RecruitingNot ApplicableNCT06722014

Integrating Pain-CBT Into an mHealth Analgesic Support Intervention for Patients With Chronic Pain From Advanced Cancers


Sponsor

Dana-Farber Cancer Institute

Enrollment

60 participants

Start Date

Mar 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Smartphone Technology to Alleviate Malignant Pain (STAMP) + Cognitive Behavioral Therapy for Pain (STAMP+CBT) The purpose of the study is to develop and refine the mHealth pain-CBT app intervention and carry out a randomized pilot to test the novel mHealth (Mobile health technology) intervention, which harmonizes psychological and pharmacological support for advanced cancer pain. The name of the study smartphone application involved in this study is: -STAMP+CBT


Eligibility

Min Age: 22 Years

Inclusion Criteria5

  • Age ≥ 22 years
  • Patient diagnosed with an active cancer diagnosis (locally advanced solid tumor malignancy, multiple myeloma, or other advanced hematologic malignancy), either undergoing active treatment or receiving treatment for an advanced cancer or are receiving supportive/palliative care
  • Chronic pain related to cancer or treatment (> pain score of 4 on a 0-10 scale)
  • Has an active prescription for at least one opioid medication to treat their cancer pain (i.e. not for post-surgical pain)
  • Own/use a compatible smartphone (iPhone or Android)

Exclusion Criteria10

  • Patients in survivorship: patients who have completed their treatment regimens, are not actively receiving treatment for an advanced cancer, or have a cancer that is in remission
  • Cognitive impairment that would interfere with study participation, as judged by treating clinician (e.g. delirium, dementia)
  • Inability to speak English (the intervention has not yet been translated to Spanish)
  • Currently in CBT treatment
  • Enrolled in hospice
  • Currently hospitalized
  • Use of transmucosal fentanyl, given safety concerns and ongoing risk mitigation program required to prescribe these (TIRF REMS)
  • Pain primarily related to a recent surgery (within the last 2 weeks)
  • Conditions that hinder smartphone use
  • The study will exclude adults who are unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, and prisoners.

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Interventions

BEHAVIORALSTAMP + CBT

A mobile health, smartphone application that provides tailored multi-media, cancer pain psycho-education and pain management coping skills using algorithm-based technology to provide in the moment symptom monitoring and feedback.

BEHAVIORALDigital Cancer Pain Education Packet

Packet including Articles from the Association for Clinical Oncology and the National Cancer Institute and the pain and medication monitoring form.


Locations(1)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

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NCT06722014


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