Survivorship Plan HEalth REcord (SPHERE) Implementation Trial

NCT ID: NCT05346796

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-09
• Study Completion Date: 2027-05-31

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.

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

Group that will receive written survivorship care information.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

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

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

David A. Haggstrom

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Indiana University School of Medicine

Indianapolis, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David A Haggstrom, MD

Role: CONTACT

dahaggst@iu.edu

(317) 274-9000

Facility Contacts

David Haggstrom, MD

Role: primary

dahaggst@iu.edu

317-274-9026

Other Identifiers

1R01CA241143-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10523

Identifier Type: -

Identifier Source: org_study_id