Nctid:
NCT06616298
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>120}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2025-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2028-03", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-09-12", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2027-03-22", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Intervention fidelity as assessed by fidelity checklist", "timeFrame"=>"2.5 years", "description"=>"Intervention fidelity will be assessed using a fidelity checklist. ALIGN will be considered feasible if there is greater than 80% adherence to the fidelity checklist."}, {"measure"=>"Intervention fidelity as assessed by audio-recordings", "timeFrame"=>"2.5 years", "description"=>"Intervention visits will be recorded and a qualitative analysis will be completed to provide an indepth understanding of fidelity to the core intervention components of ALIGN."}, {"measure"=>"Assessment of the feasibility of delivering the intervention in community skilled nursing facilities", "timeFrame"=>"2.5 years", "description"=>"Skilled nursing facility staff will be asked to complete the 4 question Feasibility of the Intervention Measure. These assessments will be collected from different community skilled nursing facilities after 5 participants have received the intervention in the facility. No cut-off score for interpretation is available. Higher scores indicate greater feasibility."}, {"measure"=>"Assessment of the appropriateness of delivering the intervention in community skilled nursing facilities", "timeFrame"=>"2.5 years", "description"=>"Skilled nursing facility staff will be asked to complete the 4 question Appropriateness of the Intervention Measure. These assessments will be collected from different community skilled nursing facilities after 5 participants have received the intervention in the facility. No cut-off score for interpretation is available. Higher scores indicate greater appropriateness."}, {"measure"=>"Assessment of treatment contamination in community skilled nursing facilities", "timeFrame"=>"2.5 years", "description"=>"The investigators will determine the proportion (% total) of caregivers in the control arm who reported that they received components of the ALIGN intervention during the skilled nursing facility stay. ALIGN will be considered feasible if contamination where ALIGN effects usual care is less than 10%."}, {"measure"=>"The proportion (% total) of screened patients that are eligible for enrollment in the trial", "timeFrame"=>"2.5 years", "description"=>"The investigators will determine the proportion of screened patients (% total) who meet the inclusion criteria"}, {"measure"=>"The proportion (% total) of enrolled patients that are assessed for patient-centered outcomes", "timeFrame"=>"2.5 years", "description"=>"The investigators will determine the proportion of (% total) of enrolled patients that are succesfully assessed for patient-reported and patient-centered outcomes (please see secondary outcomes below)"}, {"measure"=>"The proportion (% total) of enrolled caregivers that are assessed for person-centered outcomes", "timeFrame"=>"2.5 years", "description"=>"The investigators will determine the proportion of (% total) of enrolled caregivers that are succesfully assessed for person-centered outcomes (please see secondary outcomes below)"}, {"measure"=>"The proportion (% total) of enrolled patients that are randomized", "timeFrame"=>"2.5 years", "description"=>"The investigators will determine the proportion of (% total) of enrolled patients that are succesfully randomized"}, {"measure"=>"The proportion (% total) of enrolled caregivers that are randomized", "timeFrame"=>"2.5 years", "description"=>"The investigators will determine the proportion of (% total) of enrolled caregivers that are succesfully randomized"}], "secondaryOutcomes"=>[{"measure"=>"Assessing changes in days at home", "timeFrame"=>"6 months after randomization", "description"=>"Days at home will be calculated as 180 days minus the number of inpatient days in an acute care facility, an inpatient rehabilitation facility, a skilled nursing facility, or an inpatient hospice unit."}, {"measure"=>"Assessing Changes in hospice length of stay", "timeFrame"=>"6 months after randomization", "description"=>"Changes in the length of a hospice stay in both arms of the clinical trial will be measured"}, {"measure"=>"Health Care Utilization", "timeFrame"=>"6 months after randomization", "description"=>"Rehospitalization and emergency department visits for any cause and receipt of chemotherapy within 14 days of death will be collected"}, {"measure"=>"Change in quality of life as assessed by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-PAL-14)", "timeFrame"=>"At enrollment and then at 1, 3, and 6 months after randomization", "description"=>"Patients will be asked to complete this 14 item Likert-type scale that measures four primary quality of life domains: physical well-being, social/family well-being, emotional well-being, functional well-being, and spiritual well-being. Scores range from 0-56. Lower scores indicate lower quality of life."}, {"measure"=>"Changes in agreement with health-related outcome statements as assessed by the Attitude Scale", "timeFrame"=>"From enrollment and then 1, 3 and 6 months after randomization", "description"=>"Patients will be asked to complete the Attitude Scale which is a 5-point Likert scale that identifies the extent to which patients agree with 8 health-related outcome statements such as: The most important thing to me is living as long as I can, no matter what my quality of life is. Changes in agreement will be measured in both groups of the trial."}, {"measure"=>"Change in frailty as assessed by the Practical Geriatric Assessment", "timeFrame"=>"From enrollment and then 1, 3, and 6 months after randomization", "description"=>"Patients and caregivers will be asked to complete this 19 item assessment measures individual domain impairments in areas of physical function, nutrition/weight loss, social support, psychological, comorbidities, and cognitive functioning to guide treatment decisions. There is no composite score for this measure, rather scores from each domain help identify impairments. Higher scores in the physical function, comorbidities, psychological health, domain suggest greater impairment. Lower scores in cognitive and nutritional domains suggest greater impairment."}, {"measure"=>"Change in Advance Care Planning Documentation", "timeFrame"=>"From enrollment and then at 6 months after randomization", "description"=>"Advance Care Planning documents such as Medical Durable Power of Attorney (MDPOA) forms, cardiopulmonary resuscitation (CPR) directives, and the Medical Orders for Scope of Treatment (MOST) forms 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 and changes to wishes expressed in these documents in all patients who participate in the trial."}, {"measure"=>"Changes in the Perception of Patient Centeredness of Care Delivered as assessed by the Perception of Patient Centeredness of Care Measure", "timeFrame"=>"At enrollment and then 1, 3, and 6 months after randomization", "description"=>"Patients and caregivers will be asked to complete this 18-item instrument using a 4-point Likert scale. Scores range from 18 -72. Higher scores indicate a greater perception of patient-centeredness of care."}, {"measure"=>"Changes in caregiver coping as assessed by the Brief-Cope Questionaire", "timeFrame"=>"At enrollment and 1, 3, and 6 months after randomization", "description"=>"This scale ascertains how people are responding emotionally to a serious circumstance and will be completed by caregivers in this study. Scores are presented over three overarching coping styles (problem-focused, emotion-focused, and avoidant) as average scores indicating the degree to which the respondent has been engaging in that coping style. Scores for each coping strategy can range from 2-8. We will measure changes in coping styles over the course of the trial."}, {"measure"=>"Changes in illness understanding and coping support as assessed by the Advanced Illness Coordinating Care Survey", "timeFrame"=>"At enrollment and then 1, 3, and 6 months after randomization", "description"=>"This 5 question survey assesses perceived illness understanding and coping support. The range of scores is from 0 - 24 with higher scores indicating increased illness understanding and coping support."}, {"measure"=>"Changes in the experience of feeling heard and understood as assessed by the Heard and Understood Survey", "timeFrame"=>"At enrollment and then 1, 3, and 6 months after randomization", "description"=>"This 4 question Likert scale survey will be completed by patients and caregivers to assess how well they felt heard and understood by their oncology team of clinicians. Scores can range from 0-16. Higher scores indicate delivery of higher quality care."}, {"measure"=>"Change in the burden or benefits of caregiving as assessed by the Caregiver Reaction Assessment", "timeFrame"=>"At enrollment and then at 1, 3 and 6 months after randomization", "description"=>"Caregivers will be asked to complete this 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 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."}, {"measure"=>"Changes in congruence between patient and oncologist understanding of the goals of treatment", "timeFrame"=>"At enrollment and then at 3 months after randomization", "description"=>"Patients and their oncologists 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 oncologists will be asked this question at enrollment and 3 months after randomization. We are measuring whether there is increased congruence in the response between patient and their oncologists."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Skilled Nursing Facility", "Caregiver"], "conditions"=>["Advanced Cancer"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this clinical trial is to learn if it is possible to deliver a palliative care intervention called ALIGN (Assessing and Listening to Individual Goals and Needs) to hospitalized older adults with advanced cancer who are discharged to a skilled nursing facility and their caregivers. The main questions it aims to answer are:\n\n* Can the investigator successfully deliver the ALIGN intervention in different skilled community nursing facilities?\n* Can the investigator successfully collect information from participants throughout the study?\n* How can the investigator best prepare caregivers to make medical decisions for loved ones that become unable to do so themselves?\n\nResearchers will compare ALIGN to care as it is usually delivered.\n\nParticipants will:\n\n* Visit virtually with an ALIGN palliative care social worker every 1-2 weeks during their skilled nursing facility stay and up to 45 days after discharge from the facility or will see a palliative care clinician if recommended by their oncologist or other involved clinician.\n* Participants will provide information about how they are doing 1 month, 3 months, and 6 months after enrolling in the study."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"98 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Patients\n\nInclusion Criteria:\n\n1. Adults between 18-98 years\n2. Stage II-IV solid tumors\n3. Discharging from an acute care hospital to a SNF in Colorado\n4. English speaking\n5. Receiving or establishing care at the University of Colorado Cancer Center\n6. If a patient lacks capacity, a legal surrogate decision-maker will be approached to provide proxy consent.\n7. Must have access to the technology needed to complete consenting visit and subsequent intervention visits. This includes 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).\n\nExclusion Criteria:\n\n1. Discharging with hospice care\n2. Age less than 18\n3. Lacking capacity without a legal surrogate decision maker or proxy. Patient with limited English\n\nCaregivers\n\nInclusion Criteria:\n\n1. Patient-selected\n2. Age ≥ 18\n3. English speaking\n4. Able to complete baseline measures.\n\nExclusion Criteria:\n\n1. Discharging with hospice care\n2. Age \\< 18\n3. Caregivers with limited English proficiency will be excluded as ALIGN intervention content and documents have only been validated in an English-speaking population.\n\nSNF Staff\n\nInclusion Criteria:\n\n1. One of 25 interdisciplinary clinicians from the 5 most common community SNFs\n2. Staff must be employed by on of the 5 most common community SNFs named above. (care managers, social workers, nurses, physical therapists, occupational therapists, advanced practice providers, and physicians)\n\nExclusion Criteria:\n\n1. Not employed by one of the top 5 community SNFs patients were discharged to during the pilot trial\n\nPCSW\n\nInclusion Criteria:\n\n1. PCSWs who conducted the ALIGN intervention and consent to an interview"}, "identificationModule"=>{"nctId"=>"NCT06616298", "acronym"=>"ALIGN", "briefTitle"=>"ALIGN for Older Adults With Cancer in SNFs", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Colorado, Denver"}, "officialTitle"=>"Improving Person-Centered Outcomes for Older Adults With Cancer Discharged to Skilled Nursing Facilities and Their Family Caregivers", "orgStudyIdInfo"=>{"id"=>"24-0548.cc"}, "secondaryIdInfos"=>[{"id"=>"K23AG076866", "link"=>"https://reporter.nih.gov/quickSearch/K23AG076866", "type"=>"NIH"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Older patients with advanced cancer", "description"=>"Older adults with advanced cancer from the University of Colorado Hospital being discharged to skilled nursing facilities (SNF).", "interventionNames"=>["Other: Assessing and Listening to Individual Goals and Needs (ALIGN)"]}, {"type"=>"EXPERIMENTAL", "label"=>"Caregivers of older patients with advanced cancer", "description"=>"Caregivers of older adults with advanced cancer from the University of Colorado Hospital being discharged to skilled nursing facilities.", "interventionNames"=>["Other: Assessing and Listening to Individual Goals and Needs (ALIGN)"]}, {"type"=>"NO_INTERVENTION", "label"=>"Control Arm", "description"=>"Control arm participants will receive usual care. Patients will interact with SNF staff and involved providers who may refer them to palliative care or hospice like previous rigorous palliative care trials."}], "interventions"=>[{"name"=>"Assessing and Listening to Individual Goals and Needs (ALIGN)", "type"=>"OTHER", "description"=>"Assessing and Listening to Individual Goals and Needs (ALIGN). ALIGN utilizes the skills of palliative care social workers (PCSWs) trained in family and systems-level theory to address changing preferences for care, family distress, and to facilitate communication across care transitions to improve care aligned with preferences.3 The intervention is implemented virtually in community SNFs and follows patients for 45 days after SNF discharge to reflect real-world patient flow.", "armGroupLabels"=>["Caregivers of older patients with advanced cancer", "Older patients with advanced cancer"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"80045", "city"=>"Aurora", "state"=>"Colorado", "country"=>"United States", "contacts"=>[{"name"=>"Sarguni Singh, MD", "role"=>"CONTACT", "email"=>"sarguni.singh@ucdenver.edu", "phone"=>"503-703-0797"}, {"name"=>"Sarguni Singh, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"University of Colorado Anschutz Medical Campus", "geoPoint"=>{"lat"=>39.72943, "lon"=>-104.83192}}], "centralContacts"=>[{"name"=>"Sarguni Singh, MD", "role"=>"CONTACT", "email"=>"sarguni.singh@ucdenver.edu", "phone"=>"503.703.0797"}], "overallOfficials"=>[{"name"=>"Sarguni Singh, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Colorado, Denver"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Colorado, Denver", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Institute on Aging (NIA)", "class"=>"NIH"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
