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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-04827 | Other Identifier | NCI-CTRP Clinical Trials Reporting Registry |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (The Intervention Group) | Experimental | Participants will receive guided imagery and deep breathing technique exercises. |
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| Group 2 ( The Control Group) | Experimental | Participants will not receive any relaxation techniques. Participants will receive the current standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Intervention Group | Other | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Uzondu Osuagwu, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Houston | Texas | 77051 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 21, 2022 | Oct 21, 2024 |
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| The Control Group | Other | Participants will continue to receive your current care, but will not receive guided imagery or deep breathing exercises from a social worker. |
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| ICF_000.pdf |
| ID | Term |
|---|---|
| D013001 | Somatoform Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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