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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

Primary Purpose

Pain Syndrome, Pain, Symptom Management

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

The Intervention Group

The Control Group

About this trial

This is an interventional supportive care trial for Pain Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Breast Cancer patients who were performed mastectomy in previous 12 months
Chronic post-mastectomy pain syndrome (≥3 months)
Patients who report 5-10 on the baseline pain severity score or 5-10 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:

Current chemotherapy or radiation
Pending surgery during treatment
Other chronic pain diagnosis besides post mastectomy pain syndrome (PMPS)
Suicidal ideation
Diagnosis of a formal thought disorder (e.g., schizophrenia)

Sites / Locations

MD Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group 1 (The Intervention Group)

Group 2 ( The Control Group)

Arm Description

Participants will receive guided imagery and deep breathing technique exercises.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05408741

First Posted

June 1, 2022

Last Updated

August 22, 2023

Sponsor

M.D. Anderson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT05408741

Brief Title

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

Official Title

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 Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 6, 2022 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain Syndrome, Pain, Symptom Management

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1 (The Intervention Group)

Arm Type

Experimental

Arm Description

Participants will receive guided imagery and deep breathing technique exercises.

Arm Title

Group 2 ( The Control Group)

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

The Intervention Group

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

The Control Group

Intervention Description

Participants will continue to receive your current care, but will not receive guided imagery or deep breathing exercises from a social worker.

Primary Outcome Measure Information:

Title

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

Time Frame

through study completion, an average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Breast Cancer patients who were performed mastectomy in previous 12 months Post-mastectomy pain syndrome >4weeks Patients who report 4-10 on the baseline pain severity score or 4-10 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: Current chemotherapy or radiation Pending surgery during treatment Other chronic pain diagnosis besides post mastectomy pain syndrome (PMPS) Suicidal ideation Diagnosis of a formal thought disorder (e.g., schizophrenia)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Uzondu Osuagwu, MD

Phone

(281) 787-8818

uosuagwu@mdanderson.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Uzondu Osuagwu, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77051

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Uzondu Osuagwu, MD

Phone

281-787-8818

uosuagwu@mdanderson.org

First Name & Middle Initial & Last Name & Degree

Uzondu Osuagwu, MD

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

MD Anderson Cancer Center

Learn more about this trial

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

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