Breathing Exercise for Chronic Pain Management in Breast Cancer Survivors

NCT ID: NCT05257876

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-08-12

Brief Summary

The study will follow the MRC Framework to develop an evidence-based BE intervention protocol to help breast cancer survivors with better management of cancer-related chronic pain.

Detailed Description

Cancer-related chronic pain remains as a big challenge for cancer survivors, which significantly affects the quality of life of cancer survivors. Evidence suggests that pain is well managed through combination of pharmacological and non-pharmacological interventions. Among all non-pharmacological interventions, breathing exercise (BE) might have potential effect for chronic pain management in cancer survivors, but the evidence is sparse in current literature. Therefore, this study will follow the Medical Research Council Framework for Developing and Evaluating Complex intervention (the MRC Framework) to develop an evidence-based BE protocol to help with cancer-related chronic pain management in breast cancer survivors. The first two phases of the MRC Framework will be included in this study. In the first phase, an evidence-based method will be utilized to develop the BE intervention protocol. In the second phase, a pilot randomised controlled trial (RCT) will be conducted to examine the feasibility of study and the acceptability of the BE intervention by the participants as well as to preliminarily assess the effect of the BE on chronic pain management in breast cancer survivors. Semi-structured interviews will be conducted after the RCT to explore participants' experiences of participating in the study and practicing the BE.

Conditions

Chronic Pain; Breast Neoplasms; Cancer Survivors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group

Participants in the intervention group will receive breathing exercise training, pain information booklet, and usual care.

Group Type: EXPERIMENTAL

Breathing exercise

Intervention Type: OTHER

Participants will receive breathing exercise training, and a 4-week self exercise

Control group

Participants in the control group will receive pain information booklet and usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Breathing exercise

Participants will receive breathing exercise training, and a 4-week self exercise

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. female breast cancer survivors ≥18 years age;

2. has a confirmed diagnosis of breast cancer at stage I, II or IIIa;

3. has been experiencing pain since cancer diagnosis constantly or intermittently for ≥3 months, with the average pain intensity in the last seven days on a numerical scale ≥4/10 ("0" indicates no pain and "10" indicates the worst pain);

4. has completed active anticancer treatment (such as chemotherapy, radiotherapy, surgery) for at least three months;

5. agrees to participate in the research and is willing to give informed consent;

6. can read and understand Mandarin Chinese.

Exclusion Criteria

1. extremely weak and unable to perform the breathing exercises;

2. mentally incapable (i.e., unable to follow the study instructions);

3. has scheduled pain management interventions, such as having a procedure or operation;

4. receiving other pain relief treatments, such as acupuncture, yoga, qigong, exercise program, etc.;

5. has any pre-existing chronic pain conditions before cancer diagnosis, such as arthritis, rheumatoid arthritis, chronic low back pain, migraines, trigeminal neuralgia, fibromyalgia, joint dysfunction, Complex Regional Pain Syndrome, endometriosis, etc.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital Of Southwest Medical University

OTHER

Sponsor Role: collaborator

Charles Darwin University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Professor Jing-Yu (Benjamin) Tan, PhD

Role: PRINCIPAL_INVESTIGATOR

Charles Darwin University

Locations

The Affiliated Hospital Of Southwest Medical University

Luzhou, Sichuan, China

Countries

China

References

Wang H, Tan JB, Wang T, Liu XL, Bressington D, Zheng SL, Huang HQ. Feasibility and potential effects of breathing exercise for chronic pain management in breast cancer survivors: study protocol of a phase II randomised controlled trial. BMJ Open. 2022 Dec 14;12(12):e064358. doi: 10.1136/bmjopen-2022-064358.

Reference Type: DERIVED

PMID: 36517097 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

H21089

Identifier Type: -

Identifier Source: org_study_id