The study utilizes individual instruction by acupressure educators to teach study participants about the acupressure intervention. Acupressure educators are local study staff (located in the county where the women are being recruited from the cancer registry) made up of nurses who have been trained by one of the study co-principal investigator (Co-PI), who is a professional acupuncture practitioner. The study Co-PI meets with the local acupressure educators for an initial training session. At this session he explains the basic philosophy of TCM and acupressure, demonstrates both sets of study acupressure points on himself and on the educator. He also gives the educators a DVD of a person performing the acupoints, laminated illustration of acupoints along with a written description of where the points are located. He also asks the educators to demonstrate the correct location of the acupoints on themselves as well as proper pressure and stimulation techniques.
The Co-PI makes a site visit to observe the acupressure educator performing both sets of acupoints (stimulating and relaxing) on themselves. He notes how many acupoints are correctly located and makes any needed corrections. He also asks them to apply the correct amount of pressure and stimulation on a point on him. The Co-PI has a checklist that interveners must match at a 95% rate. After the acupressure educator has enrolled two participants, the Co-PI returns to the site to check for the efficacy of the acupressure educators and then twice yearly afterwards. These assessments of the acupressure educators are how we measure their treatment fidelity. Acupressure educators can request additional clarification and instruction as needed.
From our previous study, participants can be taught to perform their acupoints within 15 minutes
]. Acupressure educators meet with each participant separately and demonstrate the location of each acupoints on themselves and on the participants. Participants also have the acupoints marked on them with adhesive colored dots to reinforce the location of the acupoints for the first few days. At the end of the session participants are asked to demonstrate the location of all their acupoints to the educator and appropriate adjustments are made.
Acupressure educators also demonstrate on the participant the appropriate level of pressure to apply on the acupoints and the correct stimulating motion. Participants are then asked to stimulate points on the educator until it is determined that they are using the correct pressure and stimulation. Participants are told and given a handout with the following information for correctly performing their acupressure:
“Once you have identified the pressure point location, use the pad- not the tip- of your index finger to apply pressure. Place your index finger on the selected point and turn it in a clockwise direction. Apply firm pressure to the point using a light to moderate touch depending on your sensitivity. The points may feel somewhat tender to the touch, and pressure should be enough to illicit that sensation. There should be a distinct feeling around or at the site of pressure. This may be felt as numbness, warmth, tingling, aching or buzzing sensation. If no sensation is felt, try applying more pressure. Please note that some points are more sensitive than others, and in fact you may not feel any sensation at certain points."
"Pressure should be applied for 3
minutes per point. Treatments are done every day, once
per day. Pressure points should be done in the order provided, starting from the head down to the feet. Apply pressure to ONE
point at a time. If a point is located on both sides of the body, apply pressure to the RIGHT
side, followed by the LEFT
side prior to proceeding to the following point."
"Do NOT lose contact with the point. If you need to, you may take a break in between points for a couple of minutes. Please do NOT take a break in the middle of applying pressure to a point."
"Acupressure can be performed sitting, standing or lying down.”
Participants may return at any time to be retrained or ask clarifying questions.
Acupoints were chosen by consensus of four acupressure practitioners and based on a previous study design in students with sleep disturbances as well as TCM theory for treating insomnia and fatigue. Practitioners had all been in practice for at least 2 years actively seeing patients. They also had been trained as and received one of more of the following degrees; a Naturopathic Doctorate (ND), masters in TCM or Oriental Medicine and a license of acupuncture (L.Ac.) or a diploma in acupuncture (Dipl. Ac.). Practitioners were asked to choose a set of relaxing and stimulating acupressure points based on a Western diagnosis of fatigue that could be reasonably reached by participants, i.e., not the middle of the back, and not so many points that it would take an excessive amount of time to complete a treatment. Following is a description of the two acupressure treatments and the definition of standard of care:
In addition to standard of care participants are asked to apply pressure on each of following points (bilaterally where indicated). There are five acupoints with four of the acupoints performed on both the left and the right sides of the body giving a total of nine points to stimulate. Each of the nine acupoints is stimulated for three minutes per point giving a total treatment time of 27 minutes done once daily. The acupoints are:
"Yin tang (Unilaterally), Anmian (Right and Left/bilaterally), Heart 7 (HT7) (Right and Left/bilaterally), Spleen 6 (SP6) (Right and Left/bilaterally), Liver 3 (LIV3) (Right and Left/bilaterally)."
In addition to standard of care participants are asked to apply pressure on each of following points (bilaterally where indicated). There are six acupoints with four of the acupoints performed on both the left and the right sides of the body giving a total of ten points to stimulate. Each of the ten acupoints is stimulated for three minutes per point giving a total treatment time of 30 minutes done once daily. The acupoints are:
"Du 20 (Unilaterally), Conception Vessel 6 (CV6), Large Intestine 4 (LI4) (Right and Left/bilaterally), Stomach 36 (ST36) (Right and Left/bilaterally), Spleen 6 (SP6) (Right and Left/bilaterally), Kidney 3 (K3) (Right and Left/bilaterally)."
Locations of the acupoints can be found in Figure
Standard of care
Participants are asked to continue doing whatever their healthcare providers advise for PCRF. We anticipate that most women will be treated per the National Comprehensive Cancer Network (NCCN) Clinical Guidelines for Fatigue V1.2009 (NCCN Guideline for fatigue)
]. These guidelines recommend stress management or cognitive behavioral therapy; short naps and possible use of stimulants and sleep medications. Participants will be asked to continue any current treatment and not to start or stop treatments over the course of the study. All treatments for fatigue will be recorded.