The intervention was a six-week, nine-hour weekly group intervention of high (exercise) and low (massage) intensity. “Talking time” also was included. A trained nurse and physiotherapist administered the intervention.

• The study reported on a sample of 91 patients.
• The sample was comprised of a heterogeneous cancer population receiving chemotherapy.

Denmark

A prospective follow-up design was used (one group, pre/post-test).

• Hospital Anxiety and Depression Scale (HADS) – depression and anxiety subscales
• Aerobic capacity

Anxiety and depression scores improved (p < 0.001). Patients who were physically nonactive improved more on the HADS anxiety subscale than those in the active group. Women improved more on the HADS anxiety subscale than men.

• The study was not randomized.
• The study did not include pharmacologic assessment.
• The sample was 70% female.

In cycle 1, 28 patients received irinotecan plus 1,000 mg oral-activated charcoal (AC) plus 25 ml water the evening before irinotecan and then three times per day for 48 hours after, on an empty stomach. In cycle 2, 24 patients received irinotecan without AC.

This study reported on 52 patients with advanced colorectal cancer receiving 125 mg/m² irinotecan weekly for four weeks with two weeks of rest.

This was a prospective, nonrandomized trial; patients served as their own controls.

• Patient diaries were used to record diarrhea frequency and grading using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) and daily loperamide use.
• Research nurses closely monitored compliance with the loperamide regimen (4 mg at first onset of delayed diarrhea and then 2 mg every 2 hours, 4 mg every 4 hours at night, until patient was diarrhea free for 12 hours) by inspection of provided diaries.

• Administration of AC with irinotecan in cycle 1 was associated with
  • Decreased grade 3 and 4 diarrhea
  • Decreased loperamide use
  • Increased irinotecan dose intensity.
• In cycle 1, 7.1% of patients recorded grade 3-4 diarrhea. In cycle 2, 25% of patients recorded grade 3-4 diarrhea.
• In cycle 1, 46.1% of patients recorded grade 0 diarrhea. In cycle 2, 20.8% of patients recorded grade 0 diarrhea.
• In cycle 1, 98% of patients received their planned doses. In cycle 2, 70% of patients received their planned doses.
• In cycle 1, 25% of patients received more than 10 loperamide cycles. In cycle 2, 54% of patients received more than 10 loperamide cycles.

Any statistical comparison in the efficacy parameters defined in the trial would be associated with large confidence intervals.

• The sample size was small.
• Patients acted as their own controls.
• Irinotecan dose reductions and supportive care are complex.

This was an exploratory trial with small patient numbers; results are hypothesis-generating and require additional confirmation in a larger study.

 To examine effects of a standardized cognitive-behavioral educational intervention on quality of life (QOL) of patients and their caregivers

Patients designated one caregiver as their coparticipant in the study. Dyads were randomly assigned to intervention or standard care control groups. Those in the intervention arm received a copy of The Home Care Guide for Cancer and participated in three educational sessions with a trained educator. The first session was up to seven days prior to or on the day of entry into a clinical trial. Two additional sessions were done within the next 30 days. Sessions were used to reinforce learning by focusing on patient- or caregiver-identified problems. Usual care was not described. Data were collected at baseline and at 30, 60, 90, 120, and 180 days.

• The sample included 441 patient/caregiver dyads, with 331 dyads in the intervention group. 
• Mean age for patients and caregivers was 61.5 years.
• The male sample was 44% patient and 31% caregiver; the female sample was 55% patient and 68% caregiver.
• Patients had various types of cancer, with the most frequent diagnoses being gastrointestinal, genitourinary, and thoracic cancers.
• All patients had advanced-stage disease and were enrolled in phase 1, 2, or 3 clinical trials.
• Of the caregiver sample, 49% worked full- or part-time, 55% provided four or less hours of care per day or week, 70% were spouses, 65% had college or graduate school education, and 29% had an annual income greater than $80,000.

• Mutlisite  
• Outpatient setting
• Multiple cancer centers in the United States
   

• Active treatment
• End of life and palliative care
   

A randomized controlled trial design was used.

• City of Hope Quality of Life Instrument    
• Social Problem-Solving Inventory
   

Approximately 25% of dyads in both groups withdrew from the study by their own choice. Among patients, there was a five-point decline (100-point scale) in QOL over six months, with no difference between study groups. Among caregivers, those in the control group had QOL scores decline more than those in the intervention group (p = 0.02), according to reported predicted decline from baseline. Caregivers did not show any significant changes in problem-solving skills over time in either study group. The intervention was associated with a slower rate of decline in spiritual aspect of the QOL measure. Caregivers overall showed a decrease in rational problem-solving skills over time, and there were no significant differences between groups, suggesting that the slower decline in  QOL with the intervention were not likely a direct result of improved problem-solving skills.

Findings show some potential benefits in the intervention group, but as pointed out by the authors, differences were not likely as a result of improved problem-solving skills, which was the emphasis of the intervention. The study does not demonstrate convincing effects of this intervention for caregivers.

• The study did not have an appropriate control group or attentional control. 
• The study sample had a relatively high drop-out rate.
• Several aspects of the report were confusing: Inclusion criteria stated that patients receiving chemotherapy or radiation therapy were excluded, yet all were on clinical trials involving some type of treatment intervention. Treatments received were not stated. There was no description of usual care for the control situation.
• The study had no blinding, so there was associated risk of bias.
• The statistical analysis used was a predictive model, apparently to enable analysis in the face of missing data; however, there was no description of how much missing data there was or the percent of attendance at sessions. Analysis attempts to compare actual findings in controls with predicted results in the intervention group are not reasonable. There was no direct statistical comparison between groups or examination of demographic differences between groups, which could be expected to affect results.
• The control group was much smaller than the intervention group, questioning power of analysis across groups.
• Subjects tended to be highly educated and in a higher socioeconomic group; findings may not be widely generalizable.

The study's drop-out rate suggests that this intervention may not be practical or acceptable because most of these were by individual participant choice. The study does not provide convincing evidence of effectiveness of this intervention on quality of life for patients or caregivers.

This study was conducted to test whether methylphenidate (MPH) treatment would improve neurobehavioral functioning in patients with malignant glioma.

Participants were administered 5 mg of MPH daily, increasing dosage by 5 mg twice daily until a response or dose-limiting toxicity was noted.

• The number of participants was 30.
• The average participant age was 40.3 with a range of 15–70.
• 66.7% of participants were male and 33.3% were female. 
• 76.7% of participants had anaplastic glioma, 20% had glioblastoma multiforme, and 3.3% had medulloblastoma.

The study had a pre- and post-test design.

• Digit Span for attention
• Digit Symbol Substitution Task for graphomotor skills 
• Hopkins Verbal Learning Test for memory
• Controlled Oral Word Association Test (COWAT) for verbal fluency
• Trail Making Test (TMT) Parts A and B for visual attention, motor speed, cognitive flexibility
• Grooved Pegboard Test for motor speed and dexterity
• Beck Depression Inventory (BDI) for depression
• State-Trait Anxiety Inventory (STAI) for anxiety
• Functional Independence Measure (FIM) for functional ability to perform activities of daily living

Objective improvements were observed in psychomotor speed, memory, visual-motor function, executive function, and motor speed and dexterity (all p < 0.05). Subjective improvements in improved energy, improved ability to ambulate, better concentration, and brighter mood were reported.

There was a significant improvement noted in cognition that cannot be explained by improved mood or use of glucocorticoids. The authors suggest that stimulants such MPH improve motivation and drive.

• The study had a small sample size.
• The study was limited to patients with malignant glioma.
• The study did not specify how long each participant was treated with MPH before the post-test.
• There was a lack of long-term follow-up.
• Participants were given variable dosing, so the study cannot recommend one specific dose.
• There was a large variation in patient age. 

• STUDY PURPOSE: To examine the evidence of Chinese herbal treatment in oral mucositis
• TYPE OF STUDY: Systematic review

• DATABASES USED: PubMed, MEDLINE via OVID, Embase via OVID, Cochrane Database, and CNKI
• KEYWORDS: Chemotherapy, chemotherapy-induced, oral ulcer, mouth ulcer, oral mucositis, stomatitis, Chinese herbal medicine, medicinal herbs, Chinese herbs, traditional Chinese medicine, antioxidant, anti-inflammatory
• INCLUSION CRITERIA: All induced oral mucositis treated by Chinese herbal medicine that offered an English or Chinese medicine were included.  
• EXCLUSION CRITERIA: Articles investigating radiochemotherapy-induced oral mucositis were excluded.

• TOTAL REFERENCES RETRIEVED: 686
• EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Only articles that included oral mucositis treated by Chinese herbal medicine were included. Therefore, 632 articles were excluded, leaving 54 articles of which only 18 met the inclusion criteria.

• FINAL NUMBER STUDIES INCLUDED = 18
• TOTAL PATIENTS INCLUDED IN REVIEW: 1, 476
• KEY SAMPLE CHARACTERISTICS: Patients with oral mucositis, based on the World Health Organization Oral Toxicity Scale, who were treated with either a single herb or a combination of herbs involving more than one component

PHASE OF CARE: Active treatment

All reviewed studies reported positive effects of Chinese herbal treatment for chemotherapy-induced oral mucositis.

Additional well-designed RCT studies are needed, especially to look at the mechanism of action for each herbal remedy. Due to poor design in terms of treatment and control groups, it was almost impossible to evaluate which parts of the treatment concepts are responsible for the measured effects in the reviewed trials.

Some studies used more than one herbal treatment with different routes of administration; therefore, it was difficult to determine which agent may have been more effective in treating oral mucositis. In general, most trials had a poor design.

No recommendations for use in clinical practice were made; recommendations were made for further studies. These studies could use placebo capsules or placebo liquids. It also was recommended that future studies decrease the complexity of the treatments in order to determine what treatments were effective.

To compare the benefits of two interventions on anxiety in women after initial treatment for breast cancer

Women were randomly assigned to study groups in cohorts of 12 patients. One group received 15 sessions of a single-component support intervention, and the other received a 15-session group intervention combining support with psychoeducational interventions focusing on problem-solving skills, optimizing communications and use of personal and social resources, and self-hypnosis. Interventions were delivered in group settings by clinical psychologists following a structured manual. Sessions were audio and video recorded for use in clinical supervision as needed. Psychologists delivered only one type of intervention to avoid contamination. Study measures were obtained at baseline and after the intervention. All instruments were used with dynamic tasks through completion of the Mental Adjustment to Cancer (MAC) Scale followed by 12 minutes of self-relaxation and through completion of the Fear of Cancer Recurrence Inventory (FCRI) followed by a 12-minute guided hypnosis exercise.

• N = 159 in ITT, 130 completed the study   
• MEAN AGE = 50.6 years (SD = 10.1 years)
• AGE RANGE = 30–82
• FEMALES: 100%
• CURRENT TREATMENT: Radiation 
• KEY DISEASE CHARACTERISTICS: Women were either receiving radiotherapy or had completed radiotherapy within the past month; 79% had stage 1 or 2 disease.
• OTHER KEY SAMPLE CHARACTERISTICS: Forty-four percent were married or cohabitating, 17% were working full-time, and 66% had a high school or more education.

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

PHASE OF CARE: Transition phase after active treatment

• Randomized, parallel-group trial

• 10-cm visual analog scale (VAS) for anxiety
• Heart rate
• Relaxation strategies questionnaire
• Hospital Anxiety and Depression Scale (HADS)
• Rating of everyday level of anxiety
• Mental Adjustment to Cancer (MAC) Scale
• Fear of Cancer Recurrence Inventory (FCRI) 

A significant group by time effect was observed in the multicomponent intervention compared to controls for state anxiety after self-relaxation (p = 0.006), for anxiety after guided hypnosis (p = 0.013), and for everyday anxiety level (p = 0.005). No differences were reported between groups in HADs scores. Anxiety and depression scores declined over time in both groups (p < 0.001). The item of psychological distress on the FCRI was reduced in both groups over time, with slightly better improvement in the multicomponent intervention group (p = 0.017).

Both supportive and multicomponent interventions were associated with a decline in anxiety and depression scores over time. The findings suggest that the multicomponent intervention was more effective in enabling women to manage their level of anxiety from triggers that could produce anxiety.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Subject withdrawals ≥ 10%  
• No report of any differences existed between groups in general demographic and disease variables that could have influenced the results.

Both supportive and multicomponent psychoeducational type interventions were associated with a decline in anxiety and depression over time; however, determining if these changes were associated with the general supportive atmosphere of the group-based intervention is not possible. Anxiety has been shown to decline over time in general as well, without specific intervention. The findings suggest that the combination of self-hypnosis techniques and psychoeducation may enable individuals to manage their anxiety responses more effectively.

STUDY PURPOSE: To summarize the available evidence regarding the extent to which exercise improves sleep in patients with cancer

TYPE OF STUDY: Meta-analysis and systematic review

• FINAL NUMBER STUDIES INCLUDED = 21
• TOTAL PATIENTS INCLUDED IN REVIEW = 2,077
• SAMPLE RANGE ACROSS STUDIES: 23-301
• KEY SAMPLE CHARACTERISTICS: Sample mean ages ranged from 47-64 years. Varied tumor types were included. Breast cancer was most prevalent. Four studies had a quasiexperimental design.

PHASE OF CARE: Multiple phases of care

Sleep outcomes improved in 10 studies (47.6%). Interventions included home-based programs, supervised exercise, or a combination of these two approaches. Aerobic and resistance exercise were employed individually or in combination. Meta-analysis of 12 randomized, controlled trials showed no significant effect of interventions compared to control groups.

Analysis showed no clear significant effects of exercise interventions on sleep outcomes among patients with cancer.

Evidence from this analysis does not show an effect of exercise interventions on sleep quality. However, a large body of evidence regarding numerous other benefits of exercise for people with cancer exists. The analysis and most research have included patients who do not necessarily have clinical insomnia, so it would not be expected that interventions would improve sleep. Future research needs to be conducted among patients with clinically relevant insomnia.

To compare an APP-based cream and an aloe vera-based gel to determine effectiveness in preventing and treating radiation dermatitis

The side treated with cream or gel was chosen randomly for each patient at the beginning of treatment. The nurse applied aloe vera gel and APP skin cream to the designated study site. Patients were evaluated once during each interval of five treatments and on the last day of treatment by the radiation oncologist. Follow-up examinations were done four to six weeks after completion of radiation therapy, with completion of questionnaires and photographs.

• The study sample was comprised of 45 patients.
• Age ranged from 3–19 years, with a mean of 10 years.
• Of patients in the study, 16 had Hodgkin diseas, 10 a central nervous system tumor, 8 pediatric sarcoma, and 6 neuroblastoma.
• The radiation range was 25.2–67 Gy, with an average total dose of 34.3 Gy.
• Daily fractionation was 1.5–1.8 Gy.

The study took place at St. Jude Children’s Research Hospital in Memphis, TN.

The study used a quasiexperimental design in which patients served as their own controls.

• The primary end point was skin care failure, which included moderate-to-severe dryness, pruritus, erythema, and dry desquamation.
• Skin comfort assessment consisting of 15 items on a four-level scale was completed by the patient or the patient's parent.
• Dermatologic assessment questionnaire of negative items was completed by nursing staff.
• The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (was used.

Some patients rated the APP cream better in terms of comfort and skin dryness. Grouped NCI CTCAE scores were supportive of APP cream (p = 0.004)

APP cream is more effective than aloe vera-based gel for prevention and treatment of radiation dermatitis.

• The applicability to adult patients has not been studied.
• No control group to enable determination of actual effectiveness of either product independently.
• The study had a small sample size, with less than 50 patients.
• Too much variation in time frame for follow-up visits.

To compare an anionic polar phospholipid (APP)–based cream and an aloe vera–based gel to determine their effectiveness in preventing and treating radiodermatitis.

The side treated with cream or gel was chosen randomly for each patient at the beginning of treatment. The nurse applied aloe vera gel and APP skin cream to the designated study site. Patients were evaluated once during each interval of five treatments and on the last day of treatment by a radiation oncologist. Follow-up examinations were done four to six weeks after the completion of radiation therapy (RT).

• The sample was comprised of 45 participants. 
• Average age was 10 years (range 3–19).
• Gender was not listed.
• Patients had Hodgkin disease (16), central nervous system (CNS) tumor (10), pediatric sarcoma (8), and neuroblastoma (6).
• Average total radiation dose was 34.3 Gy (range 25.2–67 Gy). 
• Daily fractionation ranged from 1.5 to 1.8 Gy.

St. Jude Children’s Research Hospital, Memphis, Tennessee

The study used a quasiexperimental design. Patients served as their own controls.

The primary endpoint was skin care failure, which included moderate to severe dryness, pruritus, erythema, and dry desquamation. Skin comfort assessment was completed by the patient or his/her parent and consisted of 15 items on a four-level scale. Dermatologic assessment included a questionnaire of negative items and was completed by nursing staff. The National Cancer Institute (NCI) Common Terminology Criteria (CTC) for adverse events involving the skin used a grade 1 to 5 scale.

Significant differences in specific variables favoring APP cream were noted in some patients, including:

• Skin comfort variables: dry (p = 0.002), soft (p = 0.057), feels good (p = 0.002), rough (p = 0.065), and smooth (p = 0.012)
• Dermatologic variables: dryness (p = 0.013), erythema (p = 0.002), and peely (p = 0.008).

Grouped CTC scores were supportive of APP cream (p = 0.004). In comparing first and last assessments, two dermatologic variables, dryness (p = 0.035) and peely (p = 0.016), favored APP cream. During RT, there was a difference in CTC scores, favoring the cream (p = 0.004). 

APP cream is more effective than aloe vera–based gel for the prevention and treatment of radiodermatitis.

• This was a study on pediatric patients; applicability to adult patients has not been studied.
• The study lacked a control group to enable determination of actual effectiveness of either product independently.
• The study had a small sample size.

To compare analgesic efficacy, adverse effects, need of increasing doses, and quality of life in patients with advanced cancer on morphine, fentanyl, and methadone

To compare the cost of pharmacologic pain management

Patients were randomized to morphine, fentanyl, or methadone. Morphine was offered as breakthrough pain medication at one-sixth of the equianalgesic 24-hour dose. Adjuvants were allowed. If the patient experienced poor opioid response or uncontrolled adverse events, he or she was switched to another opioid. Data were collected at weekly intervals for four weeks.

• The study reported on 108 patients: 36 in the morphine group (22 completed study), 36 in the fentanyl group (25 completed study), and 36 in the methadone group (23 completed study).
• Mean patient age was 59 in the morphine group, 57 in the fentanyl group, and 61 in the methadone group.
• The morphine group had 12 males and 10 females; the fentanyl group had 11 males and 14 females; and the methadone group had 11 males and 12 females.
• Patients had advanced cancer with pain and required first-line opioids for control.
• Patients were excluded from the study if they had liver or renal disease, had cognitive impairment, had less than three months’ survival, were undergoing radiation therapy, were undergoing a new course of chemotherapy, or had prevalent incident pain.
• Patients had mixed nociceptive and neuropathic pain, and breast cancer was the most frequent diagnosis.

• Multisite
• Outpatient setting
• Italy

 The study has clinical applicability for end-of-life and palliative care.

The study was a randomized controlled trial.

• Adverse events (AEs) rated on a 0–3 scale with “0” being not at all and “3” being severe; constipation measured on the number of passages per day
• Pain intensity (PI) scale (0–10)
• Number of daily dose changes to stabilization
• Opioid escalation index (OEI) = OMD–OSD/OSD per day x 100 where OMD represents doses administered at four weeks after study initiation and OSD represents the opioid starting dose at study initiation
• Spitzer Quality of Life Index
• Costs of opioid therapy

A similar number of patients in each group rotated to other opioids. There were no significant differences in the number of days to achieve dose stabilization, nor where there significant differences in the number of dose changes needed during titration. No differences existed in the PI of the three groups. OEI % was highest in the fentanyl group and significantly lower in the methadone group; 14 patients on methadone did not have a dose change, but 8 required a decrease in the dose and then a subsequent increase. There were no significant differences in quality-of-life scores between groups. Methadone was less expensive.

All three opioids were effective in controlling cancer pain in some patients. Adverse event profiles were similar. Methadone was less expensive compared to fentanyl and morphine but required clinical expertise in dosing due to the need to decrease and then increase the dose in some patients.

• The study had a small sample, with less than 100 patients.
• The study used a convenience sample and was not blinded.

Long-acting morphine, fentanyl, and methadone are effective in controlling pain in advanced cancer. Methadone is an option for patients where cost is a concern, but prescribing methadone requires clinical expertise.