Enhanced Symptom Management for Cancer

Overseen By Nicholas S Bishop

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Prior symptom therapies, Pregnancy

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

Compensation: Varies

Number of Visits: 8

Duration: 16 weeks

208 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized controlled trial will assess the effects on quality of life of two approaches to symptom management among new patients referred to a palliative care oncology clinic.

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

The protocol does not specify if you need to stop your current medications.

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

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

What data supports the idea that Enhanced Symptom Management for Cancer is an effective treatment?

The available research shows that Enhanced Symptom Management for Cancer is effective because it focuses on improving the quality of life for patients by addressing pain, mental health, and other symptoms. For example, a study found that 69% of proposed quality indicators for symptom management were valid and feasible, which means they are practical and useful for evaluating and improving care. This includes managing pain, depression, and other symptoms like nausea and fatigue. Additionally, both patients and experts agree that high-quality care should be personalized and proactive, meaning it should be tailored to each patient's needs and involve regular check-ins to manage symptoms effectively. This approach is seen as critical for providing high-quality supportive cancer care. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Offering Additional Resources to Promote Symptom Management, Palliative Care, Symptom Management for cancer?

Research shows that quality indicators for symptom management, such as pain and depression, are valid and feasible, suggesting that structured approaches to symptom management can improve care quality for cancer patients. Additionally, web and mobile-based interventions have been identified as promising tools for managing symptoms in advanced cancer, indicating that accessible resources can enhance symptom management. ^{1 2 3 4 5}

What safety data exists for Enhanced Symptom Management for Cancer treatment?

The safety data for Enhanced Symptom Management for Cancer, which may also be known as Offering Additional Resources to Promote Symptom Management, Palliative Care, or Symptom Management, includes several studies. A pilot study on community palliative care patients showed a high prevalence of symptomatic events, indicating the need for further research. Another study highlighted the poorly understood harms of medications used in palliative care, which can impact compliance and contribute to symptoms. The Cancer Quality-ASSIST Project developed quality indicators for symptom management, emphasizing the need for adherence to recommended practices. Additionally, a study on a patient-reported information sharing system showed improved management of treatment-related adverse events. Lastly, guidelines for serious adverse event reporting in non-pharmacological palliative care trials were discussed, noting the challenges due to the high risk of hospitalization or death from disease progression rather than the trial interventions. ^{2 6 7 8 9}

Is the Enhanced Symptom Management for Cancer treatment safe for humans?

Research on symptom management in palliative care shows that while medications can help, they may also cause side effects like psychological distress or other symptoms. It's important to monitor these effects closely, as they can impact patients' well-being. ^{2 6 7 8 9}

Is the treatment in the trial 'Enhanced Symptom Management for Cancer' a promising treatment?

Yes, the treatment is promising because it focuses on improving the quality of life for cancer patients by managing symptoms effectively. It uses web and mobile-based tools to provide timely help, making it easier for patients to access care. This approach is seen as a valuable way to support people with advanced cancer. ^{3 4 10 11 12}

How is this treatment different from other cancer treatments?

This treatment is unique because it focuses on enhancing symptom management for cancer patients, potentially using web and mobile-based applications to provide timely access to interventions, which is not commonly emphasized in traditional cancer treatments. ^{3 4 10 11 12}

Eligibility Criteria

This trial is for adults over 18 with cancer who are new patients at an outpatient palliative care clinic in Pennsylvania. It's not open to pregnant individuals or those who have previously used certain therapies focused on symptom management.

Inclusion Criteria

I am a new patient at an outpatient palliative care clinic.

I am over 18 years old.

Resident of Pennsylvania

Exclusion Criteria

Currently pregnant

I have used specific treatments for my symptoms.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive symptom management and complete surveys every two weeks for 16 weeks

16 weeks

8 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Offering Additional Resources to Promote Symptom Management

Trial Overview The study is testing the impact of additional resources for managing symptoms on the quality of life among cancer patients receiving palliative care, comparing two different approaches in a randomized controlled setting.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Participants in this group will consent to participate in a study about quality of life for patients with cancer seeking outpatient palliative care. They will be seen in a palliative care oncology clinic at which time they will be offered additional resources to promote symptom management. They will be asked to complete a series of surveys every two weeks for 16 weeks which will assess their quality of life, symptoms, and medication use.

Group II: Usual Care Active Control 1 Intervention

Participants in this group will consent to participate in a study about quality of life for patients with cancer seeking outpatient palliative care. They will be seen in a palliative care oncology clinic where they will receive symptom management and supportive care. They will be asked to complete a series of surveys every two weeks for 16 weeks which will assess their quality of life, symptoms, and medication use.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Findings from Research

The study identified 36 quality measures related to palliative cancer care, focusing on pain, dyspnea, depression, and advance care planning (ACP), highlighting a significant emphasis on ACP measures.

Most of the identified measures were unpublished and lacked testing in cancer populations, indicating a need for further research and validation to ensure their effectiveness in improving symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality measures for symptoms and advance care planning in cancer: a systematic review. Lorenz, KA., Lynn, J., Dy, S., et al.[2023]

A comprehensive set of 133 quality indicators for evaluating pain and non-pain symptom management in cancer patients was developed, with 69% deemed valid and feasible by an expert panel, highlighting the importance of symptom control in cancer care.

The final indicators, which include 67 for inpatient and 81 for outpatient settings, cover various aspects of care such as screening, diagnostic evaluation, management, and follow-up, providing essential tools for improving supportive cancer care quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality measures for supportive cancer care: the Cancer Quality-ASSIST Project. Lorenz, KA., Dy, SM., Naeim, A., et al.[2009]

Training programs in symptom management for palliative care providers in nonpalliative specialties significantly improve trainees' knowledge, comfort, and preparedness in managing patients' symptoms, based on a systematic review of six studies involving various educational methods.

Despite improvements in trainees' learning outcomes, the impact of this training on actual patient-related outcomes and behaviors remains unclear, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Training in Symptom Management in Palliative Care Within Postgraduate Medical Curriculums. Turrillas, P., Teixeira, MJ., Maddocks, M.[2021]

A systematic review and meta-analysis of 19 studies involving web and mobile-based interventions showed that these e-Health tools significantly reduce physical symptom burden in adults with advanced cancer, with a standardized mean difference of -0.18.

Most interventions were delivered through web applications and were guided by symptom management theories, although many studies had a high risk of bias, indicating the need for more rigorous research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web and mobile-based symptom management interventions for physical symptoms of people with advanced cancer: A systematic review and meta-analysis. Saeidzadeh, S., Kamalumpundi, V., Chi, NC., et al.[2021]

A study involving discussions between 10 clinical experts and 9 patients/caregivers highlighted the importance of proactive symptom screening and assessment in palliative care for advanced cancer patients, particularly focusing on pain and mental health.

The research emphasized that simply screening for symptoms is not enough; the information gathered must directly inform patient care, and high-quality symptom management should be individualized and may include non-medical approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Patient and Expert Perspectives to Conceptualize High-Quality Palliative Cancer Care for Symptoms in the US Veterans Health Administration: A Qualitative Study. O'Hanlon, CE., Giannitrapani, KF., Gamboa, RC., et al.[2023]

In a pilot study involving 27 community palliative care patients, a high prevalence of symptomatic events was observed, with an average rate of 0.87 events per participant per day, highlighting the significant burden of symptoms in this population.

The study demonstrated that collecting data on patient-reported symptomatic events is both feasible and acceptable, suggesting that a larger, fully powered study could effectively assess the impact of medications on symptom burden in palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptomatic Events in a Community Palliative Care Population: A Prospective Pilot Study. To, THM., Collier, A., Agar, MR., et al.[2021]

In a study of 235 cancer patients receiving palliative care, higher doses of oral morphine (MEDD) and diazepam (DEDD) were linked to worsening performance status and quality of life over time, indicating potential harms of these medications.

While increased diazepam was significantly associated with gastrointestinal symptoms, morphine did not show a direct link to cognitive or gastrointestinal issues, suggesting that careful management of these medications can mitigate some negative effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Opioids and Benzodiazepines on Clinical Outcomes in Patients Receiving Palliative Care: An Exploratory Analysis. Boland, JW., Allgar, V., Boland, EG., et al.[2018]

The introduction of a patient-oriented outcome sharing system in an outpatient chemotherapy clinic improved the management of treatment-related adverse events, with intervention rates increasing from 14.9% to 20.9% after implementation.

Specifically, the proportion of interventions for adverse events like insomnia and cancer-related pain increased significantly during the first course of chemotherapy, indicating that the system enhances communication and efficiency among healthcare teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Assessment of Chemotherapy-Induced Adverse Events Using a Sharing System of Patient-Reported Information via a Touch Panel]. Nakauchi, K., Ido, S., Sumikawa, S., et al.[2020]

The paper emphasizes the importance of developing robust serious adverse event (SAE) reporting procedures in non-pharmaceutical palliative care trials, as patients often face high risks of hospitalization or death due to their underlying conditions rather than the trial interventions.

Recommendations for improving SAE management include allowing sufficient planning time, defining what constitutes a serious adverse event for the specific study population, and refining reporting procedures throughout the trial to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What should we report? Lessons learnt from the development and implementation of serious adverse event reporting procedures in non-pharmacological trials in palliative care. Dunleavy, L., Collingridge Moore, D., Korfage, I., et al.[2021]

Effective symptom management is crucial in palliative medicine, particularly for improving the quality of life in patients with advanced cancer.

Twenty key principles have been identified to guide clinicians in systematically managing symptoms, emphasizing the importance of diagnosis, individualized therapy, and clarity in treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptom control in advanced cancer: twenty principles. Alvarez, A., Walsh, D.[2011]

Effective symptom management is crucial in oncology nursing, significantly enhancing the quality of life for patients with advanced cancer and their families throughout the cancer journey.

Oncology nurses must conduct holistic assessments of patients' symptoms and care goals to create and evaluate personalized, evidence-based care plans that address individual needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care at the end of life. Lynch, MT.[2019]

A modified ADAPTE process was successfully used to create computable algorithms for individualized symptom management in lung cancer patients, focusing on common symptoms like pain, fatigue, and anxiety.

These algorithms were developed through collaboration among multidisciplinary experts, ensuring that recommendations were tailored to individual patient needs, including their age, comorbidities, and symptom severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating computable algorithms for symptom management in an outpatient thoracic oncology setting. Cooley, ME., Lobach, DF., Johns, E., et al.[2021]

References

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

Quality measures for symptoms and advance care planning in cancer: a systematic review. [2023]

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

Quality measures for supportive cancer care: the Cancer Quality-ASSIST Project. [2009]

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

A Systematic Review of Training in Symptom Management in Palliative Care Within Postgraduate Medical Curriculums. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Web and mobile-based symptom management interventions for physical symptoms of people with advanced cancer: A systematic review and meta-analysis. [2021]

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

Integrating Patient and Expert Perspectives to Conceptualize High-Quality Palliative Cancer Care for Symptoms in the US Veterans Health Administration: A Qualitative Study. [2023]

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

Symptomatic Events in a Community Palliative Care Population: A Prospective Pilot Study. [2021]

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

Effect of Opioids and Benzodiazepines on Clinical Outcomes in Patients Receiving Palliative Care: An Exploratory Analysis. [2018]

8. Japan pubmed.ncbi.nlm.nih.gov

[Assessment of Chemotherapy-Induced Adverse Events Using a Sharing System of Patient-Reported Information via a Touch Panel]. [2020]

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

What should we report? Lessons learnt from the development and implementation of serious adverse event reporting procedures in non-pharmacological trials in palliative care. [2021]

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

Symptom control in advanced cancer: twenty principles. [2011]

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

Palliative care at the end of life. [2019]

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

Creating computable algorithms for symptom management in an outpatient thoracic oncology setting. [2021]