Telehealth Coaching for Pancreatic Cancer Survivors

Recruiting at 21 trial locations

Overseen By Vincent Chung, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Employee under PI, study team

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

Compensation: Varies

Number of Visits: 6

Duration: 3 months

136 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether telehealth coaching sessions can improve the quality of life for pancreatic cancer survivors and their family caregivers. The focus includes managing physical symptoms, emotional health, and social and spiritual well-being. Participants will receive either telehealth coaching every other week or standard care for comparison. Those diagnosed with metastatic pancreatic cancer within the last 8 weeks and experiencing challenges from the disease and its treatment may be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance support for cancer survivors and their caregivers.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that telehealth self-management coaching sessions are safe for pancreatic cancer survivors and their family caregivers?

Research has shown that telehealth self-management coaching sessions are generally safe. Unlike medication or physical treatments, these sessions do not cause typical side effects. Instead, participants engage with a coach through video calls to learn symptom management. This support has been used in other health areas without reports of harm. Participants have found these sessions helpful and comforting, indicating they are well-tolerated. As this is not a new drug or procedure, usual safety concerns do not apply. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about telehealth self-management coaching for pancreatic cancer survivors because it offers a new way to support patients and their caregivers without requiring frequent hospital visits. Unlike traditional care, which often involves in-person appointments and treatments, this telehealth approach allows patients and their family caregivers to receive guidance and support from the comfort of their own homes. This method aims to improve quality of life and empower patients and caregivers by providing them with tools and strategies to manage the challenges of living with and beyond pancreatic cancer.

What evidence suggests that telehealth self-management coaching sessions are effective for improving quality of life in pancreatic cancer survivors?

Research has shown that telehealth coaching sessions, which participants in this trial may receive, can improve the quality of life for cancer patients. These sessions assist patients and their families in managing the physical and emotional symptoms of cancer and its treatment. Early results suggest that coaching addresses needs such as emotional support and managing daily life. Studies have found that similar telehealth programs reduce stress and enhance well-being in cancer survivors. Therefore, there is hope that these sessions could ease life for pancreatic cancer survivors and their caregivers. ^{1 2 3 4 5}

Who Is on the Research Team?

Vincent Chung, MD

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for pancreatic cancer survivors and their family caregivers. Participants should be able to engage in telehealth sessions and have a desire to improve their quality of life during treatment.

Inclusion Criteria

Documented informed consent of the participant and/or legally authorized representative

Assent, when appropriate, will be obtained per institutional guidelines

I can read and understand either English or Spanish.

Exclusion Criteria

An employee who is under the direct/indirect supervision of the principal investigator (PI)/a co-investigator/the study manager

A direct study team member

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Telehealth self-management coaching sessions for pancreatic cancer survivors and their family caregivers

3 months

6 sessions (telehealth) every other week

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Telehealth Self-Management Coaching Sessions

Trial Overview The study tests if telehealth coaching can help manage symptoms, emotional, social, and spiritual well-being for patients and caregivers. It involves best practices, counseling, interviews, questionnaires via remote communication.

How Is the Trial Designed?

Group I: Arm A (telehealth self-management coaching sessions) Experimental Treatment 4 Interventions

Patients and FCGs attend telehealth self-management coaching sessions over 40-60 minutes every other week for 6 sessions over 3 months.

Group II: Arm B (standard of care) Active Control 2 Interventions

Patients and FCGs receive standard of care on study.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

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 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 of 117 pancreatic cancer survivors revealed that structured survivorship care plans (SCPs) are largely absent, with only 5% of participants having been offered one, despite many survivors experiencing significant treatment-related challenges.

The majority of survivors reported ongoing health issues like fatigue and neuropathy, and 83% of those who used an Internet-based SCP tool expressed a desire to share it with their healthcare team, highlighting the need for better communication and support in survivorship care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survivorship after treatment of pancreatic cancer: insights via an Internet-based survivorship care plan tool. Frick, MA., Vachani, CC., Hampshire, MK., et al.[2020]

The eHealth self-management program, Springboard Beyond Cancer, significantly improved self-efficacy in cancer survivors who completed treatment, with a moderate effect size (Cohen's d = 0.31).

Higher engagement levels in the intervention led to even greater improvements in self-efficacy for managing cancer-related issues, highlighting the importance of tailored support and engagement strategies for different survivor subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer health self-efficacy improvement in a randomized controlled trial. Leach, CR., Hudson, SV., Diefenbach, MA., et al.[2023]

A new remote monitoring and self-management follow-up care program for prostate cancer patients showed significant improvements in addressing unmet survivorship needs compared to traditional clinic appointments, with 25 out of 26 comparisons favoring the new program.

The program also demonstrated comparable or better outcomes in quality of life, psychological well-being, and patient satisfaction, while being slightly more cost-effective, suggesting it is a viable alternative to conventional follow-up care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-up care after treatment for prostate cancer: evaluation of a supported self-management and remote surveillance programme. Frankland, J., Brodie, H., Cooke, D., et al.[2020]

A study involving 63 Australian health professionals identified key factors for optimal care in pancreatic cancer management, emphasizing the importance of communication and patient assessment, which scored the highest in importance.

The findings revealed significant differences in priorities among various specialties regarding multidisciplinary team roles, highlighting the need for improved collaboration and treatment strategies that are not fully addressed in current clinical practice guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a Delphi process to determine optimal care for patients with pancreatic cancer. Burmeister, EA., Jordan, SJ., O'Connell, DL., et al.[2018]

Telehealth is a promising and feasible option for supporting cancer survivors, particularly in enhancing their physical and mental quality of life during the extended survival phase (1 to 3 years post-diagnosis).

However, there is a notable lack of telehealth interventions specifically designed for long-term survivors (over 5 years post-diagnosis), highlighting a gap in care that needs to be addressed, especially regarding their social and spiritual well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Telehealth Among Cancer Survivors: A Scoping Review. Irurita-Morales, P., Soto-Ruiz, N., Martín-Rodríguez, LS., 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 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]

The Interaktor app significantly improved emotional functioning and reduced various symptoms such as nausea, pain, and appetite loss in patients after pancreaticoduodenectomy, as reported six weeks post-surgery.

Patients using the app also demonstrated higher self-care activity levels and fewer hepatic symptoms six months after surgery, indicating that the app effectively supports self-management and enhances quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreased symptom burden following surgery due to support from an interactive app for symptom management for patients with pancreatic and periampullary cancer. Gustavell, T., Sundberg, K., Segersvärd, R., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06524973?cond=pancreatic+cancer

Telehealth Self-Management Coaching Sessions to Improve ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

2. withpower.com withpower.com/trial/phase-pancreatic-adenocarcinoma-metastatic-8-2024-519fe

Telehealth Coaching for Pancreatic Cancer Survivors This clinical trial evaluates the impact of telehealth self-management coaching sessions on quality of life in pancreatic cancer survivors and their family ...

3. npcf.us npcf.us/clinical-trials/telehealth-self-management-coaching-sessions-to-improve-quality-of-life-in-pancreatic-cancer-survivors-and-their-family-care-givers/

Telehealth Self-Management Coaching Sessions To ... This clinical trial evaluates the impact of telehealth self-management coaching sessions on quality of life in pancreatic cancer survivors and their family ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-06078

Telehealth Self-Management Coaching Sessions to ... This clinical trial evaluates the impact of telehealth self-management coaching sessions on quality of life in pancreatic cancer survivors and their family ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06524973/telehealth-self-management-coaching-sessions-to-improve-quality-of-life-in-pancreatic-cancer-survivors-and-their-family-care-givers

Telehealth Self-Management Coaching Sessions to ... This clinical trial evaluates the impact of telehealth self-management coaching sessions on quality of life in pancreatic cancer survivors ...