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Advanced Breast CancerEngageNCT06555588

Engage Psychosocial Intervention for Cancer Symptoms

A study testing ENGAGE and Supportive Care in people with Advanced Breast Cancer and Advanced Prostate Cancer, run by Duke University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ENGAGE and Supportive Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
1 siteUnited States
Study dates
11 Jun 2025to Nov 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Joseph G Winger, PhD contact

919-416-7506

joseph.winger@duke.edu

United States1 site, 1 recruiting

  • Duke Cancer Network

    Durham, North Carolina, 27713

    Joseph G Winger, PhD, 919-416-7506, joseph.winger@duke.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

Pain, fatigue, and distress are highly prevalent, co-occurring, and interfering symptoms in patients with advanced cancer. This trial will test a brief telehealth delivered psychosocial intervention called ENGAGE. ENGAGE aims to help patients decrease symptom interference and improve their quality of life. Patients with Stage IV cancer (breast, prostate, lung, or colorectal) and moderate-to-severe symptom interference will be randomized to ENGAGE or Supportive Care. Patient-reported outcomes will be assessed at baseline, 2 months, and 4 months. Aim 1 is to determine ENGAGE's efficacy for reducing symptom interference (primary outcome) at 2 months (primary endpoint). Aim 2 is to determine ENGAGE's efficacy for improving secondary outcomes at 2 months. Aim 3 is to test the maintenance of ENGAGE's effects on primary and secondary outcomes at 4 months. An exploratory aim seeks insights for future implementation efforts using mixed-methods data collection from patients, oncology providers, and clinic leaders.

Being tested
ENGAGE, Supportive Care
Keywords
Acceptance and Commitment Therapy, Cognitive Behavioral Therapy, Pain management, Fatigue management, Symptom management, Telehealth, Psychosocial intervention
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ENGAGEBehavioural

    This intervention is delivered by trained therapists over four, 45-60 minute, manualized telehealth sessions. The session content is based on an integration of Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT) approaches for managing symptoms of pain, fatigue, and distress. Participants are trained in behavioral symptom management skills (e.g., activity pacing, mindfulness) with an emphasis on engaging in highly valued activities.

  • Supportive CareBehavioural

    This intervention is delivered by trained therapists over four, 45-60 minute, manualized telehealth sessions. The session content is designed to provide participants with education, support, and resources for a range of issues relevant to those with advanced cancer (e.g., education on symptoms, body image concerns, and financial concerns).

Study groups in NCT06555588
Study groupRoleWhat they receive
ENGAGEExperimentalBehavioral symptom management focused on values identification and skills training.
Receives: Behavioral: ENGAGE
Supportive CareActive comparatorEducation, support, and resources focused on common cancer-related concerns.
Receives: Behavioral: Supportive Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale

    This measure assesses the degree to which, over the past 7 days, symptoms of pain, fatigue, and/or distress have interfered with patients' general activity, mood, work (including work around the house), relations with other people, walking, and enjoyment of life. Items are scored from 0 = "Did not interfere" to 10 = "Interfered completely," and averaged for a composite score.

    Measured: 2 months

Secondary outcomes (12)

  1. MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale

    This measure assesses the degree to which, over the past 7 days, symptoms of pain, fatigue, and/or distress have interfered with patients' general activity, mood, work (including work around the house), relations with other people, walking, and enjoyment of life. Items are scored from 0 = "Did not interfere" to 10 = "Interfered completely," and averaged for a composite score.

    Measured: 4 months

  2. MD Anderson Symptom Inventory (MDASI) Symptom Severity Scale

    This measure assesses the severity of pain, fatigue, and distress at their worst over the past 7 days. Items are scored from 0 = "not present" to 10 = "as bad as you can imagine". Each item is interpreted individually, with higher scores reflecting worse symptom severity.

    Measured: 2 months and 4 months

  3. Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms

    This measure assesses patients' level of confidence to manage or control their symptoms, manage their symptoms in different settings, and to keep symptoms from interfering with work, relationships, or personal care. Items are scored from 1 = "I am not confident at all" to 5 = "I am very confident." Items are summed and converted to T-scores, with higher scores indicating better self-efficacy.

    Measured: 2 months and 4 months

  4. Openness to Experience subscale of the Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT)

    This subscale assesses patients' openness to experience difficult thoughts, emotions, and sensations (i.e., psychological acceptance). Items are scored from 0 = "strongly disagree" to 6 = "strongly agree," with higher scores indicating more acceptance. Items are averaged for a composite score.

    Measured: 2 months and 4 months

  5. Behavioral Awareness subscale of the Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT)

    This subscale assesses patients' level of present moment awareness (i.e., mindfulness). Items are scored from 0 = "strongly disagree" to 6 = "strongly agree," with higher scores indicating more mindfulness. items are averaged for a composite score.

    Measured: 2 months and 4 months

  6. Valued Action subscale of the Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT)

    This subscale assesses patients' degree of values identification and willingness to take actions that align with their personal values. Items are scored from 0 = "strongly disagree" to 6 = "strongly agree," with higher scores indicating more values identification and engagement. Items are averaged for a composite score.

    Measured: 2 months and 4 months

  7. Brief Pain Inventory (BPI)

    This pain severity measure assesses pain at its worst, least, average, and now. Response options range from 0 = "no pain" to 10 = "pain as bad as you can imagine". items are averaged for a composite score.

    Measured: 2 months and 4 months

  8. Brief Fatigue Inventory (BFI)

    This fatigue severity measure assesses fatigue over the last 7 days from 0 = "no fatigue" to 10 = "as bad as you can imagine" at its usual, worst, and right now. Items are averaged for a composite score.

    Measured: 2 months and 4 months

  9. Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety-Short Form

    This anxiety symptom measure assesses fear, worry, uneasiness, nervousness, and tension. Response options range from 1 = "never" to 5 = "always." Items are summed and converted to T-scores, with higher scores indicating worse anxiety symptoms.

    Measured: 2 months and 4 months

  10. Patient-Reported Outcomes Measurement Information System (PROMIS) Depression-Short Form

    This depressive symptoms measure assesses worthlessness, helplessness, hopelessness, depressed mood, failure, and sadness. Response options range from 1 = "never" to 5 = "always." Items are summed and converted to T-scores, with higher scores indicating worse depressive symptoms.

    Measured: 2 months and 4 months

  11. Functional Assessment of Cancer Therapy-General (FACT-G)

    This quality of life measure is composed of 4 subscales: physical, social/family, emotional, and functional well-being. Items are rated on a 0 = "not at all" to 4 = "very much" scale and summed for subscale scores and an overall quality of life score.

    Measured: 2 months and 4 months

  12. Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp)

    This measure includes an overall spiritual well-being score and three subscales: 1) meaning (i.e., reason for living, sense of meaning and purpose); 2) peace (i.e., feeling peaceful, sense of harmony within oneself); and 3) faith (i.e., finding strength and comfort in faith or spiritual beliefs). Response options range from 0 = "not at all" to 4 = "very much"; two items are reverse coded. Higher scores indicate greater spiritual well-being.

    Measured: 2 months and 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2024
  2. Study start11 Jun 2025
  3. Primary completionSep 2028 (estimated)
  4. Study completionNov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned with equal (1:1) allocation to either ENGAGE or Supportive Care. A stratified block randomization scheme will be used to ensure group balance based on: 1) the primary outcome of symptom interference (i.e., less than 7 vs. 7 to 10); and 2) cancer type (i.e., breast, prostate, lung, or colorectal).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
190 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06555588
Sponsor's protocol ID
Pro00115646
Other IDs
R01CA291768
Acronym
Engage
Status last verified
Mar 2026
First submitted
13 Aug 2024
Last updated
16 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Results of this trial will be presented at professional meetings and published in peer-reviewed journals. The dataset will be made available to qualified investigators within 6 months of the publication of the primary outcome paper. The dataset will contain necessary identifiers, excluding those prohibited by HIPAA. The investigators will be required to sign a data use agreement and obtain Institutional Review Board (IRB) approval before receiving the data set. Public use study data and associated documentation will also be made available to the research community through the National Cancer Institute's Cancer Data Service (CDS) data repository.

Publications

  • Winger JG, Kelleher SA, Yu JA, Ma JE, Majestic CM, Martinson EB, Olsen MK, Lerebours R, Sutton LM, Somers TJ. Engage: Protocol of a randomized controlled trial of a telehealth-delivered psychosocial intervention to decrease symptom interference in patients with advanced cancer. Contemp Clin Trials. 2025 Sep;156:108053. doi: 10.1016/j.cct.2025.108053. Epub 2025 Aug 18.

    PubMed 40834926

Questions about this trial

What is this clinical trial studying?

A study testing ENGAGE and Supportive Care in people with Advanced Breast Cancer and Advanced Prostate Cancer, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Joseph G Winger, PhD (919-416-7506, joseph.winger@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06555588, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.

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