ePRO Reporting Methods for Multiple Myeloma

Overseen By Kuang-Yi Wen, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Disqualifiers: Under 18, Cognitive impairment

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial evaluates satisfaction and engagement with a text messaging platform (TXT-Chatbot) compared to a patient portal system (MyChart/Patient Portal) for reporting symptoms among patients with multiple myeloma (MM). Multiple myeloma is the third most common hematologic (relating to the blood and blood-forming organs) cancer. Patients with MM typically receive continuous therapy from the time of diagnosis, which often comes with treatment-related toxicities. Symptom burden and health-related quality of life (HRQOL) for those with MM can be quite poor. Effects of MM and its treatment may impact HRQOL domains such as physical and emotional well-being, social functioning, and financial burden. Assessment of toxicities through patient-reported outcome (PRO) measures is critical and can generate information to help facilitate clinical decision making and follow up care. PROs are direct reports from patients about their health status. Compared with paper versions, electronic PROs (ePRO) allow patients to report their symptoms in real time outside of their clinic visit, facilitate direct data collection through the electronic health record, and enable clinicians to track symptoms long-term. The use of ePROs is associated with improved patient health outcomes, including better quality of life, reduced emergency department usage, and prolonged overall survival. The increased use of electronic communication technologies to capture PRO data long-term has been implemented through various methods including web-based, social media, text messages, mobile applications, and electronic portals. Text messaging is an accessible, though under-explored, communication channel for promoting ePRO collection. Information gathered from this study may help researchers understand MM patients' preferences for reporting symptoms via text message compared to a patient portal system.

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

The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on how you report symptoms rather than changing your treatment.

What data supports the effectiveness of this treatment for multiple myeloma?

Research suggests that healthy lifestyle behaviors, such as physical activity, weight management, and diet, can improve the quality of life and physical functioning for patients with multiple myeloma. These lifestyle changes may help manage symptoms and enhance overall well-being during treatment. ^{1 2 3 4 5}

Is the behavioral intervention generally safe for humans?

Behavioral interventions, such as those aimed at improving diet, physical activity, and smoking cessation, have been used safely in cancer survivors to improve overall health and quality of life. These interventions are generally considered safe and focus on promoting healthy lifestyle changes. ^{6 7 8 9 10}

Eligibility Criteria

This trial is for adults with Multiple Myeloma who can use text messaging or have internet access, understand English, and are post-autologous stem cell transplant. It excludes those under 18 or with documented cognitive impairment.

Inclusion Criteria

I have been diagnosed with multiple myeloma (MM).

Able to use TXT or have Internet access

Can read and understand English

Exclusion Criteria

There is evidence in your medical records that shows you have problems with memory or thinking.

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive notifications and complete surveys through either TXT-Chatbot or MyChart/Patient Portal every two weeks for 6 months

6 months

Bi-weekly virtual interactions

Follow-up

Participants are monitored for satisfaction and adherence to the ePRO system after the intervention

30 days

Treatment Details

Interventions

• Behavioral Intervention

Trial Overview The study compares patient satisfaction using a text message-based system (TXT-Chatbot) versus a patient portal (MyChart/Patient Portal) for reporting symptoms in real-time among Multiple Myeloma patients.

Participant Groups

Group I: Group II (MyChart/Patient Portal) Experimental Treatment 5 Interventions

Patients receive an email notification and complete surveys through MyChart/Patient Portal Q2W for 6 weeks.

Group II: Group I (TXT-Chatbot ) Experimental Treatment 5 Interventions

Patients receive a text message notification and complete surveys through TXT-Chatbot Q2W for 6 months.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Findings from Research

Healthy lifestyle behaviors, including physical activity, diet, and sleep, can significantly improve the quality of life and functional status of patients with multiple myeloma, who often experience a high symptom burden.

The review suggests that developing specific guidelines for lifestyle modifications tailored to the unique challenges of multiple myeloma could enhance patient well-being during prolonged treatment periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle considerations in multiple myeloma. Shapiro, YN., Peppercorn, JM., Yee, AJ., et al.[2022]

51% of newly diagnosed multiple myeloma patients expressed a desire for psychosocial interventions, with the most common preferences being relaxation techniques, psychological counseling, and peer support groups.

Patients showing symptoms of depression were more likely to seek psychosocial support, indicating that younger and depressed patients have a greater need for diverse intervention options, suggesting that personalized approaches are essential for effective support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial support in patients with multiple myeloma at time of diagnosis: who wants what? Lamers, J., Hartmann, M., Goldschmidt, H., et al.[2015]

Patients with multiple myeloma initially felt insecure about their health-related quality of life during treatment, but after six months, they shifted towards a focus on coping strategies.

The study highlights the importance of addressing patients' coping abilities and unmet rehabilitation needs, such as physical functioning and fatigue, to improve their overall quality of life during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in Health-Related Quality of Life During Multiple Myeloma Treatment: A Qualitative Interview Study. Sonsby, L., Rahbæk Dueholm, J., Danbjørg, DB., et al.[2023]

A systematic review identified 32 randomized controlled trials involving 19,798 patients with multiple myeloma, highlighting a significant increase in studies that include patient-reported outcomes (PROs) as endpoints.

While these trials provided valuable PRO data to assess the benefits and risks of new treatments, there was a lack of consistency in how PRO results were presented and interpreted, indicating a need for standardized methods to enhance their impact on patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes in Randomized Controlled Trials of Patients with Multiple Myeloma: A Systematic Literature Review of Studies Published Between 2014 and 2021. Efficace, F., Cottone, F., Sparano, F., et al.[2022]

Genetic sequencing has not identified a specific genetic cause for multiple myeloma, but the presence of multiple disease subclones at diagnosis can affect treatment response and clinical outcomes over time.

Autologous stem cell transplantation is crucial for young and fit patients, and the introduction of maintenance therapy, along with advancements in immune therapies, has significantly improved quality of life and survival rates for patients since 2005.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biology and therapy of multiple myeloma. Joshua, DE., Bryant, C., Dix, C., et al.[2020]

A randomized clinical trial involving 3,031 relatives of cancer patients showed that an educational intervention significantly reduced five cancer risk behaviors, including smoking, drinking, poor diet, unhealthy weight, and sun exposure, compared to a control group.

The intervention, based on social cognitive theories, led to a notable decrease in the Total Cancer Behavioral Risk (TCBR) indicator, suggesting that targeted educational efforts in primary care can effectively motivate families to adopt healthier behaviors and reduce cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a primary care intervention on smoking, drinking, diet, weight, sun exposure, and work risk in families with cancer experience. López, ML., Iglesias, JM., del Valle, MO., et al.[2015]

Cancer survivors face increased risks for various health issues, including recurrent cancer and chronic diseases, highlighting the importance of lifestyle interventions to improve their overall health and quality of life.

A review of numerous studies indicates that while many lifestyle interventions (like exercise, diet changes, and smoking cessation) have shown success in promoting healthier behaviors, further research is needed to identify the most effective components of these interventions for maximizing health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting health and physical function among cancer survivors: potential for prevention and questions that remain. Demark-Wahnefried, W., Pinto, BM., Gritz, ER.[2016]

Behavioral interventions play a crucial role in managing side effects of cancer treatments, particularly in reducing nausea and vomiting caused by chemotherapy, which is a primary focus of current research.

These interventions are also being applied to alleviate other distressing symptoms such as anxiety and pain in both adult and pediatric cancer patients, highlighting their importance in comprehensive cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in behavioral intervention in comprehensive cancer treatment. Redd, WH.[2019]

A systematic review of 10 studies found that multiple health behavior change (MHBC) interventions effectively improved diet, exercise, and smoking cessation among adult cancer survivors and those at high risk for cancer.

In-person interventions were particularly effective, and longer-duration interventions that utilized phone or mail contact showed a positive impact on changing diet and exercise behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple health behavior change in adults with or at risk for cancer: a systematic review. Green, AC., Hayman, LL., Cooley, ME.[2018]

A systematic review of 20 studies on digital physical activity interventions for breast cancer survivors found that common behavior change techniques (BCTs) like self-monitoring and goal setting were effective, with 60% of studies showing improved physical activity levels.

Despite the effectiveness of these techniques, many potential BCTs were underutilized, suggesting that incorporating a wider variety of strategies could enhance the effectiveness of future digital interventions for breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior change techniques in digital physical activity interventions for breast cancer survivors: a systematic review. Cooper, KB., Lapierre, S., Carrera Seoane, M., et al.[2023]

References

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

Lifestyle considerations in multiple myeloma. [2022]

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

Psychosocial support in patients with multiple myeloma at time of diagnosis: who wants what? [2015]

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

Changes in Health-Related Quality of Life During Multiple Myeloma Treatment: A Qualitative Interview Study. [2023]

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

Patient-Reported Outcomes in Randomized Controlled Trials of Patients with Multiple Myeloma: A Systematic Literature Review of Studies Published Between 2014 and 2021. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Biology and therapy of multiple myeloma. [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of a primary care intervention on smoking, drinking, diet, weight, sun exposure, and work risk in families with cancer experience. [2015]

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

Promoting health and physical function among cancer survivors: potential for prevention and questions that remain. [2016]

8. Germany pubmed.ncbi.nlm.nih.gov

Advances in behavioral intervention in comprehensive cancer treatment. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Multiple health behavior change in adults with or at risk for cancer: a systematic review. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Behavior change techniques in digital physical activity interventions for breast cancer survivors: a systematic review. [2023]