An interventional study of Behavioral, Psychological or Informational Intervention and Educational Intervention in Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm and Recurrent Malignant Solid Neoplasm, sponsored by University of Rochester NCORP Research Base. Active, not recruiting at 113 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by University of Rochester NCORP Research Base · Not applicable, Interventional, and Health services research
This trial studies the delivery of the ENABLE palliative care program by two different methods called a Virtual Learning Collaborative or Technical Assistance for patients with advanced cancer and their caregivers. Palliative care is specialized medical care for people with a serious illness that occurs at the same time as other medical treatment. The purpose of palliative care is to provide relief from symptoms and stress of serious illness, to help patients and their families clarify goals of care, and to focus on social support and spiritual well-being. The focus of the ENABLE palliative care program is on living well, managing stress, patient communication of their personal values and hopes for care, social support, and symptom management. This study may help doctors find the best ways to include palliative care services into their practices and the impact of palliative care on cancer patients and their caregivers' quality of life.
PRIMARY OBJECTIVE:
I. Gather preliminary data on the effectiveness of virtual learning collaborative (VLC) versus (vs.) technical assistance (TA) on educate, nurture, advise before life ends (ENABLE) program uptake, defined as the proportion of patients that complete a palliative care assessment and at least 4 ENABLE sessions.
SECONDARY OBJECTIVE:
I. Evaluate the preliminary effectiveness of VLC or TA on patient quality of life (QOL) and mood outcomes.
II. Evaluate the relationship between ENABLE program uptake and patients' QOL and mood across the two strategies.
EXPLORATORY OBJECTIVES:
I. Evaluate the effectiveness of VLC vs. TA on participating institutions' overall ENABLE program implementation, as measured by the General Organizational Index (GOI).
II. Evaluate the relationship between overall ENABLE program implementation and patients' QOL and mood across the two strategies.
OUTLINE: Health care practice sites are randomized to 1 of 2 groups.
GROUP I: Patients undergo a palliative care assessment, participate in 6 ENABLE phone-based sessions with an ENABLE coach over 20-40 minutes, and monthly follow-up calls for 6 months. Caregivers participate in 3 ENABLE sessions with an ENABLE coach and monthly follow-up calls for 6 months. The practice sites participate in a Virtual Learning Collaborative (VLC) consisting of group-based learning sessions, coaching, and applied quality improvement data collection, analysis and feedback opportunities monthly for 15 months.
GROUP II: Patients undergo a palliative care assessment, participate in 6 ENABLE phone-based sessions with an ENABLE coach over 20-40 minutes, and monthly follow-up calls for 6 months. Caregivers participate in 3 ENABLE sessions with an ENABLE coach and monthly follow-up calls for 6 months. The practice sites undergo practice-based consultation calls with an ENABLE/Technical Assistance (TA) expert monthly for 15 months.
After completion of the study, participants are followed up at 12 and 24 weeks.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's planned enrollment of 208 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
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PATIENTS: Diagnosed within the last 90 days with an advanced cancer (defined as a newly diagnosed stage III/IV, recurrence, or progressive solid tumor cancer). Patients can receive any cancer treatment for their advanced cancer while participating in this study.
Exclusion Criteria:
Patients undergo a palliative care assessment, participate in 6 ENABLE phone-based sessions with an ENABLE coach over 20-40 minutes, and monthly follow-up calls for 6 months. Caregivers participate in 3 ENABLE sessions with an ENABLE coach and monthly follow-up calls for 6 months. The practice sites participate in a VLC consisting of group-based learning sessions, coaching, and applied quality improvement data collection, analysis and feedback opportunities monthly for 15 months.
Other: Behavioral, Psychological or Informational Intervention · Other: Educational Intervention · Procedure: Medical Examination Assessment · Other: Quality-of-Life Assessment · Other: Survey Administration · Behavioral: Telephone-Based Intervention
Patients undergo a palliative care assessment, participate in 6 ENABLE phone-based sessions with an ENABLE coach over 20-40 minutes, and monthly follow-up calls for 6 months. Caregivers participate in 3 ENABLE sessions with an ENABLE coach and monthly follow-up calls for 6 months. The practice sites undergo practice-based consultation calls with an ENABLE/TA expert monthly for 15 months.
Other: Behavioral, Psychological or Informational Intervention · Other: Educational Intervention · Procedure: Medical Examination Assessment · Other: Quality-of-Life Assessment · Other: Survey Administration · Behavioral: Telephone-Based Intervention
Receive ENABLE palliative care information
Participate in VLC group-based learning sessions
Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Participate in consultation with ENABLE/TA expert
Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Undergo palliative care assessment
Also known as: Exam, Examination, Health Assessment, Health Examination, Health Status Assessment, Medical Assessment, Medical Exam, Medical Inspection
Ancillary studies
Also known as: Quality of Life Assessment
Complete surveys
Receive monthly phone calls
Patient completion of the Educate, Nurture, Advise, Before Life Ends (ENABLE) program
Defined as having a palliative care assessment and completing at least 4 ENABLE sessions. A logit generalized estimating equation model with exchangeable correlation structure (to account for clustering within practice) will be fitted to a binary patient uptake indicator ("yes" if the patient completed a palliative care assessment and at least 4 ENABLE program sessions and "no" if the patient does not), with the group assignment as the main predictor. Model-predicted uptake proportions, odds ratios, relative risks, and confidence intervals for these measures will be used for interpretation. An additional analysis with sex, group assignment, and an interaction between the two as predictors will be conducted to examine whether this biological variable is a possible moderator of ENABLE program uptake.
Time frame: Up to 24 weeks
Preliminary effectiveness of VLC or TA on patient quality of life and mood outcomes
Will examine and quantify study group differences. A primary analysis, including all patients (either deceased or surviving by the scheduled 24-week follow-up) will be conducted using joint-modeling for longitudinal and time-to-event data to obtain inferences on the longitudinal outcome corrected for non-ignorable missing data due to death. In this approach, submodels for both the longitudinal process and the time-to-event process are estimated simultaneously, with a Cox model for the survival submodel, and a linear mixed-effects model for the longitudinal submodel. The two submodels share random effects for each individual, and these random effects account for both the association between the longitudinal outcome and the risk of death. A sensitivity analysis will also be performed.
Time frame: At 24 weeks
Relationship between ENABLE program uptake and patient outcomes
Will estimate the relationship between change in patient outcomes (quality of life and mood) using the number of ENABLE sessions completed (ENABLE program uptake) as the main predictor. The crude association between ENABLE sessions and change in patient outcomes will be examined graphically with profile plots, and with linear mixed models to determine whether the relationship is better fitted by a linear, a more complex trend, or as ordinal categorical data. Since the number of ENABLE sessions completed might be dependent on patient characteristics (e.g., sex, illness acuity, age), a covariate adjustment (via an adjusting score) will be conducted on the crude association estimate to determine the change in outcomes attributable to the number of ENABLE sessions completed, above and beyond patient characteristics. The adjusting score will be estimated with a random forest ensemble, based on patient characteristics.
Time frame: Up to 24 weeks
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This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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University of Rochester NCORP Research Base