Engage Psychosocial Intervention for Cancer Symptoms

Launched by DUKE UNIVERSITY · Aug 13, 2024

Keywords

ClinConnect Summary

This clinical trial, called ENGAGE, is designed to help patients with advanced cancer—specifically Stage IV breast, prostate, lung, or colorectal cancer—manage their symptoms better. The study will test a new psychosocial intervention to see if it can improve patients’ pain, fatigue, and overall well-being. Participants will be divided into two groups: one will receive the ENGAGE program, while the other will receive standard supportive care. Researchers will check in with participants at the start of the study, and again after two and four months, to see how they are feeling.

To be eligible for this trial, you must be receiving cancer care at a Duke Cancer Network clinic and have a confirmed diagnosis of Stage IV cancer. You should also be experiencing some level of pain, fatigue, or distress in the past week. Participants need to be at least 18 years old, able to speak and read English, and have hearing and vision that allow them to complete sessions over the phone or online. However, if you have significant memory issues, a serious mental health condition, or have recently participated in certain therapies for symptom management, you may not be eligible. This study is not yet recruiting participants, so there will be more information available as the trial progresses.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Receiving cancer care at a Duke Cancer Network (DCN) clinic
• • Oncologist confirmed Stage IV breast, prostate, lung, or colorectal cancer
• • Worst pain, fatigue, or distress rated at \>/= 3 out of 10 in the past 7 days for at least 2 symptoms
• • MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale average score of \>/= 3 out of 10 in the past 7 days
• • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower
• • At least 18 years old
• • Ability to speak and read English
• • Hearing and vision that allows for successful completion of telehealth sessions
• Exclusion Criteria:
• • Significant cognitive impairment indicated in medical chart or during telephone screening on a mental status questionnaire
• • Serious psychiatric condition (e.g., schizophrenia, suicidal intent) that would contraindicate safe study participation
• • Participation in the last 6 months in Cognitive-Behavioral Therapy or Acceptance and Commitment Therapy for cancer symptom management
• • Enrollment in hospice at screening