Clinical trial · Interventional
Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
NCT05346796CI-TRIAL-00115679SPHERErecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Survivorship Care Plan-Personal Health Record (SCP-PHR) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- Group that will receive written survivorship care information.
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Group that will be provided access to the survivorship care plan-personal health record tool.
- interventionNames
- Behavioral: Survivorship Care Plan-Personal Health Record (SCP-PHR)
Primary outcomes (1)
- measure
- Colorectal Cancer Surveillance Outcomes
- timeFrame
- 12 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.