CancerNCT05142345
Care Transition Intervention for Hospitalized Patients With Advanced Cancer
A study testing CONTINUUM Intervention in people with Cancer and Follow-Up Care, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study is examining whether a care transition intervention, CONTINUUM (CONTINUity of care Under Management by video visits), consisting of a supportive care-focused video visit with an oncology nurse practitioner (NP) within three business days of hospital discharge, may improve post-discharge transitions of care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Follow-Up Care, Consultation, Remote
- What is being tested?
- CONTINUUM Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2021to 30 Mar 2025
- 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
- First unplanned admission since diagnosis of advanced cancer to to the oncology service at Massachusetts General Hospital (MGH) or the medicine service with oncology consultation
- Known diagnosis of advanced breast, thoracic, genitourinary, gastrointestinal cancers, sarcoma, or melanoma
- Receiving ongoing oncology care at MGH
- Verbal fluency in English
- Internet/wifi or telephone access
- Residing in Massachusetts at the time of hospital discharge
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
About this study
Official title: Randomized Trial of a Care Transition Intervention for Hospitalized Patients With Advanced Cancer
This study is examining whether a care transition intervention, CONTINUUM (CONTINUity of care Under Management by video visits), consisting of a supportive care-focused video visit with an oncology nurse practitioner (NP) within three business days of hospital discharge, may improve post-discharge transitions of care for recently hospitalized patients with advanced cancer.
Read the detailed description
To address the rising incidence and burden of hospital readmissions for patients with advanced cancer, the investigators developed a population-specific care transition intervention based upon the scholarly literature and our qualitative study. The intervention, CONTINUUM (CONTINUity of care Under Management by video visits), consists of a video visit conducted by an oncology NP within three business days of hospital discharge, to: (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.
From 01/07/21 to 05/28/21, the investigators conducted a pilot trial of CONTINUUM in 54 patients with advanced cancer recently discharged from the Massachusetts General Hospital Cancer Center (NCT04640714). The investigators found that the intervention was feasible and acceptable in our population.
The investigators are now conducting a randomized controlled trial of the CONTINUUM intervention versus standard of care, to study whether CONTINUUM improves patients' confidence in managing their health condition, as measured by the Patient Activation Measure-13. The investigators will also assess the efficacy of CONTINUUM for improving patient satisfaction with clinician communication, and physical and psychological symptom burden. Lastly, the investigators will explore the effect of the intervention on hospital readmissions within 30-days.
Study procedures include random assignment to either the CONTINUUM intervention or standard oncology care following hospital discharge, questionnaires and medical record data collection.
Participants are expected to be on the study for up to 40 days after hospital discharge.
It is anticipated that about 286 people will take part in this research study.
- Conditions
- Cancer, Follow-Up Care, Consultation, Remote, Advanced Cancer
- Being tested
- CONTINUUM Intervention, Usual Care
- Keywords
- Cancer, Follow-Up Care, Care Services, Home, Consultation, Remote, Advanced Cancer, Hospitalization, Care Transition Intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONTINUUM InterventionOther
The intervention, CONTINUUM (CONTINUity of care Under Management by video visits), consists of a video visit conducted by an oncology nurse practitioner within three business days of hospital discharge, to: (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.
Usual CareOther
Patients assigned to the usual care group will have their post-discharge follow-up scheduled per hospital, outpatient oncology team, and patient preference.
| Study group | Role | What they receive |
|---|---|---|
| CONTINUUM Intervention Post-Hospital Discharge | Experimental | Participants will receive CONTINUUM intervention visit with a nurse practitioner within three business days of hospital discharge and complete questionnaires about their cancer and care. Receives: Other: CONTINUUM Intervention |
| Usual Care Post-Hospital Discharge | Active comparator | Participants will receive standard oncology care following hospital discharge with follow-up appointments scheduled per primary team and participant preferences. Participants will complete questionnaires about their cancer and care. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' Confidence in Managing their Health Condition using the Patient Activation Measure-13 (PAM-13)
Compare change in the PAM-13 from baseline to 10-20 days post-discharge between study groups. The PAM-13 is scored 0-100 with higher scores indicating greater confidence in managing one's health condition.
Measured: Baseline to 10-20 days after hospital discharge
Secondary outcomes (3)
Quality of Communication using the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Communication subscale
Compare differences in CAHPS-Communication at up to 10-20 days post-discharge between study groups. CAHPS-Communication has a composite score (score range 0-20) with higher scores indicating better satisfaction. As recommended by CAHPS, we will also analyze specific differences in CAHPS-Communication individual items, which relate to patients' assessment of whether clinicians discussed 1) illness course expectations, 2) what is most important to the patient, and 3) how the treatment plan should match what is most important to the patient. These items are scored as "Yes" vs. "No" responses.
Measured: Up to 10-20 days after hospital discharge
Symptom Burden using the Edmonton Symptom Assessment Scale (ESAS-r)
Compare change in the Edmonton Symptom Assessment System-Revised (ESAS-r) total score and physical sub-scale between baseline and 10-20 days of discharge between study groups. Scores on the ESAS-r range from 0-100 with higher scores indicating worse symptom burden. Scores on the ESAS-Physical sub-scale range from 0-70 with higher scores indicating worse symptom burden.
Measured: Baseline to 10-20 days after hospital discharge
Psychological Symptoms using the Patient Health Questionnaire-4 (PHQ-4)
Compare change in the Patient Health Questionnaire-4 (PHQ-4) between baseline and 10-20 days of discharge between study groups. 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 10-20 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start15 Dec 2021
- Primary completion30 Jan 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Conquer Cancer Foundation
- Responsible party
- Principal investigator, Daniel E Lage, MD, MSc, Massachusetts General Hospital
- Investigators
- Daniel E Lage, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142345
- Sponsor's protocol ID
- 21-501
- Status last verified
- Sep 2025
- First submitted
- 20 Nov 2021
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of a Care Transition Intervention for Hospitalized Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT05142345
- Acronym / sponsor ID
- 21-501
- Conditions
- Cancer, Follow-Up Care, Consultation, Remote, Advanced Cancer
- Keywords
- Cancer, Follow-Up Care, Care Services, Home, Consultation, Remote, Advanced Cancer, Hospitalization, Care Transition Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Conquer Cancer Foundation
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is examining whether a care transition intervention, CONTINUUM (CONTINUity of care Under Management by video visits), consisting of a supportive care-focused video visit with an oncology nurse practitioner (NP) within three business days of hospital discharge, may improve post-discharge transitions of care for recently hospitalized patients with advanced cancer.
Detailed description
To address the rising incidence and burden of hospital readmissions for patients with advanced cancer, the investigators developed a population-specific care transition intervention based upon the scholarly literature and our qualitative study. The intervention, CONTINUUM (CONTINUity of care Under Management by video visits), consists of a video visit conducted by an oncology NP within three business days of hospital discharge, to: (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.
From 01/07/21 to 05/28/21, the investigators conducted a pilot trial of CONTINUUM in 54 patients with advanced cancer recently discharged from the Massachusetts General Hospital Cancer Center (NCT04640714). The investigators found that the intervention was feasible and acceptable in our population.
The investigators are now conducting a randomized controlled trial of the CONTINUUM intervention versus standard of care, to study whether CONTINUUM improves patients' confidence in managing their health condition, as measured by the Patient Activation Measure-13. The investigators will also assess the efficacy of CONTINUUM for improving patient satisfaction with clinician communication, and physical and psychological symptom burden. Lastly, the investigators will explore the effect of the intervention on hospital readmissions within 30-days.
Study procedures include random assignment to either the CONTINUUM intervention or standard oncology care following hospital discharge, questionnaires and medical record data collection.
Participants are expected to be on the study for up to 40 days after hospital discharge.
It is anticipated that about 286 people will take part in this research study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTINUUM Intervention Post-Hospital Discharge | Experimental | Other: CONTINUUM InterventionParticipants will receive CONTINUUM intervention visit with a nurse practitioner within three business days of hospital discharge and complete questionnaires about their cancer and care. |
| Usual Care Post-Hospital Discharge | Active comparator | Other: Usual CareParticipants will receive standard oncology care following hospital discharge with follow-up appointments scheduled per primary team and participant preferences. Participants will complete questionnaires about their cancer and care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >= 18 years
- First unplanned admission since diagnosis of advanced cancer to to the oncology service at Massachusetts General Hospital (MGH) or the medicine service with oncology consultation
- Known diagnosis of advanced breast, thoracic, genitourinary, gastrointestinal cancers, sarcoma, or melanoma
- Receiving ongoing oncology care at MGH
- Verbal fluency in English
Key exclusion criteria (3 listed)
- Admitted electively
- Discharged to a location other than home or expired during admission
- Discharged with hospice services
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CONTINUUM InterventionThe intervention, CONTINUUM (CONTINUity of care Under Management by video visits), consists of a video visit conducted by an oncology nurse practitioner within three business days of hospital discharge, to: (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. | Other | CONTINUUM Intervention Post-Hospital Discharge |
| Usual CarePatients assigned to the usual care group will have their post-discharge follow-up scheduled per hospital, outpatient oncology team, and patient preference. | Other | Usual Care Post-Hospital Discharge |
Primary outcome
Patients' Confidence in Managing their Health Condition using the Patient Activation Measure-13 (PAM-13)
Time frame: Baseline to 10-20 days after hospital discharge
Compare change in the PAM-13 from baseline to 10-20 days post-discharge between study groups. The PAM-13 is scored 0-100 with higher scores indicating greater confidence in managing one's health condition.
3 secondary outcomes
Quality of Communication using the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Communication subscale
Time frame: Up to 10-20 days after hospital discharge
Symptom Burden using the Edmonton Symptom Assessment Scale (ESAS-r)
Time frame: Baseline to 10-20 days after hospital discharge
Psychological Symptoms using the Patient Health Questionnaire-4 (PHQ-4)
Time frame: Baseline to 10-20 days after hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel E Lage, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CONTINUUM Intervention in people with Cancer and Follow-Up Care, 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 7 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 2 Oct 2025. 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?
Patients' Confidence in Managing their Health Condition using the Patient Activation Measure-13 (PAM-13) (time frame: Baseline to 10-20 days after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2025.