Fu, M.R., Axelrod, D., Guth, A.A., Cartwright, F., Qiu, Z., Goldberg, J.D., . . . Haber, J. (2014). Proactive approach to lymphedema risk reduction: A prospective study. Annals of Surgical Oncology, 21, 3481–3489.

DOI Link

Study Purpose

To evaluate the safety, feasibility, and acceptability of the Optimal-Lymph-Flow™ program for patients with breast cancer and to evaluate its benefit when introduced presurgically

Intervention Characteristics/Basic Study Process

The Optimal-Lymph-Flow™ (OLF) program is a patient self-care program designed to reduce the development of lymphedema through specific exercises and behaviors to improve lymph flow and reduce or maintain body mass index (BMI). Participants were recruited preoperatively and followed prospectively for 12 months after surgery. Trained nurses provided each participant with the study intervention through a 30-minute face-to-face meeting. Participants were trained in various exercise techniques and then did a return demonstration (shoulder, breathing, and pumping exercises). They also were instructed in a nutrition-balanced and portion-appropriate diet to maintain preoperative BMI. Participants’ limb volume was measured with a Perometer, and BMI was measured with bioimpedance presurgery, two to four weeks after surgery, and at 6–12 months. Any patient with a limb volume measurement ≥ 10% was referred for complete decongestive therapy. If a 5% increase in limb volume occurred, patients were instructed to increase OLF activities, and limb volume was rechecked a few weeks later.

Sample Characteristics

  • N = 140
  • AVERAGE AGE = 56 years (SD = 11.8 years, range = 25–84 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: First-time diagnosis of breast cancer (stages 1–3)
  • OTHER KEY SAMPLE CHARACTERISTICS: Women aged greater than 21 years and scheduled for surgical treatment including lumpectomy, mastectomy, sentinel lymph node biopsy, or axillary lymph node dissection; excluded stage 4 breast cancer, preexisting lymphedema, patients with a history of breast cancer, and bilateral breast cancer

Setting

  • SITE: Single site    
  • SETTING TYPE: Other  
  • LOCATION: New York, United States

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care

Study Design

Prospective, longitudinal, quasi-experimental design with repeated measures

Measurement Instruments/Methods

  • The safety of the OLF program was assessed by asking participants if the program created any discomfort or injury at each follow-up visit.
  • The feasibility of the program was evaluated in terms of intervention delivery time by the trained nurses.
  • The acceptability of the program was assessed by asking the participants if the program helped the them to (a) understand how to reduce the risk of lymphedema, (b) reduce the fear and anxiety of developing lymphedema, and (c) develop a plan to reduce the risk of lymphedema.
  • Lymph volume changes were measured by an infrared Perometer, and BMI was measured by a bioimpedance device.

Results

One-hundred and thirty-four participants completed the study. At each follow-up visit, no participants reported injury or discomfort associated with the OLF program, making it safe. It took about 30 minutes for the trained nurses to deliver the program, making it feasible. Greater than 90% of the patients reported that the OLF program helped them reduce their fear and anxiety of developing lymphedema, making it acceptable.

The majority (97%) of patients maintained or improved their preoperative limb volumes and BMIs at the study endpoint of 12 months following surgery.

All four women who experienced a 10% lymph volume increase two to four weeks post-surgery and at six months decreased their lymph volume to less 5% at the 12-month visit. BMI did not change significantly. No control group was used, so the benefits of this treatment could not be determined.

Conclusions

This educational and behavioral program may be effective to enhance lymphedema risk reduction. The study provided initial evidence for an emerging change in lymphedema care from treatment focus to proactive risk reduction.

Limitations

  • Baseline sample/group differences of import
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment) 
  • Other limitations/explanation: Single-site study

Nursing Implications

Studies with more rigorous research designs (i.e., randomized, controlled trials) are needed to replicate the findings from this study, evaluate the effectiveness of the OLF program, and determine the dosage and contribution of individual components of the program.