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

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

Detailed Description
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OBJECTIVES: Primary objective: -To evaluate the effectiveness of use of Guided imagery and deep breathing techniques in pain management compared to control arm in patients with post-mastectomy pain syndrome who don't receive intervention and only receive standard care. Secondary objective: To evaluate effectiveness of Guided imagery and deep breathing techniques in symptom cluster management including fatigue, sleep, depression, and anxiety and in general quality of life compared to control arm who don't receive intervention and only receive standard care.

Official Title
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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

Conditions
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Pain, Pain Syndrome, Symptom Management

Intervention / Treatment
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* Other: The Intervention Group
* Other: The Control Group


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (The Intervention Group)<br>Participants will receive guided imagery and deep breathing technique exercises. | Other: The Intervention Group<br>* Participants will complete a 20-minute guided imagery exercise (which includes deep breathing exercises) every day at home using the selected app and/or resource you downloaded at the beginning of this study.<br>|
| Experimental: Group 2 ( The Control Group)<br>Participants will not receive any relaxation techniques. Participants will receive the current standard of care. | Other: The Control Group<br>* Participants will continue to receive your current care, but will not receive guided imagery or deep breathing exercises from a social worker.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | through study completion, an average of 1 year |