Breathing Exercise for Chronic Pain Management in Breast Cancer Survivors

Charles Darwin University

Status: Completed

Conditions: Cancer Survivors; Chronic Pain; Breast Neoplasms

Treatments: Other: Breathing exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05257876

H21089

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

72 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

Other: Breathing exercise

Control group

No Intervention group

Description:

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