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Survivorship Care Plan for Cancer (SPHERE Trial)

N/A

Recruiting

Led By David A Haggstrom, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be 18 years or older at the time of consent

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

SPHERE Trial Summary

This trialwill evaluate a type of medical record (SCP-PHR) to understand if it's effective and how it can be implemented.

Who is the study for?

This trial is for adults over 18 with stages I, II, or III colon or rectal cancer who finished initial treatment within the last year. They must speak English and have regular internet access. It's not for those with severe cognitive issues, in hospice care, a history of psychosis like schizophrenia, or cancer recurrence.Check my eligibility

What is being tested?

The SPHERE trial is testing a Survivorship Care Plan-Personal Health Record (SCP-PHR) to see how effective it is and how well it can be implemented. Participants will be randomly assigned to receive this plan as part of an effectiveness study combined with a detailed analysis of its implementation.See study design

What are the potential side effects?

Since the intervention involves using a health record system rather than medication, traditional side effects are not expected. However, participants may experience issues related to the usability of the system or emotional impacts from engaging with their survivorship information.

SPHERE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

SPHERE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Colorectal Cancer Surveillance Outcomes

Secondary outcome measures

Preventive Care Outcomes

Symptom Measures

SPHERE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Group that will be provided access to the survivorship care plan-personal health record tool.

Group II: ControlActive Control1 Intervention

Group that will receive written survivorship care information.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

983,053 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,661 Previous Clinical Trials

40,924,172 Total Patients Enrolled

David A Haggstrom, MDPrincipal InvestigatorIndiana University School of Medicine

1 Previous Clinical Trials

57,073 Total Patients Enrolled

Media Library

Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05346796 — N/A

Cancer Research Study Groups: Control, Intervention

Cancer Clinical Trial 2023: Intervention Highlights & Side Effects. Trial Name: NCT05346796 — N/A

Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05346796 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial extend to geriatric patients?

"As per the set of criteria for inclusion in this medical trial, those participating must be between 18 and 99 years old."

Answered by AI

To whom is this trial open for enrollment?

"Candidate eligibility for this study includes a diagnosis of cancer and an age between 18-99 years old. A total of 250 patients are being sought by the research team."

Answered by AI

How many participants are contributing to this research endeavor?

"Affirmative. Based on the information provided by clinicaltrials.gov, this trial is currently accepting participants with recruitment beginning on September 1st 2022 and ending December 16th 2022 - seeking 250 patients from a single site."

Answered by AI

Is this research initiative still recruiting participants?

"Yes, according to clinicaltrials.gov this study is still recruiting participants. This research initiative began advertising on September 1st 2022 and was most recently updated December 16th 2022. It is seeking 250 individuals from one location for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Survivorship Plan HEalth REcord (SPHERE) Implementation Trial

David A. Haggstrom 2022. "Survivorship Plan HEalth REcord (SPHERE) Implementation Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05346796.