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

NCT05408741 | Completed

• 2 other identifiers: 2020-1104NCI-2022-04827
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Syndrome; Pain; Symptom Management

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group 1 (The Intervention Group)

EXPERIMENTAL

Participants will receive guided imagery and deep breathing technique exercises.

Other: The Intervention Group

Group 2 ( The Control Group)

EXPERIMENTAL

Participants will not receive any relaxation techniques. Participants will receive the current standard of care.

Other: The Control Group

Interventions

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.

Group 1 (The Intervention Group)

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.

Group 2 ( The Control Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77051, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Somatoform Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Uzondu Osuagwu, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 7, 2022
• Study Start: June 6, 2022
• Primary Completion: May 10, 2024
• Study Completion: May 10, 2024
• Last Updated: October 23, 2024

Record last verified: 2024-05

Locations

US (1)