CompletedNot Applicable

A Pilot Study Assessing the Effectiveness of Use of Guided Imagery for Treatment of Pain and Symptom Management in Women With Post-mastectomy Pain Syndrome

United States9 participantsStarted 2022-06-06

Plain-language summary

To learn if using guided imagery and deep breathing techniques can help with pain management in patients who have post-mastectomy pain syndrome.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Breast Cancer patients who were performed mastectomy in previous 12 months
. Post-mastectomy pain syndrome \>4 weeks.
. Patients who report 2-10 on the baseline pain severity score or 2-10 on the baseline pain interference score
. Patients ≥ 18 years old and ≤ 70 years old
. Must understand and read English, sign a written informed consent, and follow protocol requirements
. If on medication for anxiety or depression, stable dose of medications for management of anxiety or depression symptoms for at least six weeks prior to enrollment with no plans to change medications in the subsequent four weeks. Increases or decreases allowed within drug class, but changing drug class will make patient in-evaluable

Exclusion criteria

. Pending surgery during treatment
. Suicidal ideation
. Diagnosis of a formal thought disorder (e.g., schizophrenia)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The change in pain severity score and the change in pain interference score, measured by brief pain inventory short form. Brief Pain Inventory: 0-10 No Pain-0 Worst Pain-10

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT05408741

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-10

View on ClinicalTrials.gov More Pain Syndrome trials