Survivorship Plan HEalth REcord (SPHERE) Implementation Trial

NCT05346796 | Recruiting

• 2 other identifiers: 105231R01CA241143-01A1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Preventive Care Outcomes

  12 months

• Symptom Measures

  12 months

Study Arms (2)

Control

NO INTERVENTION

Group that will receive written survivorship care information.

Intervention

EXPERIMENTAL

Group that will be provided access to the survivorship care plan-personal health record tool.

Behavioral: Survivorship Care Plan-Personal Health Record (SCP-PHR)

Interventions

Survivorship Care Plan-Personal Health Record (SCP-PHR) BEHAVIORAL

The SCP-PHR tool is an online portal that is intended to help cancer survivors manage their survivorship care.

Intervention

Eligibility Criteria

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

You may qualify if:

• Patients must be 18 years or older at the time of consent
• Patients must have regular (at least weekly) access to an internet connection, whether at home or elsewhere (family or friend).
• 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.
• English-speaking

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

David A Haggstrom, MD

CONTACT

(317) 274-9000; dahaggst@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 26, 2022
• Study Start: September 9, 2022
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

US (1)