Clinical trial NCT05257876: Breathing Exercise for Chronic Pain Management in Breast Cancer Survivors
Official title: An Evidence-based Breathing Exercise Intervention Protocol for Chronic Pain Management in Breast Cancer Survivors: A Preliminary Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Breast Neoplasms
Cancer Survivors
Keywords: Pain Management
Chronic Pain
Breast Neoplasms
Cancer survivors
Breathing Exercises
Lead sponsor: Charles Darwin University
Sponsor class: OTHER
Collaborators: name: The Affiliated Hospital Of Southwest Medical University
First posted: 2022-02-25
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-labelled parallel pilot RCT
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Feasibility: Time taken to recruit planned sample
timeFrame: Immediately after the allocation of the last subject
measure: Feasibility: Referral rate
timeFrame: Immediately after the referral of the last subject
measure: Feasibility: Recruitment rate
timeFrame: Immediately after the recruitment of the last subject
measure: Feasibility: Retention rate
timeFrame: At the follow-up assessment 4 weeks after the intervention completion (T3)
measure: Feasibility: Dropout rate
timeFrame: At the follow-up assessment 4 weeks after the intervention completion (T3)
measure: Reasons for dropping out
timeFrame: Immediately once a dropout occurs
measure: Feasibility of the questionnaires
timeFrame: At baseline (T1), immediately after the completion of the 4-week intervention (T2), and the follow-up assessment at 4 weeks after the intervention completion (T3)
measure: Feasibility: Adherence rates
timeFrame: Immediately after completion of the 4-week intervention (T2)
measure: Participants' feedback
timeFrame: Immediately after completion of the 4-week intervention (T2)
measure: Adverse events associated with the intervention
timeFrame: Immediately once an adverse event occurs
Secondary outcomes:
measure: Chronic pain
timeFrame: At baseline (T1), immediately after the completion of the 4-week intervention (T2), and the follow-up assessment at 4 weeks after the intervention completion (T3)
measure: Quality of life of breast cancer survivors ( using tool 1)
timeFrame: At baseline (T1), immediately after the completion of the 4-week intervention (T2), and the follow-up assessment at 4 weeks after the intervention completion (T3)
measure: Quality of Life of breast cancer survivors ( using tool 2)
timeFrame: At baseline (T1), immediately after the completion of the 4-week intervention (T2), and the follow-up assessment at 4 weeks after the intervention completion (T3)
measure: Anxiety and Depression
timeFrame: At baseline (T1), immediately after the completion of the 4-week intervention (T2), and the follow-up assessment at 4 weeks after the intervention completion (T3)
Other outcomes:
Locations:
city: Luzhou
country: China
facility: The Affiliated Hospital Of Southwest Medical University
state: Sichuan
Study officials:
affiliation: Charles Darwin University
name: Professor Jing-Yu (Benjamin) Tan, PhD
role: PRINCIPAL_INVESTIGATOR
References: