To evaluate the efficacy of a Japanese medicine called goshajinkigan (TJ-107) for preventing oxaliplatin-induced neuropathy, compared to placebo controls, and also to evaluate its safety

Patients were randomized to receive goshajinkigan ( TJ-107) 7.5 mg per day day, a mix of extracts of 10 crude herbs, or placebo for 26 weeks starting on the first day of chemotherapy. Neuropathy was measured before each chemotherapy cycle every two weeks until the eighth chemotherapy cycle and every four weeks thereafter until 26 weeks. Patients randomly were assigned to the intervention or control group.

• N = 89
• MEDIAN AGE = 64 years
• AGE RANGE = 36–88 years
• MALES: 53.9%, FEMALES: 41.6%
• KEY DISEASE CHARACTERISTICS: To be included in the study, patients had to be undergoing oxaliplatin-based chemotherapy for colorectal cancer.
• OTHER KEY SAMPLE CHARACTERISTICS: Primarily Eastern Cooperative Oncology Group score of 0 upon enrollment

• SITE: Multi-site   
• SETTING TYPE: Outpatient    
• LOCATION: Japan

• PHASE OF CARE: Active treatment
• APPLICATIONS: Palliative and supportive care

• Double-blinded, randomized, placebo-controlled trial

• Neuropathy was measured by National Cancer Institute Common Terminology Criteria for Adverse Events (version 3) sensory items at baseline and every two weeks until the eighth cycle of chemotherapy and monthly until the 26th week.
• The FACT/GOG-NTX-12 also was completed by patients at baseline and before every chemotherapy cycle.

Although there was a trend toward lower neuropathy scores as measured by the FACT/GOG-NTX in the intervention group at eight weeks (p = .421) and 26 weeks (p = .151), the differences were not statistically significant. The incidence of grade 2 peripheral neuropathy or greater until the eighth cycle was 39% in the experimental group and 51% in the control group (RR = 0.76, 95% CI 0.47–1.21), and the incidence of grade 3 or greater neurotoxicity was 7% in the treatment group and 13% in the placebo group (RR = 0.51, 95% CI 0.14–1.92). The time to development of grade 2 or greater toxicity was 5.5 months in the experimental group and 3.9 months in the placebo group (RR = 0.65, 95% CI 0.36–1.17). No differences were observed between those getting the different FOLFOX regimens. The goshajinkigan was tolerated well. Adverse effects were similar between study groups and most likely caused by the chemotherapy, but vomiting was significantly less prevalent in the treatment group (p = .029).

Goshajinkigan may delay development of grade 2 or greater oxaliplatin-induced peripheral neuropathy, and there was a trend toward less severe chemotherapy-induced peripheral neuropathy in the intervention group at 8 and 26 weeks as compared to the control group.

• Small sample (less than 100)
• Findings not generalizable
• Other limitations/explanation: Not generalizable to people with neuropathy caused by any other drug than oxaliplatin

This study showed that administration of goshajinkigan, a traditional Japanese kampo medicine, was associated with reduced prevalence and severity of neurotoxicity among patients receiving oxaliplatin and was tolerated well by patients. Further study is needed to support the use of goshajinkigan for oxaliplatin-induced peripheral neuropathy. Goshajinkigan may not be widely available in the United States or outside of Japan.

To determine if hangeshashinto (TJ-14) is an effective treatment for oral mucositis

Patients with oral lesions 7–10 days after chemotherapy were given a 50 ml oral rinse with 2.5 g of TJ-14 and tap water three times per day for 7 days. Patients held the solution in their mouth for 10 seconds and spit it out. TJ-14 also was applied to the lesions with a cotton pellet as soon as the lesion appeared. Patients could not eat or drink 30 minutes before or after treatment. No other mucosal treatments were used during the study. Two blinded physicians graded mucositis.

• N = 14  
• MEAN AGE: 62 years
• AGE RANGE: 34–80 years
• MALES: 43%, FEMALES: 57%
• KEY DISEASE CHARACTERISTICS: Colorectal cancer

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

• PHASE OF CARE: Active antitumor treatment

• Non-randomized trial

• Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 mucositis scale

In this study, 92.8% of patients had improvements in oral mucositis. There was a significant reduction in CTCAE grades of mucositis for all participants from 2.4 ± 0.8 to 1.1 ± 0.8 (p = 0.0012). No adverse events or side effects from NJ-14 were reported.

NJ-14 was effective at improving oral mucositis and did not have any reported side effects in this small sample. However, caution must be used in interpreting this data due to the limitations of the study.

• Small sample (< 30)
• Risk of bias (no control group)
• Risk of bias (no random assignment)
• Risk of bias (no appropriate attentional control condition)

NJ-14 is a promising intervention to treat chemotherapy-induced oral mucositis; however, more research is needed from large RCTs.

To measure the effectiveness of laughter therapy for preventing radiation-induced dermatitis in patients with breast cancer who are receiving radiation therapy (RT)

Thirty-seven patients were enrolled in the study. Eighteen patients were assigned to the experimental group, which received laughter therapy during radiation treatment, based on their preference to participate. Nineteen patients who did not want to participate in the laughter therapy were assigned to the control group. The laughter therapy started at the beginning of therapy and continued until completion of RT. In this three-part intervention study, patients were assessed by staff observation or a questionnaire before and after laughter therapy. Patients in the control group were not allowed to use any prophylactic creams or lotion (p. 2054).

• N = 37  
• MEAN AGE = Experimental group: 59.1 years, control group: 49.3 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Confirmed pathology of unilateral breast cancer; no tumor invasion of the skin; complete breast conserving surgery with or without adjuvant chemotherapy
• OTHER KEY SAMPLE CHARACTERISTICS: Postoperative RT dose greater or equal to 45 Gy without bolus, no concurrent chemotherapy, no history of RT to the chest wall, no connective tissue disorders, no rashes or unilateral wound

• SITE: Not stated/unknown    
• SETTING TYPE: Not specified    
• LOCATION: Kyung Hee University Medical Center, Korea

PHASE OF CARE: Active antitumor treatment

Single-blind, two-group, prospective, nonrandom design

• Skin toxicity grading using the Radiation Therapy Oncology Group (RTOG) was completed by a radiation oncologist who was blinded to the subject’s assignment.
• Pain was evaluated using a visual analog scale (VAS). 
• Questionnaires were completed through staff observation.

The authors stated that, although laughter therapy showed favorable therapeutic efficacy in preventing dermatitis and alleviating pain, they could not draw a definite conclusion because of the lack of statistical significance. An additional study of a larger sample group is necessary. Some limitations exist in this small pilot study, which makes it difficult to interpret the data and draw conclusions.

This single-blind, prospective, pilot study showed that laughter therapy can be beneficial in preventing radiation-induced dermatitis in patient with breast cancer; however, a well-designed randomized study with a larger sample size is needed to confirm the efficacy of the study.

• Small sample (< 30)
• Risk of bias (sample characteristics)
• Key sample group differences that could influence results
• Eligibility criteria did not address whether patients had pre-existing medical histories of anxiety/depression or mood disorder/lability.
• Eligibility criteria included patients with or without adjuvant chemotherapy, which seems to be a potential factor for skewed results, perhaps because with chemotherapy, side effects can be long-lasting (i.e., peripheral neuropathy, alopecia, mood changes). This might affect patients undergoing laughter therapy.
• The authors noted that the assignment of patients was \"based on the patients’ preferences. The patients who wanted to receive laughter therapy were assigned to the experimental group, and the others were assigned to the control group\" (p. 2054). This might skew the data, presuming that patients who wanted the therapy were already biased and perhaps likely to receive the most benefit of the therapy (self-fulfilling prophecy in a way).
• Not allowing \"any prophylactic creams or lotions for radiation dermatitis\" (p. 2054) in either group might be seen as withholding treatment and unethical.
• Some patients received an electron boost; others had three-field treatment.
• Grade 3 dermatitis in 12 patients (35.3%) seems unacceptable/intolerable because no patients received skin care using topical emollients.
• The patient characteristics included smokers, nonsmokers, and diabetics, which might affect patient skin reactions and healing (i.e., poorer or delayed wound healing in smokers and possibly diabetics).
• The study was not conducted in the United States. This would likely prove more difficult in recruiting patients because the skin reactions were not being treated with topicals.
• No discussion regarding the use of pain medications existed. Patient use of pain medications (even over-the-counter analgesics, such as acetaminophen or ibuprofen, or hydrocodone, etc.) might influence their laughter response to the treatment and, therefore, the efficacy the authors cite.

Laughter therapy may have a beneficial effect on patients with radiation dermatitis undergoing breast cancer treatment. However, not enough data exist to support the sole use of this intervention during treatment.

To evaluate Instanyl^® for breakthrough pain in patients with cancer in real-life settings

This study followed adult patients with cancer receiving Instanyl^® in seven countries at 61 centers. The Brief Pain Inventory Short Form (BPI) and patient Treatment Satisfaction Scale (TSS) questionnaires were used to assess patient satisfaction with pain management. Descriptive statistics of the patient population were also collected. The Instanyl^® doses received by patients were 50, 100, and 200 micrograms, and data were collected at three time points: baseline, week 4, and week 13.

• N = 309 overall analysis (107 completed study)  
• AVERAGE AGE = 60 years
• MALES: 56%, FEMALES: 44%
• KEY DISEASE CHARACTERISTICS: Metastases present

• SITE: Multi-site    
• SETTING TYPE: Multiple settings    
• LOCATION: Multiple study centers in Norway, Denmark, France, Greece, Ireland, Sweden, and the United Kingdom

• PHASE OF CARE: Mutliple phases of care
• APPLICATIONS: Elder care, adult care, palliative care

Observational prospective cohort study

The primary outcome variables were success of titration, measured by whether maintenance dose level was achieved, and the dose level of Instanyl^® (maintenance dose). The secondary outcome variables measured were changes in maintenance dose and the level of background pain medication, severity and impact of pain on daily life (assessed by the BPI), and satisfaction with current pain medicine (assessed by the TSS). The BPI and TSS were only used in the United Kingdom and in France and were assessed at baseline and during week 4. Adverse drug reactions were measured as well as reasons for and time to Instanyl^® termination.

The successful titration of Instanyl^® to a maintenance dose was achieved in 84.5% of patients. There was a difference noted between different countries with successful titration rates highest in Greece and Norway and lowest in France and the United Kingdom. The majority of the patients who were successfully titrated achieved this with 50 micrograms of fentanyl, which was the lowest dose. Most patients showed no change in the maintenance dose strength throughout the study even though disease progression was expected. 49.8% of patients were successfully titrated at 50 micrograms, the lowest dose. Treatment was followed to the duration of 13 weeks. In 4.5% of patients, termination was due to lack of efficacy; in 2.3% it was due to adverse effects; and in 7.1% it was due to the inability to successfully titrate the medication. Patients' worst-pain scores, pain severity, and pain interference with activities declined significantly within the first four weeks (p < .001).

The rate of successful titration and pain management using Instanyl^® was high in this study, and successful titration was often achieved with the lowest possible dose of Instanyl^®. Patients were more satisfied with their pain management and had reductions in pain severity, worst-pain score, and pain interference with daily activities.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)  
• Subject withdrawals ≥ 10% 
• Other limitations/explanation: Only about 35% of patients completed the study, there was a lack of a comparison arm, and adverse drug reactions were not reported.

This study adds to the body of evidence regarding the efficacy of opioid nasal spray for breakthrough pain. The authors suggest that patients who did not respond were likely those for whom titration to full dosage was not achieved. Nurses need to be aware of full dosage needs for efficacy. There continues to be a lack of evidence regarding the long-term effects and any potential adverse effects on the nasal cavity for this medication type.

To determine if the use of a human epidermal growth factor (EGF)-based cream can prevent radiation dermatitis in patients with breast cancer treated with radiation

Patients with breast cancer needing post-operative radiation randomly were assigned to use human recombinant EGF-based cream (intervention) or general supportive skin care (control). The intervention group applied study cream three times daily to the radiated area from start of treatment through two weeks post-completion of treatment. The control group washed gently with or without mild soap, patting to dry. No cosmetics, perfumes, creams, or lotions were allowed on the treated area in the control arm.

• N = 40
• MEAN AGE: Intervention group: 57.3 years (40.2–74.0 years); control group: 51.8 years (36.5–76.1 years)
• MALES: 0%, FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Unilateral breast cancer, no skin invasion by tumor, breast-conserving surgery, presence or absence of adjuvant chemotherapy, radiation to minimum dose of 45 cGy without use of bolus
• OTHER KEY SAMPLE CHARACTERISTICS: No concurrent chemotherapy, rashes, or unhealed wounds in treatment area. No history of previous radiation therapy (RT) to chest wall, connective tissue disorder.

• SITE: Single site  
• SETTING TYPE: Not specified  
• LOCATION: Department of Radiation Oncology, Kyung Hee University Medical Center, Seoul, Republic of Korea

• PHASE OF CARE: Active antitumor treatment

• Single-blind, randomized preliminary study

Examination of site was completed prior to RT, weekly during RT, and six weeks post-RT. Skin changes were scored using the Radiation Therapy Oncology Group (RTOG) criteria by a radiation oncologist blinded to group assignment. Pain was evaluated with a 10-point visual analog scale. Intervention patients completed a questionnaire regarding ease of cream application at the end of the study.

Although there was a difference in the intervention and control groups in terms of grade 3 dermatitis, (15% compared to 40%), there was no statistical difference between the intervention of human recombinant EGF-based cream and the control of supportive skin care. As with previous studies, total RT dose and lymph node radiation were prognostic factors for grade 3 radiation dermatitis. This study did not look at patient-related prognostic factors that potentially contribute to increased radiation dermatitis.

• Small sample (< 100)
• Risk of bias (no blinding)
• Measurement validity/reliability questionable
• Other limitations/explanation: As with other studies, the RTOG skin toxicity scoring, although utilized by many practices and clinical trials, has not been tested for validity and reliability.

There continues to be no “best practice” for prevention and treatment of radiation dermatitis. Practice varies worldwide. Further studies with a large sample size and inclusion of a double-blinding would be useful for this product as several studies have shown with EGF for wound healing.

To evaluate chemotherapy-induced nausea and vomiting and adverse events when dexamethasone is eliminated on days 2 and 3 of moderately emetogenic chemotherapy (not including anthracyclines or cyclophosphamide) in combination with palonosetron or another 5HT3 receptor antagonist

The control group received 9.9 mg of dexamethasone IV then 0.75 mg of palonosetron IV before moderately emetogenic chemotherapy then either 8 mg of oral dexamethasone or 6.6 mg of IV dexamethasone on days 2 and 3 of chemotherapy. The treatment group received only 9.9 mg of dexamethasone IV then 0.75 mg of palonosetron IV before moderately emetogenic chemotherapy and no additional prophylactic antiemetics. Rescue antiemetic drugs (excluding dexamethasone, NK1 receptor antagonists, serotonin reuptake inhibitors, and serotonin–norepinephrine reuptake inhibitors) were allowed for both the treatment and control groups. 

• N = 305 (151 in treatment group and 154 in control group)  
• MEAN AGE = 64 years (range = 23–88 years)
• MALES: 173 (57%), FEMALES: 132 (43%)
• KEY DISEASE CHARACTERISTICS: Not specified (inclusion criteria was just malignant tumor)
• OTHER KEY SAMPLE CHARACTERISTICS: Received primarily oxaliplatin-based chemotherapy then irinotecan- and carboplatin-based chemotherapy in a one-day administration; 45% (n = 138) consumed alcohol within 180 days of chemotherapy

• SITE: Multi-site    
• SETTING TYPE: Not specified    
• LOCATION: Hokkaido, Japan

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care  

Open-label, noninferiority, randomized, comparative, phase 3 study

• Gastrointestinal symptom diary of number of vomiting events and nausea rated on a four-point Likert scale that was completed by patient every 24 hours for five days after chemotherapy administration.
• Adverse events were evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE), but no indication of how the data were gathered was given.
• The exacerbation of symptoms by one grade level or higher compared to baseline was considered an adverse event.
• Complete control and complete response rates in acute and delayed phases 

The noninferiority of the experimental group in regard to complete response rate (acute and delayed phases) and complete control rate (overall, acute, and delayed phases) was demonstrated. There was no difference between the treatment and control groups. A subgroup analysis according to age, sex, and chemotherapy showed no statistical differences in complete response rates. No significant difference in adverse events was found between the treatment and control group with primary events in both groups being constipation, hiccups, anorexia, and elevated alanine transaminase.

There was no difference in chemotherapy-induced nausea and vomiting (acute and delayed) or adverse events between one-day dexamethasone plus palonosetron versus three-day dexamethasone plus palonosetron among patients receiving moderately emetogenic chemotherapy (not including anthracyclines or cyclophosphamide).

• Measurement/methods not well described
• Measurement validity/reliability questionable

The one-day administration of dexamethasone (with palonosetron) was adequate in controlling acute and delayed nausea and vomiting in patients receiving moderately emetogenic chemotherapy when the chemotherapy did not include anthracyclines or cyclophosphamide.

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.