Recruiting

SPHERE

Sponsor:

Indiana University

Code:

NCT05346796

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

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

Study Details

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

Study ID

NCT05346796

Start date

Sep 9, 2022

Status verified date

Jun, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Primary outcome measure

  • Colorectal Cancer Surveillance Outcomes [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

David A Haggstrom, MD

(317) 274-9000dahaggst@iu.edu

Locations

Indiana University School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

David Haggstrom, MD

317-274-9026dahaggst@iu.edu

Principal Investigator:

David A Haggstrom, MD, MAS

More Information

Sponsor

Indiana University

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-06-24.