Coaching Sessions for Pancreatic Cancer

Overseen By Emma Hume

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Severe dementia, 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 a 12-week digital health coaching program for individuals with pancreatic cancer and their caregivers. The goal is to assess how supportive care, including social work and dietitian consultations, aids in managing the condition. Participants must have a pancreatic cancer diagnosis or be caring for someone with the disease and plan treatment at Moffitt Cancer Center. The study aims to enhance the quality of life and support available to both patients and their caregivers. As an Early Phase 1 trial, this research focuses on understanding the program's effectiveness, offering participants a chance to be among the first to benefit from this innovative supportive care approach.

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

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

Do I have to stop taking my current medications for the trial?

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

What prior data suggests that this digital health coaching is safe for pancreatic cancer patients and their caregivers?

Research has shown that digital health coaching is well-liked by both patients and caregivers. Studies have found that people are generally satisfied with it and that it works effectively. However, specific safety information is not yet available. As this is an early stage of testing, the program is still being explored for pancreatic cancer patients and their caregivers. The main goal is to assess the program's functionality, practicality, and acceptability for users. Overall, digital health coaching programs are usually considered safe because they focus on providing support, education, and guidance, rather than introducing new medications or physical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores digital health coaching as a supportive strategy for pancreatic cancer patients and their caregivers. Unlike traditional treatments that focus solely on medical interventions like chemotherapy and surgery, this approach aims to enhance quality of life through personalized support. The trial includes consultations with social workers and dietitians, either in-person or virtually, offering flexibility and accessibility. This holistic approach may help address emotional, social, and dietary needs, potentially leading to better overall patient and caregiver well-being.

What evidence suggests that digital health coaching is effective for pancreatic cancer?

This trial will evaluate digital health coaching for pancreatic cancer patients and their caregivers. Studies have shown that digital health coaching can improve cancer patients' well-being. Specifically, for those with pancreatic cancer, coaching has been linked to better support with nutrition and comfort care. Research indicates that these programs can help reduce anxiety and depression, common issues for cancer patients. For caregivers, digital coaching has assisted in tracking symptoms and managing patient care. This support may enhance the quality of life for both patients and caregivers. While more information is needed, early findings suggest that digital health coaching could be a helpful tool for those dealing with pancreatic cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Pamela Hodul, MD

Principal Investigator

Moffitt Cancer Center

Amir Alishahi Tabriz, MD, PhD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

The CARES study is for English-speaking adults with pancreatic cancer or their caregivers, who are getting treatment at Moffitt Cancer Center. They must be able to understand and agree to the study's terms. People with severe psychiatric or neurological conditions that could affect participation, like advanced dementia, can't join.

Inclusion Criteria

Participant must be planning to receive treatment and/or care management at Moffitt Cancer Center

Participant must be able to speak and read English

Participant must be able to provide informed consent

Exclusion Criteria

Any participant that does not meet all inclusion criteria will be excluded.

I do not have severe dementia or other mental conditions that would prevent me from participating.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Consultation

Initial in-person and/or virtual supportive care, social work, and dietitian consultation

3-4 weeks

1 visit (in-person or virtual)

Digital Health Coaching

Participants receive digital health coaching for pancreatic cancer and their caregivers

12 weeks

Follow-up

Participants are monitored for acceptance, usability, and feasibility of the digital health coaching program

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Coaching Sessions

Trial Overview This pilot program tests a 12-week digital health coaching initiative designed for individuals battling pancreatic cancer and their caregivers. The aim is to see how effective these coaching sessions are in providing support and education remotely.

How Is the Trial Designed?

Group I: Digital Health Coaching for Pancreatic Cancer Patients Experimental Treatment 1 Intervention

Initial in-person and/or virtual supportive care, social work, and dietitian consultation within 4 weeks of diagnosis and/or 3 weeks of study enrollment.

Group II: Digital Health Coaching for Caregivers Experimental Treatment 1 Intervention

Initial in-person and/or virtual supportive care, social work, and dietitian consultation within 4 weeks of diagnosis and/or 3 weeks of study enrollment.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Canopy Cancer Collective

Collaborator

Trials

2

Recruited

70+

Published Research Related to This Trial

A 1-year randomized controlled trial involving cancer survivors showed that both a web-based program and a combination of health coaching with the web program significantly improved physical activity, weight management, and psychological distress compared to a control group.

The combination of health coaching and the web program led to a notable improvement in psychological well-being, as measured by the Post Traumatic Growth Inventory, indicating its effectiveness in reducing distress among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of health coaching and a web-based program on physical activity, weight, and distress management among cancer survivors: A multi-centered randomised controlled trial. Yun, YH., Lim, CI., Lee, ES., et al.[2020]

Health coaching interventions for cancer survivors showed significant improvements in quality of life, mood, and physical activity among 1038 participants across 12 studies, indicating its efficacy in enhancing patient capacity.

While health coaching positively impacted various aspects of patient capacity, it did not significantly improve self-efficacy, highlighting the need for future interventions to focus on enhancing self-efficacy and the patient's environment of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Health Coaching Grow Capacity in Cancer Survivors? A Systematic Review. Barakat, S., Boehmer, K., Abdelrahim, M., et al.[2018]

The pilot study involving 10 patients with pancreatic cancer tested a supportive care intervention that included comprehensive quality of life assessments and educational sessions, showing high patient satisfaction with 80% rating the intervention as 'excellent'.

While the intervention did not yield statistically significant improvements in quality of life outcomes, it demonstrated feasibility and acceptability, indicating potential for further development in addressing the unique needs of pancreatic cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of an interdisciplinary supportive care planning intervention in pancreatic cancer. Sun, V., Ruel, N., Chung, V., et al.[2019]

A 4-week trial involving 30 cancer patients showed that a digital therapeutic program delivered via a smartphone app was highly engaging, with 97% of participants active for at least 3 weeks and an average of 7.7 interactions per day.

Participants reported high satisfaction with the program, with 89% likely to recommend it, and while quality of life remained stable, 50% experienced less pain, indicating potential benefits of lifestyle interventions in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Feasibility of a Digital Therapeutic Program for Patients With Cancer During Active Treatment: Pre-Post Interventional Study. Gudmundsson, GH., Mészáros, J., Björnsdóttir, ÁE., et al.[2022]

A self-management mobile application for colorectal cancer survivors significantly improved self-efficacy, health practices, and quality of life after six weeks of use, as shown by surveys of 39 participants.

The intervention led to specific improvements in emotional functioning and reductions in overall symptoms and fatigue, highlighting the effectiveness of mobile technology in providing social support for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an interactive coaching intervention on quality of life and psychological factors for colorectal cancer survivors: A single group pre and posttest design. Yoon, J., Lee, H., Son, H.[2023]

The MOCHA smartphone tool significantly improved accountability and motivation among breast cancer survivors, with participants using the app an average of 3.5 times per day and losing an average of 2 lbs over a 4-week period.

The usability of MOCHA was rated highly, with an average score of 77.4, indicating that over 90% of users found it easy to navigate and 84% felt motivated to use it daily, suggesting its potential for long-term behavior modification in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Behavior-Modification, Clinical-Grade Mobile Application to Improve Breast Cancer Survivors' Accountability and Health Outcomes. Stubbins, R., He, T., Yu, X., et al.[2023]

A pilot study involving 88 men with prostate cancer demonstrated that a 12-week digital health coaching program was feasible, with 71.6% of participants completing the program, exceeding the feasibility threshold of 60%.

The coaching program covered various topics relevant to prostate cancer management, indicating that digital health coaching could be a valuable tool for improving patient engagement and self-management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Feasibility Study of Digital Health Coaching for Men With Prostate Cancer. Handley, NR., Wen, KY., Gomaa, S., et al.[2022]

The I-Can Manage program was developed through a user-centered co-design process involving 16 cancer patients and 19 clinicians, focusing on self-management of treatment toxicities with evidence-based content and features tailored to patient needs.

Usability testing showed high patient satisfaction with the program, indicated by a mean score of 3.75 on the Post-Study System Usability Questionnaire, suggesting it effectively supports patients in managing their cancer treatment side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based Cancer Self-Management Program (I-Can Manage) Targeting Treatment Toxicities and Health Behaviors: Human-Centered Co-design Approach and Cognitive Think-Aloud Usability Testing. Howell, D., Bryant Lukosius, D., Avery, J., et al.[2023]

The ICOnnecta't digital ecosystem was successfully implemented for women recently diagnosed with breast cancer, showing high acceptance (57.62%) and satisfaction rates (76.19%), which indicates its potential to improve access to psychosocial support.

The platform effectively managed the needs of 443 patients, with 94.33% of users remaining engaged in preventive steps, highlighting the importance of strong social support in improving psychosocial outcomes during the cancer journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ICOnnecta't: Development and Initial Results of a Stepped Psychosocial eHealth Ecosystem to Facilitate Risk Assessment and Prevention of Early Emotional Distress in Breast Cancer Survivors' Journey. Medina, JC., Flix-Valle, A., Rodríguez-Ortega, A., et al.[2022]

The UNC HealthScore intervention, a six-month health coaching program for cancer patients, demonstrated high feasibility with 66% enrollment and 71% completion rates among 50 participants, indicating strong interest and engagement.

Participants showed significant improvements in physical function, with scores increasing by 4.3 points from baseline to 6 months, surpassing the minimal clinically important difference, along with notable reductions in anxiety and depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Piloting HealthScore: Feasibility and acceptability of a clinically integrated health coaching program for people living with cancer. Wood, WA., Bailey, C., Castrogivanni, B., et al.[2023]

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-03276

Cancer Coaching and Remote Education for Self ... This clinical trial evaluates a 12-week program that offers digital health coaching for patients with pancreatic cancer and their caregivers.

2. withpower.com withpower.com/trial/early-phase-1-malignant-neoplasm-of-pancreas-2-2024-d4ad1

Coaching Sessions for Pancreatic Cancer · Info for Participants Trial Overview This pilot program tests a 12-week digital health coaching initiative designed for individuals battling pancreatic cancer and their caregivers.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7447627/

Digital health for optimal supportive care in oncology Digital health provides solutions that capture patient-reported outcomes (PROs) and allows symptom monitoring and patient management.

4. 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12450219/

The Case for Integration of Health Coaching within ... This review advocates for the integration of health coaching into oncology care to enhance outcomes for patients, caregivers, healthcare ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06323291

Study Details | NCT06323291 | Cancer Coaching and ... This Pilot Study will evaluate a 12-week pilot program that offers digital health coaching for individuals with pancreatic cancer and their caregivers. Official ...

7. dana-farber.org dana-farber.org/clinical-trials/21-737

Comprehensive Outcomes for After Cancer Health (COACH) This study intends to explore feasibility, acceptability, and outcomes related to the use of a digital health coaching intervention for individuals who have ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11240750/

Cancer Patients' Perspectives and Requirements of Digital ... Digital health technologies can help manage the growing cancer burden, but understanding patients' needs is crucial for these tools to be effective.

9. sciencedirect.com sciencedirect.com/science/article/pii/S0885392421004784

An Early Palliative Care Telehealth Coaching Intervention ... We pilot tested components of CASCADE, an early palliative care decision support training intervention for family caregivers of patients with advanced cancer.