Engage Psychosocial Intervention for Cancer Symptoms

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

About this trial

The goal of this clinical trial is to test the efficacy a new psychosocial symptom management intervention called ENGAGE for patients with Stage IV breast, prostate, lung, or colorectal cancer. Participants will be randomized to ENGAGE or a Supportive Care intervention. Patient-reported outcomes will be assessed at baseline, 2 months, and 4 months.

Eligibility criteria

Qualifiers

Receiving cancer care at 1) a Duke Cancer Network (DCN) clinic; or 2) the Duke Cancer Institute (DCI) and live in a rural county at least 60 miles from Duke

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • ENGAGE
  • Supportive Care

Treatment groups

190 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Duke University

Lead sponsor

National Cancer Institute (NCI)

Collaborator