To examine the influence of psycho-oncologic intervention on the psychological condition of patients with cancer

Patients, who had self-assessed regarding anxiety and depression levels, were placed in high- or low-risk groups. Participants were then randomized to either a psycho-oncologic support group or a control group. Support involved talks with a certified psychologist, who addressed development of a therapeutic relationship, supported the patient’s personal autonomy and defense mechanisms, worked to increase hopefulness and confidence, and facilitated communication between patients and providers. Patients were randomized at the time of surgery. Study measures were obtained at hospital discharge and 12 months later. The number of support sessions varied according to the length of inpatient care. High-risk groups averaged four sessions lasting an average of 41 minutes each. Low-risk patients had two or three sessions lasting an average of 40 minutes each.

• The sample was composed of 131 participants.
• Mean patient age was 57.2 years, with a range of 27–79 years.
• The sample was 36.6% male and 63.4% female.
• All cancer types were represented.

• Single site
• Inpatient setting
• Berlin, Germany

Active treatment

Randomized controlled trial

Hospital Anxiety and Depression Scale (HADS), German version

The study showed statistically significant reduction of anxiety and depression in high-risk patients who had undergone psycho-oncologic intervention at the end of inpatient care (p = 0.001). At 12 months, anxiety and depression scores increased in all patients. Depression scores increased in all low-risk patients at the time of discharge.

Patients with cancer who have anxiety may benefit from psycho-oncologic support.

• The study sample had a higher percentage of women than men, and patients had different cancer diagnoses.
• At 12 months, only 49 patients had completed the HADS tool.

Postsurgical patients with cancer who are anxious may benefit from psycho-oncologic support services. In the study, the effect of the intervention was significant in only those patients who had high anxiety scores at baseline. Study findings are similar to those produced by other research. This fact may suggest that interventions for anxiety are most beneficial for individuals who have meaningful levels of anxiety to begin with. Psycho-oncologic support did not appear to affect depression scores; however, these scores were not high at baseline.

To study the effects of two different interventions on anxiety and depression postoperatively

The interventions that were studied included a single educational session and a single session of progressive muscle relaxation delivered between the third and sixth postoperative day to women who had surgery for gynecologic cancers. Women randomly were assigned to intervention groups. Study measures were obtained preoperatively prior to hospital discharge.

• N = 35  
• MEAN AGE = 49.4 years (range = 23–79 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Varied tumor types (ovarian and cervical were most common); most had grade-2 disease

• SITE: Single-site    
• SETTING TYPE: Inpatient    
• LOCATION: Germany

• PHASE OF CARE: Active antitumor treatment

Randomized, noncontrolled trial

• Hospital Anxiety and Depression Scale (HADS)
• Perceived-stress questionnaire
• NeXus 1 (device for measuring physiological measures, respiratory rate, heart rate, skin conductance, etc.)

Anxiety scores declined significantly in both groups (p < .005), and depression declined significantly in those receiving the educational intervention (p < .001). There were no differences between groups in self-reported stress, and there were no significant changes in physiologic measures.

The findings of this study demonstrate that the interventions tested here may have some benefit; however, the strength of the results is low due to study limitations

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Unintended interventions or applicable interventions not described that would influence results
• Subject withdrawals ≥ 10%  
• Other limitations/explanation: It could be expected that anxiety levels would decline between preoperative and postoperative states without any intervention. The types of surgery were not described. It could be expected that outcomes at discharge could vary according to the type of surgical procedure performed and expected prognosis. Almost one fourth of participants dropped out of the study.

This study does not provide strong evidence in support of educational and muscle relaxation interventions for the reduction of anxiety or depression.

The primary aim was to demonstrate the efficacy of a brief nursing intervention (BNI) and cognitive-behavioral therapy (CBT) compared to usual care (UC). The secondary aim was to determine the role of physical activity in reducing fatigue during cancer treatment.

In total, 220 patients were randomly assigned to one of three groups:  BNI, CBT, or UC.

• The study was comprised of 220 patients (139 females and 81 males), and two patients dropped out.
• Age ranged from 18 to 75 years.
• Diagnoses included breast cancer (48%), prostate cancer (23%), other tumors (29%).
• The marital statuses of the patients were married/cohabiting (81%) and other (19%).
• Patients were excluded if they had head and neck and lung cancers.

• Setting Type 1:  Multisite
• Radboud University Nijmegen Medical Centre and six regional hospitals in The Netherlands

The study was a multicenter, randomized, controlled trial.

• Fatigue severity was assessed using the fatigue subscale of the Checklist Individual Strength (CIS-fat).
• Functioning was assessed using the Dutch language version of the Short Form-36 (SF-36) Health Survey.
• Symptom Checklist-90 (SCL-90) measured psychological distress.
• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
• Physical activity was measured by an actometer and the Daily Observed Activity score, and the Questionnaire Physical Activity (QPA) measured whether patients complied with advice concerning physical activity.

The CBT group was significantly less fatigued than the UC group. Between the BNI and the UC groups, no significant difference in fatigue was found. Physical activity was found not to mediate the effect of CBT on fatigue.

CBT during curative cancer treatment resulted in less fatigue compared to the BNI and UC groups. The mediation hypothesis was rejected.

• The majority of patients were from the university hospital.
• Contamination could have occurred.
• The BNI intervention by the nurses consisted only of two one-hour sessions and a booklet, whereas the CBT intervention consisted of up to ten one-hour sessions over six months with trained therapists given a protocol and supervision every two weeks with case discussions, with the nurses being less experienced than the therapists.
• Actometer and self-report data were not obtained for all patients.

Further study is warranted to determine the effects of specific nursing interventions on the experience of fatigue in patients with cancer.

To evaluate if psychosocial interventions are effective in reducing fatigue and to consider which interventions are the most effective.

Databases searched were Cochrane Central Register, PUBMED, MEDLINE, EMBASE, CINAHL, and PsycINFO to September 2008. Hand searching of reference lists was also performed.

Extensive keywords and specific search terms per database were provided.

Studies were included in the review if 

• They reported adult participants receiving active curative or palliative treatment
• The intervention involved a systematic intervention consisting of a process between the patient and the provider
• The intervention included at least two contacts between the patient and provider and, during the intervention, the provider gave the patient some type of individual feedback
• Fatigue was at least one of the outcome measures
• They were randomized, controlled trials.

Patients were excluded if they were breast cancer survivors receiving only hormonal therapy and were not considered in active treatment.

In total, 85 references were retrieved. The Jadad scale criteria were applied for quality rating, as well as additional criteria identified by vanTulder (1997).

• The final number of studies included was 27; seven studies (n = 969) were aimed specifically at fatigue.
• The sample range across the studies was 60 to 396 patients.
• All patients were receiving various active treatment types.
• Various diagnoses were involved, but the majority of studies were performed on women with breast cancer.

• Patients were undergoing multiple phases of care.
• The study has clinical applicability for palliative care.

In most studies, it was unclear at what stage of cancer the intervention ended. In most studies, the interventions were given by nurses. Formats varied and included intervention in groups; combination of face-to-face and telephonic support; and provision of additional written, videotape, or audiotape information. The number and duration of sessions varied across studies. In four studies, participants received an intervention of the same number and duration for the attention control. The number, type, and timing of outcome assessments also varied. Most studies used one instrument to measure fatigue, with the Profile of Mood States (POMS) used most often. Only five studies used a measure specifically defined to measure fatigue. Only three studies scored at least a three on the Jadad quality scale, and only one study had a good evaluation of quality scoring related to internal validity. Most had a moderate quality. Seven studies reported a significant effect on fatigue, with effect sizes ranging from 0.17 to 1.07 (p ≤ 0.05). In two of these, there was an immediate effect, but the results were not maintained at follow-up. Twenty studies were regarded as not effective. Interventions specifically aimed at fatigue, rather than multiple additional symptoms, tended to be more effective for fatigue.

Findings showed that there was no solid evidence that interventions not specifically focused on fatigue were effective in reducing fatigue. Overall, there was limited support and conflicting results for psychosocial interventions on fatigue during cancer treatment. Studies that showed an effect included education about fatigue and teaching in self-care or coping strategies and taught activity management, balancing activity, and rest.

• Only studies involving patients during active treatment were included, so the findings may not apply to other patient groups.
• There were indications that prevalence and course of fatigue may depend on the type of treatment received.
• Heterogeneity among studies in these factors limited the ability to draw firm conclusions regarding the effectiveness of various interventions.

Psychoeducational interventions, including education about fatigue, helping patients in self-care and coping, and teaching patients to balance activity and rest, may be helpful in alleviating fatigue among patients receiving cancer treatment. The degree and timing of fatigue can vary according to treatment type and the cancer trajectory. The most effective interventions based on treatment and phase of care were not clear, and further research in this area is warranted.

To determine whether cognitive behavioral therapy (CBT) for post-cancer fatigue has an effect on patients’ perceived cognitive functioning and/or neuropsychological test performance

Subjects were randomly assigned to intervention (CBT) or wait-list control (WLC) group. Participants were evaluated on six perpetuating factors of fatigue: inadequate coping with the cancer experience, fear of recurrence, dysfunctional beliefs concerning fatigue, sleep dysregulation, activity dysregulation, and low social support and negative social interactions. Results were used to customize the standardized modules for an individualized CBT intervention. Each hour-long CBT session was delivered by one of three trained therapists over a six-month interval. The number of sessions varied per participant since it was dependent upon when therapeutic goals were met. Participants were offered up to two booster sessions over an additional six months. Measurements were performed at baseline (T1) and at six months (T2).

• N = 98 (50 CBT and 48 WLC)    
• MEAN AGE = 44.9 years
• MALES: 51%, FEMALES: 49%
• KEY DISEASE CHARACTERISTICS: Primarily solid tumors (predominately breast and testicular cancer) as well some hematologic cancers
• OTHER KEY SAMPLE CHARACTERISTICS: Patients were included in the study if they were severely fatigued as defined by a score of ≥ 35 on the fatigue severity subscale of the Checklist Individual Strength scale and without evidence of a somatic origin. Additional eligibility criteria were completed last cancer treatment at least one year prior to study enrollment, had no evidence of cancer recurrence, and were not currently receiving psychological or psychiatric treatment.

• SITE:  Not stated/unknown   
• SETTING TYPE: Outpatient   
• LOCATION: Netherlands

PHASE OF CARE: Late effects and survivorship

Randomized clinical trial with waitlist control group

• Checklist Individual Strength (Concentration subscale)
• Sickness Impact Profile (Alertness Behavior subscale)
• Computerized simple-reaction time and choice-reaction time tasks
• Wechsler Adult Intelligence Scale (Symbol Digit Modalities Test)
• Checklist Individual Strength (Fatigue Severity subscale)

At baseline, most participants (78%) had clinically relevant difficulties with concentration as indicated by scores on the reaction time tasks; however, no differences existed between the intervention and control group. In contrast, the CBT group reported greater cognitive disability at baseline than WLC, as measured the CIS-concentration subscale (p = 0.04) and SIP-alertness subscale (p = 0.015). After intervention completion, there was a significant improvement in concentration and alertness behavior (p < 0.05) in participants who received CBT as compared to WLC. For CBT group, the improvements in self-reported concentration and alertness behavior were significantly associated with their decrease in fatigue severity (p < 0.001; p < 0.02); SDMT scores and computerized reaction time tests were slightly improved but not significant.

Individualized CBT may be an effective intervention in reducing self-reported fatigue. Although improvements in concentration and alertness behaviors were found, it is difficult to differentiate if they were related to reduced fatigue, CBT, or both. Improvements in perceived cognition were not associated with either depression or anxiety.

• Small sample (< 100)
• Risk of bias (no appropriate attentional control condition)
• Key sample group differences that could influence results
• Intervention expensive, impractical, or training needs
• Other limitations/explanation: 16% of subjects did not complete neuropsychological tests at T2; not statistically significant between groups; significantly higher number of WLC subjects received chemotherapy, which could possibly influence results; while CBT program was tailored for individual needs, the administration over a six-month interval by a trained therapist may limit general applications or feasibility in the clinical setting.

CBT decreased fatigue and improved perception of cognitive functioning over a six-month interval; however, the durability of those results are unknown. Further research is warranted to validate these findings and to determine whether this intervention can be adapted for general clinical use.

To evaluate the effects of active exercise using a facilitating apparatus with compression on arm lymphedema secondary to breast cancer

Patients received two sessions of four, 12-minute stints of exercise using an active apparatus pulley system. The device was a vertical iron wheel fixed to a 30-cm-high support on a metal bench. The patient revolved the wheel, thus elevating the shoulder and stretching the arm. A homemade short-stretch compression sleeve made of a cotton polyester material was used during one of the exercise sessions. Arm volume measurements were taken before and immediately after each exercise session.

• The study sample (N = 20) was comprised of female patients who had breast cancer.
• Mean age was 63.3 years, with a range 49–82 years.
• All patients had a mean difference in arm volumes of at least 200 ml.

The study took place at an outpatient setting in Brazil.

The study has clinical applicability for late effects and survivorship.

The study used an observational single group design.

Arm volume was measured by water displacement.

A mean reduction in arm volume of 24.6 ml was seen in the exercise session while wearing the compression garment (p < 0.0004). Without the compression garment, arm volume increased by a mean of 9.7 ml.

The apparatus used here was effective for provision of active exercise. Without the compression garment, exercise increased arm volume slightly. The low stretch, inelastic compression had a synergistic effect with exercise to reduce arm volume.

• The sample size was small, with fewer than 30 participants.
• The study had a risk of bias because of no control group or blinding. 
• The standard deviations reported showed high variability of results in the study sample, suggesting actual effects were highly variable even within this small sample. 
• Whether the mean is truly representative of overall group results was not clear.

Findings demonstrated the importance of use of a compression mechanism during exercise in patients with lymphedema.

To evaluate the efficacy of a new combination therapy for the management of lymphedema

All patients had a three-to-four hour weekly session that included manual lymph drainage, mechanical lymph drainage, and exercises using facilitating apparatuses and a compression sleeve made from a cotton-polyester material. Exercise and daily life activities were adapted for home use, and psychological and nutritional supports were provided. Compression sleeves were adapted for home use. Activities were individually evaluated and adapted for each patient by an occupational therapist to ensure they could be adapted to fit the treatment program. The textile used for low-stretch compression sleeves exert pressure with muscle activity and rest, and lengthwise elasticity allows flexibility in the limb.  Arm volume was measured monthly.

• The sample (N = 66) was comprised entirely of females. 
• Mean age of the sample was 58.8 years with a range of 33–72 years.

The study was conducted in a single-site, outpatient setting in Brazil.

 A prospective study design was used.

Water displacement was used to measure volume.

• Mean follow up was 12.3 months. 
• The mean volume difference at baseline was 559 ml. 
• An average of 70.1% volume reduction was found at the end of the study (p < 0.0001).

The model of treatment appeared to be effective in management of lymphedema among women with breast cancer.

• The study had a small sample size with fewer than 100 patients.
• Bias is a risk because of the lack of a control group, no blinding, and no random assignment. 
• No disease-related information or patient adherence information was provided.

This approach for lymphedema management appears to be effective. Methods shown here are similar to complete decongestive therapy, with differences in the textile used for compression sleeves, use of an apparatus for arm exercises, and once weekly manual lymph drainage.

The patient education intervention was delivered in three sessions and consisted of:  one-to-one education, training and counseling, and audio-visual computerized educational materials. In session one (first cycle of chemotherapy treatment), patients were introduced to the project and were given information about fatigue and how to manage it, as well as a diary to record their daily feelings related to fatigue. In session two (second cycle of chemotherapy treatment), the nurse and patient engaged in an open interview about treatment, side effects, and daily activities of the patient and discussed the diary notes. In session three (one month after the completion of treatment), the patient discussed with the nurse changes in fatigue perception throughout treatment using diary notes. A questionnaire was completed by both the intervention and control groups at sessions one and three. Only the intervention group completed the questionnaire at session two.

• Forty patients who were chemotherapy-naïve with colorectal or gastric cancer (experimental group:  n = 23, mean age = 58.5 years [range 32–74]; control group:  n = 17, mean age = 62.7 years [range 49–75]) were included.
• Patients were excluded if they had received previous cancer treatment; had presence of respiratory, cardiac, or hepatic dysfunction; had a learning disability; had central nervous system metastasis; and/or had received previous radiotherapy.

• Single site
• Comprehensive cancer center in Barcelona, Spain

Patients were undergoing the active treatment phase of care.

The study used an experimental, randomized, stratified design.

• Functional Assessment of Cancer Treatment (FACT)
• Diary notes

Fatigue levels were lower for the intervention group after the second session in comparison to baseline and remained steady after one month posttreatment. Fatigue levels remained stable for the control group at baseline to one month posttreatment. These differences were not statistically significant.

• The study had a small sample size; therefore, it was underpowered.
• The observed difference may not be only due to the nursing intervention and can be attributed to outside factors, such as the response to medical treatment.
• The nursing intervention was slightly different according to needs of participants about fatigue, and the nurse was not always the same for all three sessions.

To determine the clinical benefit of hyperbaric oxygen therapy on the management of bowel dysfunction in patients who receive radiation therapy to the pelvis

Study of patients with chronic gastrointestinal problems for greater than 12 months post radiation therapy in spite of optimal medical management. Patients received either hyperbaric oxygen therapy or sham.

• N = 84   
• AGE = 62 years
• MALES: 44%, FEMALES: 56%
• CURRENT TREATMENT: Radiation 
• KEY DISEASE CHARACTERISTICS: Past therapy with pelvic radiation for treatment of gynecologic, prostate, or anal cancer

• SITE: Multi-site   
• SETTING TYPE: Outpatient    
• LOCATION: U.K.

PHASE OF CARE: Late effects and survivorship

Double-blinded, sham-controlled, phase 3, randomized trial

• Inflammatory Bowel Disease Questionnaire (IBDQ)
• IBDQ rectal bleeding

No difference between treatment groups existed.

In this patient group, no improvement using hyperbaric oxygen versus sham occurred.

• Small sample (< 100)
• Intervention expensive, impractical, or training needs

Large randomized, phase 3 studies are required before any conclusions can be made about the use of hyperbaric oxygen in patients with bowel dysfunction after radiation therapy.

To examine the effects of interventions for the prevention, treatment, or both, of herpes simplex virus (HSV) in patients receiving treatment for cancer.

• Databases searched were Cochrane Oral Health Group’s Trials Register, CENTRAL, MEDLINE, EMBASE, CINAHL, CANCERLIT, SIGLE, and LILACS.
• Keywords searched were neoplasm, cancer, bone marrow transplant, herpes simplex or herpes labialis, and mucositis herpetic.
• All randomized, controlled trials (RCTs) compared interventions for the prevention or treatment or both of HSV infection in people being treated for cancer.  Published and unpublished studies were included in the searches.
• Articles were excluded if they were not RCTs, did not involve patients with cancer, and did not meet the inclusion criteria.

Forty studies were initially reviewed.

• After excluding studies due to the exclusion criteria, 17 studies remained for analysis.
• The sample size across studies ranged from 21 to 151.
• The majority of studies were conducted in patients with hematologic malignancies.  Only one study included patients with solid tumors.

• Acyclovir was more effective than placebo in the prevention of herpes infections whether given orally (relative risk [RR] = 0.11; 95% CI [0.05, 0.24]) or intravenously (IV) (RR = 0.24; 95% CI [0.07, 0.86]). No differences were found in effectiveness between oral or IV use or between adults and children.
• Valaciclovir appeared to be as effective as acyclovir in two relatively small trials for prophylaxis. In one trial comparing prostaglandin E to placebo, placebo was more effective in prevention than prostaglandin. In terms of herpes treatment, there were only two studies found and reported. Acyclovir was more effective than placebo in terms of time to healing (p = 0.01) and the duration of viral shedding was lower with acyclovir (p = 0.00008) compared to placebo.

The evidence suggested that acyclovir may be beneficial for the prevention and treatment of herpes infection in this patient population; however, the risk ratios were relatively small, suggesting limited benefit.  Valaciclovir may also be effective; however, few studies have reported this particular agent, so firm conclusions cannot be drawn. Prostaglandin E appears to have no benefit for the prevention of herpes infection in this group of patients. The degree of immunocompromised patients in study samples was not discussed, and sample sizes varied across studies, suggesting limited ability to truly generalize the findings provided here.  Acyclovir was more effective than placebo in the prevention of herpes infections whether given orally (RR = 0.11; 95% CI [0.05, 0.24]) or IV (RR = 0.24; 95% CI [0.07, 0.86]). No differences were found in effectiveness between oral or IV use or between adults and children. Valaciclovir appeared to be as effective as aciclovir in two relatively small trials for prophylaxis.

Fifteen trials evaluated the effect for prevention of herpes infection, and two trials evaluated herpes treatment.