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NCT Number: NCT04640714

Care Transition Intervention for Patients With Cancer

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.

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Key information

Conditions

Advanced Cancer Home Care, Hospital-Based

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >= 18 years
  • Unplanned admission to the oncology service at Massachusetts General Hospital (MGH)
  • 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.
  • Receiving ongoing oncology care at MGH
  • Verbal fluency in English
  • Must have internet/wifi/cellular data access

Exclusion criteria

  • Admitted electively
  • Discharged to a location other than home or expired during admission
  • Discharged with hospice services

Treatment and study plan

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

Behavioral

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

Primary outcomes

  1. Feasibility using enrollment and retention on study

    Time frame: Discharge to 3 business days

    The 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 outcomes

  1. Patients' Confidence in Managing their Health Condition using the Patient Activation Measure (PAM-13)

    Time frame: Baseline to 15 days after discharge

    The 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.

  2. Symptom Burden using the Edmonton Symptom Assessment Scale (ESAS-r)

    Time frame: Baseline to 15 days after discharge

    The 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).

  3. Psychological Symptoms using the Patient Health Questionnaire-4 (PHQ-4)

    Time frame: Baseline to 15 days after discharge

    The 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.

  4. Patient Satisfaction using the Patient Satisfaction Questionnaire

    Time frame: 10 to 15 days after discharge

    The 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 outcomes

  1. 30-day Hospital Readmissions

    Time frame: Discharge to 30 days after discharge

    The investigators will assess whether study participants had a hospital re-admission within 30 days of discharge using the Electronic Health Record

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Care Transition Intervention for Hospitalized Patients With Advanced Cancer

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 23, 2020
Registry last updated
Nov 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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