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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the ENGAGE treatment for cancer patients?

Research shows that psychosocial interventions, like ENGAGE, can improve quality of life and emotional well-being for cancer patients by addressing anxiety, depression, and unmet needs. Studies suggest that integrating psychosocial care into cancer treatment can lead to better patient outcomes. ^{1 2 3 4 5}

Is the ENGAGE Psychosocial Intervention for Cancer safe for humans?

The research on psychosocial interventions for cancer patients, including those similar to ENGAGE, generally focuses on improving quality of life and managing symptoms without significant safety concerns. These interventions are typically non-invasive and involve support through communication, education, and therapy, which are considered safe for human participants. ^{1 6 7 8 9}

How does the ENGAGE treatment differ from other treatments for cancer?

The ENGAGE treatment is unique because it focuses on comprehensive psychosocial support, which includes prevention, early detection, restoration, support, and palliation, aiming to improve quality of life and manage cancer symptoms and treatment side-effects. Unlike standard medical treatments, it involves a multidisciplinary approach with therapies ranging from education to behavioral and cognitive therapies, tailored to the individual needs of cancer patients and their families. ^{3 5 7 10 11}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Psychosocial interventions for cancer patients. [2008]

3. United States pubmed.ncbi.nlm.nih.gov

Psychological aspects of mind-body medicine: promises and pitfalls from research with cancer patients. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a Psychosocial Care Quality Improvement Strategy to Address Quality of Life in Patients With Cancer: The HuCare2 Stepped-Wedge Cluster Randomized Trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Separating the apples and oranges in the fruit cocktail: the mixed results of psychosocial interventions on cancer survival. [2005]

6. United States pubmed.ncbi.nlm.nih.gov

Psychosocial concerns and interventions for cancer survivors. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

Psychosocial telephone interventions for patients with cancer and survivors: a systematic review. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Lessons to be learned from 25 years of research investigating psychosocial interventions for cancer patients. [2021]

10. France pubmed.ncbi.nlm.nih.gov

[Depression in cancer]. [2006]

11. Belgium pubmed.ncbi.nlm.nih.gov

[Medico-psychosocial rehabilitation of patients with cancer]. [2006]