COPE Intervention for Breast Cancer

ED
Overseen ByEileen D Hacker, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a program called Creating Opportunities for Personal Empowerment (COPE) to determine its effectiveness for women with breast cancer undergoing their first round of treatment. The COPE program includes seven weekly sessions designed to improve stress coping, resilience, and quality of life. Participants will either join these sessions or continue with their usual care. Women with stage I-III breast cancer currently receiving treatment at MD Anderson may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to explore new methods for enhancing personal well-being during treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the COPE intervention is safe for women with breast cancer?

Research has shown that the Creating Opportunities for Personal Empowerment (COPE) program is generally easy for participants to manage. Studies have found positive outcomes, such as increased personal empowerment and healthier lifestyle choices, with no reports of serious side effects. Healthcare facilities and schools have used the COPE program to improve outcomes, and no major safety concerns have been reported. This suggests the program is safe for participants.12345

Why are researchers excited about this trial?

The COPE Intervention is unique because it focuses on empowering breast cancer patients through personalized mental health support rather than just addressing physical symptoms. Unlike standard treatments that primarily focus on medical and surgical interventions, COPE provides a structured approach with seven weekly sessions aimed at improving mental resilience, reducing stress, and enhancing quality of life. Researchers are excited about this approach because it targets the psychological well-being of patients, which is often overlooked in traditional care, potentially leading to better overall outcomes.

What evidence suggests that the COPE intervention is effective for breast cancer?

Research has shown that the Creating Opportunities for Personal Empowerment (COPE) program can assist women with breast cancer. In this trial, participants in the COPE intervention arm will engage in sessions designed to empower them with strategies to feel more informed and better accept their illness. Studies have found that such empowerment strategies can lead to healthier habits, such as increased exercise and improved weight control. Participants also reported feeling less stressed, indicating better mental health. These findings support the idea that COPE can enhance the overall quality of life for breast cancer patients.12467

Who Is on the Research Team?

ED

Eileen D Hacker, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for women diagnosed with breast cancer who are currently receiving their first round of treatment. Participants should be able to take part in intervention sessions and follow study procedures.

Inclusion Criteria

Receiving treatment at MD Anderson
Able to read, speak, and consent in English
I am 18 years old or older.
See 5 more

Exclusion Criteria

Has a preexisting psychiatric diagnosis (e.g., bipolar depression)
I have been diagnosed with stage IV breast cancer.
I have been diagnosed with more than one type of tumor.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the COPE intervention, consisting of seven weekly sessions facilitated by a research team member

7 weeks
7 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Creating Opportunities For Personal Empowerment (COPE) Intervention

Trial Overview

The study compares the usual care given to women with breast cancer against an added program called COPE, which involves special support or empowerment sessions. Women are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Control GroupExperimental Treatment1 Intervention
Group II: COPE InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Citations

Study Details | NCT07610499 | Creating Opportunities For ...

Creating Opportunities for Personal Empowerment (COPE) intervention is feasible, acceptable, and helpful (compared to usual care) in women with ...

Strategies to Promote Empowerment Status of Breast Cancer ...

This study is aimed at determining the empowerment status of breast cancer patients referred to the Shahid Motahari Breast Cancer Clinic in Iran, Shiraz

Empowerment among breast cancer survivors using an online ...

The most commonly experienced empowerment outcomes were “being better informed” and “improved acceptance of the illness.” “Exchanging ...

COPE (Creating Opportunities for Personal Empowerment ...

The study showed an increase in steps per day, lower increase in body mass index (BMI), decrease in the proportion of overweight or obese, and decrease in ...

Intervention Studies Supporting COPE with Abstracts

PURPOSE: The goal of the study was to test the efficacy of the COPE (Creating Opportunities for Personal Empowerment) Healthy Lifestyles TEEN (Thinking, ...

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cope2thriveonline.com

cope2thriveonline.com/

COPE | Creating Opportunities for Personal Empowerment

The COPE Programs are manualized so that they can be readily implemented by clinicians in healthcare settings and teachers in schools to improve outcomes in ...

COPE Creating Opportunities for Personal Empowerment

Research and Scholarly Papers Supporting Positive Outcomes of the COPE Program. Melnyk, B.M. (2024). The evidence-based COPE program: Reducing the time, ...