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.
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
- Conditions the study is for
- Advanced Breast Cancer, Advanced Prostate Cancer, Advanced Lung Cancer
- What is being tested?
- ENGAGE and Supportive Care
- Type of treatment
- Lifestyle or therapy programme
- 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.
United States1 site, 1 recruiting
- Recruiting
Duke Cancer Network
Durham, North Carolina, 27713
Joseph G Winger, PhD, 919-416-7506, joseph.winger@duke.edu
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.
- Conditions
- Advanced Breast Cancer, Advanced Prostate Cancer, Advanced Lung Cancer, Advanced Colorectal Carcinoma, Advanced Colorectal Adenocarcinoma
- 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 group | Role | What they receive |
|---|---|---|
| ENGAGE | Experimental | Behavioral symptom management focused on values identification and skills training. Receives: Behavioral: ENGAGE |
| Supportive Care | Active comparator | Education, 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.
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)
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted15 Aug 2024
- Study start11 Jun 2025
- Primary completionSep 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06555588
- Acronym / sponsor ID
- Engage / Pro00115646
- Conditions
- Advanced Breast Cancer, Advanced Prostate Cancer, Advanced Lung Cancer, Advanced Colorectal Carcinoma, Advanced Colorectal Adenocarcinoma
- Keywords
- Acceptance and Commitment Therapy, Cognitive Behavioral Therapy, Pain management, Fatigue management, Symptom management, Telehealth, Psychosocial intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| ENGAGE | Experimental | Behavioral: ENGAGEBehavioral symptom management focused on values identification and skills training. |
| Supportive Care | Active comparator | Behavioral: Supportive CareEducation, support, and resources focused on common cancer-related concerns. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENGAGEThis 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. | Behavioural | ENGAGE |
| Supportive CareThis 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). | Behavioural | Supportive Care |
Primary outcome
MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale
Time frame: 2 months
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.
12 secondary outcomes
MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale
Time frame: 4 months
MD Anderson Symptom Inventory (MDASI) Symptom Severity Scale
Time frame: 2 months and 4 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms
Time frame: 2 months and 4 months
Openness to Experience subscale of the Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT)
Time frame: 2 months and 4 months
Behavioral Awareness subscale of the Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT)
Time frame: 2 months and 4 months
Valued Action subscale of the Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT)
Time frame: 2 months and 4 months
Brief Pain Inventory (BPI)
Time frame: 2 months and 4 months
Brief Fatigue Inventory (BFI)
Time frame: 2 months and 4 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety-Short Form
Time frame: 2 months and 4 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression-Short Form
Time frame: 2 months and 4 months
Functional Assessment of Cancer Therapy-General (FACT-G)
Time frame: 2 months and 4 months
Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp)
Time frame: 2 months and 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Derived from this study: PubMed 40834926Winger 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 7 Nov 2026.