Pain, Pain Syndrome, Symptom Management
Conditions
Brief summary
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
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.
Interventions
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.
OTHERThe Control Group
Participants will continue to receive your current care, but will not receive guided imagery or deep breathing exercises from a social worker.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Breast Cancer patients who were performed mastectomy in previous 12 months 2. Post-mastectomy pain syndrome \>4 weeks. 3. Patients who report 2-10 on the baseline pain severity score or 2-10 on the baseline pain interference score 4. Patients ≥ 18 years old and ≤ 70 years old 5. Must understand and read English, sign a written informed consent, and follow protocol requirements 6. 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
1. Pending surgery during treatment 2. Suicidal ideation 3. Diagnosis of a formal thought disorder (e.g., schizophrenia)
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed