What side effects are associated with this type of intervention?

Common treatments in palliative care for managing cancer pain include opioid analgesics, integrative therapies, and patient-controlled analgesia (PCA). Opioid analgesics, such as morphine and fentanyl, can cause side effects like constipation, nausea, sedation, and respiratory depression. Integrative therapies, including Reiki and therapeutic touch, are generally well-tolerated but may occasionally lead to temporary symptom worsening. PCA allows patients to self-administer opioids and can lead to similar side effects as other opioid treatments, including potential for overdose if not properly managed. It is important for patients to discuss these side effects with their healthcare providers to optimize pain management and minimize adverse effects.

What prior FDA approvals exist?

The FDA has approved several drugs for palliative care, particularly for pain management in cancer patients. These include opioids like morphine, fentanyl, and methadone, which are commonly used for severe cancer pain. Buprenorphine, available in transdermal patches, is another opioid approved for this purpose. Cannabinoid-based treatments, such as nabiximols (Sativex), have been approved in some countries for cancer pain, though not in the United States. Additionally, antidepressants and corticosteroids are used as adjuvant analgesics to manage cancer-related pain. While specific mobile applications for pain management support and education are being studied, they represent a newer approach to palliative care that complements these established pharmacological treatments.

What other types of research exist?

Promising alternatives to mobile applications for palliative care patients include: 1) Telemedicine platforms for remote consultations and continuous monitoring, 2) Wearable devices for real-time pain and symptom tracking, 3) Virtual reality (VR) for pain distraction and relaxation, 4) Artificial Intelligence (AI)-driven chatbots for personalized support and education, and 5) Remote patient monitoring systems integrated with non-invasive digital technologies.

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Behavioral Intervention

STAMP+CBT App for Cancer Pain

N/A

Waitlist Available

Led By Desiree Azizoddin, PsyD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new phone app that helps people with cancer manage their pain. The app provides methods and tips for reducing pain through behavior changes. The study aims to see if the app is useful and easy to use for cancer patients.

Who is the study for?

This trial is for adults over 18 with chronic pain from cancer or its treatment, who are being treated at specific clinics and have a smartphone. They must be undergoing active cancer treatment or palliative care, have a pain score over 4, and take opioids for cancer pain (not post-surgical). Excluded are non-English speakers, hospitalized patients, those in remission or survivorship phase, with cognitive impairments, history of opioid misuse, enrolled in hospice or using transmucosal fentanyl.

What is being tested?

The study tests an mHealth app called STAMP+CBT designed to assist patients managing cancer-related chronic pain. The effectiveness of the mobile application in improving patient outcomes will be evaluated among participants who meet the criteria.

What are the potential side effects?

Since this trial involves a mobile application rather than medication there may not be direct 'side effects' like drugs; however users might experience stress or frustration if they find the technology difficult to use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability Rate

Overall Intervention Adherence Rate

Secondary study objectives

COMPREHENSIVE ENDPOINT

Study Accrual Rate

Study retention

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: STAMP+CBT PILOTExperimental Treatment1 Intervention

Patients in this Pilot Cohort will be in the research study for 6 weeks total including: * a 4-week intervention period and 2-week post intervention period. * Patients will use the app for a total of 4 weeks (4-week intervention period), and will complete surveys at baseline, 4 weeks (end of intervention period), and at 6 weeks (end of 2-week post intervention period).

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments in palliative care include pharmacologic approaches like opioids and antidepressants, and non-pharmacologic therapies such as dignity therapy and meaning-centered psychotherapy. Opioids work by binding to receptors in the brain and spinal cord to reduce pain perception, while antidepressants increase neurotransmitter levels to manage depression and anxiety. Non-pharmacologic therapies help patients find meaning and purpose, improving spiritual well-being and reducing existential distress. These treatments are essential for palliative care patients as they address both physical and emotional suffering, enhancing overall quality of life.