Breast Conserving Surgery, Mastectomy With Reconstruction
Conditions
Keywords
BREAST-Q REACT, assessments, quality of life, 24-184
Brief summary
The researchers are doing this study to find out whether it is practical (feasible) to conduct a larger study looking at the effects of the BREAST-Q Real-time Engagement and Communication Tool (REACT) on people's quality of life, interactions with their doctors, and medical interventions after undergoing routine breast conserving surgery or mastectomy. The BREAST-Q REACT tool shows scores from standard questionnaires completed before and after breast surgery about overall physical wellbeing, arm pain or tightness, the ability to move the arms and perform everyday tasks, and any symptoms related to the arms, and provides feedback including recommendations and detailed information that help explain these scores and guide topics for people and their doctor to discuss.
Interventions
OTHERBREAST-Q Physical Well-Being
This BREAST-Q domain measures pain or tightness and difficulty with mobility, such as lifting arms or running. The preoperative survey contains 10 items, whereas the postoperative survey contains 11 items. Values for BREAST-Q subscales are converted to summary scores, ranging from 0 to 100, via Q-Score software. Higher scores correlate with better patient quality of life. 37 This survey is administered as part of standard care for all patients.
OTHERQuickDASH
QuickDASH, also known as the Arm and Shoulder Range of Motion survey within MSK Engage is an 11-item survey that measures physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. It is currently standard of care for breast cancer surgery patients. It is a valid, reliable, and responsible survey that can be used for clinical and/or research purposes. Higher scores indicate greater disability.
Sponsors
Memorial Sloan Kettering Cancer Center
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
* Scheduled to undergo BCS or mastectomy followed by breast reconstruction with tissue expander, autologous tissues, or direct-to-implant, regardless of neoadjuvant chemotherapy or radiation history * Female sex * Able to speak and understand English * ≥18 years of age * Able to access the patient portal online
Exclusion criteria
* Patient is male * Younger than 18 years of age * Cannot communicate in English * Recurrent breast cancer * Patients without access to the internet.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| feasibility of recruitment | up to 3 months | assessed by frequency data from initial eligibility screening to enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| feasibility of protocol delivery | up to 3 months | by evaluating survey completion rates and proportion of patients who are being referred to medical interventions. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJonas Nelson, MD, MPH
Memorial Sloan Kettering Cancer Center
Outcome results
None listed