Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Survivorship Care Plan-Personal Health Record (SCP-PHR).
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Colorectal Cancer Surveillance Outcomes [Time frame: 12 months]
Secondary outcome measures (2)
- Preventive Care Outcomes [Time frame: 12 months]
- Symptom Measures [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Indiana University School of Medicine — Indianapolis
Identifiers
NCT: NCT05346796 · 10523 · 1R01CA241143-01A1