Evaluate the effects of a self-help program on depression and anxiety in women with breast cancer receiving chemotherapy

Patients were assigned to intervention or treatment groups by authors (not random assignment). The intervention was a self-learning package aimed at rehearsing the chemotherapy procedure, improving beliefs in managing side effects, and helping build problem-solving skills. This group also was given a professional-led support group that met two to three times during the study. The control group received usual care including a chemotherapy education leaflet. Nurses monitored patient progress from review of patient diaries in the intervention group that documented side effects and self management performed at the beginning of each cycle of chemotherapy. Nurses involved with the intervention were educated and demonstrated increased knowledge regarding improving coping processes in daily living. Data were collected at baseline, one week, three months, and six months.

• N = 65      
• MEAN AGE: Intervention = 47.7 years (SD = 8 years), control = 49.5 years (SD = 10.9 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer at stages 1–3. All had previous surgery.
• OTHER KEY SAMPLE CHARACTERISTICS: Most had breast-conserving surgery. The majority had less than a bachelor’s degree education level.

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

PHASE OF CARE: Active antitumor treatment

Non-random, two-group comparison, quasi-experimental—historical control approach

• Center for Epidemiological Studies Depression Scale (CESD)
• State-Trait Anxiety Inventory (STAI)
• SF-36
• National Cancer Institute-Common Toxicity Criteria version 2.0

No significant differences were found in outcomes between study groups. Study measures improved over time in all patients.

This study did not find that the intervention tested here had an effect on depression or anxiety.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (no appropriate attentional control condition)
• Questionable protocol fidelity
• No information is provided about patient compliance with diaries and symptoms experienced. No method was used for determining intervention fidelity. No information is provided as to patients' actual attendance at support group sessions. If patients in both groups were being treated in the same location, whether group contamination could have occurred is unclear. The control comparison used was actually a historic control. How the program was designed is unclear, and no apparent theoretical foundation of the program design exists. Although not statistically significant, baseline anxiety and depression scores were lower in the control group, which may have affected the ability to detect differences. Analysis was the comparison of average scores at each study time point, but changes in these scores were not analyzed. Changes in anxiety and depression scores appeared to be greater in the intervention group—analysis of differences in the size of the improvement may have shown different significance. Data reporting is questionable—confidence intervals reported with F values do not appear to be actually related to those values.

This particular study did not demonstrate effectiveness of the intervention tested here. The study had several limitations. Anxiety and depression improved in all patients, suggesting that usual nursing education provided was just as effective as the expanded approach used here. Several study results have suggested that interventions aimed at improving anxiety and depression are most effective for patients who have clinically relevant anxiety and depression.

To evaluate the effectiveness of dexamethasone and pyridoxine on the frequency and severity of palmar-plantar erythrodysesthesia (PPE) in patients with solid tumors receiving pegylated liposomal doxorubicin (PLD).

Evaluable patients had at least two cycles of therapy. A total of 51 cycles of PLD was applied to the 19 patients. The maximum tolerated dose was 60 mg/m² every 28 days. In a second step, interval reductions at the highest four weekly doses from 28 to 21 to 14 days were planned. Patients received oral dexamethasone 8 mg BID on days 1 to 5 with vitamin B6 100 mg BID continuously along with PLD.

• The study reported on a sample of 19 patients who had solid tumors and were receiving PLD.
• PLD doses ranged from 40 to 60 mg/m².

• Department of Medicine at the University of Tuebingen Medical Center in Germany
• Department of Medicine at the University of Essen Medical Center in Germany

PPE was evaluated with a scale from grade 1 to 4. The specific grading scale was not discussed.

• Three of seven patients with 21-day PLD intervals developed grade 3 or 4 PPE.
• At the 28-day PLD interval, grade 3 PPE occurred in only in 1 of 12 patients who were receiving 60 mg/m² PLD during the third cycle. That patient discontinued dexamethasone on day 2.

Compared to reported frequencies of up to 25%, the incidence of PPE caused by PLD appeared to decrease with concomitant dexamethasone and vitamin B6.

• The sample size was small.
• This was not a randomized clinical trial, and no control or comparison group was used.
• The description of the measurement tool or method used to grade PPE symptoms was inadequate, and reliability and validity were unclear.

• Databases searched were MEDLINE, CINAHL, and the Cochrane Library (December 2007–November 2010).
• Authors used the same search terms as Bennett, Bagnall, and Jose Closs (2008), whose publication said that details of the search were available upon request.
• Studies were included if they
  • Were randomized controlled trials or controlled trials in which the control group received usual care or attention only.
  • Included adults with pain from active cancer and not pain from cancer treatment.
  • Used a patient-based educational intervention on an individual basis.
  • Assessed pain-related outcomes. 
• Studies were excluded if they used psychobehavioral methods in the intervention.

• The final number of studies included was 34.
• The sample range across studies included a total of 4,139 patients in 24 interventions. The number of patients in the 11 statistically significant studies was 1,041. The range of sample size was 30–1,256 patients.
• The range of mean patient age was 48–77 years.
• Of all patients, 57% were women and 43% were men.
• Cancer diagnoses in the sample were primarily lung, breast, prostate, gastrointestinal, gynecologic, hematologic, and head and neck cancers.
• The majority of studies (14) were conducted in the United States.

• Structural components of the intervention included the factors that follow.
  • How the intervention was delivered.
  • What materials were given to patients.
  • Receiver and provider of the intervention.
  • Whether interactions took place between providers and receivers.
  • Level of individualization (structured or tailored) for each patient.
  • Contact time between clinicians and patients or family caregivers.
  • Timing of the intervention
• The 16 content components of the intervention were divided into four categories:
  • Cognition.
  • Behavioral.
  • Goal setting.
  • Direct contact between research staff and clinicians.
• Authors found no apparent patterns, for any single component or any combination of components, with statistically significant and clinically meaningful effects. This may be due to the lack of homogeneity in study designs and the variability of the structure and content components.
• Other factors may play a role in an intervention's efficacy (e.g., provider’s empathy, setting of the intervention).
• Spending more time with patients did not always result in increased knowledge or changes in patients’ behaviors. Similarly, multiple interventions did not always result in increased knowledge or behavior changes.
• Optimal dose and timing of the intervention to improve cancer pain management are unknown.

Although the efficacy of various intervention components could not be clearly delineated, this systematic review provides an overview of the various structural and content components of intervention studies to improve cancer pain management and an evaluation of combinations of components.

• One limitation was the fact that authors included published studies only.
• The number of studies included was small, which may have led to overestimation of effect sizes.

Nurses need to be aware of the various structural and content components of interventions to support patients’ self-management of cancer pain. The interventions should be culturally appropriate and include written material; a face-to-face educational session of at least 15 minutes; and information about pain treatment, cognitive barriers to pain management, and implementation of self-management pain strategies.

To evaluate the PRO-SELF^© Plus Pain Control Program in a German population to determine effect sizes and feasibility

Participants received six visits and four phone calls from an intervention nurse, who taught them effective ways to self-manage their pain, including how to set pain goals, how to titrate prescribed analgesics, how to communicate with their physician, and how to identify management strategies to achieve their pain goals. They also received nurse coaching on their recent successes and failures, as well as individualized information about their medications during each visit and phone call.

• N = 39
• AVERAGE AGE = 59.5 years
• MALES: 51%, FEMALES: 49%
• KEY DISEASE CHARACTERISTICS: Lung, breast, and other cancers; also evaluated fatigue, cognition, anxiety, and depression

• SITE: Single site 
• SETTING TYPE: Outpatient 
• LOCATION: Freiburg, Germany

• PHASE OF CARE: Active antitumor treatment

• Single-center, pilot, randomized, controlled trial

• Numerical Pain Rating Scale for primary outcome measures
• Patient pain questionnaire to evaluate patients’ knowledge of how to manage cancer pain
• For additional symptoms (e.g., fatigue, cognition, anxiety):
  • Hospital Anxiety and Depression Scale
  • German Memorial Symptom Assessment Scale
  • Fatigue assessment questionnaire
  • DemTect
  • Eastern Cooperative Oncology Group performance status
  • Self-efficacy questionnaire

Neither average nor worst pain scores demonstrated statistically significant group-by-time interaction effects between the intervention and control group over the 10-week or 22-week period. The difference in the knowledge scores between the intervention and control groups was statistically significant. A large percentage of participants did not complete the study for various reasons.

This study was the first to adapt a U.S.-developed pain intervention for a German audience. It did increase pain self-management knowledge and determine effect sizes for pain intensity scores.

• Small sample (less than 100)
• Subject withdrawals 10% or more

The nursing intervention piece of this trial can have a great effect on the participants. In the U.S. and German trials, the nursing interventions were able to have an effect on fear of addiction, fear of tolerance, physical dependence, and the patients' understanding of taking their medications on a schedule.

A group exercise training (GET) intervention was delivered in a structured format three times per week for 16 weeks. The one-hour GET training sessions emphasized physical activities that promote aerobic fitness, strength, and flexibility. The warm-up period lasted 10–15 minutes, the aerobic training phase lasted 20 minutes, and the resistance training and cool-down phase lasted 20 minutes. Exercise intensity and duration were prescribed on an individual basis using the results from baseline fitness assessments. Two exercise physiologists provided each session. Data were collected at baseline, week 8, and week 16.

• The study reported on a sample of 40 sedentary women, aged 45 or older, who had been diagnosed and surgically treated for stage I, II, or III breast cancer.
• Most women were within 12 months of diagnosis, and all were postsurgery.
• Most women were concurrently undergoing adjuvant therapies.

A quasi-experimental design was used.

• Beck Depression Inventory (BDI)
• State-Trait Anxiety Inventory (STAI)
• Positive and Negative Affect Schedule (PANAS)
• Hamilton Rating Scale for Depression (HRSD)
• Functional Assessment of Cancer Therapy (FACT)
• Cancer Rehabilitation Evaluation System (CARES)
• Global Assessment Scale (GAS)
• Life Functioning Scales (LFS)
• Physiologic measures
  • Heart rate and blood pressure, height and weight
  • Body fat through skinfold fat thickness
  • Single-stage submaximal treadmill walking test
  • Sit-and-Reach Test to measure flexibility
  • Variable resistance equipment to measure body strength

BDI, PANAS, and HRSD were significantly improved from baseline to week 16. There was no statistically significant change in anxiety, as measured by STAI, after the exercise intervention. At baseline, participants were not experiencing high levels of distress.

Anxiety levels were not changed significantly from this exercise program, although other health benefits were reported.

• The study had a small sample.
• Outcomes were conceptualized and measured multidimensionally rather than unidimensionally (e.g., aerobic capacity or mood/distress only).
• The sample included patients with breast cancer only.
• The study had special costs or training due to use of exercise physiologists.
• The study required individual tailoring of intervention.

To assess effectiveness of a once-a-day fentanyl patch for patients receiving a 72-hour patch that does not last for 72 hours

Patients identified as having end-of-dose failure with a 72-hour fentanyl patch were identified and converted to the once-a-day patch according to manufacturer recommendations. In the evening of the switch day, the new patch was applied immediately after removing the 72-hour patch. Treatment for breakthrough pain was adjusted according to the fentanyl dose, and immediate-release morphine or oxycodone was used for breakthrough pain. If patients were on anti-inflammatories, they remained on this medication. Patients recorded study data daily. Of the patients, 15.6% had the 72-hour patch changed to use every 48 hours. Mean frequency of daily rescue doses for breakthrough pain were analyzed.

• N = 45   
• AGE RANGE: 60–69 years
• MALES: 54.8%, FEMALES: 45.2%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Varied tumor types
• OTHER KEY SAMPLE CHARACTERISTICS: Most were on 25–50 mcg fentanyl per hour.

• SITE: Single site   
• SETTING TYPE: Not specified    
• LOCATION: Japan

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Palliative care 

• Retrospective cross sectional

• Numeric pain rating scale from patient diaries

Of the patients with suspected end-of-dose failure, 84% were switched to the once-a-day patch. The rest had patches switched at 48 rather than 72 hours. On the last day of the 72-hour patch, mean daily dosing for breakthrough pain was 3.61; on the third day after the switch, the mean daily dosing was 1.18 (p < 0.05). Adverse events occurred in 18% of patients with the new patch, including local skin irritation and sensitivity. Of the patients with shortened interval to 48 hours, three showed a decrease in pain score, two showed no change, and two showed increased scores. After the switch to the once-a-day patch, 61% showed more than a 30% reduction in average pain.

Patients switched to the once-a-day fentanyl patch had a reduction in average pain scores and a reduction in rescue medications needed.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement validity/reliability questionable
• Timing of pain measurement from diaries is not stated.

Differentiating between breakthrough pain and end-of-dose pain medication failure is important. This study suggests that these may not always be well determined. Study findings suggest that a once-a-day fentanyl citrate patch may be more effective for pain control than the usual 72-hour fentanyl matrix, particularly in patients with end-of-dose failure. This study is limited by its design and sample size. Further well-designed research is warranted.

To determine whether biofeedback improves outcomes for patients with pelvic floor dysfunction (PFD), and to assess the relative effectiveness of different types of biofeedback therapy.

Databases searched were CINAHL, Embase, Medline, PsycINFO, Evidence-Based Medicine Reviews (EBMR), and the Cochrane Database. References of retrieved articles also were hand searched.

Search keywords were constipation, anismus, dyssynergia, obstructive defecation, rectocele, rectal intussusception, rectal prolapse, ​and biofeedback.

Studies were included in the review if they

• Were randomized controlled trials (RCTs)
• Reported on adults with PFD
• Included biofeedback as at least one of the treatments studied.

Studies were excluded from the review if they reported on pediatric cases.

The initial searching provided 5,028 references. Study selection and screening for inclusion criteria provided a final set of seven studies. Study quality was evaluated by two reviewers.

• The final sample of seven RCTs included 413 patients.
• Sample sizes ranged from 26 to 109.
• Medical diagnostic information across studies was not provided.

• Three trials compared biofeedback with other interventions such as laxatives, diazepam, and placebo. Meta-analysis showed an odds ratio (OR) of 5.861 (95% confidence interval [CI] [2.175, 15.794], p < 0.001) in favor of biofeedback.
• Four trials compared differences in biofeedback techniques. A meta-analysis of the most widely used technique, electromyogram biofeedback, showed an OR of 6.738 (95% CI [2.194, 15.58], p < 0.001) in favor of biofeedback.

• Results suggest biofeedback is associated with symptomatic relief of constipation; however, the number of studies included was very small and substantial heterogeneity existed across studies.
• Study quality overall was poor.
• Findings are not specific to the oncology population, and whether any of the studies included patients with cancer is not known.

Additional, better-designed studies are needed in this area to determine efficacy. Future studies should compare different biofeedback modalities to identify the most effective approaches.

The study's primary aim was to examine the effect of modafinil on persistent fatigue after treatment. Its secondary aim was to examine the effect of modafinil on cognitive function of patients with breast cancer.

In phase 1, participants were given 200 mg of modafinil daily for four weeks. Participants with a positive response in phase 1 were randomized to phase 2. In phase 2, participants continued to receive 200 mg of modafinil orally once per day or a placebo for four weeks. Repeated measures were completed at baseline (week 0), week 4, and week 8. Participants were stratified by treatment type: chemotherapy, radiation, or both chemotherapy and radiation. 

• The total number of participants was 82, with 76 completing phase 1 and 68 completing phases 1 and 2.
• The median participant age was 54, with a range of 33–83.
• All participants were female.
• All participants had breast cancer and were being treated with surgery and chemotherapy; 87% also received radiation.
• 75% of participants had at least some college education.

The study took place at the University of Rochester Medical Oncology Clinic in New York. 

The study was a prospective, open-label clinical trial.

• The Cognitive Drug Research (CDR) assesses domains of attention and memory, including speed of memory, continuity of attention, quality of episodic and working memory, and power of attention.
• The Brief Fatigue Inventory (BFI) assess fatigue.

Approximately 70% of the participants in the active treatment group had an improvement in continuity of attention from baseline to after treatment (week 8), compared with 52% in the placebo group; however, this difference was not statistically significant (p = 0.19).

In phase 1, modafinil had a significant effect on speed of memory (p = 0.0073) and quality of episodic memory (p = 0.0001). No significant effect in continuity of attention, quality of working memory, or power of attention was observed during this phase.

In phase 2, those who continued modafinil demonstrated significantly greater improvement in cumulative speed of memory (p = 0.029), quality of episodic memory (p = 0.0151), and continuity of attention (p = 0.0101).

Modafinil significantly improved some cognitive functioning, including speed of memory and episodic memory, but failed to demonstrate improvement in working memory.

• Findings were a secondary analysis; cognitive functioning was not the study's primary outcome.
• The study was an open-label trial, and thus participants were not blinded to their assignment.
• The study had a relatively small sample size.
• The majority of participants were an educated group of Caucasian women, limiting generalizability.
• The study did not report if differences existed between the original enrolled sample (n = 82) and those who completed the entire study (n = 68).
• Although not statistically significant, the participants assigned to the modafinil group had a mean age which was five years younger than the placebo group.
• Although the Cognitive Drug Research has been used reliably in other populations, it does not indicate if it has been used in cancer populations.

The objective of this study was to investigate the influence on consciousness of sedative drugs to relieve severe physical distress refractory to standard interventions.

The study was a retrospective review of medical records of 124 consecutive patients admitted to a single palliative care unit between January and December 1999 to evaluate the use of sedation, defined as “a medical procedure to palliate patient symptoms refractory to standard therapy by intentionally dimming consciousness.\" Nocturnal sedation was excluded.

• The study reported on a sample of 63 participants.
• The mean age was 64 years, with a range of 35–87 years.
• Of the sample, 67% were males and 33% were females.
• A key disease characteristic was cancer, with the primary tumor sites being lung (38, 60%) and stomach (7, 11%).
• Symptoms requiring sedation were dyspnea (63%), general malaise/restlessness (40%), pain (25%), agitation (21%), and nausea and vomiting (6%).
• Thirty-five patients (54%) had more than one uncontrollable symptom.

This single-site study was conducted in an inpatient setting in Japan.

• Patients were undergoing end-of-life care.
• The study has clinical applicability for palliative care.

• Retrospective chart review was conducted to obtain patient characteristics, symptoms, and treatments.
• Statistical analysis of patient data was performed using unpaired t-test.

• Equivalent daily dose (MEDD) of parenteral morphine
• Parenteral equivalent of midazolam (PME)
• Palliative Performance Scale (PPS) (0 = death, 100 = normal)
• Communication Capacity Scale to measure level of consciousness (0 = awake with no drowsiness, 3 = aroused by verbal stimuli, 5 = unarousable by physical stimuli)

• Palliative Performance Scale results were poor in the group before sedation (10 [46%], 20[37%], 30[14%], 40[3%]).
• The longest duration of sedation was 11 days.
• Midazolam was the most frequently administered sedative (98%) by continuous IV infusion (60%) and SQ infusion (35%).
• Between patients receiving sedation and those not requiring sedation, no significant difference was seen in admission duration or level of consciousness day six–day three before death.
• A significant difference in mean CCS only lasted three days prior to death (day two before death CCS 3.3 [SD = 0.8] [p < 0.05], day one before death CCS 3.8 [SD = 0.7] [p < 0.05], day of death CCS 4.7 [SD = 0.6] [p < 0.01]).
• The mean dose of opioid used was greater in the sedated group but only statistically significantly on day two before death (p = 0.04), day one before death (p = 0.03), and day of death (p = 0.08).

This study contributes descriptive information about the use of terminal sedation (midazolam and opioids) for symptom control and the influence sedation has on the level of consciousness during the last days of life. In this study, patients receiving sedation were significantly drowsier and less responsive only during the last three days of life. What is not known from this study, although it is implied, is the degree of symptom control achieved by this intervention.

Limitations of this study included

• Small sample size of less than 100
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias(sample characteristics)
• Selective outcomes reporting
• Questionable measurement validity/reliability
• Nongeneralizable findings
• Limited strength of evidence due to retrospective chart review in single site
• Evidence peripheral to dyspnea relief outcome.

This is helpful, descriptive, and low-level evidence about the use of terminal sedation to control symptoms. No measurement of dyspnea relief was included in the report, although it implies that sedated patients were not in distress.

The objective of the study is to assess the effect of nebulized furosemide (20 mg) on dyspnea uncontrolled by standard therapy in patients with terminal cancer.

Patients inhaled 20 mg of furosemide diluted with 3 ml of normal saline through an ultrasonic nebulizer over 10 minutes.

The study reported on a sample of 15 patients in a palliative care unit with histologic diagnosis of malignant disease and the presence of dyspnea that resists standard treatments.

Uncontrolled, open study

Initial severity of dyspnea was grade 4, assessed with the Hugh-Jones 0–4 classification. Effects were evaluated using the Cancer Dyspnea Scale before treatment and 60 minutes following treatment. Hemoglobin oxygen saturation and heart rate (HR) were measured with a pulse oximeter. Respiratory rate (RR), HR, and arterial blood gas parameters also were determined before and 60 minutes after use of nebulized furosemide. In addition, patients were asked whether they felt relief with the treatment and whether they hoped to continue the treatment.

The study showed that the inhalation of nebulized furosemide alleviated the sensation of dyspnea according to decreased Cancer Dyspnea Scale scores for sense of effort, sense of anxiety, and total dyspnea. However, objective data such as arterial oxygenation (PaO₂), arterial partial pressure of carbon dioxide (PaCO₂), oxygen saturation, HR, and RR did not change with treatment.

The study had several limitations. It was an uncontrolled, open study and, thus, the results may include a placebo effect from the intervention itself. The assessment of dyspnea was conducted on only two occasions—before and after administration of a single dose. Finally, the sample size was small.