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

20 Participants Needed

Trial Summary

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 data supports the idea that Coaching Sessions for Pancreatic Cancer is an effective treatment?

The available research shows that coaching sessions can improve the quality of life and mood for cancer survivors, as well as increase their physical activity. Although the studies mainly focus on other types of cancer like breast, colorectal, prostate, and lung, they suggest that coaching helps patients manage their symptoms and feel better overall. Compared to other treatments, coaching is effective in enhancing patients' ability to handle their health and daily life, which is important for their recovery and well-being. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Coaching Sessions for Pancreatic Cancer?

Research shows that health coaching can improve the quality of life, mood, and physical activity for cancer survivors, which suggests it might also help those with pancreatic cancer. Digital health tools and coaching have been effective in supporting lifestyle changes and managing symptoms in cancer patients, potentially benefiting those with pancreatic cancer as well. ^{1 2 3 4 5}

What safety data exists for coaching sessions in cancer treatment?

The available studies focus on the feasibility, acceptability, and preliminary outcomes of digital health coaching and similar interventions in various cancer types, such as prostate, breast, and colorectal cancer. These studies generally report positive outcomes in terms of feasibility and user satisfaction, but specific safety data is not detailed. The interventions are generally well-received, with high satisfaction and usability rates, suggesting they are safe and beneficial as supportive care tools. ^{2 3 6 7 8}

Is digital health coaching safe for cancer patients?

Digital health coaching has been studied in various cancer patients, including those with prostate, breast, and colorectal cancer, and has shown to be generally safe and well-accepted. Participants reported satisfaction and ease of use, with no significant safety concerns noted in the studies. ^{2 3 6 7 8}

Is the treatment Coaching Sessions a promising treatment for pancreatic cancer?

Coaching Sessions, which include digital health coaching and integrative coaching, show promise as a treatment for cancer patients. They can help improve physical activity, manage weight, reduce distress, and enhance quality of life. These benefits have been observed in various types of cancer, suggesting that similar positive outcomes might be possible for pancreatic cancer patients. ^{4 5 6 9 10}

How is the Coaching Sessions treatment for pancreatic cancer different from other treatments?

Coaching Sessions for pancreatic cancer is unique because it focuses on digital health coaching, which aims to improve patients' quality of life by providing lifestyle support, education, and remote symptom monitoring, rather than directly targeting the cancer itself. This approach is different from traditional treatments that primarily focus on medical interventions to treat the cancer. ^{4 5 6 9 10}

What is the purpose of this trial?

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

Research Team

Pamela Hodul, MD

Principal Investigator

Moffitt Cancer Center

Amir Alishahi Tabriz, MD, PhD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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 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 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 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]

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]

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]

References

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

Does Health Coaching Grow Capacity in Cancer Survivors? A Systematic Review. [2018]

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

Piloting HealthScore: Feasibility and acceptability of a clinically integrated health coaching program for people living with cancer. [2023]

3. Scotland 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. [2023]

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

A Behavior-Modification, Clinical-Grade Mobile Application to Improve Breast Cancer Survivors' Accountability and Health Outcomes. [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

Evaluating the Feasibility of a Digital Therapeutic Program for Patients With Cancer During Active Treatment: Pre-Post Interventional Study. [2022]

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

A Pilot Feasibility Study of Digital Health Coaching for Men With Prostate Cancer. [2022]

7. Switzerland 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. [2022]

8. Canada 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. [2023]

9. England 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. [2020]

10. Germany pubmed.ncbi.nlm.nih.gov

Pilot study of an interdisciplinary supportive care planning intervention in pancreatic cancer. [2019]