Evaluation of a Symptom and Needs Assessment for Patients With Cancer

NCT04014751 | Completed DMC

• 1 other identifier: 1R18HS026170-01
• Study Type: observational
• Target: 1,166
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cancer

Keywords

Symptom-monitoring

Outcome Measures

Primary Outcomes (4)

• Effects of the symptom monitoring system on patient-reported quality of life related to cancer and cancer treatment

  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.

  Change from baseline quality of life at 12-months

• Effects of the symptom monitoring system on severity of patient-reported symptoms related to cancer and cancer treatment

  Symptom severity will be assessed via a Patient-Reported Outcome Measurement Information System (PROMIS) computer adaptive test (CAT) that will ask about depression, anxiety, pain, fatigue, and physical functioning. CAT items are dynamically selected for administration from an item bank based upon the respondent's previous answers. Patient usually completes 4-12 items with a high level of measurement.

  Change from baseline symptom severity at 12-months

• Effects of the symptom monitoring system on patient-reported adverse events related to cancer and cancer treatment

  Adverse events will be assessed using the Patient-Reported Outcomes- Common Terminology Criteria for Adverse Events (PRO-CTCAE™) assessment. The PRO-CTCAE questionnaire will ask questions about nausea, constipation, insomnia, vomiting, and diarrhea.

  Change from baseline adverse events at 12-months

• Impact of the symptom monitoring system on health care services used by patients

  Utilization of services related to physical and mental health will be measured using a patient-reported questionnaire to assess healthcare services used by participants, such as number of emergency room visits, oncology urgent care visits, general urgent care visits, doctor visits, referrals for services within and outside the health system, and overnight stays in the hospital.

  Change from baseline use of healthcare services at 12 months

Secondary Outcomes (2)

• Impact of the symptom monitoring system on patient experiences with their cancer care team

  Change from baseline patient experiences with their cancer care team at 12 months

• Patient experiences (barriers and facilitators) using the symptom and needs assessment

  Patient experiences will be assessed at one time point between baseline and 12 months

Study Arms (1)

Symptom Monitoring Cohort

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.

Other: Symptom Monitoring Intervention

Interventions

Symptom Monitoring Intervention OTHER

This study involves a cancer care delivery process improvement component where all cohort participants, at specified timepoints, are assessed for psychological distress, pain, fatigue, physical function, practical and supportive needs, and dietary and nutritional needs. Patients with severe elevations in psychological distress, physical symptoms or those who endorse supportive care and/or dietary needs are triaged in real time to appropriate providers within the health system (i.e., social work, nursing pool, nutrition services) to address elevated scores and/or stated needs. As such, within the context of this process improvement care delivery project, real time referrals function as interventional processes within the health system to route patients to relevant points of care based on their needs.

Symptom Monitoring Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes patients at Northwestern Medicine (NM) who have a confirmed diagnosis of a solid or hematological malignancy and have had oncology services at NM within the past 12-months.

Sponsors & Collaborators

• Northwestern University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

• Smith 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 DERIVED

• Garcia 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 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Sofia Garcia, PHD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: July 10, 2019
• Study Start: July 15, 2019
• Primary Completion: April 1, 2022
• Study Completion: May 31, 2022
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)