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Advanced CancerNCT04640714

Care Transition Intervention for Patients With Cancer

A study testing CONTINUity of care Under Management by Video visits (CONTINUUM-V) in people with Advanced Cancer and Home Care, Hospital-Based, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer, Home Care, Hospital-Based
What is being tested?
CONTINUity of care Under Management by Video visits (CONTINUUM-V)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteUnited States
Study dates
7 Jan 2021to 14 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Care Transition Intervention for Hospitalized Patients With Advanced 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.

Read the 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.

Being tested
CONTINUity of care Under Management by Video visits (CONTINUUM-V)
Keywords
Advanced Cancer, Home Care, Hospital-Based, Transitions of Care, Care Transition Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT04640714
Study groupRoleWhat they receive
CONTINUity of care Under Management by Video visits (CONTINUUM-V)ExperimentalParticipants with advanced cancer will receive a video visit conducted by an oncology Nurse Practitioner (NP) within three (3) business days of hospital discharge. The visit will involve: (1) reconcile medications, (2) manage symptoms, (3) review the post-hospital care plan for hospitalization-specific issues, and (4) schedule follow-up with the outpatient oncology team. Participant and clinician may also be interviewed for their feedback on the video visit. The ultimate goal of the intervention is to improve patients' confidence in managing their health condition and reduce burdensome health care utilization after discharge, particularly reducing 30-day hospital readmissions.
Receives: Behavioral: CONTINUity of care Under Management by Video visits (CONTINUUM-V)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility using enrollment and retention on study

    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.

    Measured: Discharge to 3 business days

Secondary outcomes (4)

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

    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.

    Measured: Baseline to 15 days after discharge

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

    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).

    Measured: Baseline to 15 days after discharge

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

    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.

    Measured: Baseline to 15 days after discharge

  4. Patient Satisfaction using the Patient Satisfaction Questionnaire

    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.

    Measured: 10 to 15 days after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2020
  2. Study start7 Jan 2021
  3. Primary completion28 May 2021
  4. Study completion14 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04640714
Sponsor's protocol ID
20-418
Status last verified
Nov 2021
First submitted
11 Nov 2020
Last updated
19 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Publications

  • Lage DE, Burger AS, Cohn J, Hernand M, Jin E, Horick NK, Miller L, Kuhlman C, Krueger E, Olivier K, Haggett D, Meneely E, Ritchie C, Nipp RD, Traeger L, El-Jawahri A, Greer JA, Temel JS. Continuum: A Postdischarge Supportive Care Intervention for Hospitalized Patients With Advanced Cancer. J Pain Symptom Manage. 2024 Dec;68(6):613-621.e1. doi: 10.1016/j.jpainsymman.2024.08.024. Epub 2024 Aug 27.

    PubMed 39197695

Questions about this trial

What is this clinical trial studying?

A study testing CONTINUity of care Under Management by Video visits (CONTINUUM-V) in people with Advanced Cancer and Home Care, Hospital-Based, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility using enrollment and retention on study (time frame: Discharge to 3 business days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04640714, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021; AzTrials last refreshed its copy on 6 Nov 2026.

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