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

Trial Summary

What is the purpose of 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.

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 data supports the effectiveness of the treatment Survivorship Care Plan-Personal Health Record (SCP-PHR)?

Research shows that cancer survivors who receive a survivorship care plan (SCP) have better coordinated follow-up care, higher satisfaction, and fewer emotional concerns after treatment. ^{1 2 3 4 5}

Is the Survivorship Care Plan safe for humans?

The available research does not provide specific safety data for the Survivorship Care Plan, but it is generally used as a communication tool between doctors and patients, suggesting it is safe for use in humans. ^{2 3 6 7 8}

How is the Survivorship Care Plan treatment different from other cancer treatments?

The Survivorship Care Plan (SCP) is unique because it focuses on improving communication and coordination between cancer survivors, oncologists, and primary care providers after treatment, rather than being a direct medical treatment. It provides a personalized document outlining the survivor's diagnosis, treatment history, and follow-up care, which helps guide ongoing health management and decision-making. ^{1 3 7 8 9}

Research Team

David Haggstrom, MD

Principal Investigator

Indiana University School of Medicine

Eligibility Criteria

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.

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Primary Care Provider Evaluation of Cancer Survivorship Care Plans Developed for Patients in their Practice. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The impact of cancer survivorship care plans on patient and health care provider outcomes: a current perspective. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluating Internal Medicine Residents' Awareness on Cancer Survivorship Care Plan: A Pilot Survey. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The Integration of Survivorship Care Planning at a Comprehensive Cancer Center. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Colorectal cancer survivorship care plans: Variations in documentation and posttreatment surveillance recommendations. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Cancer survivors' experiences of using survivorship care plans: a systematic review of qualitative studies. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Healthcare provider perspectives on pediatric cancer survivorship care plans: a single institution pilot study. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Comparing Web-Based Provider-Initiated and Patient-Initiated Survivorship Care Planning for Cancer Patients: A Randomized Controlled Trial. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Survivorship Care Plan Preferences and Utilization Among Asian American Breast Cancer Survivors. [2022]