Clinical trial · Observational
Evaluation of a Symptom and Needs Assessment for Patients With Cancer
Expansion, Implementation & Evaluation of Electronic Health Record (EHR)-Integrated Patient-Reported Symptom Screening in a Multi-Site Cancer Center
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a quality improvement study that aims to improve on the timely identification and management of symptoms and supportive care needs in patients with cancer. The study will be evaluating the relative success of an existing on-line patient-reported symptom and needs assessment, and then the implementation and use of an updated version of the symptom and needs assessment with Northwestern Medicine (NM) cancer patients. It also aims to evaluate the impact of the symptom and needs assessment system on healthcare delivery and quality of care. Participants who complete the symptom and needs assessment as part of their usual care are invited to participate in the study by agreeing to complete an on-line survey (at 3 different time points) that asks about quality of life, adverse symptoms related to cancer and cancer treatment, patient experiences with their cancer care team, and the healthcare services they have received. Patients may also be invited to participate in a one-time interview or focus group about patient experiences with the symptom and needs assessment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Symptom Monitoring Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Symptom Monitoring Cohort
- description
- This cohort will include up to1,050 cancer patients being seen at regional Northwestern Medicine (NM) cancer centers for their cancer care. Patients who have recently completed an on-line, EHR-integrated patient-reported symptom and needs assessment as part of their regular care will be invited to complete a survey at baseline, 6- and 12-months targeting the assessment of their symptoms, healthcare experiences and utilization. Patients may also be invited to participate in a one-time interview or focus group designed to help study investigators better understand the value of the symptom and needs assessment from the patient perspective.
- interventionNames
- Other: Symptom Monitoring Intervention
Primary outcomes (4)
- measure
- Effects of the symptom monitoring system on patient-reported quality of life related to cancer and cancer treatment
- timeFrame
- Change from baseline quality of life at 12-months
- description
- Quality of life will be assessed using a brief, validated 7-item patient-reported questionnaire (Functional Assessment of Cancer Therapy-General 7-item or FACT-G7) that asks about symptoms of fatigue, pain, and nausea, sleep quality and contentment with life.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
1. Must have medical chart confirmed diagnosis of a solid or hematological malignancy 2. Must have had oncology services at a Northwestern Medicine location within the past 12 months 3. Must have completed the current symptom monitoring assessment offered by Northwestern Medicine 4. Must be willing to complete electronic patient-reported measures (i.e. patient reported health care utilization and satisfaction surveys) at baseline, 6-month, and 12-month follow-up time points, and 5. Must consent to give authorized study staff access to details of their cancer diagnosis and treatment as documented in their electronic health record 6. If participating in a semi-structured interview or focus group, must consent to have their comments audio-recorded Exclusion Criteria: \-
References
Publications (2)
- DERIVEDSmith JD, Merle JL, Webster KA, Cahue S, Penedo FJ, Garcia SF. Tracking dynamic changes in implementation strategies over time within a hybrid type 2 trial of an electronic patient-reported oncology symptom and needs monitoring program. Front Health Serv. 2022 Nov 1;2:983217. doi: 10.3389/frhs.2022.983217. eCollection 2022. PMID 36925901
- DERIVEDGarcia SF, Smith JD, Kallen M, Webster KA, Lyleroehr M, Kircher S, Bass M, Cella D, Penedo FJ. Protocol for a type 2 hybrid effectiveness-implementation study expanding, implementing and evaluating electronic health record-integrated patient-reported symptom monitoring in a multisite cancer centre. BMJ Open. 2022 May 3;12(5):e059563. doi: 10.1136/bmjopen-2021-059563. PMID 35504641