Breast Cancer Survivor
Conditions
Keywords
breast cancer survivors, Baduanjin exercise, pilot study, randomised control trail
Brief summary
The goal of this clinical trial is to learn if Baduanjin exercise could be adopted by breast cancer survivors and improve their upper limb dysfunction. The main questions it aims to answer are: * Does Baduanjin exercise improve upper limb dysfunction among breast cancer survivors? * What problems or adverse events do participants have if they adopt Baduanjin exercise to improve upper limb dysfunction? Participants will: * Adopt Baduanjin exercise following an evidence-based intervention protocol * Report their exercise frequency, length, and unexpected symptoms * Receive three times assessment and follow-up every week
Detailed description
To evaluate the feasibility, acceptability, and preliminary effects of Baduanjin exercise on upper limb dysfunction (ULD), shoulder range of motion (ROM), pain, sleep quality, depression and anxiety, and quality of life (QoL) in breast cancer survivors. The objectives of this study are to: 1. Develop an evidence-based Badunajin exercise intervention protocol for managing ULD among breast cancer survivors ; 2. Design and conduct a pilot Randomised Controlled Trial (RCT) using the Buduanjin exercise intervention protocol to manage the ULD; 3. Test the feasibility and acceptability of the Baduanjin exercise intervention and RCT procedures by the recruitment rate, retention rate, and attrition rate during the pilot RCT; 4. Evaluate the safety, efficacy, and acceptability of the Baduanjin exercise intervention by identifying potential adverse effects associated with the Baduanjin exercise intervention; 5. Examine the potential effects of Baduanjin exercise intervention on ULD, shoulder ROM, pain, sleep quality, depression and anxiety, as well as QoL among breast cancer survivors; 6. Explore the participants' experience and suggestions for the Baduanjin exercise intervention and study procedures; and 7. Provide evidence for refinement of the Baduanjin exercise intervention for a multi-center, full-scale RCT among breast cancer survivors.
Interventions
BEHAVIORALBaduanjin exercise
Baduanjin exercise is a low-to-moderate-intensity aerobic mind-body exercise that integrates movement (physical postures), meditation (focused attention), and controlled breathing. When practicing it, people stand in a position and perform eight movements, including 1) Two Hands Hold up the Heavens; 2) drawing the bow to shoot the eagle; 3)separate heaven and earth, 4)wise owl gazes backward or looking back, 5)sway the head and shake the tail, 6)two hands hold the keen to strengthen the kidneys and waist, 7) clench the fists and glare fiercely; 8) bouncing on the toes seven times.
Sponsors
University of Southern Queensland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female, aged ≥ 18 years, diagnosed with non-metastatic unilateral Stage I-IIIa non-metastatic breast cancer, regardless of cancer type; 2. Surgeries completed at least two months before enrolment, and completion of radiotherapy and/or chemotherapy, with or without aromatase inhibitor therapy, upon enrolment; 3. Experiencing breast cancer treatment-related ULD, which is measured by the Disabilities of the Arm, Shoulder, and Hand (DASH) scale with a score of 20 or above; 4. Karnofsky Performance Status Scale (KPS), used to measure a patient's ability to perform daily activities and self-care independently, with a score of 90 or above; 5. Ability to read, write, and communicate in Chinese; 6. Have a personal cellphone; 7. Agree to participate in this study and provide written informed consent.
Exclusion criteria
1. Any patient with a history of upper limb surgery, injury (fracture or shoulder dislocation), or other conditions not related to breast cancer treatments; 2. With other complications or adverse medical conditions that cannot perform BdjE, such as severe lymphedema, axillary web syndrome, or adhesive capsulitis; 3. Undergoing any physiotherapy for ULD or leading regular physical exercises in the previous three months; 4. Had skin grafting and autologous myocutaneous flap breast reconstruction; 5. Current clinical diagnosis of depression or anxiety, or receipt of active psychological treatment for significant mood or anxiety disorders; 6. Currently involved in other clinical studies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Upper Limb Dysfunction | At enrollment, at the end of the intervention, and eight weeks after the intervention completion | The Disability of Arm, Shoulder, and Hand (DASH) (Chinese version) will assess upper limb dysfunction. The DASH has 30 items, and 5-Likert scale was used to demonstrate the disability of the upper limb (1=not at all, 2= slightly, 3= moderately, 4= quite a bit, 5= extremely), and DASH symptom score = \[(sum of n response)/n-1\] \*25 (n is the number of completed responses)(Hudak et al., 1996). A higher score indicates a greater disability. At least 27 items must be completed for each questionnaire, or it will not be able to calculate a score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder Range of Motion (ROM) | At enrollment, at the end of the intervention, and eight weeks after the intervention completion | The shoulder ROM includes flexion, extension, abduction, adduction, and internal and external rotation. A digital goniometer is a precision instrument commonly used to measure shoulder ROM in clinical settings. each movement will be measured and recorded once per assessment to minimize fatigue and prevent artificially increased ROM due to repeated measurements |
| Pain | At enrollment, at the end of the intervention, and eight weeks after the intervention completion | The brief pain inventory (BPI) will be employed to measure pain among BCSs, which is a self-administered measure that can rapidly assess the intensity of pain and the impact of pain on daily function. |
| Sleep Quality | At enrollment, at the end of the intervention, and eight weeks after the intervention completion | The Pittsburgh Sleep Quality Index (PSQI) (Chinese version) was adopted to evaluate sleep quality in the project. It was developed in 1989, with 19 items in seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medication, and daytime dysfunction (Buysse et al., 1989). Each component score ranges from 0 (no difficulty) to 3 (severe difficulty), and the global score ranges from 0 to 21 points; a higher score indicates a worse sleep quality (Buysse et al., 1989). |
| Depression and Anxiety | At enrollment, at the end of the intervention, and eight weeks after the intervention completion | The Hospital Anxiety and Depression Scale (HADS) was selected to assess the participants' depression and anxiety. HADS was developed in 1983 with 14 items, 7 items measuring cognitive and emotional aspects of depression, intermingled with 7 items that focus on cognitive and emotional aspects of anxiety(Zigmond \& Snaith, 1983). Each item is scored from 0 to 3, resulting in a total subscale score ranging from 0 to 21. Higher scores indicate greater levels of depression or anxiety(Zigmond \& Snaith, 1983) |
| Quality of Life(QoL) | At enrollment, at the end of the intervention, and eight weeks after the intervention completion | FACT-B+4 will be used to assess the QoL among breast cancer survivors with upper limb dysfunction. FACT-B has 37 items, including 7 items for physical well-being, 7 items for social/family well-being, 6 items for emotional well-being, 7 items for functional well-being, and 10 additional items specific to breast cancer concerns(Brady et al., 1997). The FACT-B+4 is an extended version of the original one, and the "+4" refers to four additional items specifically designed to assess arm morbidity in BCSs(Coster et al., 2001). Each item of the FACT-B+4 is rated on a 5-point Likert scale from 0 (not at all) to 4 (very much), and the total score range is 0-168 (Some items are reverse scored). A higher score indicates a better QoL. |
Countries
China
Contacts
CONTACTJinqiu LI
Outcome results
None listed