ENGAGE Psychosocial Intervention for Cancer

(Engage Trial)

Overseen By Joseph G Winger, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Cognitive impairment, Serious psychiatric condition, Recent therapy, Hospice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 months

190 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new psychosocial treatment called ENGAGE to determine if it helps people with Stage IV breast, prostate, lung, or colorectal cancer manage symptoms more effectively. Participants will either use the ENGAGE approach, which focuses on identifying personal values and building skills, or receive supportive care that provides education and resources for common cancer-related issues. The trial aims to determine which approach improves patients' quality of life by assessing their feedback over four months. Eligible participants have been diagnosed with Stage IV cancer, experience significant pain, fatigue, or distress, and receive care at a Duke Cancer Network clinic. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance symptom management for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on a psychosocial intervention, so it's likely you can continue your current treatments, but you should confirm with the trial coordinators.

What prior data suggests that the ENGAGE psychosocial intervention is safe for cancer patients?

Research shows that the ENGAGE program is being tested to help patients with Stage IV cancer manage their symptoms. Although specific safety data for ENGAGE is not available, it is important to note that the program does not involve drugs or medical procedures, which usually results in fewer physical side effects.

Psychosocial programs like ENGAGE focus on mental health and coping skills, making them generally easy for participants to handle. This can reassure those concerned about safety. The trial is in the "Not Applicable" phase, meaning the main goal is to assess how well ENGAGE works, not to test its safety, suggesting it is likely low risk.

Overall, ENGAGE aims to support emotional well-being, which can be a safe and helpful addition to cancer treatment plans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ENGAGE psychosocial intervention for cancer because it offers a unique approach to managing behavioral symptoms. Unlike standard supportive care options that primarily provide education and resources, ENGAGE focuses on helping patients identify their personal values and develop skills to manage their symptoms effectively. This personalized approach aims to empower patients, potentially improving their quality of life by aligning treatment with what matters most to them.

What evidence suggests that this trial's treatments could be effective for cancer?

Research shows that ENGAGE, a new program tested in this trial, might help people with Stage IV cancer manage their symptoms better. Participants will receive either the ENGAGE program, which focuses on personal values and skills, or supportive care, which provides education, support, and resources for common cancer-related concerns. Earlier studies have found that similar programs can reduce pain, tiredness, and stress. These symptoms often occur together and can greatly impact daily life. ENGAGE aims to help by teaching patients practical skills to handle these issues. While direct evidence on ENGAGE's effectiveness is still being gathered, it is based on methods that have proven helpful in similar situations. The goal is to help patients feel better and function more easily every day. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Stage IV breast, prostate, lung, or colorectal cancer who experience significant daily interference from symptoms. They must be able to complete telehealth sessions and speak English. Treatment must be at a Duke Cancer Network clinic with an ECOG status of 2 or lower.

Inclusion Criteria

I can speak and read English.

I am receiving cancer treatment at a Duke Cancer Network clinic.

I can see and hear well enough to use video calls.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the ENGAGE or Supportive Care intervention via telehealth to manage symptoms

2 months

Telehealth sessions

Follow-up

Participants are monitored for maintenance of treatment effects on primary and secondary outcomes

2 months

What Are the Treatments Tested in This Trial?

Interventions

• ENGAGE

Trial Overview The ENGAGE psychosocial intervention is being tested against standard supportive care in managing cancer symptoms. Participants will randomly receive either the new ENGAGE treatment or supportive care and report on their outcomes after 2 and 4 months.

How Is the Trial Designed?

Group I: ENGAGE Experimental Treatment 1 Intervention

Behavioral symptom management focused on values identification and skills training.

Group II: Supportive Care Active Control 1 Intervention

Education, support, and resources focused on common cancer-related concerns.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study involving 356 cancer patients, the telephone caseworker (TCW) model showed a significant improvement in physical functioning at 3 months compared to usual care, suggesting potential benefits of this intervention.

Participants in the TCW model reported better communication with their healthcare team and were more likely to have their needs addressed, indicating that this model may help in managing psychosocial needs, although no overall intervention effect was observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of two supportive care interventions on anxiety, depression, quality of life, and unmet needs in patients with nonlocalized breast and colorectal cancers. Girgis, A., Breen, S., Stacey, F., et al.[2022]

Recent studies indicate that while group therapy does not improve survival rates in advanced breast cancer, it can enhance quality of life and alleviate physical symptoms for patients.

Therapies tailored to specific patient needs are more effective than general approaches, highlighting the importance of therapist experience and training in delivering psychosocial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial interventions for cancer patients. Daniels, J., Kissane, DW.[2008]

Psychosocial support for cancer patients is crucial for enhancing their quality of life by addressing not only emotional distress but also managing cancer symptoms and treatment side effects.

Interventions can be categorized into five types: prevention, early detection, restoration, support, and palliation, each tailored to meet the varying needs of patients throughout their cancer journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The psychiatrist's perspective on quality of life and quality of care in oncology: concepts, symptom management, communication issues. Razavi, D., Delvaux, N.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12380187/

Protocol of a Randomized Controlled Trial of a Telehealth ... This trial is the first RCT to evaluate the efficacy of Engage, a novel psychosocial intervention that uniquely integrates traditional Cognitive ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06555588

Engage Psychosocial Intervention for Cancer Symptoms Patient-reported outcomes will be assessed at baseline, 2 months, and 4 months. Pain, fatigue, and distress are highly prevalent, co-occurring, and interfering ...

3. prevention.cancer.gov prevention.cancer.gov/clinical-trials/clinical-trials-search/nct06555588

Engage Psychosocial Intervention for Cancer Symptoms Participants will be randomized to ENGAGE or a Supportive Care intervention. Patient-reported outcomes will be assessed at baseline, 2 months, and 4 months.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1551714425002472

Engage: Protocol of a randomized controlled trial ... This paper describes the protocol of a randomized controlled trial to evaluate Engage's efficacy for reducing symptom interference in patients ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06555588/engage-psychosocial-intervention-for-cancer-symptoms

Engage Psychosocial Intervention for Cancer Symptoms Patient-reported outcomes will be assessed at baseline, 2 months, and 4 months. Aim 1 is to determine ENGAGE's efficacy for reducing symptom ...

6. formative.jmir.org formative.jmir.org/2025/1/e67171

Analysis of Log-Data From the ENGAGE Feasibility Trial We developed an internet-administered, guided, low-intensity cognitive behavioral therapy (LICBT)–based self-help intervention for parents of children treated ...