Cancer Clinical Trial
— ALIGNOfficial title:
ALIGN - A Palliative Care Social Work Intervention for Cancer Patients Discharging to a Skilled Nursing Facility
Verified date | November 2021 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | November 1, 2021 |
Est. primary completion date | November 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Hospital | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | Icahn School of Medicine at Mount Sinai, National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Advanced Illness Coordinating Care Survey | A survey of satisfaction with care for patients and caregivers | Baseline and 60 days | |
Other | 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. | Baseline and 60 days | |
Other | 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. | Baseline and 60 days | |
Other | 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. | Baseline and 60 days | |
Other | 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. | Baseline and 60 days | |
Other | 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. | Baseline and 60 days | |
Primary | 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 | Qualitative interviews of ALIGN participants | Study staff will conduct individual semi-structured interviews with 15 patients and 15 caregivers who receive the ALIGN intervention. | 1.5 years | |
Secondary | 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. | 1.5 years |
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