Survivorship Plan HEalth REcord (SPHERE) Implementation Trial

ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorIndiana University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
12 months

Secondary outcomes

1

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

Time frame
12 months
2

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

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Indiana University

Lead sponsor

National Cancer Institute (NCI)

Collaborator