CancerIMPROVENCT04589247
Improving Cancer On-treatment Symptom Management
An observational study of Cancer and Thoracic Neoplasms, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 4 sites in United States.
Trial summary
Patient-reported outcome measures (PROMs) is an umbrella term that refers to any report on a health status measure that is reported directly by the patient, without the influence of clinicians or anyone else. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cancer, Thoracic Neoplasms, Gastrointestinal Cancer
- How many people
- 104 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 Nov 2020to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- All sexes
- Adult, Older adult
Study population: Our study population will be treating radiation oncologists and their primary cancer patients requiring definitive treatment with radiation with or without concurrent chemotherapy as per the inclusion criteria below. Cancer patients receiving stereotactic body radiation therapy or hypo-fractionated definitive radiation will not be recruited as these patients represent a different treatment population with a much lower overall treatment toxicity burden.
Who may be able to join
- Men and women over 18 years of age
- Able to read and write in English or able to understand/answer questions with the aid of an interpreter
- Histologically confirmed loco-regional to advanced primary cancer, including but not limited to lung cancer, esophageal, or gastro-intestinal cancers at risk of developing radiotherapy-related toxicity.
- Receiving definitive conventionally-fractionated radiation treatment with or without chemotherapy
- Must be the physician overseeing the care of the patient who answers the PROMS
Who cannot join
- Patients receiving radiation for palliative intent
- Patients who do not provide informed consent
- Patients who chose to withdraw from the study
- Radiation Oncologists
- Have not provided informed consent
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Bayview Medical Center
Baltimore, Maryland, 21227
Khinh Voong
Baltimore, Maryland, 21230
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
Suburban Hospital
Bethesda, Maryland, 20814
About this study
Official title: Improving Cancer Care by Incorporating the Patient's Voice Into On-treatment Symptom Management
Patient-reported outcome measures (PROMs) is an umbrella term that refers to any report on a health status measure that is reported directly by the patient, without the influence of clinicians or anyone else. PROMs have been shown to more closely reflect a patient's daily health status when compared to physician-reported measures. However, research is needed to evaluate if patient symptom reporting during definitive-intent radiotherapy allows earlier and improved detection of treatment toxicity.
The IMPROVE pilot study will describe the proportion of patients with cancer with changes in physician-perception of treatment-related toxicity that result from routine physician review of PROMs reported during definitive radiotherapy.
Read the detailed description
Patient-reported outcome measures (PROMs) is an umbrella term that refers to any report on a health status measure that is reported directly by the patient, without the influence of clinicians or anyone else. PROMs have been shown to more closely reflect a patient's daily health status when compared to physician-reported measures. However, research is needed to evaluate if patient symptom reporting during definitive-intent radiotherapy allows earlier and improved detection of treatment toxicity, and leads to individualized interventions which may improve the toxicity outcomes for patients with locally-advanced and oligometastatic cancer.
The investigators hypothesize that routine physician review of PROMs during on-treatment visits will (1) increase proportion of patients with an increased in their physician' s assessment of their overall toxicity burden during definitive radiotherapy, and (2) correspondingly increase the proportion of patients receiving physician-directed interventions for treatment-related symptoms.
The IMPROVE pilot study will describe the proportion of patients with cancer with changes in physician-perception of treatment-related toxicity that result from routine physician review of PROMs reported during definitive radiotherapy. The IMPROVE study will also describe (1) the proportion of patients with changes in the management of treatment-related symptoms and (2) the type of management changes that result from routine physician review of PROMs reported during definitive radiotherapy.
- Conditions
- Cancer, Thoracic Neoplasms, Gastrointestinal Cancer, Lung Cancer
- Keywords
- Patient Reported Outcomes, Radiotherapy
- Medical subject headings
- Neoplasms, Thoracic Neoplasms, Gastrointestinal Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cancer treated with definitive-intent radiotherapy | Histologically confirmed loco-regional to advanced primary cancer, including but not limited to lung cancer, esophageal, or gastro-intestinal cancers at risk of developing radiotherapy-related toxicity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Change in Their Physician-assessed Burden Score
The primary outcome is patients with any change in physicians-assessed burden scores for at least one radiotherapy on-treatment visit. Lee et al. demonstrated the feasibility of using a global burden score to capture the provider's overall perception of the combined burden of all assessed symptoms, using a visual analogue scale demarcating an aggregate score from 0 to 10. This scale uses anchors at 0, 2, 4, 6, 8, and 10 for no, mild, moderate, severe, life-threatening adverse events, and death, respectively. A 2-point score change correlates to a change to the next anchored score (i.e., mild to moderate, 2 to 4; or moderate to severe, 4 to 6)
Measured: Up to 2 months
Secondary outcomes (1)
Participants With Changes in the Management of On-treatment Symptoms
During weekly on-treatment visits and prior to reviewing the patient's PROMs, physicians will formulate an initial symptom management plan based on available clinical data. After reviewing the patient's PROMs, physicians will report participants with changes in recommended interventions due to review of the PROMs.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start16 Nov 2020
- Primary completion23 Jul 2023
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- WellSpan Health
- Responsible party
- Sponsor
- Investigators
- Ranh Voong, MD, Principal investigator, SKCCC at Johns hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589247
- Sponsor's protocol ID
- J2048
- Other IDs
- IRB00218263
- Acronym
- IMPROVE
- Status last verified
- Sep 2025
- First submitted
- 6 Oct 2020
- Last updated
- 25 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cancer Care by Incorporating the Patient's Voice Into On-treatment Symptom Management
- ClinicalTrials.gov ID
- NCT04589247
- Acronym / sponsor ID
- IMPROVE / J2048
- Conditions
- Cancer, Thoracic Neoplasms, Gastrointestinal Cancer, Lung Cancer
- Keywords
- Patient Reported Outcomes, Radiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- WellSpan Health
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 23 Jul 2023 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Posted 25 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patient-reported outcome measures (PROMs) is an umbrella term that refers to any report on a health status measure that is reported directly by the patient, without the influence of clinicians or anyone else. PROMs have been shown to more closely reflect a patient's daily health status when compared to physician-reported measures. However, research is needed to evaluate if patient symptom reporting during definitive-intent radiotherapy allows earlier and improved detection of treatment toxicity.
The IMPROVE pilot study will describe the proportion of patients with cancer with changes in physician-perception of treatment-related toxicity that result from routine physician review of PROMs reported during definitive radiotherapy.
Detailed description
Patient-reported outcome measures (PROMs) is an umbrella term that refers to any report on a health status measure that is reported directly by the patient, without the influence of clinicians or anyone else. PROMs have been shown to more closely reflect a patient's daily health status when compared to physician-reported measures. However, research is needed to evaluate if patient symptom reporting during definitive-intent radiotherapy allows earlier and improved detection of treatment toxicity, and leads to individualized interventions which may improve the toxicity outcomes for patients with locally-advanced and oligometastatic cancer.
The investigators hypothesize that routine physician review of PROMs during on-treatment visits will (1) increase proportion of patients with an increased in their physician' s assessment of their overall toxicity burden during definitive radiotherapy, and (2) correspondingly increase the proportion of patients receiving physician-directed interventions for treatment-related symptoms.
The IMPROVE pilot study will describe the proportion of patients with cancer with changes in physician-perception of treatment-related toxicity that result from routine physician review of PROMs reported during definitive radiotherapy. The IMPROVE study will also describe (1) the proportion of patients with changes in the management of treatment-related symptoms and (2) the type of management changes that result from routine physician review of PROMs reported during definitive radiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cancer treated with definitive-intent radiotherapy | – | –Histologically confirmed loco-regional to advanced primary cancer, including but not limited to lung cancer, esophageal, or gastro-intestinal cancers at risk of developing radiotherapy-related toxicity. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Our study population will be treating radiation oncologists and their primary cancer patients requiring definitive treatment with radiation with or without concurrent chemotherapy as per the inclusion criteria below. Cancer patients receiving stereotactic body radiation therapy or hypo-fractionated definitive radiation will not be recruited as these patients represent a different treatment population with a much lower overall treatment toxicity burden.
Key inclusion criteria (5 listed)
- Men and women over 18 years of age
- Able to read and write in English or able to understand/answer questions with the aid of an interpreter
- Histologically confirmed loco-regional to advanced primary cancer, including but not limited to lung cancer, esophageal, or gastro-intestinal cancers at risk of developing radiotherapy-related toxicity.
- Receiving definitive conventionally-fractionated radiation treatment with or without chemotherapy
- Must be the physician overseeing the care of the patient who answers the PROMS
Key exclusion criteria (5 listed)
- Patients receiving radiation for palliative intent
- Patients who do not provide informed consent
- Patients who chose to withdraw from the study
- Radiation Oncologists
- Have not provided informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Participants With Change in Their Physician-assessed Burden Score
Time frame: Up to 2 months
The primary outcome is patients with any change in physicians-assessed burden scores for at least one radiotherapy on-treatment visit. Lee et al. demonstrated the feasibility of using a global burden score to capture the provider's overall perception of the combined burden of all assessed symptoms, using a visual analogue scale demarcating an aggregate score from 0 to 10. This scale uses anchors at 0, 2, 4, 6, 8, and 10 for no, mild, moderate, severe, life-threatening adverse events, and death, respectively. A 2-point score change correlates to a change to the next anchored score (i.e., mild to moderate, 2 to 4; or moderate to severe, 4 to 6)
1 secondary outcome
Participants With Changes in the Management of On-treatment Symptoms
Time frame: Up to 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ranh Voong, MD principal investigator
SKCCC at Johns hopkins
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Thoracic Neoplasms, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 4 sites 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 5 inclusion and 5 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 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 25 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participants With Change in Their Physician-assessed Burden Score (time frame: Up to 2 months). 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 25 Sep 2025.