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Care Transition Intervention for Patients With Cancer

Care Transition Intervention for Hospitalized Patients With Advanced Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04640714
Enrollment
58
Registered
2020-11-23
Start date
2021-01-07
Completion date
2021-07-14
Last updated
2021-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancer, Home Care, Hospital-Based

Keywords

Advanced Cancer, Home Care, Hospital-Based, Transitions of Care, Care Transition Intervention

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.

Interventions

BEHAVIORALCONTINUity of care Under Management by Video visits (CONTINUUM-V)

Video visit by nurse practitioner within 3 business days of hospital discharge.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility using enrollment and retention on studyDischarge to 3 business daysThe intervention will be deemed feasible if at least 70% of eligible patients participate in the study, and if at least 70% complete the video visit within three business days of discharge.

Secondary

MeasureTime frameDescription
Patients' Confidence in Managing their Health Condition using the Patient Activation Measure (PAM-13)Baseline to 15 days after dischargeThe investigators will use the Patient Activation Measure 13 (PAM-13) to assess participants' confidence in managing their health condition at baseline and within 10-15 days of discharge (post-intervention). The PAM-13 is scored 0-100 with higher scores indicating greater confidence in managing one's health condition.
Symptom Burden using the Edmonton Symptom Assessment Scale (ESAS-r)Baseline to 15 days after dischargeThe investigators will use a modified version of the self-administered, revised Edmonton Symptom Assessment System (ESAS-r) to assess participants' symptoms at baseline and within 10-15 days of discharge (post-intervention). The ESAS-r assesses pain, fatigue, drowsiness, nausea, appetite, dyspnea, depression, anxiety, and well being over the previous 24 hours. The ESAS-r also includes constipation. Individual symptoms are scored on a scale from 0 (reflecting absence of the symptom) to 10 (reflecting the worst possible severity). The investigators will compute the composite ESAS physical and total symptom variables that included scores of participants' physical symptoms (pain, fatigue, drowsiness, nausea, appetite, dyspnea, constipation) and total symptoms (pain, fatigue, drowsiness, nausea, appetite, dyspnea, depression, anxiety, well being, constipation).
Psychological Symptoms using the Patient Health Questionnaire-4 (PHQ-4)Baseline to 15 days after dischargeThe investigators will use the Patient Health Questionnaire-4 (PHQ-4) to assess psychological symptoms at baseline and within 10-15 days of discharge (post-intervention). The PHQ-4 is a 4-item tool that contains two 2-item subscales assessing depression and anxiety symptoms. Both subscales and the composite PHQ-4 score can also be evaluated continuously, with higher scores indicating worse psychological distress. Scores on each subscale range from 0 to 6.
Patient Satisfaction using the Patient Satisfaction Questionnaire10 to 15 days after dischargeThe investigators will use the patient satisfaction questionnaire within 10-15 days after discharge. The participants will be asked how useful the participants found the intervention, on a 0 to 10 scale, with 0 being not useful at all and 10 being extremely useful.

Other

MeasureTime frameDescription
30-day Hospital ReadmissionsDischarge to 30 days after dischargeThe investigators will assess whether study participants had a hospital re-admission within 30 days of discharge using the Electronic Health Record

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026