Breast Cancer
Conditions
Keywords
Breast Cancer, Mastectomy, Acupuncture
Brief summary
The purpose of the study is to compare the effect of acupuncture to the standard of care (control group) on pain, nausea, anxiety, ability to cope, costs and length of hospital stay in post-mastectomy patients at Abbott Northwestern Hospital.
Detailed description
About 40 subjects will be participating in this study. Following qualification for the study, participants will be randomly assigned by chance to receive either acupuncture or to receive the standard of care without an integrative medicine session. * One group will receive acupuncture after surgery. Acupuncture involves inserting thin, sterile needles at certain points on your body. * The other group will receive the standard of care without an acupuncture session. Before surgery participants will complete a demographics questionnaire. After surgery, participants will be visited in their hospital room by either an acupuncturist or another member of the research team. For those assigned to the acupuncture group, participants will receive up to two sessions of acupuncture, at least twelve hours apart. For those assigned to the control group, a research team member will visit the participant in their room up to two times, at least twelve hours apart. During those visits, participants will be asked about pain, nausea, anxiety, and ability to cope at the beginning and end of each treatment or visit. Additional information will be gathered from participants hospital charts, such as the type of surgery that was performed, length of hospital stay, and the costs associated with the hospital stay.
Interventions
OTHERAcupuncture
Acupuncture involves inserting thin, sterile needles into the skin at certain points in the body.
Sponsors
Allina Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women * 18 years or older * Undergoing mastectomy surgery
Exclusion criteria
* Non-English speaking * Pregnant * Also undergoing an oophorectomy, TRAM or Latissimus flap surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Eligible Compared to the Number Approached and Enrolled | One year | Feasibility will be measured by the number of patients eligible for enrollment, the number approached, the number consented, and the final sample with completed data. The study population will be described in terms of demographics and background characteristics collected on the enrollment questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Post Intervention | Participants will be followed on post operations day 1 and 2 of their hospital stay | Change in pain on a single question 11-point Numeric Rating Scale (NRS) where 0 equals no pain and 10 equals most severe pain. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Pain Day 1 - Pre-Pain Day 1). A lower score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2. |
| Change in Anxiety Post Intervention | Participants will be followed on post operations day 1 and 2 of their hospital stay | Change in anxiety on a single question 11-point Numeric Rating Scale (NRS) where 0 equals no anxiety and 10 equals most severe anxiety. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Anxiety Day 1 - Pre-Anxiety Day 1). A lower score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2. |
| Change in Nausea Post Intervention | Participants will be followed on post operations day 1 and 2 of their hospital stay | Change in nausea on a single question 11-point Numeric Rating Scale (NRS) where 0 equals no nausea and 10 equals most severe nausea. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Nausea Day 1 - Pre-Nausea Day 1). A lower score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2. |
| Change in Ability to Cope Post Intervention | Participants will be followed on post operations day 1 and 2 of their hospital stay | Change in ability to cope on a single question 11-point Numeric Rating Scale (NRS) where 0 equals absence of an ability to cope and 10 equals complete ability to cope. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Coping Day 1 - Pre-Coping Day 1). . A higher score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acupuncture Two sessions of acupuncture, at least twelve hours apart, post-mastectomy.
Acupuncture: Acupuncture involves inserting thin, sterile needles into the skin at certain points in the body. | 15 |
| Standard of Care Standard of care post-mastectomy. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Acupuncture | Total | Standard of Care |
|---|---|---|---|
| Age, Continuous | 53.74 years STANDARD_DEVIATION 9.41 | 57.52 years STANDARD_DEVIATION 11.27 | 62.47 years STANDARD_DEVIATION 11.47 |
| Education <9th Grade | 0 participants | 0 participants | 0 participants |
| Education 9th to 12th Grade | 0 participants | 1 participants | 1 participants |
| Education Bachelor's Degree or Higher | 6 participants | 10 participants | 4 participants |
| Education High School Graduate | 4 participants | 7 participants | 3 participants |
| Education Some College or Associate Degree | 5 participants | 12 participants | 7 participants |
| Employment Status Full-time | 8 participants | 12 participants | 4 participants |
| Employment Status Homemaker | 2 participants | 4 participants | 2 participants |
| Employment Status Other | 0 participants | 0 participants | 0 participants |
| Employment Status Part-time | 3 participants | 6 participants | 3 participants |
| Employment Status Retired | 2 participants | 8 participants | 6 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 30 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Family Income <$24,999 | 0 participants | 2 participants | 2 participants |
| Family Income $25,000-39,999 | 1 participants | 1 participants | 0 participants |
| Family Income $40,000-54,999 | 4 participants | 5 participants | 1 participants |
| Family Income $55,000-74,999 | 2 participants | 5 participants | 3 participants |
| Family Income $75,000 or more | 8 participants | 15 participants | 7 participants |
| Family Income Unknown | 0 participants | 2 participants | 2 participants |
| Marital Status Divorced/separated | 2 participants | 5 participants | 3 participants |
| Marital Status Living in marriage-like relationship | 0 participants | 0 participants | 0 participants |
| Marital Status Married | 12 participants | 24 participants | 12 participants |
| Marital Status Never married | 0 participants | 0 participants | 0 participants |
| Marital Status Widowed | 1 participants | 1 participants | 0 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 30 Participants | 15 Participants |
| Sex: Female, Male Female | 15 Participants | 30 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Number of Patients Eligible Compared to the Number Approached and Enrolled
Feasibility will be measured by the number of patients eligible for enrollment, the number approached, the number consented, and the final sample with completed data. The study population will be described in terms of demographics and background characteristics collected on the enrollment questionnaire.
Time frame: One year
Population: A total of 252 women were scheduled to receive a unilateral or bilateral mastectomy during the study period. Of those, 61 were eligible for study participation, and there were 30 women who provided consent and were randomized.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Undergoing Mastectomy Surgery | Number of Patients Eligible Compared to the Number Approached and Enrolled | Elligible | 61 Participants |
| Patients Undergoing Mastectomy Surgery | Number of Patients Eligible Compared to the Number Approached and Enrolled | Approached | 252 Participants |
| Patients Undergoing Mastectomy Surgery | Number of Patients Eligible Compared to the Number Approached and Enrolled | Consented | 30 Participants |
| Patients Undergoing Mastectomy Surgery | Number of Patients Eligible Compared to the Number Approached and Enrolled | Declined | 31 Participants |
| Patients Undergoing Mastectomy Surgery | Number of Patients Eligible Compared to the Number Approached and Enrolled | Final Sample with complete data | 26 Participants |
Secondary
Change in Ability to Cope Post Intervention
Change in ability to cope on a single question 11-point Numeric Rating Scale (NRS) where 0 equals absence of an ability to cope and 10 equals complete ability to cope. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Coping Day 1 - Pre-Coping Day 1). . A higher score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2.
Time frame: Participants will be followed on post operations day 1 and 2 of their hospital stay
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Undergoing Mastectomy Surgery | Change in Ability to Cope Post Intervention | Visit 1 Change in Ability to Cope | 1.87 units on a scale | Standard Deviation 2.97 |
| Patients Undergoing Mastectomy Surgery | Change in Ability to Cope Post Intervention | Visit 2 Change in Ability to Cope | 0.30 units on a scale | Standard Deviation 3.06 |
| Standard of Care | Change in Ability to Cope Post Intervention | Visit 1 Change in Ability to Cope | -0.47 units on a scale | Standard Deviation 1.36 |
| Standard of Care | Change in Ability to Cope Post Intervention | Visit 2 Change in Ability to Cope | 0.07 units on a scale | Standard Deviation 0.47 |
p-value: <0.01t-test, 2 sided
Secondary
Change in Anxiety Post Intervention
Change in anxiety on a single question 11-point Numeric Rating Scale (NRS) where 0 equals no anxiety and 10 equals most severe anxiety. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Anxiety Day 1 - Pre-Anxiety Day 1). A lower score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2.
Time frame: Participants will be followed on post operations day 1 and 2 of their hospital stay
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Undergoing Mastectomy Surgery | Change in Anxiety Post Intervention | Visit 1 Change in Anxiety | -1.33 units on a scale | Standard Deviation 1.59 |
| Patients Undergoing Mastectomy Surgery | Change in Anxiety Post Intervention | Visit 2 Change in Anxiety | -0.90 units on a scale | Standard Deviation 1.45 |
| Standard of Care | Change in Anxiety Post Intervention | Visit 1 Change in Anxiety | 0.53 units on a scale | Standard Deviation 2.88 |
| Standard of Care | Change in Anxiety Post Intervention | Visit 2 Change in Anxiety | 0.14 units on a scale | Standard Deviation 1.03 |
p-value: <0.01t-test, 2 sided
Secondary
Change in Nausea Post Intervention
Change in nausea on a single question 11-point Numeric Rating Scale (NRS) where 0 equals no nausea and 10 equals most severe nausea. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Nausea Day 1 - Pre-Nausea Day 1). A lower score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2.
Time frame: Participants will be followed on post operations day 1 and 2 of their hospital stay
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Undergoing Mastectomy Surgery | Change in Nausea Post Intervention | Visit 1 Change in Nausea | -1.53 units on a scale | Standard Deviation 2.7 |
| Patients Undergoing Mastectomy Surgery | Change in Nausea Post Intervention | Visit 2 Change in Nausea | -0.50 units on a scale | Standard Deviation 1.27 |
| Standard of Care | Change in Nausea Post Intervention | Visit 1 Change in Nausea | 0.73 units on a scale | Standard Deviation 1.75 |
| Standard of Care | Change in Nausea Post Intervention | Visit 2 Change in Nausea | -0.29 units on a scale | Standard Deviation 1.38 |
Secondary
Change in Pain Post Intervention
Change in pain on a single question 11-point Numeric Rating Scale (NRS) where 0 equals no pain and 10 equals most severe pain. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Pain Day 1 - Pre-Pain Day 1). A lower score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2.
Time frame: Participants will be followed on post operations day 1 and 2 of their hospital stay
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Undergoing Mastectomy Surgery | Change in Pain Post Intervention | Visit 2 Mean Change in Pain | -1.50 units on a scale | Standard Deviation 0.97 |
| Patients Undergoing Mastectomy Surgery | Change in Pain Post Intervention | Visit 1 Mean Change in Pain | -1.47 units on a scale | Standard Deviation 1.06 |
| Standard of Care | Change in Pain Post Intervention | Visit 1 Mean Change in Pain | -0.07 units on a scale | Standard Deviation 1.67 |
| Standard of Care | Change in Pain Post Intervention | Visit 2 Mean Change in Pain | -0.43 units on a scale | Standard Deviation 1.02 |
p-value: <0.01t-test, 2 sided