To determine if healing touch can benefit women undergoing diagnostic procedures for breast cancer

Patients were randomized to receive healing touch or to a control group receiving usual care by the day of the week after completing baseline surveys. Those in the experimental group were placed in a treatment room and placed on a massage table. Healing touch was provided by a trained practitioner for 15 minutes. Surveys were again completed after the breast biopsy procedure in both study groups. Participants were given a third set of surveys to return via mail the following day.

• N = 53   
• MEAN AGE = 52.59 (SD = 12.67 years)
• FEMALES: 100%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Undergoing breast biopsy
• OTHER KEY SAMPLE CHARACTERISTICS: Sixty-two percent indicated that their baseline stress level was high or very high.

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: Minnesota

PHASE OF CARE: Diagnostic

Randomized, controlled trial

• State-Trait Anxiety Inventory (STAI)
• Coping Resources Inventory
• Heart and respiratory rate
• Blood pressure

State anxiety levels declined significantly immediately after the biopsy in both groups. On the next day, anxiety remained lower in the therapeutic touch group, but the difference between groups was only marginally significant (p = 0.06). Physiologic measures showed that the intervention groups respiratory rate and heart rate decreased, but differences between groups were not significant.

The findings suggest that healing touch may be helpful to reduce anxiety associated with undergoing a breast biopsy. Further study is needed to demonstrate efficacy.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Unintended interventions or applicable interventions not described that would influence results
• Findings not generalizable
• The assignment was not truly random.  
• No information is given regarding the number of participants who actually returned mailed surveys, and the sample size for the follow-up data is not stated.
• The findings for women undergoing breast biopsy may not be applicable to other patient groups.

Therapeutic touch is a noninvasive intervention that may be helpful for some individuals undergoing periods of stress and anxiety related to diagnostic procedures. Further research is needed to determine the effectiveness of this intervention compared to usual care. Future studies should incorporate comparison to a sham intervention.

Patients were randomized, in double-blind fashion, to pentoxifylline 400 mg by mouth three times daily or placebo three times daily. If patients lost 5% of their on-study weight, the bind was broken and patients could cross over to the pentoxifylline arm.

• N = 70 patients (randomized, 35 in each arm)
• ELIGIBILITY CRITERIA: Older than 18 years of age, Eastern Cooperative Oncology Group (ECOG) performance status 0–2, life expectancy greater than three months, weight loss greater than five pounds over two months, estimated calorie intake of less than 20 kcal/kg/d
• EXCLUSION CRITERIA: Parenteral or tube feeding; edema or ascites; use of corticosteroids, androgens, progestational agents, or hydrazine sulfate within one month; mechanical gastrointestinal (GI) obstruction; more than five episodes of emesis per week; primary or metastatic brain tumors; hemoptysis, GI hemorrhage, or Sr. Cr more than two times normal
• Patients were stratified by
  • Primary tumor site
  • Amount of weight loss
  • Use of chemotherapy (CDDP versus non-CDDP)
  • Sex, ECOG performance status, and MD estimate of survival.

Patients were randomized in a double-blind fashion.

• Objective evidence of weight change (excluded if patient had edema or ascites)
• Questionnaires to evaluate appetite and perceived food intake

No significant difference was seen between cohorts in weight gain (P = .43). According to the questionnaires, there was no evidence that pentoxifylline is more effective than placebo in enhancing appetite. Toxicity data were similar for both groups for nausea and vomiting, fluid retention, and abdominal pain. The study was closed after the planned interim analysis, and it was concluded that pentoxifylline is not an effective treatment for cancer anorexia and cachexia.

The 95% confidence interval for the difference in the percentage of weight gain for pentoxifylline minus placebo ranged from a loss of 3.3% to a gain of 1.9%; this confidence interval suggests that the percentage of weight gain for pentoxifylline-treated patients is about the same for patients receiving placebo.

• Heterogeneous group of patients with cancers arising from a variety of primary sites

To evaluate the effectiveness of a self-managed, home-based walking program of moderate intensity

Prior to randomization, patients completed baseline questionnaires before beginning chemotherapy and after completing two of six cycles of chemotherapy. Patients were then randomized to usual care control or usual care plus exercise groups. Patients in the exercise group were given an intervention booklet with recommendations to ensure adherence, tips, guidance, and a diary to keep a log of walking duration and intensity. Self-management strategies used for guidance were based on the theory of planned behavior, including setting weekly goals, reflecting by writing achievements and shortfalls, and modifying goals. Pedometers were provided to the walking group. The intervention lasted 12 weeks.

• N = 50   
• MEAN AGE = 53.7 years
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: All had breast cancer, and most were grade 2 or 3; 72% were postmenopausal.
• OTHER KEY SAMPLE CHARACTERISTICS: Sixty percent were reported to be inactive at baseline.

• SITE: Single site   
• SETTING TYPE: Home    
• LOCATION: United Kingdom

PHASE OF CARE: Active antitumor treatment

Randomized, controlled trial

• Hospital Anxiety and Depression Scale (HADS)
• Functional Assessment of Cancer Therapy (FACT)-Fatigue scale
• Self-Esteem Scale
• Profile of Mood States (POMS) short form
• Borg Rating of Perceived Exertion (RPE) scale
• Pedometer measures of steps taken each day
• General Practice Physical Activity Questionnaire

Eighty percent adhered to the intervention based on walking diaries. Group by time analysis showed that the intervention had a positive effect on fatigue (p = 0.02). No effects on anxiety or depression as measured by HADS were reported.

The self-managed, home-based walking program had a positive effect on fatigue.

• Small sample (< 100)
• Risk of bias (no blinding)

This study adds to the body of evidence showing that exercise has a positive effect on fatigue. A self-managed, home-based walking program is a practical approach to incorporating activity during active treatment. 

The purpose of this systematic review was to evaluate studies conducted with various antifungal agents to determine whether or not commonly used antifungals decrease mortality in patients with cancer.

The search strategy used databases such as the Cochrane Central Register of Controlled Trials (CENTRAL) and PubMed, as well as the reference lists of articles attached to the publications identified. Also reviewed were the proceedings of the ICAAC (from 1990–2007), General Meeting of the ASM (from 1990–2007), and the European Congress of Clinical Microbiology and Infectious Diseases (1995–2007). The authors also contacted expert researchers in the field.

Key words included random,  control,  blind,  nystatin,  amphotericin,  fluconazole, itraconazol,  ketoconazole,  miconazol,  voriconazol,  bone-marrow, cancer, fungemia, hematologic, fumalignan, neoplasm, neutropenia,  granulocytopenia,  leukemia,  or lymphoma

Randomized trials of antifungal treatments that were experimental in nature for patients with cancer were included. Studies that applied to treatment or prevention of oral candidiasis were excluded, as well as any non-randomized trials or randomized trials with noncancer patients.
 

Forty-four articles were retrieved. The authors reviewed the identified studies for mortality, mortality associated with a fungal infection, invasive fungal infection, colonization, use of additional antifungal therapy, and harm to patients.

The final article sample size was 32, with total subjects numbering 4,287.

Active treatment

Amphotecerin B was the only antifungal studied that showed reduced mortality significantly and consistently, used either prophylactically or empirically. Ketaconozole, fluconazole, and amhotercerin B were shown to be significant in overall effect for prophylactic administration. Itraconozole, fluconazole, and amphotecerin B all showed effectiveness in treating invasive fungal infection.

Amphotecerin B is highly effective in reducing mortality associated with fungal infection in patients with cancer. More studies should be done with large sample sizes to effectively compare amphotecerin B to other anti-fungals.

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.