Nunes, D.F., Rodriguez, A.L., da Silva Hoffmann, F., Luz, C., Braga Filho, A.P., Muller, M.C., & Bauer, M.E. (2007). Relaxation and guided imagery program in patients with breast cancer undergoing radiotherapy is not associated with neuroimmunomodulatory effects. Journal of Psychosomatic Research, 63, 647–655.

DOI Link

Study Purpose

To evaluate the psychological, endocrine, and immunologic effects of a relaxation and visualization therapy (RVT) in breast cancer patients undergoing radiotherapy

Intervention Characteristics/Basic Study Process

Investigators randomly assigned participants to one of two groups: the relaxation visualization (RVT) group or the control group. The RVT intervention consisted of 30-minute structured group sessions led daily by a trained investigator. Each RVT session took place immediately following radiation. Subjects were also instructed to perform the RVT exercise at home twice a day, with the aid of a telephone-call reminder and a tape. The RVT intervention occurred daily for 24 days. The control group received radiation only. Investigators obtained psychological assessments as well as blood and saliva samples at baseline and after the 24-day intervention.

Sample Characteristics

  • The sample was composed of 34 participants; 20 in the experiment (RVT) group and 14 in the control group.
  • Mean patient age in the control group was 50.07 years (SD = 2.68 years); the age range in the control group was 36–70 years.
  • Mean patient age in the RVT group was 54.20 years (SD = 1.24 years); the age range in the RVT group was 45–65 years.
  • Investigators discovered no significant differences between groups in regard to any of the demographic variables, including age.
  • All the participants were female; all had stage I or II breast cancer, and all were receiving radiotherapy.

Setting

  • Single site
  • Outpatient
  • Brazil

Phase of Care and Clinical Applications

Active treatment

Study Design

Prospective randomized trial design with randomization and repeated measures

Measurement Instruments/Methods

  • Lipp Inventory of Stress Symptoms for Adults (ISSL)
  • State-Trait Anxiety Inventory (STAI)
  • Beck Anxiety Inventory (BAI)
  • Beck Depression Inventory (BDI)
  • Structured clinical interview to assess psychosocial variables
  • Neuroimmunologic parameters: salivary cortisol and peripheral blood cells

Results

At baseline the experimental group was significantly more anxious than the control group, according to the BAI and STAI. Within-group analysis for the control group revealed no significant changes in any of the psychological scores over time. However, the experimental group demonstrated significant declines in levels of stress, anxiety, and depression over time (p < 0.05 for all measures). Interestingly, the mean scores relating to the psychological measures of the experimental group, at the post-time point (after completion of the study), were all higher than the mean post- scores of the control group. Cortisol levels and lymphocyte proliferation did not change over time for either group.

Conclusions

The RVT intervention was effective in reducing psychological distress but did not seem to affect the endocrine (cortisol) or immune measures (lymphocyte proliferation).

Limitations

  • The study had a small sample size, with fewer than 100 participants.
  • The study had risks of bias due to no appropriate attentional control condition and because participants' levels of anxiety differed.
  • All participants had gone without chemotherapy for two weeks, but this may not have been sufficient for complete immune recovery; the study presents no way to ascertain this because it lacks a \"true\" baseline value.

Nursing Implications

Use of adjunct therapies, such as relaxation and visualization, may help ease the psychological distress associated with cancer and its treatment.