CancerSPHERENCT05346796
Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
A study testing Survivorship Care Plan-Personal Health Record (SCP-PHR) in people with Cancer, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Survivorship Care Plan-Personal Health Record (SCP-PHR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2022to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University School of Medicine
Indianapolis, Indiana, 46202
David Haggstrom, MD, 317-274-9026, dahaggst@iu.edu
David A Haggstrom, MD, MAS
About this study
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.
Read the 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
- Being tested
- Survivorship Care Plan-Personal Health Record (SCP-PHR)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survivorship Care Plan-Personal Health Record (SCP-PHR)Behavioural
The SCP-PHR tool is an online portal that is intended to help cancer survivors manage their survivorship care.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Group that will receive written survivorship care information. |
| Intervention | Experimental | Group that will be provided access to the survivorship care plan-personal health record tool. Receives: Behavioral: Survivorship Care Plan-Personal Health Record (SCP-PHR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
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
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start9 Sep 2022
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, David A. Haggstrom, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346796
- Sponsor's protocol ID
- 10523
- Other IDs
- 1R01CA241143-01A1
- Acronym
- SPHERE
- Status last verified
- Jun 2026
- First submitted
- 21 Apr 2022
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
- ClinicalTrials.gov ID
- NCT05346796
- Acronym / sponsor ID
- SPHERE / 10523
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Group that will receive written survivorship care information. |
| Intervention | Experimental | Behavioral: Survivorship Care Plan-Personal Health Record (SCP-PHR)Group that will be provided access to the survivorship care plan-personal health record tool. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention |
Primary outcome
Colorectal Cancer Surveillance Outcomes
Time frame: 12 months
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.
2 secondary outcomes
Preventive Care Outcomes
Time frame: 12 months
Symptom Measures
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survivorship Care Plan-Personal Health Record (SCP-PHR) in people with Cancer, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David A Haggstrom, MD ((317) 274-9000, dahaggst@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colorectal Cancer Surveillance Outcomes (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.