Survivorship Plan HEalth REcord (SPHERE) Implementation Trial (SPHERE)

To understand the effectiveness and implementation of the SCP-PHR, we will conduct a hybrid type 1 effectiveness-implementation trial consisting of the following components: (A) a randomized clinical effectiveness trial, and (B) a mixed methods implementation study.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Survivorship Care Plan-Personal Health Record (SCP-PHR)

Detailed Description

The Institute of Medicine recommends that each cancer patient receive a survivorship care plan that summarizes information important to the individual's long-term care, including the following: (1) cancer type and treatments, (2) their potential consequences, (3) recommendations regarding preventive practices, and (4) specific information about recommended follow-up. Despite their clinical importance, gaps in colorectal cancer (CRC) surveillance care and preventive care exist among CRC survivors. Unmet symptom needs are also prevalent and undertreated.

We propose to evaluate the capacity of an interactive survivorship care plan (SCP) delivered through an Internet-based personal health record (PHR) to meet the needs of CRC survivors. PHRs combine health information and medical data with knowledge management and software tools to potentially enable patients to become active participants in their own care. A SCP delivered via an appropriately designed PHR may promote increased concordance with CRC surveillance and preventive care guidelines through the exchange of health information with CRC survivors. A survivorship care plan-personal health record (SCP-PHR) may also improve care for symptoms through the combination of longitudinal PHR- based symptom measurement and tailored self-management tools. To understand the effectiveness of the SCP-PHR, we will conduct a randomized clinical effectiveness trial at the patient level. We will assess impact of the SCP-PHR across a variety of measures and outcomes, including CRC surveillance, preventive care receipt, patient symptoms, and patient-centered quality.

To simultaneously understand the effectiveness and implementation of the SCP-PHR, we will conduct a hybrid type I effectiveness-implementation trial consisting of the following components: (A) a randomized clinical effectiveness trial at the patient level, and (B) a mixed methods implementation study. The mixed methods portion of the study will consist of a qualitative process evaluation using semi- structured interviews to assess facilitators and barriers to implementation of the SCP-PHR among key stakeholders: patients, health care providers, and organizational leaders. This study design will enable us to meet the simultaneous needs of understanding the effectiveness and the health care context of SCP implementation.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David A Haggstrom, MD; Phone Number: (317) 274-9000; Email: dahaggst@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University School of Medicine
      • Contact: David Haggstrom, MD; Phone Number: 317-274-9026; Email: dahaggst@iu.edu
      • Principal Investigator: David A Haggstrom, MD, MAS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patients must be 18 years or older at the time of consent
2. Patients must have regular (at least weekly) access to an internet connection, whether at home or elsewhere (family or friend).
3. Diagnosis of colon or rectal cancer, Stages I, II, or III (AJCC, American Joint Committee on Cancer) and have undergone initial curative-intent therapy for their CRC diagnosis within the past 12 months.
4. English-speaking

Exclusion Criteria:

1. Patient will be excluded if they have had recurrence of their colorectal cancer.
2. Patient's with severe cognitive impairment
3. Patient's with schizophrenia or other psychosis
4. Patients currently in hospice care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Group that will receive written survivorship care information.
Experimental: Intervention; Group that will be provided access to the survivorship care plan-personal health record tool.	Behavioral: Survivorship Care Plan-Personal Health Record (SCP-PHR); The SCP-PHR tool is an online portal that is intended to help cancer survivors manage their survivorship care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colorectal Cancer Surveillance Outcomes	The CRC Surveillance Index (SI) will be extracted from the electronic medical record. For each observation period, every person-month is classified as either "covered" (eligible for the test during the month and covered) or "uncovered" (eligible for the test, but not covered). If a surveillance test (S) is delivered to an eligible patient at a particular time, then all person-months for the following recommended interval fall under a period of coverage (P1). If it is not renewed, then an uncovered portion of the observation period (U) is created. Further, if a second surveillance test (S2) is performed after some uncovered interval (U), additional covered months (P2) may be present during the observation period. For each patient, SI=100*[(P1+P2)/(P1+P2+U)] for each surveillance test.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preventive Care Outcomes	All preventive care measures will be measured in the electronic medical record based upon U.S. Preventive Services Task Force (USPSTF) or Advisory Committee for Immunization Practices guidelines. Measures are calculated using a methodology similar to the one described for the Surveillance Index, but in this instance, a Prevention Index (PI) is created. The following preventive care is included in the index: influenza vaccine, pneumococcal vaccine, cholesterol screening, blood pressure screening, and HIV screening screening118, tobacco status and counseling119, screening mammography119, and cervical cancer screening	12 months
Symptom Measures	The primary symptom outcome measure will be the composite 5-symptom T score from the PROMIS which includes scales for sleep, pain, anxiety, depression, and energy/fatigue (SPADE) via self-report. Conversion tables allow conversion of simple summed raw scores from PROMIS scales into T-score values. The composite Patient-Reported Outcomes Measurement Information System (PROMIS) score is the mean of the 5 symptom scores.	12 months

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: David A Haggstrom, MD, Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2022
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 10523; 1R01CA241143-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No