The study was conducted to assess the feasibility of quantifying the effect of epoetin alfa in patients with breast cancer who were receiving adjuvant chemotherapy on asthenia, executive cognitive functioning, and quality of life. 

Participants were randomized to receive 40,000 units weekly of erythropoietin or a placebo. Erythropoietin or placebo administration began on day 1 of chemotherapy. Both the erythropoietin and placebo were then dose-escalated, with the goal of keeping Hgb levels between 12 g/dL and 14 g/dL. All assessments were administered prior to the start of chemotherapy, one week prior to cycle 4, and 6 months following the completion of chemotherapy.

• All participants were female and had breast cancer.
• The number of participants was 100.
• There were 51 participants in the treatment group and 49 in the control group.
• The median age of the treatment group was 53 years.
• All patients were treated with four cycles of doxorubicin and cyclophosphamide.
• All participants had a Karnofsky performance status of ≥ 70%.
• Individuals who had packed red blood cell transfusions within 14 days of study entry, clinically significant anemia (not defined), or uncontrolled or severe cardiovascular disease were excluded from the study.

The study's setting is unknown. 

The study utilized a longitudinal, double-blind, randomized, controlled design. 

• The Executive Interview (EXIT-25) measured executive function.
• The Clock Drawing Task (CLOX) measured executive function.
• The Functional Assessment of Cancer Therapy (FACT)-Anemia measured cancer-related quality of life specific to the symptom of anemia.
• The Karnofsky Performance Status scale (KPS) measured general well-being. Scores range from 0 (death) to 100 (perfect health with no complaints or signs of disease).
• Quality of life was measured by a validated linear analogue scale (LASA).
• The Profile of Mood States (POMS) was also utilized.

A significantly higher mean Hgb level in patients on erythropoietin treatment was reported (p < 0.001). However, there were no significant differences in cognitive function.

The study failed to demonstrate a difference in cognitive functioning between patients in the erythropoietin and placebo groups.

• The number of erythropoietin doses administered to the treatment group was unclear, which could influence study results.
• The CLOX test was determined to be an insensitive measure for detecting cognitive changes.
• There was a lack of alternate forms for cognitive tests, so practice effects may have influenced study outcomes.

To assess whether a previously supported patient-directed palliative care intervention would decrease caregiver burden

Patients received a random assignment to either an intervention (palliative care) or usual care group. Intervention patients participated in four weekly telephone sessions focused on communicating with healthcare providers, learning problem-solving skills, managing disease symptoms, and planning for end-of-life care. Patient caregivers received invitations and volunteered to participate in the intervention. Following the intervention, nurses called patients at least once a month to lend support and present additional information. Patients in the usual care group received standard oncology care at the cancer care center. Caregivers and patients completed questionnaires at baseline, one month post-baseline, and every three months until the end of the study. Following patient death during the study period, caregivers were asked to complete the After-Death Bereaved Family Member Interview (ADI).

• N = 198   
• MEAN AGE = 59 years
• MALES: 23%, FEMALES: 77%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: Patients with advanced cancer receiving outpatient palliative care 
• OTHER KEY SAMPLE CHARACTERISTICS: Intervention caregivers were significantly more educated than those in usual care group.

• SITE: Multi-site   
• SETTING TYPE: Outpatient    
• LOCATION: U.S. comprehensive cancer centers in northern New England

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Palliative care

Randomized, controlled trial

• Caregiver burden: 14-item Montgomery Borgatta Caregiver Burden Scale to measure objective burden, stress burden, and demand burden
• Quality of care: 67-item After-Death Bereaved Family Member Interview (ADI) to measure caregiver perception of patient quality of care four to six months after patient death
• Patient quality of life: 46-item Functional Assessment of Chronic Illness Therapy-Palliative Care (FACIT-Pal) to measure patient overall end-of-life well-being
• Physical symptoms: 10-item Edmonton Symptom Assessment Scale (ESAS) to measure patient symptom severity
• Depressed mood: 20-item Center for Epidemiological Studies-Depression (CES-D) to measure patient and caregiver depression frequency

Patient FACIT-Pal scores correlated negatively and at high levels with ESAS scores and CES-D scores, and ESAS and CES-D scores correlated positively. Fewer and less consistent correlation of caregiver burden scores occurred: caregivers perceiving objective burden sources reported stress but not demand burden (unreasonable patient requests for care). Demand burden was positively correlated with stress burden in caregivers. Patients who identified lower patient quality of life (FACIT-Pal) had caregivers scoring higher on objective and stress burden. Caregivers scored higher on objective burden and stress burden if patients had higher ESAS and CES-D scores (latter evident one month postbaseline). Of 96 caregiver burden correlations, patient well-being, and quality of care, five achieved statistical significance. These included patient spiritual and emotional support concerns associated with patient well-being (p < 0.01) and decreased caregiver stress burden (p < 0.01) at baseline. One month postbaseline, unmet patient needs correlated with caregiver stress burden (p < 0.05), and concerns with patient respectful treatment correlated with increased caregiver demand burden (p < 0.05).

Despite evidence in a previous ENABLE II study supporting the success of a palliative care interventions to decrease patient symptom intensity, depression, and improve quality of life, this study did not support improvement in caregiver burden with a similar methodology.

• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results
• Findings not generalizable (96% Caucasian , 77% female, and 84% married or living with partner)
• Subject withdrawals ≥ 10% 
• Caregiver participation in intervention inconsistent to affect study outcomes
• High caregiver attrition prevented measurements after four months.
• ADI reports focused on only patients' quality of care, not caregiver experience.

Multiple studies document that minimizing caregiver burden requires specialized interventions focusing on emotional, financial, spiritual, and physical strains but also caregiving benefits gained in a dyadic relationship (patient and caregiver). Well-designed long-term randomized, controlled trials sensitive to documented health interaction outcomes of caregiving dyads may provide clinical direction for improved patient well-being and lower caregiver burden during palliative cancer care.

To provide evidence-based recommendations for the prevention of intravascular catheter-related infections for healthcare personnel who insert and care for intravascular catheters and for those responsible for surveillance and infection control in hospital, outpatient, and home health settings. Patients addressed in the guidelines were adult and pediatric patients with intravascular catheters.

The resource is comprised of evidence-based guidelines. For the development process, evidence was categorized as category 1A to category 2 based on strength of recommendation and support from clinical or epidemiological studies.

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

The results were not summarized.

The guidelines provided extensive recommendations regarding the education and training of staff; selection of catheters and sites, including avoidance of the femoral vein for central venous access and use of the central venous catheter with the minimum number of ports needed; hand hygiene; use of maximal sterile barrier precautions for insertion; skin preparation with alcohol, iodine, or chlorhexidine; use of standard catheter site dressing regimens; specific aspects of care for umbilical and dialysis catheters; and use of piggybacks, stopcocks, and catheter flushing. Guideline recommendations include a bundling of multiple recommendations: antimicrobial-impregnated catheters and cuffs are recommended in patients with long-term use if the organizational central line-associated blood stream infection (CLABSI) rate is not decreasing despite the implementation of comprehensive strategies for improvement. Lower-level (category II) recommendations include the use of prophylactic antimicrobial lock solutions in patients with long-term catheters who have a history of CLABSIs despite optimal aseptic technique as well as daily cleansing of patients in the intensive care unit with 2% chlorhexidine-impregnated washcloths. Recommends changing IV administration sets no more often than every 96 hours unless used for blood products. For needleless components, recommends changing according to administration set timing as above, and states no benefit to changing more than every 72 hours.

Provides extensive recommendations for management of all types of intravenous catheters and system components. Nurses should refer to the full set of guidelines for all specific aspects of care.

 To determine whether lidocaine-prilocaine cream decreases injection pain related to sentinel lymph node biopsy

Eligible subjects were randomized to either the treatment or control group, then provided with a syringe that contained either the study medication (lidocaine-prilocaine cream) or a placebo cream that looked identical to it. Subjects also received instructions on how to apply the cream and a copy of the postprocedure survey, which asked patients to evaluate ease of application as well as level of pain. The subjects were to apply the given cream and then a barrier dressing to the area. Patients went to one of three radiology departments to receive an injection of the Tc sulfur colloid for the sentinel lymph node biopsy. Postoperatively, over the telephone, the patients completed the survey with help from a researcher. 

• The sample was composed of 39 patients.
• All patients were older than 18 years.
• All the patients were female.
• All the patients had breast cancer
   

• Multisite
• Inpatient and outpatient settings
   

Phase of care: active treatment

Triple-blinded prospective randomized placebo-controlled trial

• Scale measuring ease of cream and dressing application, a five-point Likert-type scale    
• 10-point pain scale, to measure pain
• A tool that recorded whether patient would recommend cream (yes/no)
   

Thirty-nine subjects completed the study. Subjects from both groups rated the cream as easy to apply, and both groups responded similarly in regard to dressing retention. Authors reported no significant difference in median injectional pain scores between the treatment and control groups. Authors noted two trends: The treatment group was more likely than the control group to recommend the cream, and the control group was more likely to rate the injection as painful or extremely painful.

The pain scores of subjects who received the lidocaine-prilocaine cream were not significantly lower than those of the control group.

• The study had a small sample size, with fewer than 100 patients.
• The study comprised variability in injection techniques and volumes.
• Study design was based on the prediction of a large difference (4) between the two groups on a 10-point Likert scale.  
   

This study does not indicate that a topical anesthetic, lidocaine-prilocaine cream, had a significant effect on injectional pain; however, the finding may be a consequence of the study design. Further studies, with larger sample sizes and smaller predicted differences in the study groups, may produce a different result.

To evaluate the effects of a tailored information package for patients with rectal cancer on levels of satisfaction with information, anxiety, depression, and readjustment to normal living

This study was conducted at six sites in four healthcare systems in Northern Ireland. A process evaluation of usual standards-of-care established that all patients with rectal cancer were referred to a stoma nurse specialist following diagnosis. A tailored information packet of 14 leaflets dealing with various aspects of disease and treatment was developed based on the theoretical framework of andragogy, developed by Malcolm Knowles, along with a preliminary needs assessment and a literature review. Preparation for the study involved a liaison between stoma-care nurse specialists to determine interest in participation. The researchers then met with the stoma nurse specialists to discuss the study protocol and provide consistent training regarding the use of the information packet. Data were collected using a researcher-administered set of scales at three time points in structured interviews. These were preintervention, postintervention, after surgery, prior to hospital discharge, and six months after surgery.

• N = 43 (intervention group), 33 (control group)  
• AGE RANGE = 42–76+ years
• MALES: 64.5%, FEMALES: 35.5%
• KEY DISEASE CHARACTERISTICS: Sixty-eight out of 76 patients were considered a B or C in Duke’s staging system. The majority of patients (40) had low anterior resections with loop ileostomies, and 27 patients had abdominoperineal resections (permanent colostomies).
• OTHER KEY SAMPLE CHARACTERISTICS: Thirty-two patients received short-course radiation prior to surgery. Ten of these patients also had adjuvant chemotherapy. Nine patients had long-course preoperative chemotherapy/radiation, and nine patients had adjuvant chemotherapy only.

• SITE: Multi-site    
• SETTING TYPE: Multiple settings  
• LOCATION: Northern Ireland

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

Randomized, controlled trial

The Patient Satisfaction with Cancer Treatment Education (PSCaTE) questionnaire was used. It consists of 14 items. Each item has a scale from 1 (strongly disagree) to 5 (strongly agree). The Hospital Anxiety and Depression Scale (HADS), which contains seven intermingled items answered on a four-point scale, and the Reintegration to Normal Living Index (RNLI), which consists of 11 items on scales of 1–10, also were used. Data analysis was carried out using SPSS software.

There was a statistically significant difference in levels of satisfaction with information between the intervention and control groups. Patients who received the tailored information packet were more satisfied with their information than the control group. There were no differences in depression scores between the intervention and control groups at any time. Females were shown to have significantly higher anxiety and depression scores at the preintervention assessment. All participants with high depression scores also had elevated anxiety scores. Anxiety and depression scores showed medium to large negative associations with adjustment levels as measured by the RNLI scores at all three time points.

Patients who received the tailored information packets were significantly more satisfied than those in the control group at the second and third time points.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (sample characteristics)
• Key sample group differences that could influence results
• Other limitations/explanation: This study only assessed satisfaction up to six months following surgery. Caregivers were not included in the study. This study focused predominantly on paper-based literature as an intervention. The Pearson coefficient was used in the analysis to assess for satisfaction; although this is appropriate, it is not as robust in terms of statistical significance.

To test the effectiveness of a six-week, web-based, multiple health behavior change program called Surviving and Thriving With Cancer (STC) for adult cancer survivors

STC was a six-week online patient education course with modules on nutrition, changes in body, sleep, and other side effects associated with cancer treatment recovery. Nine online cohorts consisted of 20–25 survivors. Sessions had 30–35 webpages of material geared toward skills building with specific content to build self-efficacy. Each week, users identified a health behavior to change and were guided to set realistic, achievable goals. Action plans were posted in a discussion center where two trained cancer survivor facilitators provided feedback and help. Participants were prompted at the middle and end of the week via an automated message to update progress and give feedback to other participants. The website contained components called \"Discussion Center,\" \"My Tools,\" \"Post Office,\" and \"Help.\" The discussion center facilitated social networking through four threaded bulletin boards: action planning, problem solving, difficult emotions, and celebrations. Randomization occurred by groups of 40–50 participants after the completion of baseline a questionnaire. Half were assigned to treatment and half to a wait-list control group. Data collection occurred at baseline and after six months during follow-up.

• N = 352  
• MEAN AGE = 49.3 years (control); 52.4 years (intervention)
• MALES: 16% (control); 20% (intervention), FEMALES: 84% (control); 80% (intervention)
• KEY DISEASE CHARACTERISTICS: Adult cancer survivors recruited online, though referrals, or by mailings; 18 years of age or older; after completion of primary cancer treatment at least four weeks prior but not more than five years before joining the study; diagnosis with only one cancer and no recurrence; access to the Internet; ability to read English
• OTHER KEY SAMPLE CHARACTERISTICS: 85%–89% Caucasian; 83%–84% breast cancer (early stage); majority were healthy; highly educated and well-adjusted

• SITE: Multi-site
• SETTING TYPE: Other
• LOCATION: Recruited from oncology clinics, a tumor registry, and online mechanisms such as Facebook and the Association of Cancer Online Resources

• PHASE OF CARE: Late effects and survivorship

Randomized, controlled, delayed-treatment design

• Demographic and clinical information
• Brief Fatigue Inventory (BFI)
• Women’s Health Initiative Insomnia Rating Scale (WHIIRS)
• Godin Exercise Questionnaire
• The Block Food Frequency Questionnaire (number of servings of fruits and vegetables per week)
• Patient Health Questionnaire (PHQ-8)

In total, 303 survivors completed the follow-up survey (six months after completion of the baseline survey), and participants in the intervention arm reported significantly greater reductions in insomnia and greater increases in minutes per week of vigorous exercise and stretching compared to patients in the control arm. Compared to the control group, the intervention group experienced an improvement in insomnia from baseline to six months 9.6–9.2 versus 9.6–10.1 (p = 0.03). There were no significant changes in fruit and vegetable consumption or other outcomes.

The intervention affected insomnia and exercise; however, the majority of the sample met or exceeded national recommendations for health behaviors and were not suffering from depression or fatigue at baseline. Participants’ ability to make substantial health behavior changes may have been limited.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (sample characteristics)
• Measurement validity/reliability questionable
• Findings not generalizable
• Subject withdrawals ≥ 10%
• Other limitations/explanation: Roughly 14% of participants who were randomized did not provide any data at six months (but groups did not differ). Sixty percent of the interested participants were highly educated and were recruited from online social networking sites, suggesting that participants were active on the Internet. Therefore, the sample characteristics may bias the results. Overall, the participants were healthy and well-adjusted with little to no need for significant changes in their health behaviors. The majority of participants were Caucasian (87.2%) and female (82.1%), limiting generalizability. A significant difference in age was found among the treatment and wait-list groups. The mean number of sessions logged on at least once was 5.3 (SD = 1.28, range = 0–6), and 67% of participants attended all six sessions, which may have affected the outcomes. Health behaviors were self-reported, and there may have been over- and underestimation of exercise and fruit and vegetable intake because of social desirability or recall bias. The significance level was not adjusted for the multiple comparisons of numerous outcomes.

Web-based interventions are relevant for people who are not near facilities that could offer face-to-face interventions. Health behavior change interventions are relevant for cancer survivors, so continuing to test and refine interventions is imperative in the area of cancer survivorship.

To determine the effect and preferred dose of polyethylene glycol 3350 (PEG3350) in children with functional constipation.

Patients were randomly assigned to placebo or PEG at different doses that were identical in appearance. Dosage groups were 0.2, 0.4, or 0.8 g/kg per day. Patients took the medication for two weeks. Patients in both PEG and placebo groups also underwent behavior modification. Patients returned for evaluation after seven and 14 days of medication.

• The study reported on a sample of 103 healthy patients with functional constipation.
• Mean patient age was 8.5 years (SD = 3.1).
• The sample was 34% female.

• Multi-site
• Outpatient
• United States

The study has clinical applicability for pediatrics.

This was a double-blind, placebo-controlled, prospective, randomized study.

• Diary (parents)
• Physical examination
• Laboratory (chemistry, serum osmolarity, and liver function tests)
• Printed calendars (pediatrics with stickers)

• More patients taking PEG had bowel movements compared with the placebo group (p = 0.026), but no difference existed among the PEG dose groups in terms of one dose being better than another.
• Patients in the PEG groups had more stools than those in the placebo group (p = 0.017).
• Response rates were not significantly different between children aged younger than 8 or older than 8.
• Patients in the PEG groups had other benefits such as improved stool consistency and less straining.
• The treatment was well tolerated.

PEG is a well-tolerated, effective treatment for chronic constipation in healthy children.

• The study only lasted for two weeks.
• A behavioral modification given as part of the collection process in which children received positive and negative reinforcement could have influenced the results.
• The sample was healthy children; application in children with cancer is not clear.

This well-done study demonstrated the usefulness of PEG in the management of constipation for healthy children. PEG may be useful for children with cancer, but this specific application has not been studied.

To evaluate the efficacy of a smoking cessation medication in controlling symptoms of hot flashes in patients with breast cancer receiving hormonotherapy

In the first phase of this crossover clinical trial, the intervention group received bupropion 150 mg for three days and 300 mg during the rest of the four-week period. The control group received placebo in the same four weeks. After one week of washout time, the groups were combined and crossed over to receive the same dose as the intervention or placebo at the beginning for four more weeks. The study was 10 weeks in length for both groups.

• N = 55  
• MEAN AGE: 49 years (33–71 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Women with breast cancer undergoing hormonal therapy, with seven or more hot flashes per week
• OTHER KEY SAMPLE CHARACTERISTICS: Not tumor disease, already completed active treatment at least three months prior

• SITE: Single site  
• SETTING TYPE: Not specified   
• LOCATION: Foundation School of Medicine, Sao Paulo, Brazil

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Elder care, palliative care

• Double-blinded clinical trial
  • Randomized, placebo-controlled, crossover, pilot

• A daily diary on the number and severity of hot flashes
• ASEX scale to assess sexual function
• Beck Depression Inventory (BDI)
• Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
• Blood pressure and heart rate to evaluate physical signs

The reduction in hot flashes for the intervention group was 1.26 per day, without any difference in sexual function occurring nor statistical significance of side effects experienced between groups.

There was no activity shown for bupropion over placebo for control of hot flashes.

• Small sample (< 100)

Bupropion is not recommended in practice for women with breast cancer. It was not statistically significant in controlling the symptoms of hot flashes in comparison with the placebo group.

To evaluate the psychological, endocrine, and immunologic effects of a relaxation and visualization therapy (RVT) in breast cancer patients undergoing radiotherapy

Investigators randomly assigned participants to one of two groups: the relaxation visualization (RVT) group or the control group. The RVT intervention consisted of 30-minute structured group sessions led daily by a trained investigator. Each RVT session took place immediately following radiation. Subjects were also instructed to perform the RVT exercise at home twice a day, with the aid of a telephone-call reminder and a tape. The RVT intervention occurred daily for 24 days. The control group received radiation only. Investigators obtained psychological assessments as well as blood and saliva samples at baseline and after the 24-day intervention.

• The sample was composed of 34 participants; 20 in the experiment (RVT) group and 14 in the control group.
• Mean patient age in the control group was 50.07 years (SD = 2.68 years); the age range in the control group was 36–70 years.
• Mean patient age in the RVT group was 54.20 years (SD = 1.24 years); the age range in the RVT group was 45–65 years.
• Investigators discovered no significant differences between groups in regard to any of the demographic variables, including age.
• All the participants were female; all had stage I or II breast cancer, and all were receiving radiotherapy.

• Single site
• Outpatient
• Brazil

Active treatment

Prospective randomized trial design with randomization and repeated measures

• Lipp Inventory of Stress Symptoms for Adults (ISSL)
• State-Trait Anxiety Inventory (STAI)
• Beck Anxiety Inventory (BAI)
• Beck Depression Inventory (BDI)
• Structured clinical interview to assess psychosocial variables
• Neuroimmunologic parameters: salivary cortisol and peripheral blood cells

At baseline the experimental group was significantly more anxious than the control group, according to the BAI and STAI. Within-group analysis for the control group revealed no significant changes in any of the psychological scores over time. However, the experimental group demonstrated significant declines in levels of stress, anxiety, and depression over time (p < 0.05 for all measures). Interestingly, the mean scores relating to the psychological measures of the experimental group, at the post-time point (after completion of the study), were all higher than the mean post- scores of the control group. Cortisol levels and lymphocyte proliferation did not change over time for either group.

The RVT intervention was effective in reducing psychological distress but did not seem to affect the endocrine (cortisol) or immune measures (lymphocyte proliferation).

• The study had a small sample size, with fewer than 100 participants.
• The study had risks of bias due to no appropriate attentional control condition and because participants' levels of anxiety differed.
• All participants had gone without chemotherapy for two weeks, but this may not have been sufficient for complete immune recovery; the study presents no way to ascertain this because it lacks a \"true\" baseline value.

Use of adjunct therapies, such as relaxation and visualization, may help ease the psychological distress associated with cancer and its treatment.

To evaluate the use of morphine as a first-line medication for pain in patients with advanced or metastatic cancer instead of the World Health Organization (WHO) ladder

• N = 60  
• AVERAGE AGE = G1 58.7 years (SD = 12.4 years); G2 57.5 years (SD = 12.7 years)    
• MALES: G1 83.33%; G2 90%, FEMALES: G1 16.67%; G2 10%
• KEY DISEASE CHARACTERISTICS: No specific disease was targeted although there was a high incidence of head and neck cancer. 

• SITE: Single site    
• SETTING TYPE: Inpatient

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Elder care and palliative care 

Retrospective, randomized study

• A confidence level of 95% and a study power of 80% were used. This determined that 30 patients per group were needed.
• In total, 150 patients were screened, and 60 met inclusion criteria.

Twenty-four patients in G1 and 29 in G2 completed the study. There was no difference in patient satisfaction between the groups. There was a higher incidence of adverse effects (i.e., vomiting, nausea, constipation) in G2. This supported what is seen in the literature. These effects were manageable and did not negatively affect quality of life. The study was conducted over three months although the sample was obtained over two years and six months. There were no consistent differences in pain severity between the groups.

This study demonstrated the efficacy of both methods for the reduction of pain intensity in both groups, and that both methods are comparable.

• Small sample (< 100)
• Other limitations/explanation: Double-blinding was not possible.

Morphine as a first-line treatment for patients with advanced and moderate cancer appeared to be acceptable as a treatment for pain. The management of adverse symptoms was manageable and was comparable to traditional therapy.