Clinical trial NCT04640714: Care Transition Intervention for Patients With Cancer
Official title: Care Transition Intervention for Hospitalized Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Home Care, Hospital-Based
Keywords: Advanced Cancer
Home Care, Hospital-Based
Transitions of Care
Care Transition Intervention
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research study is investigating an intervention called CONTINUity of care Under Management by Video visits (CONTINUUM-V). CONTINUUM-V involves a video visit with an oncology nurse practitioner within three business days of hospital discharge for patients with advanced cancer with the goal of reducing burdensome care transitions after hospitalization, including hospital readmissions.

Detailed description: This is a single-site, single-arm pilot trial to assess the feasibility and acceptability of a CONTINUUM-V for patients with advanced cancer

The research study procedures include:

* A video visit with a nurse practitioner within three business days of hospital discharge
* Questionnaires asking about demographic information (e.g. sex, ethnicity, income) and participant experience with cancer (e.g. symptoms and confidence in managing their health condition)
* A satisfaction survey to assess the participants' impressions of the intervention and any suggestions the participants may have
* Data collection from their medical record
* One time interview of participant and clinician for feedback on CONTINUUM-V

Participants will be in this research study for up to 45 days after hospital discharge.

54 patients and 4 clinicians took part in this research study.

The Conquer Cancer Foundation and the Rising Tide Foundation for Clinical Cancer Research are supporting this research study by providing a Career Pathway Grant in Symptom Management to support the research team.

Eligibility criteria: Inclusion Criteria:

1. Age \>= 18 years
2. Unplanned admission to the oncology service at Massachusetts General Hospital (MGH)
3. Known diagnosis of advanced breast, thoracic, genitourinary, or gastrointestinal cancers. Advanced cancer defined as not being treated with curative intent as determined by clinic notes and chemotherapy order entry.
4. Receiving ongoing oncology care at MGH
5. Verbal fluency in English
6. Must have internet/wifi/cellular data access

Exclusion Criteria:

1. Admitted electively
2. Discharged to a location other than home or expired during admission
3. Discharged with hospice services

Primary outcomes:
measure: Feasibility using enrollment and retention on study
timeFrame: Discharge to 3 business days
Secondary outcomes:
measure: Patients' Confidence in Managing their Health Condition using the Patient Activation Measure (PAM-13)
timeFrame: Baseline to 15 days after discharge
measure: Symptom Burden using the Edmonton Symptom Assessment Scale (ESAS-r)
timeFrame: Baseline to 15 days after discharge
measure: Psychological Symptoms using the Patient Health Questionnaire-4 (PHQ-4)
timeFrame: Baseline to 15 days after discharge
measure: Patient Satisfaction using the Patient Satisfaction Questionnaire
timeFrame: 10 to 15 days after discharge
Other outcomes:
measure: 30-day Hospital Readmissions
timeFrame: Discharge to 30 days after discharge
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jennifer S Temel, MD
role: PRINCIPAL_INVESTIGATOR
References: