To evaluate the efficacy of pharmacologic and nonpharmacologic treatments for depression in patients with cancer

Literature review of works, published through June 2005, conducted by the Supportive Care Guidelines Group (Ontario). Databases searched were MEDLINE, EMBASE, CINAHL, PsycINFO, and the Cochrane Database.

Authors identified seven pharmacologic randomized control trials and four nonpharmacologic trials.

Pharmacologic trials: Three trials detected significant differences (symptom improvement) among treatment groups on a measure of depression. Two compared the antidepressant mianserin to placebo. The third, which compared use of alprazolam to muscle relaxation, found reduction in symptoms of depression with the use of alprazolam. Two studies compared active treatments—fluoxetine versus desipramine and paroxetine versus amitriptyline. They found improvement of symptoms of depression in all groups, with no differences in treatment efficacy. The remaining two trials found no significant differences among patients randomized to fluoxetine versus placebo; however, only low-dose fluoxetine was evaluated in one of the studies, and both studies were for a short duration, only five weeks.

Nonpharmacologic trials: Two of the four studies reported greater improvement in symptoms of depression in the intervention groups rather than in groups with usual care. Interventions included an orientation program with educational information and a multicomponent intervention. One of the remaining studies found that adjuvant psychotherapy did not significantly affect patients’ Hospital Anxiety and Depression Scale (HADS) subscores for depression. The final study found no significant difference among patients receiving cognitive-existential group therapy plus relaxation and those receiving relaxation therapies alone.

The evidence of treatment effectiveness for depressive disorders in patients with cancer is limited and of modest quality.

At present, treatment guidelines must be based on limited evidence and on data derived from the general population, other medically ill populations, and on expert opinions.

To assess the effect of leptospermum honey as a primary dressing for managing wounds with radiation-impaired healing

The cases involved patients who experienced fragile friable areas of damaged skin that did not respond to conventional treatment. Patients 1, 2, and 4 had long-term effects from radiation therapy treatment received several years or months earlier. Patient 3 experienced short-term effects from radiation therapy treatment received immediately before referral. Dressings to suit the condition of the wound had been applied before referral. The study product, Medihoney Antibacterial Honey is a mix of gamma-irradiated, sterile Australian and New Zealand leptospermum honeys, licensed in the United Kingdom and indicated for use in chronic wound care.

• The study examined four cases.
• Age ranged from 63–93 years.
• Three patients were female and one was male.
• Patient diagnoses were local cord carcinoma, squamous cell carcinoma of left cheek, ductal carcinoma of the left breast status postmastectomy, and vulvar cancer.

The study took place at the Wound Clinic in a United Kingdom hospital.

The study used a case series design.

• No tools were used to measure outcome.
• Progress report was descriptive with photographs of the patients’ progress.
• No pain measurement tool was used.

In all cases, a change from conventional dressings to the topical application of honey was followed by a noticeable improvement in healing. No adverse events were observed and even though one patient had type 2 diabetes, daily honey applications to her wound had no adverse effect on her blood sugar levels. All patients readily accepted honey as a dressing for their wounds.

No adverse events were reported. Honey as an adjunct to conventional wound and skin care post radiation therapy shows promise for less painful healing in these chronic wounds. Prospective, randomized, controlled clinical studies are needed to confirm these observations.

• The study was very small, with less than five cases.
• No recognized pain scale was used.
• Vehicle or dressing type was not consistent for honey application.
• Multiple other products were used in conjunction with the honey for wound care.

To determine whether a larger trial using acupuncture and acupressure therapies would be feasible.

Patients were randomized into three groups. The acupuncture group received three 20-minute sessions per week for two weeks using the same points. The acupressure group was taught self-treatment techniques for the same points. Pressure was held for one minute every day for two weeks. The sham group was taught to hold pressure on three points not related to energy for one minute each day for two weeks.

• Mean age was 54 years.
• Patients were reported as being “predominantly female.” 
• Patients were at least one month from completing chemotherapy and reported a fatigue score of at least 5 on a 0-to-10 scale.

Not reported

The study was a randomized, controlled trial.

• Patients completed the Multidimensional Fatigue Inventory (MFI) before randomization, at the completion of treatment, and two weeks after.
• Patients in the acupressure and sham groups also filled out a diary reporting whether they had applied pressure to the points each day.

Improvements were noted in fatigue scores in the acupuncture and acupressure groups in general fatigue, physical fatigue, reduced activity, and motivation. The sham group showed no significant improvements.

The use of acupuncture may be helpful for fatigue. Because such little data was provided, it is difficult for readers to make this same conclusion. The report of significant improvements was not cited with statistical methodologies. A larger, multicenter trial is needed.

• The study examined a small, homogenous population with limited data collection.
• The results were poorly reported.
• The implementation of these two treatments in practice may be difficult for smaller institutions.

To determine the effect of antifungal prophylaxis on all-cause mortality, invasive fungal infections (IFIs), and adverse events in patients with cancer treated with chemotherapy or hematopoietic stem cell transplantation (HSCT).

Databases searched were PubMed (January 1966–January 2007) and the Cochrane Library (CENTRAL) (through 2007).  Conference proceedings in oncology, hematology, and infectious diseases were also searched. The references of all included trials and reviews were searched for additional studies.

Search keywords were neutropenia, chemotherapy and similar, specific antifungals or antifungal and similar, and prophylaxis and similar.

The authors included studies that were randomized, controlled trials comparing a systemic antifungal drug with placebo, no intervention, or other antifungal agents for prophylaxis of fungal infections in afebrile patients with cancer after chemotherapy or hematopoietic cell transplantation (HCT).

Studies were excluded if they lacked a randomized, controlled design or used empiric or pre-emptive antifungal therapy.

• One hundred twenty-four studies were initially reviewed.
• Sixty-four studies were included in the report.
• Study quality was evaluated using the Oxford scale.

• The total sample size comprised 64 randomized, controlled trials. 
• The sample size across all included studies ranged from 24 to 889.
• Thirty-five trials included a majority (>70%) of patients with hematologic malignancies (mostly acute leukemia but also lymphoma, chronic myelocytic leukemia in blast crisis, high-risk myelodysplastic syndromes, and multiple myeloma).
• Fifteen studies included patients who underwent bone marrow transplantation.
• Fourteen trials included a mixed population of patients with solid tumors or hematologic malignancies and those who had undergone HSCT.
• Children were included in five trials.

Systemic Antifungals Versus Placebo, No Treatment, or Nonsystemic Antifungals All-Cause Mortality

• In 31 trials that reported all-cause mortality, antifungal prophylaxis decreased the risk of mortality significantly at the end of follow-up (relative risk [RR] = 0.84; 95% confidence interval [CI] [0.74, 0.95]), with no significant heterogeneity (p = 0.46; I² = 0.7%).
• The number of patients needed to treat to prevent one death at end of follow-up was 43 (95% CI, [26, 138], with a control group mortality rate of 15%). 

Subgroup Analysis

• Antifungal prophylaxis resulted in a significant reduction in mortality in allogeneic HSCT (four trials; RR = 0.62; 95% CI [0.45, 0.85]) and autologous HSCT (one trial; RR = 0.27; 95% CI [0.08, 0.9526]).
• One trial, which included 52% autologous and 48% allogeneic HSCT recipients, showed no survival advantage with prophylaxis.
• There was a borderline statistically significant reduction in mortality at the end of follow-up among patients with acute leukemia, mostly undergoing induction therapy (24 trials; RR = 0.88; 95% CI [0.74, 1.06]).
• There was a nonsignificant reduction in mortality in other malignancies (12 trials; RR = 0.83; 95% CI [0.62, 1.11]).  

Specific Antifungals

• Fluconazole prophylaxis reduced early (day 30 posttreatment) mortality significantly (13 trials; RR = 0.78; 95% CI [0.64, 0.95]) and with borderline significance (15 trials; RR = 0.88; 95% CI [0.75, 1.02]) at the end of follow-up.
• Intravenous (IV) amphotericin B significantly reduced mortality at the end of follow-up (two trials; RR = 0.31; 95% CI [0.13, 0.72]).
• Trials in which itraconazole was administered as oral suspension demonstrated a significant reduction of documented IFIs (RR = 0.58; 95% CI [0.34, 0.98]) and of documented candida infections (RR = 0.35; 95% CI [0.14, 0.84]) in the itraconazole group. In this subset of trials, there was a trend toward more invasive aspergillus infections in the fluconazole arm (RR = 1.35; 95% CI [0.82, 2.21]).
• The RRs for the indirect comparison of fluconazole versus itraconazole for mortality was 1.0 (22 trials; 95% CI [0.67, 1.33]); the same comparison for IFIs was 0.68 (27 trials; 95% CI [0.18, 1.19]).

Fluconazole Versus IV Amphotericin B

• Three trials (two included patients undergoing HSCT and one included patients with acute leukemia) compared oral fluconazole versus low-dose IV amphotericin B (0.2 mg/kg once daily or 0.5 mg/kg three times a week), and no difference was noted in all-cause mortality, fungal-related mortality, any (documented, probable, and possible) IFIs, documented candida or aspergillus infections, and superficial fungal infections.
• Fluconazole resulted in a significant reduction of documented IFIs (RR = 0.49; 95% CI [0.28, 0.86]).
• There were more adverse events in the amphotericin group, necessitating discontinuation of the drug (RR = 6.67; 95% CI [2.6, 16.7]).

Posaconazole Versus Fluconazole or Itraconazole

• Two studies compared oral posaconazole with oral fluconazole or itraconazole (itraconazole in a small subgroup in one trial; 58 of 298 patients in the non-posaconazole arm) in patients with acute leukemia undergoing induction chemotherapy and patients after HSCT with graft-versus-host disease.
• The use of posaconazole compared with fluconazole or itraconazole resulted in a reduction in all-cause mortality of borderline statistical significance (RR = 0.77; 95% CI [0.59, 1.01]).
• When posaconazole was compared with fluconazole alone (data provided from the author), there was a significant reduction in all-cause mortality (RR = 0.74; 95% CI [0.56, 0.98]).
• Posaconazole prophylaxis also resulted in a significant reduction in fungal-related mortality (RR = 0.25; 95% CI [0.11, 0.57]) and in documented or probable IFIs (RR = 0.47; 95% CI [0.3, 0.74]).
• Posaconazole prophylaxis yielded a significant reduction in documented invasive aspergillus infections (RR = 0.22; 95% CI [0.11, 0.42]).
• There was no difference in the prevalence of adverse reactions causing discontinuation of the study drug (RR = 0.88; 95% CI [0.66, 1.17]).

Fluconazole Versus Antifungals with Antimold Activity

• There was a trend toward higher all-cause mortality with fluconazole (12 trials; RR = 1.14; 95% CI [0.95, 1.37]), which originated mostly from the comparison with posaconazole (two trials) and micafungin (one trial).
• Compared with antifungals that have antimold activity, fluconazole was associated with a significantly higher rate of fungal-related mortality, any IFI, and IFIs caused by the aspergillus species.

Other Trials

• Seven trials compared two regimens of systemic antifungals—comparisons that were not repeated in other trials.
• In patients undergoing HSCT, micafungin prophylaxis was superior to fluconazole in overall success rate, with no difference in mortality, and the combination of micafungin and fluconazole versus fluconazole alone showed similar efficacy. 
• A comparison of a low dose (200 mg) versus a high dose (400 mg) of fluconazole resulted in comparable efficacy. 
• In patients with high-risk acute leukemia, voriconazole prophylaxis decreased IFIs at the cost of more adverse reactions when compared with itraconazole.
• One study that compared amphotericin B colloidal dispersion with fluconazole was terminated prematurely because of a high rate of adverse events with amphotericin B colloidal dispersion.
• IV caspofungin and itraconazole provided similar protection against IFIs, and liposomal amphotericin B prophylaxis resulted in similar efficacy as the combination of itraconazole and fluconazole.

Current data support the use of fluconazole, itraconazole suspension, or posaconazole for prophylaxis.

Antifungal prophylaxis in patients with solid tumors and autologous HCT is not recommended. Prophylaxis should be administered to patients with acute leukemia during induction chemotherapy and to other patients with high-risk leukemia.

To determine the effectiveness of transcutaneous electric nerve stimulation (TENS) in management of cancer-related pain and to provide guidance for optimal parameters of TENS for pain relief

Databases searched were The Cochrane Library, MEDLINE, Embase, CINAHL, AMED, PEDro, and PsycINFO. Hand-searching of reference lists of articles retrieved was also done.

MeSH terms were Neoplasms [*complications]; Pain [etiology;*therapy] Randomized controlled trials as Topic; Transcutaneous Electric Nerve Stimulation (TENS) [*methods] Adults; Humans. An extensive listing of search strategies and terms for each database used are provided.

Studies were included in the review if they

• Were a randomized controlled trial (RCT) where the control group was either receiving no treatment or no active stimulation/placebo
• Evaluated TENS administered with a standard device that delivered mono or biphasic electrical currents
• Reported on TENS delivery that provided a strong but comfortable sensation in either the area where pain was present or over nerve bundles proximal to the site of pain
• Reported on adult patients with cancer-related pain
• Reported pain outcomes.

Studies were excluded if they

• Compared TENS with active treatment
• Used percutaneous electrical stimulation
• Evaluated TENS delivered at a reported intensity that was mild or barely perceptible.

The search identified 36 studies from 1975 to 2008, and reference lists identified an additional 7 studies. Only two studies met all inclusion criteria. Study quality was assessed using the Oxford Quality Scale (Jadad scale).

• The final sample of two studies included in the review encompassed a total of 54 patients: 41 entered in one study and 13 in the other.
• All patients were 18 years of age or older and had experienced persistent cancer-related pain for three months or longer.
• One study was done in patients receiving palliative care at the end of life.

The majority of studies initially retrieved from the search were eliminated due to design that was either not an RCT or where clinical results were not reported. No meta-analysis could be done due to the small sample size with final studies included. In one study, TENS was compared to sham TENS in women. The only outcome measure with significant differences between groups was one dimension of a patient satisfaction questionnaire. In the other study, there were no significant differences between groups.

No conclusions regarding the effectiveness of TENS could be made due to the lack of studies that met criteria.

This review was limited by the inclusion criteria that TENS had to be compared to no treatment. The ethics of having such a control or placebo group in patients with chronic pain and in end-of-life care is questionable, and the inability to find enough studies that met this strict criteria is not surprising. Results were inconclusive due to lack of suitable RCTs.

There is little data to demonstrate effectiveness of TENS for cancer-related pain. In patients with chronic pain, the insistence upon a placebo control group in an RCT is not reasonable and appropriate, and such limitations will not serve to advance knowledge in this area. Additional research with adequate sample sizes is needed in this area.

To summarize recommendations for care providers regarding screening and prevention practices for adult autologous and allogeneic hematopoietic cell transplantation survivors.

This was classified as an expert opinion.

Recommended practices were developed by a consensus panel from three major blood and marrow transplantation organizations. Most recommendations were developed from studies (not cited) identifying specific complications and associated risk factors in long-term survivors.

• Patients were undergoing long-term follow-up care.
• The study has clinical applicability for late effects and survivorship. 

Guidelines for the prevention of infection for all transplantation patients include Pneumocystis carinii pneumonia prophylaxis for six months and immunization with inactivated vaccines beginning at one year posttransplantation and annually thereafter.  Other infection prevention recommendations include antibiotic prophylaxis for encapsulated microorganisms during immunosuppressive therapy for chronic graft-versus-host disease (cGVHD), possible antifungal prophylaxis for patients on chronic steroids, adhering to the American Heart Association (AHA) guidelines of antibiotic prophylaxis for oral procedures, cytomegalovirus antigen or polymerase chain reaction testing for allogeneic hematopoietic cell transplantation recipients with chronic immunosuppression or cGVHD, and possible prophylaxis for the herpes simplex virus for those on chronic immunosuppressants for cGVHD. This article also includes recommendations for many other aspects of posttransplantation care. Recommendations are summarized in two tables, one organized by body system and the other organized by time after transplantation.

The authors did not include the sources used to arrive at the consensus recommendations, with the following exceptions:

• Recommendations for prophylactic antibiotics for oral procedures follow the AHA guidelines for endocarditis prophylaxis.
• Recommendations for annual vaccinations follow either the Center for Disease Control guidelines or the European Group for Blood and Marrow Transplantation guidelines.

To evaluate the effects of two topical agents (Biafin and an emulsion made of natural extracts containing Capparis spinosa, Opuntia coccinellifera, and olive leaf extracts) used supportively to minimize radiation-induced erythema and skin reactions using noninvasive instrumental methods  

Patients applied a thin layer of one of the two topical agents twice daily starting the first day of radiotherapy. The topical formulations were not applied within four hours of the radiation session. Skin regions in the radiation field that were assessed were divided into three areas: lateral breast, medial breast, and area under the breast. For each skin region, skin reaction was evaluated by an instrumental erythema index obtained from non-invasive reflectance spectrophotometry and recorded once per week. Visual assessment regarding erythema, edema, desquamation and ulceration of each region was performed in weekly inspections using the Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC) scoring system. Photo documentation of treated skin was done to verify the RTOG/EORTC visual score.

• The study sample (N = 68) was comprised of female patients with breast cancer.   
• Mean age of the sample was 50 years, with a range of 38–65 years.
• Patients were undergoing radiation therapy after breast-conserving surgery.
• Patients were excluded from the study if they showed signs of cutaneous disease (rash, bleeding, ulceration or unhealed scar) or had an allergy or sensitivity to the formulations.
   

The study took place at the Department of Radiotherapy at Humanitas Centro Catanese di Oncologia in Italy.

Patients were undergoing active treatment for cancer. The study has clinical applicability for late effects and survivorship.

The study used a double-blinded, computer-generated, randomized design with nontreatment control groups monitored over eight weeks.

• Weekly reflectance spectrophotometry-noninvasive instrumental method was used, with skin reactions measured via light reflectance instrument, and erythema index measured.  
• Weekly RTOG/EORTC visual score was used to grade acute toxicity of radiation-induced skin erythema.
   

The 68 patients were randomized as follows: 26 subjects randomly received treatment A (the topical emulsion made of herbal extracts), 24 patients received treatment B (Biafin), and 18 subjects received no treatment. A significant increase in erythema index was seen in the nontreatment group after the second week of radiation, with maximal values recorded between weeks 4 and 6 of treatment. Formulation A was significantly more effective than B in preventing or reducing radiotherapy-induced skin reactions (p < 0.05). The modified RTOG/EOTRC visual score system showed that both treatment A and treatment B were effective against the development of erythema in comparison with the nontreatment group (p < 0.01). There was no significant difference in the RTOG/EOTRC visual score system between treatment A and treatment B in reducing skin erythema induced by radiation therapy.

Use of topical emollients at the onset of radiation therapy and throughout treatment twice per day is effective at reducing the appearance of skin erythema for patients with breast cancer undergoing radiation therapy. Patients not using topical emollients at all during radiation treatment results in increased erythema and desquamation in irradiated skin areas. The use of reflectance spectrophotometry showed that early erythema could be reduced with the application of topical emollients.

• The sample size was small, with less than 100 participants.
• The study was done in Italy. It is not clear that U.S. institutions routinely use reflectance spectrophotometry to measure skin reactions from radiation therapy. The feasibility of using this method is not known.
• The article doses not describe who was performing either the visual assessments or the reflectance spectrophotometry. The training of personnel or staff used for these assessments is not known.  
• The study took place at a single site.
• It is unclear if the herbal extract blend is reproducible.
   

The use of topical agents applied to radiated skin fields at least twice per day throughout treatment is more effective than no treatment at all to reduce the incidence of skin reactions and early erythema. The research study article supports the use of topical agents containing ingredients that can provide protective effects against skin damage incurred during radiation therapy. The reduction of skin irritation with the use of Biafin or herbal extracts supports recommendation of the routine use of topical emollients for all patients receiving radiotherapy who have the potential for skin reactions with treatment.

To determine the efficacy, tolerability, and patient satisfaction with treatment for breakthrough pain with sublingual fentanyl citrate and oral morphine

Patients were allocated consecutively to receive either oral morphine or sublingual fentanyl. Doses were adjusted individually until an effective dose was obtained. Effective dose was defined as the dose needed to achieve a 50% pain reduction in each breakthrough episode. Patients maintained a pain diary. Side effects were assessed by a physician who was blinded to group allocations in each visit. Outcomes were assessed at three, seven, 15, and 30 days.

• N = 40
• MEAN AGE = 65.6 years
• MALE: 57%, FEMALES: 43%
• KEY DISEASE CHARACTERISTICS: Multiple tumor types
• OTHER KEY SAMPLE CHARACTERISTICS: Patients were receiving fentanyl, oxycodone-naloxone, hydromorphone, or tapentadol for chronic pain.

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

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

Prospective, double-blinded, two-group trial

• Pain intensity on a 0–10 Visual Analog Scale (VAS)
• Frequency of breakthrough episodes and onset of relief from diaries
• Time required for dose titration
• Questionnaire for adverse effects

Mean pain intensity was consistently lower for those receiving sublingual fentanyl at all time points (p < 0.0001). Sublingual fentanyl gave faster relief onset at all time points with an average of 5–8.5 minutes for fentanyl compared to 15–23 minutes for oral morphine (p < 0.001). The titration period for fentanyl was a mean of 6.6 days compared to 13.3 days for oral morphine (p < 0.001). No patients treated with fentanyl were dissatisfied with treatment compared to 37.5% of those receiving oral morphine who were dissatisfied or very dissatisfied. There were no significant differences in side effects, and the side effects reported were typical of those seen with opioid medications.

The findings of this study showed that compared to oral morphine, sublingual fentanyl citrate had a faster onset and was associated with greater reductions in pain intensity for episodes of breakthrough pain in patients with cancer. It took less time to titrate to an effective dose with sublingual fentanyl.

• Small sample (< 100)
• Measurement/methods not well described
• Measurement validity/reliability questionable
• Other limitations/explanation: The exact methods of measurement of satisfaction were not clear. There was no discussion of any missing data from patient diaries, and the reliability of diary data alone may be questionable.

Sublingual fentanyl was more effective than oral morphine for breakthrough pain in terms of faster onset and greater reduction in pain intensity. In this study, it also was quicker to titrate to the effective dosage with sublingual fentanyl. This study added to the growing body of evidence suggesting superior results with transmucosal opioids for breakthrough pain. Effective pain control is a critical aspect of care for patients with cancer, and the goal in the management of breakthrough pain episodes is the achievement of rapid relief, including the length of time it takes to titrate doses and the length of time for onset of relief. Nurses need to advocate for the most effective interventions to manage breakthrough pain for their patients.

To evaluate the effect of intraperitoneal bupivacaine on postoperative pain in patients undergoing minimally invasive gynecologic surgeries

At the end of the surgical procedure, a single dose of 20 ml of 0.25% bupivacaine was given intraperitoneally. Patients receiving this intervention were compared with historical control subjects who had the same types of surgical procedures. Regimens for postoperative pain management were the same for both groups of patients, including IV fentanyl during surgery and in the postanesthesia care unit, ketorolac until discharge or 24 hours postoperatively, and transition to ibuprofen 600 mg orally every six hours. Oral oxycodone/acetaminophen and IV hydrocodone or hydromorphone was used as needed if oral medications were insufficient. Patient-reported pain scores and narcotic analgesic use were obtained on the day of surgery and for two days postoperatively.

• N = 130   
• MEAN AGE = 57.7 years 
• FEMALES: 100%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: All had robotic or laparoscopic gynecological procedures, 50% of the sample had gynecologic cancer, and a higher percentage of those in the bupivacaine group had cancer.

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

• PHASE OF CARE: Active antitumor treatment

• Retrospective cohort comparison

• 100-point pain visual rating scale
• Medical record documentation of narcotic use (in morphine equivalents)

Median narcotic use was significantly lower in the bupivacaine group on the day of surgery (p = 0.007) and postop day 1 (p < 0.001). On postop day 2, narcotic use in the bupivacaine group was lower, but the difference was not significant. Pain score on the day of surgery was lower in the bupivacaine group (p = 0.05). Pain ratings were also lower on postop days 1 and 2, but differences were not statistically significant.

Instillation of local anesthetic into the peritoneal cavity was associated with improved postoperative pain control among women undergoing minimally invasive gynecologic procedures.

• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Findings not generalizable
• Only minimally invasive surgeries were evaluated. Though authors reported use of a 10-point pain rating scale, data reported appears to be from a 100-point scale.

This study adds to the body of evidence showing efficacy of local anesthetic instillation into the surgical site area for improvement in acute pain control. Nurses can advocate for consideration of this type of approach for acute pain management.

To determine the feasibility and efficacy of an internet-based, cognitive-based therapy (CBT-I) program—Sleep Healthy Using the Internet (SHUTi)—to improve insomnia symptoms in cancer survivors.

To explore whether an internet-based CBT-I intervention would improve fatigue, mood, and quality of life (QOL).

Patients completed preassessment questionnaires and sleep diaries for 10 days over a two-week period. Patients randomized to the intervention group were enrolled in the SHUTi program. They were given nine weeks to complete six interactive core programs, each lasting about 45 to 60 minutes. During the program, they entered daily sleep diary information. The first core, “Overview,” introduced the SHUTi program, and the next two cores, Behavior 1 and Behavior 2, introduced sleep restriction and stimulus control. The “Education” core focused on sleep hygiene, and the “Sleep Thoughts” core helped users identify and restructure faulty beliefs about sleep. Lastly, patients received “Problem Prevention,” which covered relapse prevention. Upon completion, all patients completed postassessment questionnaires and sleep diaries for 10 days. 

• The sample was comrprised of 28 patients (14% male, 86% female).
• Average age was 56.7 years (standard deviation = 11.7 years).
• Patients were cancer survivors of all types who had, on average, completed treatment about four years prior to the study. Of the patients, 46% had stage I cancer and 21% had stage II cancer.
• On average, the patients had completed 17 years of education, were married (79%), and were white (93%).
• Of the patients in the internet group, 100% were women. In addition, 93% of the internet group had a diagnosis of breast cancer, compared to 36% in control group.

• Patients were recruited from postings at a university cancer center and the surrounding community.
• Home  
• Virginia

• Patients were undergoing the long-term follow-up phase of care.
• The study has clinical applicability for survivorship.

The study was a randomized, controlled trial with a wait-list control.

• Insomnia Severity Index (ISI)
• Sleep diary - self-report
• Multidimensional Fatigue Symptom Inventory–Short Form (MFSI-SF)
• Hospital Anxiety and Depression Scale (HADS)
• Social Funcitioning Health Survey (SF-12)

The internet group showed marked improvement in insomnia severity from pre-/postassessment, and the control group showed no significant change (p < 0.01). The internet group ISI score decreased from 17.1 preassessment to 8.2 postassessment (p < 0.01), and control group scores showed no significant changes from preassessment (15.9) to postassessment (14.4). In addition, the internet group showed clinically significant changes, pre-/postintervention, with 64% having clinically significant insomnia preintervention to 14% having clinically significant insomnia postintervention. Postintervention, 50% of internet group scored “no insomnia” versus 14% in the control group. Effect size for insomnia severity, sleep efficiency, sleep onset latency (SOL), and wake after sleep onset (WASO) were all d > .72.

Improvements were also shown in sleep efficiency and SOL for the internet group. No effect was noted in total sleep time, WASO, and time in bed.

Improvements were seen in the internet group's overall fatigue scores over time (p < 0.01), especially when compared to the control, who showed no improvement over time. There were no significant changes in HADS scores or the SF-12 QOL scores over time or between groups.  
 

An internet-based CBT-I intervention is feasible and efficacious in improving insomnia and fatigue in some cancer survivors in a small sample of highly educated, white, married women. 

• The study had a small, self-selected sample.
• A large percentage of the patients were highly educated, white, married women with breast cancer. The study is not generalizable.

There seemed to be excellent response to this intervention in this population. However, a wider study with a more diverse sample is required.