.
Time frame: Baseline and 60 days
FACIT-Pal
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.
Time frame: Baseline and 60 days
Advance Care Planning documentation
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.
Time frame: Baseline and 60 days
Decision Regret Scale
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.
Time frame: Baseline and 60 days
Caregiver Reaction Assessment
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.
Time frame: Baseline and 60 days
Plan to share: No
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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver