Cancer, Gastrointestinal Cancer, Lung Cancer, Thoracic Neoplasms
Conditions
Keywords
Patient Reported Outcomes, Radiotherapy
Brief 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. 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.
Interventions
None listed
Sponsors
WellSpan Health
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Inclusion criteria
* 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
Exclusion criteria
* Patients receiving radiation for palliative intent * Patients who do not provide informed consent * Patients who chose to withdraw from the study Radiation Oncologists Inclusion criteria: • Must be the physician overseeing the care of the patient who answers the PROMS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Change in Their Physician-assessed Burden Score | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Changes in the Management of On-treatment Symptoms | Up to 2 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Management Changes as Assessed by a Clinician Feedback Form | Up to 2 months | At the end of each patient's course of radiotherapy, providers will complete a Clinician Feedback Form that details the types of new management interventions resulting from routine review of the PROMs over the course of definitive radiation. |
Countries
United States
Participant flow
Pre-assignment details
A total of 104 patients enrolled in the study. Four patients were excluded from the analysis.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Patients With Cancer Treated With Definitive-intent Radiotherapy |
|---|---|
| Age, Continuous | 70 years |
| Race/Ethnicity, Customized African American | 13 Participants |
| Race/Ethnicity, Customized Caucasian, non-Hispanic | 81 Participants |
| Race/Ethnicity, Customized Other | 6 Participants |
| Region of Enrollment United States | 100 Participants |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
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)
Time frame: Up to 2 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients With Cancer Treated With Definitive-intent Radiotherapy | Participants With Change in Their Physician-assessed Burden Score | Patients with an increased or decreased burden-score of 1 point. | 43 Participants |
| Patients With Cancer Treated With Definitive-intent Radiotherapy | Participants With Change in Their Physician-assessed Burden Score | Patients with an increased or decreased burden-score of ≥ 2 points. | 32 Participants |
| Patients With Cancer Treated With Definitive-intent Radiotherapy | Participants With Change in Their Physician-assessed Burden Score | Patients with no change in burden-score. | 25 Participants |
Secondary
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.
Time frame: Up to 2 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients With Cancer Treated With Definitive-intent Radiotherapy | Participants With Changes in the Management of On-treatment Symptoms | New Medications/ New Interventions | 29 Participants |
| Patients With Cancer Treated With Definitive-intent Radiotherapy | Participants With Changes in the Management of On-treatment Symptoms | Counseling/ Modification of Medications | 39 Participants |
| Patients With Cancer Treated With Definitive-intent Radiotherapy | Participants With Changes in the Management of On-treatment Symptoms | Referral to Other Services/ Further Tests | 19 Participants |
Other Pre-specified
Management Changes as Assessed by a Clinician Feedback Form
At the end of each patient's course of radiotherapy, providers will complete a Clinician Feedback Form that details the types of new management interventions resulting from routine review of the PROMs over the course of definitive radiation.
Time frame: Up to 2 months