Survivorship Care Planning + Telehealth Education for Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fred Hutchinson Cancer Research Center

Must be taking: Non-cytotoxic maintenance therapy

Disqualifiers: Palliative care, No phone, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well cancer survivors can use self-created care plans combined with telehealth education to enhance their knowledge and confidence in managing their health post-treatment. The study focuses on individuals in rural areas who often face challenges accessing follow-up care. Participants will either develop their own care plans, receive counseling through a call, or obtain general information on survivorship care. Cancer survivors who have completed curative therapy for certain types of adult-onset cancer in the past five years and live in rural areas might be suitable for this trial. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative approaches in survivorship care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants may still be on long-term maintenance therapy, like tamoxifen or aromatase inhibitors, so it seems likely you can continue your current medications.

What prior data suggests that self-generated survivorship care plans and telehealth education are safe for cancer survivors?

Research has shown that self-created survivorship care plans (SCPs) are generally safe for cancer survivors. A review of multiple studies found that SCPs did not cause negative effects and improved patients' perceptions of their health, such as reducing distress and boosting confidence in health management (source 1). Another study focusing on minority, rural, and low-income groups also reported no safety issues with SCPs for these populations (source 5).

Regarding telehealth education, research indicates it is a safe and effective way to provide healthcare services. One study found that telehealth successfully addresses both the mental and physical effects of cancer without causing harm (source 2). Another study concluded that telehealth is a fast and convenient method that reduces the burden of treatment for cancer care, showing no safety concerns (source 4).

Overall, both self-created survivorship care plans and telehealth education appear to be well-tolerated and safe for cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how personalized survivorship care plans (SCPs) can enhance cancer recovery through self-generation and telehealth. Unlike standard care, which often provides generic follow-up, these SCPs are tailored from patient responses, potentially making them more relevant and actionable. Additionally, the trial tests the impact of a 30-minute phone counseling session by trained health counselors, which could offer valuable guidance and support remotely, increasing accessibility for patients. By combining personalized plans with telehealth education, this approach might significantly improve the quality of life for cancer survivors.

What evidence suggests that this trial's treatments could be effective for improving knowledge and self-efficacy in cancer survivors?

Research has shown that creating personal survivorship care plans (SCPs) benefits cancer survivors. Studies indicate that SCPs improve communication between patients and doctors, leading to better health outcomes. A review of multiple studies found that SCPs help cancer survivors feel more informed and in control of their care. In this trial, some participants will receive a self-generated SCP.

Research also shows that telehealth education effectively provides healthcare services remotely. Studies suggest that telehealth can improve mental health and quality of life for cancer patients. This method helps those in rural areas access important information and support. In this trial, participants in different arms will receive varying combinations of SCPs, telehealth education, and counseling. Combining SCPs with telehealth education may increase patients' knowledge and confidence in managing their health after cancer treatment. ^{1 4 6 7 8}

Who Is on the Research Team?

Eric J. Chow

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for adult cancer survivors who finished curative therapy within the last 5 years and have a history of lymphoma, breast, colorectal, lung, or prostate cancer. They must be able to do study tasks like questionnaires and agree to randomization. Participants need access to a phone and can receive materials electronically. It excludes those on palliative care or without telephone access.

Inclusion Criteria

I finished my cancer treatment within the last 5 years and may still be on maintenance therapy.

I had cancer (lymphoma, breast, colorectal, lung, or prostate) as an adult.

I can understand and agree to the study's details.

Exclusion Criteria

Lacks mailing address or ability to receive study materials electronically

Currently being followed in a pediatric clinical setting (either for primary care or for cancer care)

I am receiving or considering palliative or hospice care soon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline questionnaire and have medical records reviewed

1 week

1 visit (in-person or virtual)

Intervention

Participants receive a self-generated SCP and may receive additional educational counseling depending on cohort assignment

Up to 8 weeks

Follow-up

Participants are monitored for outcomes related to survivorship knowledge and self-efficacy

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Self-generated Survivorship Care Plans
• Telehealth Education

Trial Overview The IMPACT Study tests if self-generated survivorship care plans combined with telehealth education improve knowledge and self-efficacy in rural cancer survivors. The goal is better transition from oncology to primary care and improved communication between healthcare providers.

How Is the Trial Designed?

Group I: Arm V (generic information, patient-generated SCP, counseling) Experimental Treatment 4 Interventions

Patients receive generic information on survivorship care as well as a self-generated SCP as in Arm I and a telephone-based educational counseling session as in Arm II on study.

Group II: Arm II (patient-generated SCP, counseling) Experimental Treatment 3 Interventions

Patients receive a self-generated SCP as in Arm I. Patients also receive a 30-minute telephone-based educational counseling session on survivorship care administered by trained lay health counselors.

Group III: Arm III (generic information) Active Control 2 Interventions

Patients receive generic information on survivorship care on study.

Group IV: Arm IV (generic information, patient-generated SCP) Active Control 3 Interventions

Patients receive generic information on survivorship care and a self-generated SCP as in Arm I on study.

Group V: Arm I (patient-generated SCP) Active Control 2 Interventions

Patients receive a self-generated SCP (i.e., generated from baseline questionnaire responses).

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Research Center

Lead Sponsor

Trials

444

Recruited

148,000+

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Telehealth could significantly improve cancer survivorship care planning by facilitating better communication and coordination between oncology and primary care providers, as well as enhancing access for survivors, based on a mixed-methods study involving interviews and surveys with providers and survivors in Vermont and New Hampshire.

Despite the potential benefits, challenges such as scheduling coordination among clinicians and ensuring payment parity for telehealth services need to be addressed to fully realize the advantages of telehealth in survivorship care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From active treatment to surveillance: how the barriers and facilitators of implementing survivorship care planning could be an opportunity for telehealth in oncology care for rural patients. Alford-Teaster, J., Vaclavik, D., Imset, I., et al.[2023]

Survivors of lung and colorectal cancer often face significant post-treatment challenges, including poor quality of life and greater health complications, yet they are underrepresented in research, leading to disparities in care.

This study outlines a new telehealth intervention designed to enhance care coordination between oncology and primary care, aiming to empower cancer survivors through self-management skills and improve their post-treatment outcomes, which will be tested in a randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and Design of a Telehealth Self-Management, Shared Care Intervention for Post-treatment Survivors of Lung and Colorectal Cancer. Sun, V., Reb, A., Debay, M., et al.[2023]

Telehealth could significantly improve cancer survivorship care planning by facilitating better communication and coordination between oncology and primary care providers, as well as enhancing survivor access to care.

Despite its potential, there are important challenges to address, such as scheduling coordination among clinicians and ensuring fair payment for telehealth services, to fully realize the benefits of telehealth in survivorship care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From active treatment to surveillance: How the barriers and facilitators of implementing survivorship care planning could be an opportunity for telehealth in oncology care for rural patients. Alford-Teaster, J., Vaclavik, DD., Imset, I., et al.[2023]

A study involving 13 primary care clinicians highlighted the need for improved survivorship care plans (SCPs) that are more user-friendly and relevant for primary care settings, emphasizing follow-up care over treatment summaries.

Clinicians found the redesigned SCPs valuable but noted that significant effort is required to integrate the information into their health records, indicating a need for better formats that facilitate easier data entry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Re-engineering Survivorship Care Plans to Support Primary Care Needs and Workflow: Results From an Engineering, Primary Care and Oncology Collaborative for Survivorship Health (EPOCH). Tevaarwerk, AJ., Zhang, X., Haine, J., et al.[2023]

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. asco.org asco.org/abstracts-presentations/ABSTRACT157064

Patient-generated online survivorship care plans for adult ... Approximately 80% of patients contacted consented and completed SCP indicating high acceptability; two-thirds (66%) completed the survey. Participants were a ...

4. 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 ( ...

5. 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 ...

6. cancer.jmir.org cancer.jmir.org/2019/2/e12090/

Evaluation of a Technology-Based Survivor Care Plan for ... Objective: This pilot study for breast cancer survivors was undertaken to: (1) examine self-reported changes in knowledge, confidence, and ...

7. researchprotocols.org researchprotocols.org/2024/1/e59222/

Digitizing Survivorship Care Plans Through the POST- ... This study is among the first to digitize the SCP in a mobile app and test the effects of a mobile health–delivered behavioral health intervention on symptom ...

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

A scoping review of the evidence on survivorship care ... The purpose of this scoping review is to understand the evidence on SCPs among minority, rural, and low-income populations.