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Engage Psychosocial Intervention for Cancer Symptoms

Engage: A Randomized Controlled Trial Testing the Efficacy of a Telehealth-Delivered Psychosocial Intervention to Decrease Symptom Interference in Patients With Advanced Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ENGAGE, a program that uses mental and social support to help manage cancer symptoms. It is for adults with stage IV breast, prostate, lung, or colorectal cancer. People are assigned by chance to ENGAGE or supportive care and report their symptoms at the start, 2 months, and 4 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Get cancer care at a Duke Cancer Network clinic, or at Duke Cancer Institute while living in a rural county at least 60 miles from Duke.
  • Have doctor-confirmed stage IV breast, prostate, lung, or colorectal cancer. Stage IV means the cancer has spread to distant parts of the body.
  • In the past 7 days, have at least 2 symptoms—pain, tiredness, or emotional distress—each rated at least 3 out of 10 at their worst.
  • Have an average score of at least 3 out of 10 on a survey about how symptoms affected daily life in the past 7 days.
  • Have an ECOG activity score of 2 or lower: able to care for yourself and be out of bed or a chair for more than half of waking hours.
  • Be at least 18 years old.
  • Be able to speak and read English.
  • Be able to hear and see well enough to complete remote health visits.

Who can't join

  • Have major problems with thinking or memory, shown in your medical record or a phone screening.
  • Have a serious mental health condition, such as schizophrenia or intent to end your life, that makes joining unsafe.
  • Have had cognitive-behavioral therapy or acceptance and commitment therapy—types of talk therapy—to manage cancer symptoms in the past 6 months.
  • Be enrolled in hospice care when screened for the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 * 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

Study sites (1)

NC