Oncology Associated Symptoms & Individualized Strategies

NCT03122249 | Withdrawn DMC

• 1 other identifier: 201605851
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Nearly 20% of Americans and 41% of Iowans live in rural or non-metropolitan areas.(1) Lack of access to providers, long travel distances, and a disconnected health system contribute to increased distress and lower quality-of-life (QOL) in people with advanced cancer living in rural areas. (2) In the state of Iowa, 94% of rural residents have high-speed internet access. (3) The University of Iowa Health Care (UIHC) eHealth eNovation Center has developed the infrastructure to address the health care access gap in Iowa. The combination of wide availability of high-speed internet and the eHealth network provides an opportunity to develop and test interventions that leverage this infrastructure in order to address this important palliative care gap. This is a pilot study to evaluate the feasibility of an eHealth self-management intervention for cancer symptom management. The intervention consists of a web-application that provides tailored educational information about cancer symptoms and a monitoring platform to track symptom distress and strategies used to manage them. Participants will also receive e-visits from a research nurse or research assistant via UIHC eHealth and eNovation video platform. The purpose of this study is obtain feasibility data about the intervention for a future RCT and to evaluate the OASIS intervention with patients living in rural Iowa receiving treatment for advanced cancer. The specific aims are:

1. 1.to evaluate the feasibility of the OASIS intervention to self-manage symptoms of rural patients with advanced cancer, including a) recruitment and retention, b) use patterns, c) usability of each component of the intervention (i.e., the e-visit platform and the web-application), d) acceptability of the intervention and study (i.e., satisfaction, barriers and facilitators to use, burden); and
2. 2.to determine preliminary effects of the intervention on self-management behaviors and symptom severity, symptom distress, and symptom interference.

Conditions

Advanced Cancer

Keywords

Palliative care; Symptom management; Self-management; Rural area; eHealth; telehealth

Outcome Measures

Primary Outcomes (3)

• Measuring change in Health Education Impact Questionnaire (heiQ)

  An outcomes and evaluation measure for patient education and self-management interventions for people. This scale is assessing change between four time points

  Week 0,4, 8, 12

• Measuring change in Symptom burden (MDASI - core)

  Assess patient-reported symptom severity and interference in patients with cancer. This scale is assessing change between four time points

  Week 0,4, 8, 12

• Measuring change in QOL (FACT-G)

  This is a patient-reported outcome measure used to assess health-related quality of life in patients undergoing cancer therapy. This scale is assessing change between four time points.

  Week 0,4,8,12

Secondary Outcomes (5)

• Recruitment

  Week 0

• Retention rates

  Week 0

• Retention rates

  Week 4

• Retention rates

  Week 8

• Retention rates

  Week 12

Study Arms (1)

OASIS

OTHER

Patients that meet the eligibility criteria will be enrolled in the study and will receive the advanced cancer symptom management intervention

Behavioral: Advanced Cancer Symptom Management

Interventions

Advanced Cancer Symptom Management BEHAVIORAL

For a period of eight weeks patients will use the OASIS web-application daily to help them get better control of their cancer symptoms. In addition, to daily symptom and strategy tracking, participants will have eight e-visits with the nurse-coach via the Zoom application through the UIHC eHealth and eNovation Center to evaluate their progress with managing their symptoms, assess for barriers to implementing strategies, and offering coaching on how to improve symptom management. Questionnaires and blood samples will be collected at baseline (week 0) and follow-up (weeks 4, 8, and 12).

OASIS

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18 yrs or older) with a current diagnosis of advanced cancer of solid tumor (stage 3 or 4) origin considered incurable by the treating oncologist,
• Experiencing with at least one distressing symptoms (rated 3 or greater on 0-10 numeric rating scale for symptom distress),
• Able to read and write in English
• Have a laptop, mobile phone and/or tablet with a video camera that can use to access the internet
• Have high-speed internet connection in his/her home

You may not qualify if:

• Patients who are not able to complete the study surveys (alone or with assistance) due impaired mental, cognitive, or physical status.

Sponsors & Collaborators

• Stephanie Gilbertson-White: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

McCreery Cancer Center

Fairfield, Iowa, 52556, United States

Location

Related Publications (3)

• U.S. Census Bureau. Urban, Urbanized Area, Urban Cluster, and Rural Population, 2010 and 2000: United States. 2010; https://www.census.gov. Accessed 12/23/2015.

  BACKGROUND

• Pedro LW, Schmiege SJ. Rural living as context: a study of disparities in long-term cancer survivors. Oncol Nurs Forum. 2014 May;41(3):E211-9. doi: 10.1188/14.ONF.E211-E219.

  PMID: 24769604 BACKGROUND

• Connect Iowa. Broadband Infrastructure at a State and Local Level in Iowa. 2015.

  BACKGROUND

Study Officials

• Stephanie Gilbertson-White, PhD

  University of Iowa College of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All participants will receive the intervention delivered via the internet

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: April 20, 2017
• Study Start: March 10, 2017
• Primary Completion: January 20, 2019
• Study Completion: September 20, 2019
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)