Survivorship Care Plan for Cancer

(SPHERE Trial)

Recruiting at 1 trial location

Overseen By David A Haggstrom, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Cancer recurrence, Cognitive impairment, Schizophrenia, Hospice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on understanding how the Survivorship Care Plan-Personal Health Record (SCP-PHR) can assist individuals who have had colon or rectal cancer. One group will use this tool to manage their care post-treatment, while the other group will receive standard written information. The trial aims to evaluate the tool's effectiveness and ease of use in managing long-term health. Suitable participants have recently completed treatment for Stage I, II, or III colon or rectal cancer within the past year and have regular internet access. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance long-term health management for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Survivorship Care Plan-Personal Health Record (SCP-PHR) is safe?

Research has shown that survivorship care plans (SCPs) are generally safe for patients. These plans assist cancer survivors in managing their health post-treatment by providing information and enhancing communication between doctors and patients. No specific safety issues have been reported for SCPs.

The Survivorship Care Plan-Personal Health Record (SCP-PHR) tool is a digital version of this plan, designed to simplify patient access to health information. Existing studies focus more on the effectiveness of these plans rather than safety concerns.

This trial is labeled "Not Applicable" for its phase, indicating it is not primarily testing safety but rather the effectiveness of the SCP-PHR. This generally suggests that the SCP-PHR is likely well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Survivorship Care Plan-Personal Health Record (SCP-PHR) because it offers a novel way to support cancer survivors in managing their post-treatment health. Unlike traditional methods that provide written survivorship care information, SCP-PHR integrates a digital tool that empowers patients with easy access to their personalized health records. This approach not only enhances patient engagement but also facilitates a more proactive management of health, potentially leading to better long-term outcomes for cancer survivors.

What evidence suggests that the Survivorship Care Plan-Personal Health Record (SCP-PHR) is effective for cancer survivorship?

Research shows that a Survivorship Care Plan-Personal Health Record (SCP-PHR) can benefit cancer survivors. In this trial, participants in the intervention group will access the SCP-PHR tool, while the control group will receive written survivorship care information. A review of several studies has found that survivors with an SCP report better outcomes than those without one. Another study found that SCPs can improve health and healthcare for cancer survivors. However, some research did not find significant improvements in areas like satisfaction with treatment or depression. Overall, SCPs might help manage symptoms and provide better long-term care for cancer survivors. ^{5 6 7 8 9}

Who Is on the Research Team?

David Haggstrom, MD

Principal Investigator

Indiana University School of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Patients must have regular (at least weekly) access to an internet connection, whether at home or elsewhere (family or friend)

I was treated for early-stage colon or rectal cancer in the last year.

English-speaking

Exclusion Criteria

I have severe difficulties with thinking, understanding, or remembering.

Patients currently in hospice care

My colorectal cancer has not come back after treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomized Clinical Effectiveness Trial

Participants are involved in a randomized clinical effectiveness trial to assess the impact of the SCP-PHR on CRC surveillance, preventive care, and patient symptoms.

12 months

Mixed Methods Implementation Study

A qualitative process evaluation using semi-structured interviews to assess facilitators and barriers to implementation of the SCP-PHR among key stakeholders.

Concurrent with the effectiveness trial

Follow-up

Participants are monitored for safety and effectiveness after the trial, focusing on CRC surveillance, preventive care, and symptom management.

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Survivorship Care Plan-Personal Health Record (SCP-PHR)

Trial Overview

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.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 Intervention

Group that will receive written survivorship care information.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The review identified a lack of evidence regarding the utilization of survivorship care plans (SCPs) among Asian American cancer survivors, particularly focusing on breast cancer survivors of Southeast Asian descent.

Barriers to effective delivery of SCPs were linked to socioeconomic factors, highlighting the need for more research to improve care for this diverse population of survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survivorship Care Plan Preferences and Utilization Among Asian American Breast Cancer Survivors. Nolan, TS., Arthur, E., Nwodim, O., et al.[2022]

The analysis of 74 colorectal cancer survivorship care plans (SCPs) revealed that while over 80% included essential information about cancer diagnosis, treatment details, and health promotion, critical aspects like predisposing conditions and genetic counseling were less frequently documented.

Post-treatment surveillance recommendations were generally well-documented, with 100% adherence to guidelines for colonoscopy in Year 1, but significant variability was observed in other surveillance methods, indicating a need for more consistent recommendations across cancer centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colorectal cancer survivorship care plans: Variations in documentation and posttreatment surveillance recommendations. Chodoff, A., Smith, KC., Shukla, A., et al.[2022]

A study comparing provider-initiated and patient-initiated web-based survivorship care plans (SCPs) found that both approaches faced significant barriers to implementation, with only 33% of providers enrolling and 61% of patients completing follow-up.

Despite the challenges, patients reported high levels of knowledge and confidence regarding their care, indicating that SCPs can be valuable tools for improving communication between patients and healthcare providers, regardless of who initiates the process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Web-Based Provider-Initiated and Patient-Initiated Survivorship Care Planning for Cancer Patients: A Randomized Controlled Trial. Smith, KC., Tolbert, E., Hannum, SM., et al.[2020]

A survey of 39 primary care providers revealed that 90% found survivorship care plans (SCPs) useful, indicating that these plans enhance understanding of cancer treatment and follow-up care.

However, 15% of providers felt unclear about their role in follow-up care, particularly among those in rural areas, suggesting a need for clearer guidelines and additional education on survivor care coordination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary Care Provider Evaluation of Cancer Survivorship Care Plans Developed for Patients in their Practice. Dittus, KL., Sprague, BL., Pace, CM., et al.[2022]

Cancer survivors who receive a survivorship care plan (SCP) experience better follow-up care and report fewer emotional concerns, highlighting the importance of these plans in improving patient outcomes.

A quality improvement initiative at a National Cancer Institute-designated center standardized the SCP process, increasing the completion rate from less than 10% to 34%, moving closer to the goal of providing SCPs to all eligible patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Integration of Survivorship Care Planning at a Comprehensive Cancer Center. McGrath, EB., Schaal, A., Pace, C.[2021]

A survey of 37 internal medicine trainees revealed that awareness and utilization of survivorship care plans (SCPs) is very low, with none of the participants using SCPs for cancer-free patients or planning to use them for information.

The majority of trainees (78.3%) reported not being taught about SCPs during their residency, highlighting a significant gap in training that could hinder effective communication and care for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Internal Medicine Residents' Awareness on Cancer Survivorship Care Plan: A Pilot Survey. Riano, I., Pomares-Millan, H., Prasongdee, K., et al.[2023]

Creating Survivorship Care Plans (SCPs) for pediatric leukemia patients involved significant time investment from oncology nurses (averaging 209 minutes per SCP) and oncologists (averaging 47.4 minutes), highlighting the resource demands of this process.

Despite the time required to create SCPs, 80% of primary care providers (PCPs) believe these plans improve communication with oncologists, and 100% feel they enhance their knowledge for managing pediatric cancer survivors, indicating SCPs are valuable tools for ongoing care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthcare provider perspectives on pediatric cancer survivorship care plans: a single institution pilot study. Mann, K., Wu, YP., Pannier, ST., et al.[2022]

Survivorship care plans (SCPs) are recognized as a valuable tool for supporting cancer survivors during their transition from treatment to survivorship, according to a systematic review of 11 qualitative studies.

However, there are significant gaps in their implementation, including inconsistent delivery to survivors and a lack of consensus on their format and content, highlighting the need for further research to optimize their use in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer survivors' experiences of using survivorship care plans: a systematic review of qualitative studies. Keesing, S., McNamara, B., Rosenwax, L.[2022]

Survivorship care plans (SCPs) have not shown significant improvements in patient satisfaction, distress, or quality of life compared to usual care, based on four randomized trials.

However, SCPs did enhance communication between primary care providers and specialists, and a recent trial suggested that focusing on behavioral interventions within SCPs may lead to better self-reported health outcomes and increased self-efficacy among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of cancer survivorship care plans on patient and health care provider outcomes: a current perspective. van de Poll-Franse, LV., Nicolaije, KA., Ezendam, NP.[2017]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7011634/

Survivorship Care Plans in Cancer: A Meta‐Analysis and ...

Our meta‐analysis compares patient‐reported outcomes between SCP and no SCP (control) conditions for cancer survivors.

2.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2018.77.7482

Systematic Review of the Impact of Cancer Survivorship ...

This systematic review evaluates whether delivery of SCPs has a positive impact on health outcomes and health care delivery for cancer survivors.

3.

jons-online.com

jons-online.com/issues/2021/january-2021-vol-12-no-1/survivorship-care-plans-initial-evidence-of-impact-on-distress-and-self-efficacy-among-high-risk-cancer-survivors

Survivorship Care Plans: Initial Evidence of Impact on ...

Results: Most (93%) of the sample had a family history of cancer; only 31% (n = 38) received some form of written care plan (SCP/treatment summary). Receipt of ...

4.

link.springer.com

link.springer.com/article/10.1007/s11764-024-01609-z

A scoping review of the evidence on survivorship care ...

This study found no significant improvements in patient-reported outcomes like treatment satisfaction, survivor concerns, depression, and impact ...

5.

maps.cancer.gov

maps.cancer.gov/overview/DCCPSGrants/abstract.jsp?applId=10624770&term=CA241143

Division of Cancer Control & Population Sciences - Grant Details

A survivorship care plan-personal health record (SCP-PHR) may also improve care for symptoms through the combination of longitudinal PHR- based symptom ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7883333/

Developing a survivorship care plan (SCP) delivery ...

Survivorship care plans (SCPs) summarize patients' treatment and act as an education and communication tool between oncologists and primary care providers ( ...

7.

cdph.ca.gov

cdph.ca.gov/Programs/CCDPHP/DCDIC/CDSRB/Pages/Cancer-Survivorship-Care-Plans.aspx

Cancer Survivorship Care Plans - CDPH - CA.gov

This toolkit was designed to help health care professionals and cancer centers to incorporate care plans into their survivorship programs.

8.

cancercontrol.cancer.gov

cancercontrol.cancer.gov/ocs/special-focus-areas/national-standards-cancer-survivorship-care

National Standards for Cancer Survivorship Care

Cancer survivorship care standards represent recommendations for health systems to apply to the survivors they serve. These new standards can be utilized to ...

9.

researchprotocols.org

researchprotocols.org/2024/1/e59222

Digitizing Survivorship Care Plans Through the POST ...

Background: Survivorship care plans (SCPs) are provided at the completion of cancer treatment to aid in the transition from active treatment ...