Breathing Exercise for Chronic Pain Management in Breast Cancer Survivors

NCT05257876 | Completed

• 1 other identifier: H21089
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Breast Neoplasms; Cancer Survivors

Keywords

Pain Management; Chronic Pain; Breast Neoplasms; Cancer survivors; Breathing Exercises

Outcome Measures

Primary Outcomes (10)

• Feasibility: Time taken to recruit planned sample

  The time that was taken to recruit the planned sample size of participants

  Immediately after the allocation of the last subject

• Feasibility: Referral rate

  The number of referrals made by clinicians in different departments divided by all referrals

  Immediately after the referral of the last subject

• Feasibility: Recruitment rate

  Proportion of subjects who participated in the study from all subjects eligible for participation

  Immediately after the recruitment of the last subject

• Feasibility: Retention rate

  Proportion of participants who completed the whole study divided by all subjects who enrolled in the study

  At the follow-up assessment 4 weeks after the intervention completion (T3)

• Feasibility: Dropout rate

  The number of subjects who dropped out after randomization divided by all subjects who enrolled in the study

  At the follow-up assessment 4 weeks after the intervention completion (T3)

• Reasons for dropping out

  Feedback from the dropout subjects to identify their reasons for dropping out

  Immediately once a dropout occurs

• Feasibility of the questionnaires

  The percentage of missing values for each item of the scales used, including the Brief Pain Inventory (BPI), Quality of life Cancer Survivors Version (QOL-CSV), Functional Assessment Cancer Therapy-Breast (FACT-B), and Hospital Anxiety and Depression Scale (HADS)

  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)

• Feasibility: Adherence rates

  the percentage of BE sessions performed by participants divided by the total number of BE sessions required

  Immediately after completion of the 4-week intervention (T2)

• Participants' feedback

  Participants' feedback on and satisfaction with the intervention using a specifically designed feedback form

  Immediately after completion of the 4-week intervention (T2)

• Adverse events associated with the intervention

  Data will be collected from the participants' BE logbooks and supplemented by information collected during weekly telephone contact

  Immediately once an adverse event occurs

Secondary Outcomes (4)

• Chronic pain

  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)

• Quality of life of breast cancer survivors ( using tool 1)

  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)

• Quality of Life of breast cancer survivors ( using tool 2)

  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)

• Anxiety and Depression

  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)

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Other: Breathing exercise

Control group

NO INTERVENTION

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

Interventions

Breathing exercise OTHER

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Gender eligibility is based on the physical appearance.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female breast cancer survivors ≥18 years age;
• has a confirmed diagnosis of breast cancer at stage I, II or IIIa;
• 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);
• has completed active anticancer treatment (such as chemotherapy, radiotherapy, surgery) for at least three months;
• agrees to participate in the research and is willing to give informed consent;
• can read and understand Mandarin Chinese.

You may not qualify if:

• extremely weak and unable to perform the breathing exercises;
• mentally incapable (i.e., unable to follow the study instructions);
• has scheduled pain management interventions, such as having a procedure or operation;
• receiving other pain relief treatments, such as acupuncture, yoga, qigong, exercise program, etc.;
• 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.

Sponsors & Collaborators

• Charles Darwin University: lead
• The Affiliated Hospital Of Southwest Medical University: collaborator

Study Sites (1)

The Affiliated Hospital Of Southwest Medical University

Luzhou, Sichuan, 646000, China

Location

Related Publications (1)

• 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.

  PMID: 36517097 DERIVED

MeSH Terms

Conditions

Chronic Pain; Breast Neoplasms; Agnosia

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Professor Jing-Yu (Benjamin) Tan, PhD

  Charles Darwin University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Open-labelled parallel pilot RCT

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 25, 2022
• Study Start: January 1, 2023
• Primary Completion: August 12, 2023
• Study Completion: August 12, 2023
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)