Engage Psychosocial Intervention for Cancer Symptoms

Description

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.

Conditions

Advanced Breast Cancer, Advanced Prostate Cancer, Advanced Lung Cancer, Advanced Colorectal Carcinoma, Advanced Colorectal Adenocarcinoma

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Study Overview

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Study Details

Study overview

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.

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

Engage Psychosocial Intervention for Cancer Symptoms

Condition
Advanced Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Durham

Duke Cancer Network, Durham, North Carolina, United States, 27713

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

Study Record Dates

2029-07