What side effects are associated with this type of intervention?

Behavioral interventions for cancer pain, such as cognitive-behavioral therapy (CBT) and mindfulness-based stress reduction (MBSR), are generally safe with minimal side effects. Some patients may experience temporary increases in emotional distress as they confront painful thoughts and feelings. Pharmacologic treatments, including opioids, are commonly used for cancer pain but can have significant side effects such as constipation, nausea, sedation, and the risk of dependency. Integrative therapies like acupuncture and yoga are also used and are generally well-tolerated, though some patients may experience mild discomfort or soreness.

What prior FDA approvals exist?

The FDA has approved several treatments for cancer pain, including strong opioids like morphine and oxycodone, which are commonly used for severe pain management. Additionally, cannabinoids such as dronabinol have been approved for nausea and appetite stimulation in cancer patients, though not specifically for pain. Behavioral interventions, such as cognitive-behavioral therapy (CBT) and mindfulness-based stress reduction (MBSR), have shown promise in managing cancer pain by altering pain perception and coping strategies, although these are not FDA-approved treatments but are widely recommended in clinical practice.

What other types of research exist?

Promising novel alternatives to behavioral interventions for cancer pain patients include new opioid formulations with alternative delivery systems, interdisciplinary team approaches combining medical and psychological care, and mind-body therapies such as mindfulness and hypnosis. Additionally, advancements in online-based Acceptance and Commitment Therapy (ACT) and Cognitive Behavioral Therapy (CBT) show potential for effective pain management.

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Acceptance and Commitment Therapy for Cancer Pain Survivorship

N/A

Waitlist Available

Led By Susan Hong, MD, MPH

Research Sponsored by Virginia Commonwealth University

Eligibility Criteria Checklist

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

Must have

Completed active therapy must have been curative in intent (for example stage IV cancer patients such as head and neck cancer patients treated with curative intent are eligible).

Self-reported cancer pain for >= 3 months

Must not have

Anyone diagnosed with cancer recurrence or new cancer during their study period

Anyone found to have progression of cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a short therapy program called Acceptance and Commitment Therapy for chronic pain (ACT-CP) in cancer survivors who no longer have the disease but still suffer from chronic pain. The goal is to help these patients manage their pain without becoming dependent on opioids. The therapy teaches them to accept their pain and focus on living a meaningful life. Acceptance and Commitment Therapy (ACT) is a form of cognitive-behavioral therapy that has been shown to be effective in treating chronic pain by enhancing psychological flexibility.

Who is the study for?

This trial is for cancer survivors who are disease-free, have finished their primary therapy but still use opioids for pain. They must be part of the VCUHealth system and have had cancer-related pain for at least 3 months post-treatment. Those with a history of substance abuse or current psychotherapy for certain mental health issues cannot join.

What is being tested?

The study tests Acceptance and Commitment Therapy (ACT-CP) to help long-term cancer survivors manage chronic pain without relying on opioids. It's a pilot trial to see if this behavioral intervention can reduce opioid dependence in patients who've completed curative treatment.

What are the potential side effects?

Since ACT-CP is a form of therapy rather than medication, it may not have typical drug side effects. However, participants might experience emotional discomfort as they explore new ways to cope with chronic pain during the sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My previous cancer treatment was intended to cure me.

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I have been experiencing cancer pain for 3 months or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has come back or I have a new cancer during the study.

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My cancer has gotten worse over time.

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I do not have cognitive issues that would stop me from engaging in treatment.

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I cannot communicate in English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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

Participant Satisfaction

Recruitment yield number of participants enrolled

Recruitment yield of participants consented

+2 more

Secondary study objectives

Opioid Refill Frequency

Opioid Use Frequency

Pain Intensity

+1 more

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: InterventionExperimental Treatment1 Intervention

Acceptance and Commitment Therapy for Chronic Pain (ACT-CP)

0 / 6Eligibility criteria met

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

Behavioral interventions for cancer pain, such as cognitive-behavioral therapy (CBT) and mindfulness-based stress reduction (MBSR), work by altering pain perception and improving coping strategies. CBT helps patients reframe negative thoughts and develop problem-solving skills, which can reduce the emotional impact of pain. MBSR focuses on increasing awareness and acceptance of pain through meditation and mindfulness practices, which can decrease stress and improve pain tolerance. These approaches are crucial for cancer pain patients as they address both the physical and psychological aspects of pain, leading to improved overall well-being and potentially reducing the need for pharmacologic treatments.