Cognitive Behavioral Therapy App for Cancer Pain

(STAMP+CBT Trial)

Overseen By Desiree Azizoddin, PsyD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Must be taking: Opioids

Must not be taking: Transmucosal fentanyl

Disqualifiers: Survivorship, Cognitive impairment, Hospice, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

26 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must have an active prescription for at least one opioid medication for cancer pain. You cannot participate if you use transmucosal fentanyl.

What data supports the effectiveness of this treatment for managing cancer pain?

Research shows that cognitive-behavioral interventions, including mindfulness-based approaches, are effective in managing cancer pain by helping patients change their thoughts and behaviors related to pain. These treatments can reduce suffering and improve overall well-being by providing new ways to interpret and cope with pain. ^{1 2 3 4 5}

Is mindfulness-based cognitive therapy (MBCT) safe for cancer patients?

Mindfulness-based cognitive therapy (MBCT) has been studied in cancer patients and is generally considered safe, with no significant safety concerns reported in the research. ^{6 7 8 9 10}

How is Cognitive Behavioral Therapy App for Cancer Pain different from other treatments for cancer pain?

Cognitive Behavioral Therapy (CBT) for cancer pain is unique because it focuses on teaching patients strategies like relaxation, distraction, and positive mood interventions to manage pain, rather than relying on medication. This approach is effective in reducing suffering and controlling symptoms, offering a non-drug alternative for pain management. ^{2 4 11 12 13}

What is the purpose of this trial?

This trial tests the STAMP+CBT app, a smartphone tool for advanced cancer patients to manage pain and mood. It tracks health metrics and provides personalized advice and educational content to improve pain management.

Research Team

Desiree Azizoddin, PsyD

Principal Investigator

Stephenson Cancer Center

Eligibility Criteria

This trial is for adults over 18 with advanced cancer experiencing chronic pain (pain score >4) and using opioids to manage it. They must be undergoing treatment or receiving supportive care, not in remission, hospice, or hospitalized. Excludes those with cognitive impairments affecting participation, non-English speakers, recent surgery patients, and individuals under opioid risk mitigation programs.

Inclusion Criteria

I am currently prescribed opioids for my cancer pain.

I have an advanced cancer diagnosis and am currently receiving treatment or supportive care.

My cancer or its treatment causes me significant pain.

Exclusion Criteria

You are currently receiving hospice care.

My main pain is from a surgery I had within the last 2 weeks.

I can communicate effectively in English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants use the STAMP+CBT app to track pain, mood, opioid use, and receive tailored education and self-management advice

4 weeks

Daily app usage

Post-intervention

Participants continue to use the app for monitoring and follow-up surveys

2 weeks

Daily app usage

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

• Cognitive Behavioral Therapy

Trial Overview The study tests a new smartphone app called STAMP+CBT designed to help track pain levels, mood changes, opioid use and side effects while providing personalized education and self-management tips for managing cancer-related pain.

Participant Groups

Group I: STAMP+CBT app Experimental Treatment 1 Intervention

This app will allow the patient to access daily surveys designed to assess pain, stress, mood, and related symptoms. Based on patient-reported symptoms, this app will disseminate tailored education to manage the symptoms.

Cognitive Behavioral Therapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Approved in United States as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)
• Substance use disorders

Approved in Canada as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Meaning-Centered Pain Coping Skills Training (MCPC) is a feasible and effective intervention for managing pain in patients with advanced cancer, showing significant improvements in pain severity and self-efficacy after 10 weeks.

In a study of 60 adults with stage IV solid tumors, those receiving MCPC reported better pain management outcomes compared to usual care, with moderate-to-large effect sizes in pain severity and interference, indicating its potential as a valuable addition to standard pain management practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meaning-centered pain coping skills training for patients with metastatic cancer: Results of a randomized controlled pilot trial. Winger, JG., Kelleher, SA., Ramos, K., et al.[2023]

In a study of 178 cancer patients undergoing pain coping skills training (PCST), 34% experienced significant reductions in pain severity and 46% in pain interference, highlighting the intervention's effectiveness.

Factors such as education level, cancer type, and marital status influenced the likelihood of experiencing pain relief, suggesting that tailored approaches could enhance the benefits of PCST for different patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Response to an Evidence-Based Behavioral Cancer Pain Management Intervention: An Exploratory Analysis From a Clinical Trial. Check, DK., Winger, JG., Jones, KA., et al.[2021]

The three-session acceptance-based cognitive behavioral therapy (CBT-ACT) significantly improved sleep efficiency, insomnia severity, and worry in 28 patients with advanced cancer compared to a waitlist control group.

Participants in the CBT-ACT group also experienced notable reductions in depression and emotional distress, indicating that this intervention effectively addresses multiple psychological symptoms associated with advanced cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of a symptom cluster intervention in advanced cancer. Wells-Di Gregorio, SM., Marks, DR., DeCola, J., et al.[2019]

Cognitive-behavioral interventions have been shown to effectively control symptoms and reduce suffering in patients experiencing cancer pain, highlighting their importance as a nonmedical treatment option.

The article provides theoretical and technical principles of these interventions, supported by two case reports that demonstrate their practical application in real-world scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral interventions in management of cancer pain: principles and applications. Fishman, B., Loscalzo, M.[2019]

Approximately 50% of cancer patients experience pain that can lead to a complex state of 'total pain,' which may not respond well to traditional medications.

Mindfulness-based interventions can help patients change their perception of pain, potentially reducing pain catastrophizing and improving overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions for Hematology and Oncology Patients with Pain. Hess, D.[2019]

Mindfulness-based therapy (MBT) significantly reduces symptoms of anxiety and depression in adult cancer patients and survivors, with moderate effect sizes observed in both nonrandomized studies (0.60 for anxiety, 0.42 for depression) and randomized controlled trials (0.37 for anxiety, 0.44 for depression).

The systematic review included 22 studies with a total of 1,403 participants, indicating that while the quality of studies varied, there is promising evidence from higher-quality randomized controlled trials supporting the efficacy of MBT in improving mental health outcomes for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of mindfulness-based therapy on symptoms of anxiety and depression in adult cancer patients and survivors: a systematic review and meta-analysis. Piet, J., Würtzen, H., Zachariae, R.[2022]

Mindfulness-based cognitive therapy (MBCT) significantly reduced distress and improved quality of life, mindfulness, and post-traumatic growth in a study of 50 women with breast and gynecologic cancer, with improvements maintained three months after the intervention.

Participants found the group-based MBCT program beneficial, indicating high acceptability, and the results suggest that MBCT could offer psychosocial benefits for women with cancer, although further randomized trials are needed for more definitive evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive group therapy for women with breast and gynecologic cancer: a pilot study to determine effectiveness and feasibility. Stafford, L., Foley, E., Judd, F., et al.[2022]

In a study involving 245 cancer patients, both mindfulness-based cognitive therapy (MBCT) and individual internet-based MBCT (eMBCT) significantly reduced psychological distress compared to treatment as usual (TAU), with effect sizes of 0.43 and 0.63 respectively.

Both MBCT and eMBCT were found to be equally effective in alleviating anxiety and depressive symptoms in cancer patients, suggesting that eMBCT could be a viable alternative for those facing barriers to traditional face-to-face therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[RCT about mindfulness-based cognitive therapy for psychological distress in cancer patients]. Compen, F., Bisseling, EM., Schellekens, M., et al.[2019]

In a pilot study involving 16 cancer patients, mindfulness-based cognitive therapy (MBCT) significantly improved mindfulness and reduced anxiety, with lasting effects on depression and anxiety observed at a 3-month follow-up.

Self-compassion was identified as a potential mediator for the improvements in anxiety and depression, suggesting that enhancing self-compassion may play a key role in the effectiveness of MBCT for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for psycho-oncology patients: an exploratory study. Kingston, T., Collier, S., Hevey, D., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Meaning-centered pain coping skills training for patients with metastatic cancer: Results of a randomized controlled pilot trial. [2023]

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

Predictors of Response to an Evidence-Based Behavioral Cancer Pain Management Intervention: An Exploratory Analysis From a Clinical Trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of a symptom cluster intervention in advanced cancer. [2019]

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

Cognitive-behavioral interventions in management of cancer pain: principles and applications. [2019]

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

Mindfulness-Based Interventions for Hematology and Oncology Patients with Pain. [2019]

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

The effect of mindfulness-based therapy on symptoms of anxiety and depression in adult cancer patients and survivors: a systematic review and meta-analysis. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of New Mindfulness-Based Swinging Technique Intervention: A Pilot Randomised Controlled Trial Among Women With Breast Cancer. [2023]

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

Mindfulness-based cognitive group therapy for women with breast and gynecologic cancer: a pilot study to determine effectiveness and feasibility. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

[RCT about mindfulness-based cognitive therapy for psychological distress in cancer patients]. [2019]

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

Mindfulness-based cognitive therapy for psycho-oncology patients: an exploratory study. [2019]

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

Brief cognitive-behavioral audiotape interventions for cancer-related pain: Immediate but not long-term effectiveness. [2018]

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

Strategies of Coping with Pain: Differences Associated with the Histological Type of Lung Cancer. [2020]

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

Psychological Treatment. [2019]