To determine the impact of sertraline on executive function and quality of life in patients with advanced stage cancer and depression

At baseline, patients were evaluated for high levels of depressive symptoms. Patients with high levels were assigned to the intervention group. Patients in the intervention group were prescribed sertraline hydrochloride at 25–75 mg daily for 12 weeks. The dose of sertraline was evaluated two weeks after initiation and titrated to a therapeutic level as necessary. All patients were assessed at baseline prior to the initiation of sertraline in the intervention group and at 12 weeks. Participants were restricted from taking medications that might affect their cognitive functioning for greater than three days.

• N = 106
• MEAN AGE = 60.2 years (SD = 12.59 years)
• MALES: 53, FEMALES: 47
• KEY DISEASE CHARACTERISTICS: Stage 3 or 4 gastrointestinal, hematologic, or respiratory cancer; 86% received both chemotherapy and radiation therapy
• OTHER KEY SAMPLE CHARACTERISTICS: The mean educational level of the overall sample was 11.3 years (SD = 4.68 years). 

• SITE: Multi-site 
• SETTING TYPE: Multiple hospital settings
• LOCATION: First Affiliated Hospital of Zhejiang University, Zhejiang Hospital of Oncology, Shanxi Hospital of Oncology, China

Controlled trial with a pre- and post-trial design

• Wisconsin Card Sorting Test (WCST)
• Medical Outcomes Study Short Form survey (SF-36) 
• Hospital Anxiety and Depression Scale (HADS)
• Hamilton Anxiety Scale (HAM-A)
• Hamilton Depression Scale (HAM-D)

At baseline, patients with depressive symptoms had significantly higher scores indicating lower executive functioning than non-depressed patients on total errors, perseverative errors, nonperseverative errors, and categories achieved (p < 0.01), but not failure to maintain set as measured by the WCST. In addition, these patients had greater anxiety (p < 0.01) as measured by the HAM-A and poorer quality of life (p < 0.01) in all eight dimensions measured by the SF-36. At the 12-week follow-up, although patients in the intervention group had decreased HAM-D and HAM-A scores, scores were still significantly higher than in the control group (p < 0.05). In contrast, there were no longer any significant differences in executive functioning between groups. Similarly, because patients in the intervention group had improved scores on the SF-36 (p < 0.05), there were no longer any significant differences in quality of life between groups.

Sertraline may improve executive functioning and quality of life in patients with cancer. This improvement may be mediated by improvements in depressive symptoms.

• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (no appropriate attentional control condition)  
• Measurement/methods not well described
• Findings not generalizable
• Subject withdrawals ≥ 10% 
• Other limitations/explanation: Although participants were restricted from taking medications for greater than three days that might impact their cognitive functioning, it is unclear whether the patients might have been under the influence of those medications during their evaluation. The duration of the intervention effect is unknown because of the lack of long-term (i.e., greater than months) follow-up assessments.

Sertraline may improve executive function and quality of life in patients with advanced stage cancer and depression. However, more research with larger sample sizes, randomized group assignments, and longer follow-up is warranted to determine whether the intervention is effective and sustainable.

To evaluate the acceptability and feasibility of a couples-based coping intervention, Caring for Couples Coping with Cancer (4Cs), and to gather preliminary data on the efficacy of the intervention

A convenience sample of couples received the 4Cs intervention, a couples-based intervention delivered weekly for six weeks by a researcher or therapist to small groups of couples (three to eight). The couples received semistructured instruction using information via didactic instruction, group sharing and group interaction. Sessions were supplemented using the guidebook Live With Love: Hope for the Best, Prepare for the Worst. Assessments were made at baseline and upon completing the six-week intervention.

• N = 117 
• MEAN AGE = Caregivers; 56.8 years (range = 26–76 years), patients; 57.7 years (range = 26–79 years)
• MALES: Caregivers (33%); patients (76%), FEMALES: Caregivers (67%); patients (33%)
• KEY DISEASE CHARACTERISTICS: Gastrointestinal, lung, and urogenital cancers (55.6%, 29.9%, and 11.1%, respectively)
• OTHER KEY SAMPLE CHARACTERISTICS: Stage III and IV cancer; Chinese adult married couples

• SITE: Single site  
• SETTING TYPE: Inpatient  
• LOCATION: China

• PHASE OF CARE: Multiple phases of care

Nonrandomized, pre- and postintervention study

• Cancer Behavior Inventory (CBI-B)
• Dyadic Coping Inventory (DCI)
• Cancer-Related Communication Problems (CRCP-SF12)
• Hospital Anxiety and Depression Scale (HADS) 
• Benefit Finding Scale (BFS)
• Revised Dyadic Adjustment Scale (RDAS)

The 4Cs cancer program for couples was easy to recruit for, had relatively low drop-out rate, and was well-tolerated by the participants. The couples showed significant increases in self-efficacy (p < 0.01), the DCI (p < 0.05), the PCS of SF12 (p < 0.05), and positive emotions on benefit finding (p < 0.05). Participants also experienced a significant decrease in overall CRCP (p < 0.05) and anxiety (p < 0.01).

The 4Cs program was feasible to administer to couples facing cancer and appeared to have preliminary data supporting its benefit for the emotional health and coping of couples dealing with cancer.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no random assignment)

The 4Cs couples-based intervention shows promise for improving couple efficacy, coping, physical health, and positive emotions. Larger, multisite, randomized, controlled trials of this intervention are needed.

STUDY PURPOSE: To explore the existing interventions for spousal couples coping with cancer in terms of type of intervention, contents, approach, and outcome measurements, and to identify directions for the development of interventions

DATABASES USED: Science Citation Index Expanded, PsycInfo, MEDLINE via OVIS SP, CINAHL

KEYWORDS: intervention; program; therapy; cope; coping; cancer; oncology; carcinoma; couple; partner; spouse

INCLUSION CRITERIA: Published in English or Chinese within the four databases searched; couple-based interventions; studies had to focus on couple-based interventions; outcome measures included the patients with cancer and their spousal caregivers

EXCLUSION CRITERIA: Commentaries, editorials, literature reviews, conference proceedings

• FINAL NUMBER STUDIES INCLUDED = 17
• SAMPLE RANGE ACROSS STUDIES: 9–263
• TOTAL PATIENTS INCLUDED IN REVIEW: 1,142 couples
• KEY SAMPLE CHARACTERISTICS: Patients were coping with prostate cancer, breast cancer, or gynecologic cancer; 70% focused on a gender-specific cancer; interventions involved an average of 6.2 sessions, with a range of 1–16 sessions; face-to-face sessions lasted an average of 79 minutes, with a range of 45–120 minutes; telephone contact time lasted an average of 32 minutes, with a range of 20–45 minutes; interventions lasted 8.3 weeks, with a range of 1–24 weeks from the first to last session; follow-up periods of the interventions were immediately post-intervention (n = 5 [29.4%]), eight weeks (n = 1 [5.9%]), 3 months (n = 4 [23.5%], 6 months (n + 1 [5.9%], and 12 months (n = 6 [35.3%]).

• APPLICATIONS: Palliative care

Of the 17 articles reviewed, interventions were focused mainly on patient caregiving and caregiver self-care, usually lasted for six weeks using a face-to-face group mode., and had follow-up around three months. The outcomes measures were grouped into three main dimensions: dyadic appraisal, dyadic coping, and dyadic adjustments. Positive outcomes were reported for these interventions, including improvements in communications, dyadic coping, quality of life of the patients and their partners, psychosocial distress, sexual functioning, marital satisfaction, and caregiver self efficacy. The majority of interventions were delivered to individual couples face-to-face. Attrition rate ranged from 6%–34%, with an average of 20%. Interventions were grouped as skills training (n = 11), counseling (n = 6), and psychoeducation (n = 2). Skills training and psychoeducation were most often provided together.

The findings highlighted the positive outcomes of couple-based interventions that focus on couples coping with cancer. Although all studies focused on the couple's communication and relationship, only 40% focused on the subject of the caregiver's self-care. All of  the intervention studies included in the review reported positive outcomes to some extent, including quality of life, psychosocial distress, sexual functioning, and marital satisfaction of the patients and their partners.

• Heterogeneity of studies included, such as varied types of cancer and differences in delivery of the intervention, is a limiting factor.  
• What phases of cancer care were involved in the studies included is not clear.  
• Cohort studies were included and not differentiated from RCTs.

Future couple-based intervention research should focus on patients with cancer whose spouse is an active caregiver and provide intervention and assessment of both partners as a unit (dyad). Findings from this review show that couple-based interventions had multiple benefits for patients and caregivers. The high attrition rates seen suggest that the most acceptable timing, duration, and method of delivery is not clear. Although benefit was shown, what factors would indicate those couples who would be most likely to benefit from couples interventions is not clear, and findings do not clarify which approaches are most beneficial.

To evaluate the effects of music therapy on anxiety in women undergoing breast cancer surgery

Patients admitted to the hospital for mastectomy were randomly assigned to receive either music therapy or usual care. Patients in the intervention group listened to music they selected through a headphone connected to an MP3 player during their hospital stay. Music was provided twice daily for 30 minutes per session. The total time in the hospital receiving therapy was an average of 13.6 days following radical mastectomy and 18.9 days for chemotherapy. Assessments were done at baseline on the day before surgery, the day before hospital discharge, on second hospital admission for chemotherapy, and on a third hospital admission for chemotherapy.

• The study reported on a sample of 120 female patients with breast cancer.
• Mean patient age was 45 years.
• Most patients (93%) had modified radical mastectomy, and the rest had radical mastectomy.
• Approximately 20% of patients had some college education.

• Single site
• Inpatient setting
• China

Patients were undergoing active antitumor treatment.

A randomized controlled trial design was used.

State Anxiety Inventory

Pretest results showed that patients had moderate to severe anxiety levels prior to surgery. Mean post-test anxiety scores were lower in the experimental group, on the first post-test 4.57 points, and increasing across time to 9.69 points lower at the final post-test (p < 0.0001). Mean anxiety scores declined over time in all patients.

Findings suggest that listening to music can be beneficial in reducing anxiety during treatment for breast cancer.

• The study had baseline sample/group differences of import.
• The study had risk of bias due to no blinding, no appropriate attentional control condition, and sample characteristics.
• Control patients had higher anxiety levels at baseline.
• Usual care was not described. It is not known if all patients received the same type and schedule of chemotherapy, which could have influenced results. Data reported shows that more patients in the control group did not receive as many courses of chemotherapy, so it would appear that some of these patients did not complete all follow-up self reports. Actual sample sizes contributing to the data at all time points were not reported.
• The sample consisted of lower economic group patients in China and may not be generalizable to other cultures.

Listening to music is a simple and low-cost intervention that may be helpful for some patients in reducing anxiety associated with cancer treatment.

To examine the effectiveness of play, consisting of virtual reality computer games, in reducing anxiety and symptoms of depression in children hospitalized for cancer treatment

Children hospitalized for cancer treatment were invited to participate in the study. Patients received 30 minutes of a play intervention, consisting of virtual reality gaming, five days per week. Play was in a small-group setting that included no more than four patients. A historical comparison group was used in the study. Study measures were obtained at hospital admission and at day 7.

• The study reported on a sample of 122 pediatric patients.
• Patient age range was 8–16 years.
• The sample was 53% male and 47% female.
• Most patients had leukemia or lymphoma and were undergoing inpatient treatment.
• At baseline, patients had high anxiety and depression scores.

• Single site
• Inpatient setting
• China

• Phase of care: active antitumor treatment
• Clinical application: pediatrics

 Prospective, single-blind trial with historical control comparison

• State-Trait Anxiety Inventory for Children
• Center for Epidemiological Studies Depression Scale for Children

ANOVA showed a main effect for time, suggesting significantly lower anxiety and depression symptoms in the group that participated in the play intervention. There were no significant differences in baseline scores between groups. In both groups, anxiety scores declined between baseline and day 7.

Play involving virtual reality may reduce symptoms of depression in children hospitalized for cancer treatment.

• The study had risk of bias due to no random assignment and no appropriate attentional control condition.
• Several age groups were involved. The study did not include subgroup analysis, to see if effects varied in different age and education groups.

Findings suggest that use of virtual reality play may help pediatric inpatients being treated for cancer. Further well-designed research in this area is warranted. It is unclear if virtual reality is more effective than other means of distraction.

To compare absolute neutrophil count (ANC) and febrile neutropenia (FN) in patients who receive pegfilgrastim on the same day of chemotherapy versus the next day

Data from a prior randomized, controlled trial was pooled for analysis. The trajectory of ANC and incidence of FN and related events were analyzed.

• N = 192   
• MEAN AGE = 58.9 years (SD = 12.7)
• MALES: 32.3%, FEMALES: 67.7%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Multiple tumor types—most were breast, lung, and non-Hodgkin lymphoma
• OTHER KEY SAMPLE CHARACTERISTICS: Sixty-two percent were at intermediate FN risk, and 38% were at high risk.

• SITE: Multi-site   
• SETTING TYPE: Not specified    
• LOCATION: United States

• PHASE OF CARE: Active antitumor treatment

• Secondary analysis of four phase-II, randomized, controlled trials

• Grade 3–4 FN defined at body temperature greater than or equal to 38.2 degrees Celsius, infection-related hospitalization, or infection related adverse event occurring within one day of grade 3–4 neutropenia
• Common Terminology Criteria for Adverse Events (CTCAE) for neutropenia grade

ANC at nadir was significantly lower in those who received same-day pegfilgrastim (p = 0.003). Time to nadir was slightly lower in those with same-day pegfilgrastim (p = 0.019). ANC at nadir was much lower among those who got same-day treatment (0.27 compared to 0.74 x 10⁹/l, p < 0.001).  Risk of grade 4 neutropenia was higher among those who got same-day treatment (odds ratio [OR] = 0.23, 95% CI [0.1, 0.49]). No significant difference existed between groups in incidence of FN as defined for this pooled analysis; however, the actual incidence was lower among those who received next-day treatment. ANC recovery was faster in those who received next-day pegfilgrastim.

Patients who received pegfilgrastim the day after chemotherapy had less severe ANC suppression and more rapid ANC recovery. No clear differences in incidence of FN were reported.

Initial trials were not designed to capture the incidence of FN and infections, so pooled analysis capability was limited.

This study adds to the body of evidence supporting the administration of pegfilgrastim as recommended, one to three days after chemotherapy.

• Median injections per patient: 4 (1–14) greater than 100K
• If TBI, leuprorelin stopped two months after irradiation
• Leuprorelin 3.75 mg subcutaneous every 28 days (except second administration at 21 days) until finishing chemotherapy and stable platelet count
• Nomegestrol acetate 10 mg days 1–35 and then as needed and combined with leuprorelin in the case of moderate or heavy bleeding  
• Six of 20 received oral contraceptives.
• Four received progestin only; two out of four of these were amenorrheic.

• N = 21 patients enrolled (one not eligible)
• AGE = 16–50 years
• MEDIAN AGE = 33 years
• WOMEN: 100%
• KEY DISEASE CHARACTERISTICS: Leukemia, Hodgkin disease, nonHodgkin lymphoma, or multiple myeloma with or without transplant
• OTHER KEY SAMPLE CHARACTERISTICS: Women undergoing myelosuppressive therapy with platelet nadir expected to be less than 100K. Platelet nadir was less than 20K in 17 patients.

• Efficacy was assessed clinically.
• Failure was defined by the occurrence of bleeding.
• Hormonal efficacy was checked by plasma assay of estradiol, follicle-stimulating hormone, and luteinizing hormone.
   

Nineteen bleeding episodes occurred in 11 patients. Three patients required additional treatment, including additional nomegestrol acetate, methylergometrine, and/or platelet transfusions. Eleven episodes of spotting and six episodes of moderate bleeding not requiring treatment occurred in 10 patients. The majority of bleeding episodes were short with a median of three days (1–23). Seventeen patients had no clinically or therapeutically relevant bleeding. There was no premature termination because of toxicity. There was one subcutaneous nodule at injection site and eight superficial hematomas.

• Seven of 21 patients were terminated early because of TBI (patients without vaginal bleeding) or patient death because of disease progression (3 of 20 patients); one patient of 20 was lost to follow-up.
• Small sample size completed treatment.
• No mention of controlling for comorbidities/other risk factors or actual nadir

To evaluate the efficacy and safety of palifermin in the reduction of oral mucositis (OM) associated with definitive chemoradiotherapy for locally advanced head and neck cancer (HNC)

• Patients were randomized to receive 180 mcg/kg palifermin or a matching IV placebo (consisting of sterile water, 4% mannitol, 2% sucrose, 10 mmol/L histadine, 0.010% polysorbate-20, pH 6.5, and no preservatives). Palifermin or placebo was administered as a bolus injection over 30–60 seconds in eight weekly doses, starting three days before initiation of radiation therapy (RT) and then once weekly after the week’s last RT treatment.
• Medications for mucositis and mouthwash solutions containing chlorhexidine, hydrogen peroxide, or diphenhydramine were not allowed.
• Hematopoietic growth factors were allowed only to manage severe anemia or myleosuppresion.

• The study reported on 188 patients with a mean age of 55.
• The study arm sample was 84% male and 16% female; the control arm was 85% male and 15% female.
• Patients were newly diagnosed with unresected stage III–IVB squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx: no evidence of a secondary malignancy; and planned RT dose of more than 50 Gy to different subsites of the inspected oral cavity and oropahrynx.

The study was conducted in a multi-institutional setting.

Patients were undergoing the active treatment phase of care.

This was a randomized, placebo-controlled study.

• The World Health Organization (WHO) Oral Toxicity Scale was used for grading OM.
• Investigators were all trained uniformly, and the same investigators were asked to assess individual patients serially.    
• Patients reported mouth and throat soreness (MTS) scores with the Oral Mucositis Weekly Questionnaire-Head and Neck Cancer.
• Researchers recorded duration of severe OM, time to onset of severe OM, incidence of greater than or equal to 2 xerostomia at month 4, average MTS scores, opioid analgesic use, incidence of RT breaks of at least five consecutive fractions, and incidence of chemotherapy delays.

The incidence of severe OM was significantly lower in patients receiving palifermin than those receiving placebo (54% versus 69%). In the palifermin arm, the median time to severe OM was delayed, median duration of severe OM was shortened, and the incidence of xerostomia at grade 2 or more was lower, favoring palifermin; however, the differences were not significant after multiplicity adjustment.

Opioid analgesic use, average mouth and throat soreness scores, and chemoradiotherapy compliance were not significantly different between treatment arms.

Adverse events were similar between arms. The most common study drug related adverse events were rash, flushing, and dysgeusia. After median follow-up of 25.8 months, overall survival and progression-free survival were similar between the treatment arms.

There was no mention as to whether the study was blinded to the researchers.

Oral mucositis is a severe complication of treatment for head and neck cancer, and effective treatment strategies are still needed. Although palifermin reduced severe functional OM, its role in the management of locally advanced HNC during chemotherapy remains unclear. Effective treatment strategies to manage OM associated with high-dose chemoradiotherapy still are needed.

To test the feasibility of hypnosis as a preoperative intervention; to explore the effects of preoperative hypnosis on anxiety and pain

Investigators gathered baseline assessments of pain, nausea, vomiting, distress, and anxiety. The hypnosis intervention was a 15-minute scripted hypnotic experience provided, within an hour before surgery, in the preoperative holding area of the operating suite. Investigators collected data and interviewed patients postsurgery. Data pertaining to historical controls were obtained from medical records matched for age, date, and type of procedure.

• The sample was composed of 20 patients.
• The age range of patients was 30–79 years. Authors did not report mean patient age.
• All the patients were female.
• All the patients had breast cancer and were undergoing surgical procedures. Authors do not cite specific procedures.
• Of all patients, 65% were married or partnered and 65% were Caucasian.
• Of all participants, 90% reported previous experience with mind-body techniques: 90% had used prayer, 45% had used deep breathing, and 40% had used relaxation.

• Single site
• California, United States

Active treatment

Prospective pre- and postdesign with historical control comparisons; mixed method

• MD Anderson Symptoms Inventory, condensed and modified
• Measures of physical symptoms
• Assessment of personal preference (Authors developed this assessment to allow a patient to show intervention preference, on a continuum of imagery-hypnosis and other preferences.)

Postintervention measures showed a decrease in anxiety, worry, and nervousness; however, authors did not report significant pre- and poststudy differences. The hypnosis group had a higher prevalence of postoperative pain and nausea than did the historical group.

Providing a hypnosis intervention preoperatively appears to be feasible. Results reported do not provide substantial evidence of the efficacy of hypnosis in preventing postoperative pain and nausea.

• The study had a small sample size, with fewer than 30 participants.
• The study had a risk of bias due to no appropriate prospective control and no blinding.
• Authors did not list the procedures that participants underwent.
• Authors did not describe the timing of postintervention measurement or the method of extracting measurements from medical records.

This study suggests that providing a hypnosis intervention preoperatively can be feasible. The impact of such an intervention cannot be determined from this study.

To evaluate the effects of aluminum- and nonaluminum-containing deodorants

Patients were randomly assigned to use (a) just soap and water, (b) nonaluminum-containing deodorant and soap and water, or (c) aluminum-containing deodorant and soap and water. Low irritant soap was provided to study participants for use, as were both deodorants. The axilla of the breast or chest wall undergoing radiation was assessed weekly. One month after completion of treatment, patients were interviewed to assess their compliance with the treatment assignment.

• N = 285
• MEAN AGE = 55.67 years
• AGE RANGE = 31–88
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer.
• OTHER KEY SAMPLE CHARACTERISTICS: A little more than one-third were obese with a high body mass index. The majority received at least 50 Gy in 25–28 fractions.

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

PHASE OF CARE: Active antitumor treatment

Randomized, controlled, three-arm trial

• Radiation Therapy Oncology Group (RTOG) skin toxicity scale
• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLC-30)
• Hyperhidrosis Disease Severity Scale (HDSS) for underarm sweating
• Visual analog scale (VAS) for assessment of itch, pain, and burning sensation

There were no skin toxicities at two weeks, and at four weeks, less than 5% in all groups had at least grade 2 skin toxicity. At seven weeks, 66.7% of 12 remaining aluminum-containing users, 80% of the remaining 10 nonaluminum-containing deodorant users, and 58.8% of the 17 remaining controls had at least grade 2 toxicity. There was no statistically significant difference in axillary skin toxicity associated with study group, and there were no significant differences among groups in pain, itch, or burning sensation.

This study found no evidence that aluminum- or nonaluminum-containing deodorant use had an adverse effect on axillary skin toxicity during radiation therapy.

• Unintended interventions or applicable interventions not described that would influence results
• Subject withdrawals ≥ 10%
• On follow-up evaluation for compliance, it was found that many patients also used sorbolene cream during treatment.
• One specific brand of deodorant and soap were used, so results may not apply to all available brands.

This study demonstrated that the use of deodorants, including aluminum-containing deodorant, did not adversely effect skin reactions during radiation therapy for breast cancer. Nurses can educate patients that they do not need to avoid using such deodorants during radiation therapy.