Relaxation and Visual Imagery

To identify and synthesize the evidence for mind-body interventions for which the evidence suggests benefit for at least two of the three cluster symptoms of pain, fatigue, and sleep disturbance.

Databases searched were CINAHL, MEDLINE, and PsycINFO through March 2009.

Search keywords were guided imagery, hypnosis, relaxation, biofeedback, cognitive behavioral therapy, coping skills training, meditation, virtual reality, music AND cancer AND fatigue, sleep disturbance, sleep difficulty, insomnia, and pain.

Studies were included in the review if they

• Were limited to research
• Included adults aged 18 years and older
• Included mind-body activities that involved primarily mental activity that could be performed by almost all patients
• Included pain, fatigue, or sleep among study dependent variables.

Studies were excluded if they

• Involved the use of yoga
• Involved patients in whom a diagnosis of cancer was not yet established
• Had a sample that included people without cancer.

A total of 47 studies were identified. In four of those, all testing virtual reality, only the symptom of fatigue was measured, so these were eliminated.

The final sample included 43 studies. Study sample sizes and total patients involved across studies were not reported.

Relaxation

Six studies examined relaxation interventions in hospitalized patients, outpatients with chronic pain, and women with early-stage breast cancer.

• Significantly greater pain relief was obtained with progressive muscle relaxation compared to massage, usual treatment, mood manipulation, distraction, and controls.
• One study found no difference in pain between a daily relaxation exercise and distraction.
• Training in muscle relaxation did not improve fatigue in one study compared to provision of information.
• In one study, muscle relaxation improved sleep compared to usual treatment controls.

Imagery and Hypnosis

Six studies examined imagery and hypnosis.

• In four studies, imagery was used in hospitalized patients with cancer pain, and beneficial effects were reported.
• One study found no differences in pain or fatigue between patients with an imagery intervention and those receiving standard care.
• Four studies used imagery in comparison to cognitive-behavioral therapy (CBT) and combined imagery with relaxation. Of those, one study reported no significant effect, two reported significant pain reduction, and one reported significant reduction in fatigue and sleep disturbance.

Cognitive Behavioral Therapy (CBT)/Coping Skills Training (CST)

Twenty-one studies tested CBT/CST.

• In three studies, fatigue was the primary focus. Significantly more improvement in fatigue was reported with a six- to 12-week CBT/CST intervention compared to usual treatment and controls.
• Three studies evaluated CST effects on the combination of pain and fatigue. In all of these, a one-session CST intervention resulted in no difference in symptoms compared to controls.
• Seven studies evaluated the effects of CBT/CST on fatigue and sleep disturbance. One study reported a decreased incidence of fatigue and sleep disturbance using an audio recording for coping skills training prior to chemotherapy. Two studies reported improvement in sleep with a four- to eight-week CBT intervention, but only one of these also reported improvement in fatigue. One study reported improvement in sleep and fatigue with a five-session CBT intervention, two other studies showed improvement in sleep but no change in fatigue, and one study reported no improvement in either of these two symptoms.
• Four studies reported effects of CBT/CST on all three symptoms concurrently. One showed improvement in fatigue and sleep but no impact on pain. One study reported less sleep disturbance but no difference in pain or fatigue. One reported lower ratings of worst pain immediately after the CBT program and greater reduction in pain and fatigue six months after the intervention compared to controls. One study found no differences in any of the three symptoms with a CST intervention.

Meditation

Four studies were included.

• Three of these studies used mindfulness-based interventions. One study reported significant improvements in both fatigue and sleep among outpatients who participated in an eight-week intervention.

Music

• Four studies looked at the effect of music on pain. Two studies found significant improvements in a pre-/posttest design using 30 minutes of preferred music among hospitalized patients. Two other studies found no difference in pain with listening to music compared to control groups.
• Two studies tested a music intervention on fatigue. One found a significant effect, and one found no difference in fatigue between intervention and control groups.

Findings of this review were equivocal.

• Although the authors stated a criterion for inclusion of examination of at least two of the three symptoms of interest, the review appeared to include studies in which only one of these symptoms was reported.
• Few investigators used multisymptom interventions and evaluations.
• Measures of symptom clusters were not been well identified.
• Some instruments were stated to potentially be more sensitive; however, the scales and individual items that were most useful to measure this symptom cluster were not determined.
• Timing, dosage, and frequency of interventions varied among studies, making it difficult to draw systematic conclusions. Most music interventions were very brief.
• This review did not provide study details, such as clear sample descriptions, sample sizes, or actual statistical results, and no effect sizes were calculated, although some studies used the same outcome measures.

Although the findings did not clearly demonstrate the effects of these interventions across studies, the authors concluded that these interventions hold promise. Although such interventions carry minimal risk to patients, some interventions would require substantial time and resource commitment to provide.

Patients attended 90-minute weekly sessions for a total of nine weeks. The cognitive-behavior (CB) component of the intervention emphasized learning to identify negative thinking patterns and restructure them into more adaptive, stress-reducing patterns. Mental distraction, problem-solving, and decision-making strategies were also covered. The behavioral component emphasized activity scheduling, graded task assignment, behavioral distraction, and behavioral experiment techniques. Homework exercises were assigned, and written material was provided for the application of CB strategies. Relaxation and guided imagery (RGI) participants practiced deep breathing and autogenic relaxation. Each relaxation experience lasted 20 to 30 minutes, and after sessions, participants discussed their sensations, feelings, and experiences to identify and work on problems identified in the relaxation process. Strategies to overcome sleep problems were also discussed and practiced. Participants were given RGI audio cassettes for further use at home. Group size consisted of six to eight participants. Questionnaires were completed at preintervention, postintervention, and at a four-month follow-up.

The study included 114 women with early stage breast cancer (stages I and II) who were 2 to 12 months postsurgery and were receiving chemotherapy or radiotherapy.

CB Group

• Mean age was 55.9 years (range 28–74).
• Mean education was 13.5 years (range 9–20).
• Of the patients, 76.3% were married, 52.6% were unemployed, 57.9% were secular, and 60.5% received chemotherapy treatment.

RGI Group

• Mean age was 51.8 years (range 27–74).
• Mean education was 13.2 years (range 8–19).
• Of the patients, 64.1% were married, 61.5% were unemployed, 61.5% were secular, and 64.1% received chemotherapy treatment.

Control Group

• Mean age was 52.9 years (range 27–70).
• Of the patients, 81.1% were married, 64.9% were unemployed, 56.8% were secular, and 56.8% received chemotherapy treatment.

The study was conducted at a large oncology department in northern Israel.

Patients were undergoing the active treatment phase of care.

The study was a randomized, controlled trial with three groups:
•    CB (n = 38)
•    Relaxation and guided imagery (n = 39)
•    Control (n = 37).

Fatigue Symptom Inventory (FSI)

Means of the fatigue symptoms declined in both intervention groups between pre- and posttest time points, but only the decline in the RGI group was statistically significant. Similar results were observed at the four-month follow-up, and fatigue means remained significantly lower in the RGI group compared to the CB and control groups.

Study participants may have been more motivated or suffered from less psychological distress than those who did not agree to participate; therefore, the generalizability of the results is questionable. Four-month follow-up may have been too short. The authors did not measure the compliance of patients in the intervention protocols (i.e., using audiotapes on their own time).

To evaluate the feasibility of a patient-controlled, cognitive-behavioral intervention for pain, fatigue, and sleep disturbance during treatment for advanced cancer and to assess the initial efficacy of the intervention.

Patients provided baseline measures, such as measures relating to demographics and a symptom inventory, received education, and underwent training to use an mp3 player loaded with 12 cognitive-behavioral strategies (relaxation exercises, guided imagery, nature sounds). Patients used the strategies as needed for symptom management for two weeks and kept a log of symptom ratings with each use. Following the two-week intervention, patients completed a second symptom inventory and an evaluation of the intervention. Clinic staff identified patients who met the eligibility criteria based on diagnosis and treatment and then were briefly introduced to the study and asked if a research nurse could visit to provide additional information. The research nurse met with interested patients, assessed symptoms, and completed eligibility screening. Study purpose and procedures were explained, and written informed consent was obtained.

• The sample was comprised of 30 patients (20% male, 80% female).
• Mean age was 56.27 years (range 36–79).
• All patients had advanced (recurrent or metastatic) cancer and were receiving chemotherapy or radiotherapy. Half of the patients had a diagnosis of gynecologic cancer. Patients had been diagnosed with lung cancer (n = 8), colorectal cancer (n = 6), and prostate cancer (n = 1).
• Most patients were Caucasian, women, and had earned a bachelor’s degree or higher.
• Almost all patients (n = 27) were taking two or more prescribed supportive medications to treat symptoms.
• Studies were included if they included at least two of the following three symptoms:  pain rated 3 or higher on a 0-to-10 scale in the previous 48 hours, fatigue in the previous week, and sleep disturbance in the previous week. 
• Studies were excluded if they involved postoperative or neuropathic pain.

• Multisite
• Outpatient
• Midwestern United States
   

• Patients were undergoing multiple phases of care.
• The study has clinical applicability for late effects and survivorship, end of life care, and palliative care.

The study used a one-group, pre- and postintervention design.

• Demographic questionnaire and chart review form to record age, gender, education, race, ethnicity, cancer diagnosis, current treatments, and supportive medications prescribed, such as analgesics, steroids, psychostimulants, hypnotics, or sedatives
• Symptom inventory, to measure
  • Pain severity, by means of four, 0-to-10 numeric rating scales for pain now, worst pain, least pain, and average pain in the last 24 hours
  • Fatigue severity, by means of four, 0-to-10 scales for fatigue now, worst fatigue, least fatigue, and average fatigue in the last 24 hours
  • Sleep disturbance, by means of a 0-to-10 scale rating sleep disturbance in the last 24 hours and, from the Pittsburgh Sleep Quality Index (PSQI), a verbal rating of sleep quality
• Additional symptoms and their effects on daily functioning, as assessed by the MD Anderson Symptom Inventory (MDASI), which includes items measuring 13 common cancer-related symptoms and their effect on general activity, mood, work, relations with others, walking, and enjoyment of life
• Treatment log book, in which patients tracked each time they used a cognitive-behavioral strategy. Data tracked were time of day; strategy used; and immediate pre- and posttreatment scores, on a 0-to-10 scale, regarding severity of pain, fatigue, and sleep disturbance
• Poststudy evaluation, a 12-item survey created, for the current study, to assess patients’ perceptions of the acceptability of the study procedures. Among the items evaluated were time commitment; equipment; and questionnaires and factors relating to the patient-controlled, cognitive-behavioral intervention, such as length, variety, and usefulness.
   

• Symptom scores at two weeks did not differ significantly from baseline scores; however, significant reductions in pain, fatigue, and sleep disturbance severity were found in ratings made immediately before and after the use of a cognitive-behavioral strategy.
• Mean pain scores decreased from 4.54 pretreatment to 2.77 posttreatment.
• Mean fatigue scores decreased from 4.9 pretreatment to 3.44 posttreatment.
• Average sleep disturbance scores decreased from 5.05 pretreatment to 2.81 posttreatment.

The patient-controlled, cognitive-behavioral intervention is feasible and may reduce the day-to-day severity of co-occurring pain, fatigue, and sleep disturbance.

• The study had a small sample size, with less than 100 patients.
• The study had a risk of bias due to no control group.
• The study used a convenience sample comprised of well-educated, primarily female patients—a sample that may not be representative of all populations.
• Uncontrolled extraneous variables, such as supportive medication use, could have influenced symptom outcomes.

The findings support nurse education and the recommendation of the specified patient-controlled, cognitive-behavioral interventions for the management of pain, fatigue, and sleep disturbance. In regard to patient care and symptom management at all stages of cancer, nurses are the front-line educators of patients. This intervention supports the principle of autonomy for patients able to participate actively in care. Further study—a randomized, controlled trial to test the efficacy of the intervention for co-occurring pain, fatigue, and sleep disturbance—was under way at the time this study was published.