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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how different approaches to managing symptoms can improve the quality of life for cancer patients in palliative care. One group will receive additional resources for symptom management, while the other will continue with usual care. Participants will complete surveys every two weeks for 16 weeks to assess their quality of life and symptom control. This study suits new patients at a palliative care clinic in Pennsylvania who have not previously used certain symptom-focused therapies. As an unphased trial, it offers patients the opportunity to explore new symptom management strategies that could enhance their quality of life.

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 prior data suggests that offering additional resources to promote symptom management is safe?

Research shows that patients appreciate extra help in managing cancer symptoms. Studies have found that these resources can improve cancer patients' quality of life without major side effects. The goal is to help patients feel better and manage symptoms more effectively.

Additionally, research on digital health tools for managing cancer symptoms suggests these methods are generally safe and integrate easily into regular care. These tools have helped control symptoms better and increased patient satisfaction.

Overall, enhancing resources for symptom management appears to be a safe and supportive way to help cancer patients handle their symptoms. This approach focuses on ensuring comfort and enhancing life quality during treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on enhancing symptom management for cancer patients through additional resources, rather than introducing a new drug or procedure. Unlike standard care options that typically involve medication and routine supportive care, this approach aims to improve patients' quality of life by providing supplementary resources tailored to manage their symptoms more effectively. The trial seeks to understand if these additional resources can lead to better outcomes in terms of symptom relief and overall well-being, potentially offering a more holistic approach to cancer care.

What evidence suggests that offering additional resources to promote symptom management is effective for cancer patients?

This trial will compare enhanced symptom management with usual care for cancer patients. Research has shown that extra support for managing symptoms benefits cancer patients. Studies have found that these methods can reduce symptoms in individuals with cancers such as head and neck cancer. Digital health tools also assist both patients and doctors in managing symptoms more effectively. Including palliative care, which focuses on comfort and quality of life, has been linked to better overall outcomes for cancer patients. In this trial, participants in the intervention arm will receive additional resources to promote symptom management, potentially leading to fewer symptoms and an improved quality of life. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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 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]

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]

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]

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]

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]

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 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]

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