COPENCT07610499
Creating Opportunities For Personal Empowerment (COPE) In Women With Breast Cancer During First-Line Therapy: A Pilot Randomized Controlled Trial
A study testing Intervention sessions in people with COPE and Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if the Creating Opportunities for Personal Empowerment (COPE) intervention is feasible, acceptable, and helpful (compared to usual care) in women with breast cancer who are receiving first line treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- COPE, Breast Cancer, First Line Therapy
- What is being tested?
- Intervention sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2026to 1 May 2029
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Diagnosed with multiple tumor types
- Diagnosed with stage IV breast cancer
- Unable to provide consent, such as cognitively impaired individuals
- Has a preexisting psychiatric diagnosis (e.g., bipolar depression)
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
MD Anderson Cancer Center
Houston, Texas, 77030
Eileen D Hacker, MD, 713-563-4004, ehacker@mdanderson.org
Eileen D Hacker, MD
About this study
To learn if the Creating Opportunities for Personal Empowerment (COPE) intervention is feasible, acceptable, and helpful (compared to usual care) in women with breast cancer who are receiving first line treatment.
Read the detailed description
Primary Objectives The primary objective of this study is to assess the feasibility and acceptability of the COPE intervention, a nurse-led cognitive-behavioral skills-building intervention, in women undergoing their first line of treatment for breast cancer.
- The primary endpoint of feasibility will be evaluated by the percentage of participants in the intervention arm who completes at least five of the seven intervention sessions. If at least 70% of the intervention group participants complete five or more intervention sessions, the COPE intervention will be deemed feasible in women undergoing their first line of treatment for breast cancer.
- The primary endpoint of acceptability will be evaluated by an investigator-developed instrument, the Acceptability of COPE in Breast Cancer Intervention Survey, The COPE intervention will be evaluated as acceptable if ≥50% of participants report that the intervention increased their ability to cope with their breast cancer diagnosis in their response to Question 1, "The COPE sessions affected my ability to cope with my breast cancer diagnosis in the following way: A) Increased my ability to cope with my breast cancer diagnosis: B) Decreased my ability to cope with my breast cancer diagnosis; or C) No change in my ability to cope with my breast cancer diagnosis."
- Being tested
- Standard of Care (SOC), Intervention sessions
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care (SOC)Other
Given by Questionnaires
Intervention sessionsOther
7 week sessions
| Study group | Role | What they receive |
|---|---|---|
| COPE Intervention | Experimental | There are seven sessions within the COPE intervention. Sessions will be facilitated by a research team member weekly over the course of seven weeks and each session will take approximately 45 minutes. Receives: Other: Intervention sessions |
| Control Group | Other | Usual care will consist of standard care provided by the participant's healthcare team, including any recommendations regarding coping with stress, anxiety, depressive symptoms, resilience, and quality of life related to their breast cancer diagnosis and treatment. Receives: Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Outcomes Measurement Questionnaire
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start30 Oct 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPEStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eileen D Hacker, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610499
- Sponsor's protocol ID
- 2026-0163
- Other IDs
- NCI-2026-03932
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating Opportunities For Personal Empowerment (COPE) In Women With Breast Cancer During First-Line Therapy: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07610499
- Acronym / sponsor ID
- 2026-0163
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 28 May 2026 (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.
To learn if the Creating Opportunities for Personal Empowerment (COPE) intervention is feasible, acceptable, and helpful (compared to usual care) in women with breast cancer who are receiving first line treatment.
Detailed description
Primary Objectives The primary objective of this study is to assess the feasibility and acceptability of the COPE intervention, a nurse-led cognitive-behavioral skills-building intervention, in women undergoing their first line of treatment for breast cancer.
- The primary endpoint of feasibility will be evaluated by the percentage of participants in the intervention arm who completes at least five of the seven intervention sessions. If at least 70% of the intervention group participants complete five or more intervention sessions, the COPE intervention will be deemed feasible in women undergoing their first line of treatment for breast cancer.
- The primary endpoint of acceptability will be evaluated by an investigator-developed instrument, the Acceptability of COPE in Breast Cancer Intervention Survey, The COPE intervention will be evaluated as acceptable if ≥50% of participants report that the intervention increased their ability to cope with their breast cancer diagnosis in their response to Question 1, "The COPE sessions affected my ability to cope with my breast cancer diagnosis in the following way: A) Increased my ability to cope with my breast cancer diagnosis: B) Decreased my ability to cope with my breast cancer diagnosis; or C) No change in my ability to cope with my breast cancer diagnosis."
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPE Intervention | Experimental | Other: Intervention sessionsThere are seven sessions within the COPE intervention. Sessions will be facilitated by a research team member weekly over the course of seven weeks and each session will take approximately 45 minutes. |
| Control Group | Other | Other: Standard of Care (SOC)Usual care will consist of standard care provided by the participant's healthcare team, including any recommendations regarding coping with stress, anxiety, depressive symptoms, resilience, and quality of life related to their breast cancer diagnosis and treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Diagnosed with multiple tumor types
- Diagnosed with stage IV breast cancer
- Unable to provide consent, such as cognitively impaired individuals
- Has a preexisting psychiatric diagnosis (e.g., bipolar depression)
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 |
|---|---|---|
| Standard of Care (SOC)Given by Questionnaires | Other | Control Group |
| Intervention sessions7 week sessions | Other | COPE Intervention |
Primary outcome
Patient-Reported Outcomes Measurement Questionnaire
Time frame: Through study completion; an average of 1 year
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 28 May 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for COPE
Not yet recruiting
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
Not yet recruitingObservational study
Stress, Coping, and Sleep Health Study
Sleep
Recruiting
Modulating Anxious Coping
Anxiety Disorders
Recruiting
Momentary Coping Prompts and Hair Steroids in College Students
Emotional Regulation, Alcohol Drinking in College
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
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.
Eileen D Hacker, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention sessions in people with COPE and Breast Cancer, run by M.D. Anderson Cancer Center 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 0 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: opening soon, as of the sponsor's last update on 28 May 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 Eileen D Hacker, MD (713-563-4004, ehacker@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcomes Measurement Questionnaire (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2026.