Breast Reconstruction Clinical Trial
Official title:
The Effect of Neurotization on Quality of Life and Sensory Restoration After Autologous Breast Reconstruction
This is a single-site, randomized, double-blinded trial to assess whether neurotization following autologous breast reconstruction in patients with breast cancer increases quality of life and sensation in the breast compared to breast reconstruction without neurotization. 50 participants will be enrolled and can expect to be on study for up to 18 months after reconstruction surgery.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | May 2026 |
Est. primary completion date | May 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Willing to provide informed consent - The patient is = 18 years - Patients presenting to UW Health who have had or will have unilateral or bilateral mastectomy (therapeutic or prophylactic) and are planning to undergo autologous reconstruction with TRAM/DIEP will be included Exclusion Criteria: - Patient is non-English speaking - Patient is known or believed to be pregnant - Patient is a minor (individuals <18 years old) - Patient is a prisoner - Individuals unable to give consent due to another condition such as impaired decision-making capacity - Autologous reconstruction where the flap is buried (e.g. there is no autologous skin exposed for sensation testing) - Patient is a male - Any patient with: diabetic neuropathy, thyroid disorders, collagen vascular disease, alcoholism, pernicious anemia, or any other severe underlying peripheral neuropathy - Women with recurrent breast cancer - Women who have undergone previous breast reconstructive procedures - Not suitable for study participation due to other reasons at the discretion of the investigators - Patient is currently lactating - History of radiation therapy - Patient undergoing a latissimus dorsi flap for reconstruction - Patient undergoing alloplastic reconstruction |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Wisconsin, Madison |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Breast-Q® score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization | Self-reported, breast-specific health-related QoL(Quality of life) via use of the Breast-Q® in participant with breast cancer who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization.
This score represents questionnaires about different domains and each question has four possible dimensions. The values of these dimensions varies from 1 to 4 (Likert Scale). The sum of each domain raw score scale will be plotted in the Breast Q Conversion Table to convert the summed domain score to a Equivalent Rasch Transformed Score with values ranging from 0 (worst) to 100 (best). |
approximately 12 months after reconstruction | |
Secondary | Change in Breast-Q® score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization | Self-reported, breast-specific health-related QoL(Quality of life) via use of the Breast-Q® in participant with breast cancer who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization.
This score represents questionnaires about different domains and each question has four possible dimensions. The values of these dimensions varies from 1 to 4 (Likert Scale). The sum of each domain raw score scale will be plotted in the Breast Q Conversion Table to convert the summed domain score to a Equivalent Rasch Transformed Score with values ranging from 0 (worst) to 100 (best). |
Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction | |
Secondary | Change in Ability to Participate in Social Roles and Activities assessed by the PROMIS SF8a score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization | The Patient-Reported Outcome Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities SF8a is a self-administered instrument to assess perceived ability to perform one's usual social roles and activities. Items are worded negatively in terms of perceived limitations, but responses are reverse-coded so that higher scores represent fewer limitations (better abilities). The item bank does not use a time frame (e.g. over the past seven days) when assessing ability to participate in social roles and activities. | Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction | |
Secondary | Change in Pain Interference assessed by PROMIS SF8a score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization | The Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference SF8a is a self-administered instrument that assesses the interference of pain on daily activities. Participants are asked to respond to questions regarding the extent of their pain. Responses range from 1 to 5, where 1 represents "not at all" and 5 represents "very much". A lower score indicates the least amount of pain interference. | Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction | |
Secondary | Change in PROMIS Psychosocial Illness Impact-Positive SF8a score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization | Measures the direct positive psychosocial effect related to illness using Computer Adaptive Testing (CAT) with higher scores reflecting better outcomes. | Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction | |
Secondary | Change in PROMIS Psychosocial Illness Impact-Negative SF8a score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization | Measures the direct negative psychosocial effect related to illness using Computer Adaptive Testing (CAT) with higher scores reflecting worse outcomes. | Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction | |
Secondary | Change in Pressure-Specified Sensory Device (PSSD) score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization | The PSSD Sensory Score is based on 1-point static and 2-point static pressure thresholds and 2- point distances. Cutaneous pressure thresholds and inter-prong distances are reported by the PSSD and determined to be normal or abnormal at a 99% confidence limit based on age (= 45, or >45). These results correlate to a grading scheme which combines 1- and 2-point static pressure threshold with 2-point distance. An increase of greater than or equal to 1 grade from baseline as measured with the PSSD will be considered a meaningful change. The grading scale integrates normative data for each PSSD testing site. | Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction | |
Secondary | Change in mean monofilament value in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization | Each monofilament value represents the logarithm of the force in milligrams required to bend the monofilament. Therefore, a thinner monofilament requires less pressure to bend and, if felt by the participant, represents improved one-point static discrimination compared to a participant who is not able to feel it.
Perpendicular pressure will be applied to the same spot until monofilament bending is noted each time for a duration of 1.5 s, three times in succession, with intervals of 1.5 s. Testing will start with the thinnest monofilament and progress to monofilaments of increasing pressure until touch is identified in at least one out of three times by the participant. Participants will be asked to lay on their back and close their eyes, and measurements will take place in a quiet room. The different sites will be tested in a random sequence to ensure touch at a particular site cannot be predicted. |
Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction | |
Secondary | Change in number of touch sensitive breast locations in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization | The participant will be tested at 9 different spots on the breast and the number of locations on the breast participant are able to detect the filament will be recorded. | Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction |
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