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Epstein, D. R., & Dirksen, S. R. (2007). Randomized trial of a cognitive-behavioral intervention for insomnia in breast cancer survivors. Oncology Nursing Forum, 34, E51–E59.

Study Purpose

To determine the efficacy of a cognitive-behavioral intervention for treating insomnia in survivors of breast cancer.

Intervention Characteristics/Basic Study Process

Participants were assigned to either a multicomponent intervention with stimulus control, sleep restriction, and sleep education and hygiene or a control intervention with sleep education and hygiene. Participants attended four weekly treatment group sessions (the first session was two hours and the other three were one hour) followed by two weekly 15- to 30-minute individual telephone sessions. Outcomes measures were sleep-onset latency, wake-after-sleep onset, total sleep time, time in bed, sleep efficiency, and sleep quality.

Sample Characteristics

  • The study was comprised of 34 participants in the multicomponent intervention and 38 in the control group.
  • Participants were women older than 18 years with a diagnosis of stage I, II, or III breast cancer and with insomnia of at least three months' duration.

Setting

The study was conducted in university and medical center classrooms.

Phase of Care and Clinical Applications

Patients were undergoing the follow-up phase of care.

Study Design

This was a randomized, controlled trial.

Measurement Instruments/Methods

  • Daily sleep diary
  • Actiwatch®

Results

After the intervention, based on daily sleep diaries, both groups improved in sleep-onset latency, wake-after-sleep onset, total sleep time, time in bed, sleep efficiency, and sleep quality. A between-group difference existed for time in bed. Wrist actigraph data showed significant pre- to postintervention changes for sleep-onset latency, wake-after-sleep onset, total sleep time, and time in bed. When compared to the control group, the multicomponent intervention group rated overall sleep as more improved.
 

Conclusions

A nonpharmacologic intervention is effective in the treatment of insomnia in survivors of breast cancer.

Limitations

  • The study used a selective sample:  the women were primarily white, well educated, and, on average, were diagnosed with cancer six years previously.
  • Recruitment was via an advertisement and support groups; therefore, participants were more motivated to receive treatment.
  • Space was required for group meetings.
  • Actigraphs incurred a cost.
  • The study required a Master’s level clinical nurse specialist in psychiatric-mental health nursing trained in the delivery of the intervention.
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Epstein, J.B., Silverman, S., Paggiarino, D.A., Crockett, S., Schubert, M.M., Senzer, N.N., … Leveque, F.G. (2001). Benzydamine HCl for prophylaxis of radiation-induced oral mucositis: Results from a multicenter, randomized, double-blind, placebo-controlled clinical trial. Cancer, 92, 875–885.

Intervention Characteristics/Basic Study Process

Participants were randomized to receive either benzydamine HCl oral rinse, containing 0.15% benzydamine oral rinse (1.5 mg/ml benzydamine) or placebo, which identical in appearance and taste consisting of the vehicle only (approximately 10% alcohol by volume, menthol, peppermint oil, clove oil, and other flavoring agents).

Patients were to rinse with 15 ml of solution for two minutes, 4–8 times daily, before and during radiation therapy (RT) and for two weeks after completion of RT. If burning or stinging occurred, dilution of the rinse with water at 1:1 or 1:2 was allowed.  

Patients were evaluated before RT, twice weekly during RT, at the end of RT, and 2–3 weeks after RT.

Sample Characteristics

  • The sample consisted of 172 patients, with 84 receiving benzydamine and 88 receiving placebo.
  • Patients ranged in age from 18–80 years old.
  • Patients had been diagnosed with head and neck cancer and were scheduled to receive at least 5000 cGy RT via megavoltage treatment. Patients were eligible if at least two oral sites were included in RT.
  • Patients were excluded if they had Karnofsky performance status of less than 80%, known hypersensitivity to benzydamine or typical nonsterioidal anti-inflammatory drugs, had residual oral or pharyngeal mucositis from previous RT or chemotherapy, or were already on RT and had taken experimental drugs within 30 days of study start.

Setting

The study was conducted at 16 centers in North America (15 in the United States and 1 in Canada).

Measurement Instruments/Methods

  • Mucositis assessment involved evaluating 14 anatomic areas for erythema, pseudomembrane, and ulceration using a 4-point scale ranging from 0–3.
  • Pain in the mouth or throat and pain during meals was assessed on a 7-point categorical self-rating scale ranging from 0–6.

Results

Benzydamine produced a 26.3% reduction in mean mucositis area under the curve (AUC) compared with placebo for overall 0–5000 cGy (p = 0.009).

Pain also decreased as evidenced by a delay in use of concomitant systemic analgesics. Mouth pain showed a 25.8% reduction in AUC (p = 0.064) versus placebo, and throat pain showed a 22.5% reduction in AUC (p = 0.064).

Pain during meals was not effectively reduced.

Conclusions

Benzydamine was not effective in reducing more severe mucositis in patients receiving high, single, daily RT regimens of 220 cGy per day or more.

Limitations

  • The study is limited because of the small sample size.
  • The intervention is not approved by the U.S. Food and Drug Administration.
  • The decrease in pain was not statistically significant.
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Epstein, J.B., Epstein, J.D., Epstein, M.S., Oien, H., & Truelove, E.L. (2008). Doxepin rinse for management of mucositis pain in patients with cancer: One week follow-up of topical therapy. Special Care in Dentistry, 28(2), 73–77.

Study Purpose

To determine the impact of repeated dosing with doxepin rinse over the course of one week in patients with oral mucositis

Intervention Characteristics/Basic Study Process

Patients were instructed to rinse the oral cavity for 1 minute with 5 mL doxepin suspension (5 mg/mL) and then spit it out. Patients were to continue using the rinse as needed, 3–6 times per day, for the following week until their second visit and assessment. Standard of care for mucositis also was used during this time. Subjects used diaries to record analgesic use and mouth rinses.

Sample Characteristics

  • The study reported on 9 patients, 3 women and 6 men, with a median age of 41 years.
  • Patients were receiving radiation therapy, chemotherapy, hematopoietic stem cell transplantation (HSCT), or a combination of these for head and neck cancer.
  • All patients had painful oral mucositis.

Setting

The study was conducted at a single site, outpatient setting in Canada.

Study Design

This was a nonrandomized, unblinded, uncontrolled, open-label study.

Measurement Instruments/Methods

  • Data was compiled in Microsoft Excel. Statistical analysis was conducted using SAS 9.0 for Windows. Frequencies, medians, and ranges were used to report subject characteristics.
  • Oral pain was graded using a visual analog scale (VAS) (0 = no pain, 10 = worst pain). Oral pain when eating and without function was graded prior to oral rinse and at 5 minutes, 15 minutes, 1 hours, 2 hours, 3 hours, and 4 hours following doxepin rinse.
  • A VAS was used to report the taste of the rinse, discomfort, and fatigue.
  • An Oral Mucositis Assessment Scale (OMAS) was used.
  • Patients were asked to record in a diary estimates of their average pain up to four hours after using the rinse.

Results

Statistically significant reductions in pain scores were reported for two hours following doxepin rinse during the initial visit (p < 0.05). Patients recalled that their pain significantly dropped within 5 minutes of rinsing over the week of repeated dosing (p < 0.05). At the follow-up visits, subjects reported statistically significant pain reduction 5 minutes after doxepin rinsing (p < 0.05). No changes were reported in systemic analgesics used during the study week despite the increasing severity of mucositis. No significant differences were found in mucositis scores over time.

Conclusions

Doxepin rinsing in addition to usual oral care produced reduced intensity of pain levels but no apparent difference in mucositis severity. No firm conclusions can be drawn from this extremely small sample.

Limitations

  • The sample size was small.
  • Risk of bias exists because this was not a randomized, controlled, blinded study
  • The standard care protocol, which also was used for oral care, was not described.

Nursing Implications

The doxepin rinse was well tolerated, and the results warrant a larger, randomized, controlled clinical trial.

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Epstein, A.S., Hartridge-Lambert, S.K., Ramaker, J.S., Voigt, L.P., & Portlock, C.S. (2011). Humidified high-flow nasal oxygen utilization in patients with cancer at Memorial Sloan-Kettering Cancer Center. Journal of Palliative Medicine, 14, 835–839. 

Study Purpose

To understand the prevalence of humidified high-flow nasal oxygen (HHFNOx) use at the authors’ institution, and to investigate characteristics related to HHFNOx initiation, discontinuation, and consistency with patient goals of care

Intervention Characteristics/Basic Study Process

In this retrospective study, the characteristics of HHFNOx—Optiflow™—use, including malignancy diagnosis, underlying cardiopulmonary disease, reason for HHFNOx initiation (hypoxia/dyspnea), duration of HHFNOx therapy, reported HHFNOx impact, reason for discontinuation (stable, declined, or expired), and patient outcome were analyzed (discharge/code status). Patients who used the HHFNOx device—Optiflow™—since 2008 were identified via the institution’s database search. Of the 353 patients identified, 183 were randomly selected for analysis. Objective (documented patient comfort and SaO2 on the device, and “step up” and “step down” grading to other oxygen support devices) and subjective (recorded patient and clinician impressions of tolerability) outcomes, oxygen saturation (SaO2), and oxygen interventions pre and post HHFNOx were examined.

Sample Characteristics

  • N = 183   
  • MEDIAN AGE = 67 years
  • AGE RANGE = 20–95 years
  • MALES: Not specified, FEMALES: Not specified
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: The population includes the following malignancies: hematologic (29%), lung (17%), gastrointestinal (15%), sarcoma (6%), head/neck/CNS tumors (5%), breast (4%), and other tumors (24%)
  • OTHER KEY SAMPLE CHARACTERISTICS: HHFNOx was used in the intensive care unit (ICU) in 72% of cases and otherwise in the hospital ward alone or in the post-ICU stay.

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Memorial Sloan Kettering Cancer Center in New York, NY

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Palliative care 

Study Design

  • Retrospective

Measurement Instruments/Methods

  • Oxygen saturation (SaO2) percentile range subsets (e.g., 60s, 70s, and so forth)
  • Recorded patient and clinician impressions of tolerability to HHFNOx
  • Documented SaO2 
  • “Step up” and “step down” grading to other oxygen support devices
  • Documented reasons for initiation or discontinuation of HHFNOx
  • Documented outcome (discharge, vitals, code status)

Results

  • Forty-one percent improved while on HHFNOx, 44% remained stable, and 15% declined.
  • Subjective reports by the patients were well-documented as well as tolerated with seldom complaints.
  • The majority (66%) of patients appeared to benefit indirectly from HHFNOx as it acted as a “step up” or “step down” device between more intensive or invasive forms of ventilation and lower oxygenation.
  • Recorded pre-and post-HHFNOx saturations were maintained within the normal range of 90%–100% SaO2.
  • At time of data abstraction, 44% of patients were alive, 33% died at the institution, and 22% died outside the institution. 
  • Median time of HHFNOx was three days (range = 1–27 days).
  • The majority of patients with DNR status pre (12%) or post (43%) HHFNOx died at the institution (78%).
  • Full-code status patients (82%) were discharged either to home (82%) or to an outside facility (11%).

Conclusions

HHFNOx was effective in the stabilization or improvement of oxygen saturation in the majority of treated patients. Though HHFNOx devices are expensive, they are a more cost-effective oxygen delivery alternative because they may help prevent escalation to more invasive oxygenation (e.g., mechanical ventilation).

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no random assignment)
  • Risk of bias (sample characteristics)
  • Key sample group differences that could influence results
  • The sample included patients with differing goals of care (e.g., curative versus palliative) which would have affected interpretation of effectiveness of the intervention. Distinction between treatment intents are, therefore, not clearly defined because of the limitation of the retrospective design of the study. No data recorded on oxygen support devices after discharge limits the understanding of the role of HHFNOx in discharge planning. Reporting and scoring of dyspnea were not available and, therefore, limits the ability to compare with other studies examining dyspnea and other symptoms. No measurement or report of symptoms of dyspnea exist.

Nursing Implications

HHFNOx seems well tolerated by various malignancies and clinical trajectories and generally safe. The study claims to be the only clinical description of HHFNOx device used exclusively in the cancer population. Users were able to benefit from high flow of oxygen delivery while still being able to eat and drink (as opposed to oxygen delivery via face mask or face tent).

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Enomoto, T.M., Johnson, T., Peterson, N., Homer, L., Walts, D., & Johnson, N. (2005). Combination glutathione and anthocyanins as an alternative for skin care during externalbeam radiation. American Journal of Surgery, 189, 627–631.

Study Purpose

To evaluate if the topical application RayGel (contains glutathione and anthocyanin) decreases radiation dermatitis

Intervention Characteristics/Basic Study Process

Both groups received instruction in standard skin care and used aloe vera gel and vitamin E after treatment. Gel or placebo was applied to breasts one to three hours prior to radiation therapy. The placebo was a water-based gel.

Sample Characteristics

  • The study sample was comprised of 30 female patients with breast cancer.
  • Mean age was 54.9 years (SD = 8.3 years) in the placebo group and 62.5 years (SD =12.2 years) in the RayGel group.
  • Average treatment was 180–200 cGy per day.

Study Design

The study used a prospective, placebo-controlled design.

Measurement Instruments/Methods

  • Skin reactions were evaluated using modified Radiation Therapy Oncology Group skin toxicity scoring.
  • The breast was divided in to nine regions and then each region was assigned a grade (0–4). The score was calculated for each of the nine breast regions by multiplying the grade of skin reaction by the percentage of area within that region. The whole breast score was the sum of the nine regions. A separate score was calculated for the area with the worst degree of skin reaction.

Results

Whole breast severity scores were lower with RayGel at 93.7% versus the placebo at 123%. The difference in the worst site score was not as pronounced; however, the RayGel Group was 14% less than that of the placebo group, at 39.2% and 45.5%, respectively. None of the findings were significant.

Conclusions

RayGel tended to be superior to the placebo, although significance could not be determined because of the small sample size.

Limitations

  • The sample size was small, with less than 50 participants.
  • All patients were using aloe and Vitamin E; use of multiple topical treatments confounds results.
  • Modified Radiation Therapy Oncology Group scoring is difficult to compare with other studies not using modified scoring.
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Engert, A., Griskevicius, L., Zyuzgin, Y., Lubenau, H., & del Giglio, A. (2009). XM02, the first granulocyte colony-stimulating factor biosimilar, is safe and effective in reducing the duration of severe neutropenia and incidence of febrile neutropenia in patients with non-Hodgkin lymphoma receiving chemotherapy. Leukemia and Lymphoma, 50, 374–379.

Study Purpose

The purpose of the study was to demonstrate the activity and safety of XM02 compared to filgrastim for the prevention of chemotherapy-induced neutropenia in patients with non-Hodgkin lymphoma.

Intervention Characteristics/Basic Study Process

Patients randomized in a 2:1 ratio of XM02 to filgrastim for the first cycle of chemotherapy (CHOP or R-CHOP [rituximab added per national guidelines and physician discretion]). All patients received XM02 in subsequent cycles, with a maximum of six cycles; three weeks per cycle. Subcutaneous injections given daily (5 mg/kg per day) for at least five days and a maximum of 14 days. Drug stopped with the absolute neutrophil count (ANC) of  10 x 109/L or greater after nadir was reached (blood samples to evaluate ANC taken within 24 hours prior to start of chemotherapy and then daily from day 2 on in the first cycle and day 5 on in cycles 2–6 until day 15 or until ANC reached greater than 2.0 x109/L). Body temperature measured daily until day 15 or until ANC reached greater than 2.0 x109/L.

Sample Characteristics

  • 92 total patients were in the sample.
  • Age ranged from 18-83 years.
  • For women, were in the XM02 group and 12 were in the filgrastim group.
  • For men, 31 were in the XM02 group and 17 were in the filgrastim group.
  • Patients had aggressive NHL, defined as diffuse large B-cell lymphoma, mediastinal large B-cell lymphoma, follicular lymphoma grade 3, or anaplastic large cell lymphoma.
  • Eligible patients had to be chemotherapy-naïve, have a life expectancy of six months or longer, an international prognostic index score of 3 or lower, an ANC greater than 15 x 109/L, a platelet count greater than 100 x 109/L, and adequate hepatic, cardiac, and renal function for the chemotherapy regimen.

Setting

Multiple inpatient and outpatient settings

Phase of Care and Clinical Applications

Active treatment

Study Design

Phase III, randomized, controlled trial

Measurement Instruments/Methods

  • Duration of severe neutropenia (DSN)    
  • Febrile neutropenia    
  • ANC
  • Adverse events: musculoskeletal and connective tissue disorders (bone pain, arthralgia, back pain, musculoskeletal pain, jaw pain); general disorders and administration site conditions (pyrexia, fatigue, flu like illness); gastrointestinal (diarrhea); nervous system (HA), vascular (hot flush); and blood and lymphatic (anemia)
  • Pharmacokinetics
     

Results

XM02 was found to be pharmacokinetically similar to filgrastim and not statistically significantly different from filgrastim for febrile neutropenia (FN) in cycle 1 (11.1% for XM02 and 20.7% for filgrastim). ANC values in both groups reached a maximum at day 4 and decreased to a nadir on day 9 followed by an increase reaching a maximum on day 11, with a return to day 1 mean values reached on day 21 (similar to other filgrastim studies). Drug-related adverse events were not statistically different between XM02 and filgrastim.

Conclusions

The administration of G-CSFs for the prevention of chemotherapy-induced neutropenia and related adverse events has been proven effective in many trials. Use of XM02 has similar pharmacokinetics, safety, and efficacy compared to the established filgrastim. Other studies show greater efficacy with pegylated filgrastim that requires less dosing than the daily doses of filgrastim. The use of XM02 instead of filgrastrim does not seem favorable based on these results.

Limitations

  • Small sample size (less than 100 participants)
  • This study was sponsored and funded by BioGeneriX AG, the manufacturer of XM02.
  • Filgrastim was only compared to XM02 in the first chemotherapy cycle, then all patients received XM02; yet the results evaluated outcomes throughout the duration of all chemotherapy doses.
     

Nursing Implications

Based on this study alone, nurses can be aware that XM02 for patients 18 and older with aggressive NHL for the risk reduction of neutropenia and related adverse outcomes will be similarly effective to filgrastrim.

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Engels, E.A., Lau, J., & Barza, M. (1998). Efficacy of quinolone prophylaxis in neutropenic cancer patients: A meta-analysis. Journal of Clinical Oncology, 16, 1179–1187.

Search Strategy

DATABASES USED: MEDLINE (1966–1996); the reference lists of retrieved articles also were reviewed.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 18 RCTs
  • TOTAL PATIENTS INCLUDED IN REVIEW: 707
  • KEY SAMPLE CHARACTERISTICS: Patients were undergoing chemotherapy for malignancy (primarily hematologic malignancies). Quinolone prophylaxis was compared with placebo (nine trials) or trimethoprim/sulfamethoxazole (nine trials). The article did not state whether patients received granulocyte colony-stimulating factors.

Results

Without prophylaxis

  • 82% of patients developed fever.
  • 25% of patients developed gram-negative infections.
  • 23% of patients developed gram-positive infections.
  • 55% of patients developed any infection.

Compared with no prophylaxis, quinolone prophylaxis decreased the risk of

  • Gram-negative infections by 79%
  • Gram-negative bacteremia by 77%
  • Microbiologically documented infections by 35%
  • Total infections by 46%
  • Fever by 15%.


Compared with trimethoprim/sulfamethoxazole prophylaxis, quinolone prophylaxis decreased the risk of

  • Gram-negative infections by 70%
  • Gram-negative bacteremia by 68%
  • Microbiologically documented infections by 28%
  • Total infections by 17%.


Quinolone prophylaxis did not affect the rate of

  • Gram-positive infection or bacteremia
  • Fungal infection
  • Clinically documented infection
  • Infection-related death.


The rate of quinolone-resistant gram-negative infections was 3.0%, and the rate of quinolone-resistant gram-positive infections was 9.4% among patients who received quinolone prophylaxis, but no data were provided regarding the rate of quinolone-resistant infections among the control group. Therefore, the effect of quinolone prophylaxis on the rate of quinolone-resistant infections is unknown.

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Eng, C., Mauer, A.M., Fleming, G.F., Bertucci, D., Rotmensch, J., Jacobs, R.H., & Ratain, M.J. (2001). Phase I study of pegylated liposomal doxorubicin, paclitaxel, and cisplatin in patients with advanced solid tumors. Annals of Oncology, 12, 1743–1747.

Study Purpose

To evaluate the effectiveness of pyridoxine to prevent palmar plantar erythrodysesthis (PPE) in patients receiving pegylated liposomal doxorubicin (PLD) (Doxil®) in patients with advanced solid tumors

Intervention Characteristics/Basic Study Process

Patients were receiving a treatment regimen consisting of PLD (doses escalating in dose level 1–4 from 20–40 mg/m2 every 21 days), in combination with paclitaxel (90 mg/m2 in dose level 1, 135 mg/m2 in dose levels 2–4), and cisplatin (60 mg/m2). All patients were given oral pyridoxine 50 mg three times daily on days 2–21 of each cycle. The study occurred from May 1997–March 2000.

Sample Characteristics

  • N = 23
  • KEY DISEASE CHARACTERISTICS: Patients with advanced solid tumors
  • OTHER KEY SAMPLE CHARACTERISTICS: Receiving PLD, paclitaxel, and cisplatin

Setting

  • LOCATION: Department of Medicine, University of Chicago, Chicago, IL

 

Study Design

  • Phase I study

Measurement Instruments/Methods

  • National Cancer Institute Common Toxicity Criteria version 1.0

Results

No episodes of grade 3–4 (dose-limiting) PPE were reported. Grade 1–2 PPE occurred in 4 of 18 patients (22%) who received more than two cycles of chemotherapy, resulting in no treatment-related interruptions or dose reductions.

Conclusions

Incidence of PPE was low in patients who received pyridoxine prophylactically and Doxil 20–40 mg/m2.

Limitations

  • Small sample size
  • This was not a randomized controlled trial.
Print

Emir, S., Erturgut, P., & Vidinlisan, S. (2013). Comparison of granisetron plus dexamethasone versus an antiemetic cocktail containing midazolam and diphenhydramine for chemotherapy induced nausea and vomiting in children. Indian Journal of Medical and Paediatric Oncology, 34(4), 270–273. 

Study Purpose

To determine if the addition of midazolam and diphenhydramine to granisetron plus dexamethasone reduces chemotherapy-induced nausea and vomiting (CINV) in children receiving highly emetogenic chemotherapy (HEC)

Intervention Characteristics/Basic Study Process

Children were randomly assigned to receive one of two regimens on alternating cycles of chemotherapy. The first regimen was granisetron 0.04 mg/kg plus dexamethasone 0.2 mg/kg, and the second regimen was midazolam 0.04 mg/kg, diphenhydramine 2.5 mg/kg, and granisetron 0.04 mg/kg plus dexamethasone 0.2 mg/kg. The intervention drugs were diluted in 100 ml of 5% dextrose and administered via infusion one hour prior to chemotherapy. Patients and nurses tracked CINV symptoms in a daily diary, and CINV symptoms were assessed on day 1 (acute phase) and days 2–5 (delayed phase) of the chemotherapy cycle.

Sample Characteristics

  • N = 23  
  • MEDIAN AGE = 7 years (range = 1–16 years)
  • MALES: 56.5%, FEMALES: 43.5%
  • KEY DISEASE CHARACTERISTICS: Neuroblastoma, germ cell tumor, rhabdomyosarcoma, Ewing's sarcoma, hepatoblastoma, adrenocortical carcinoma 
  • OTHER KEY SAMPLE CHARACTERISTICS: Pediatric; all patients received cisplatin 

Setting

  • SITE: Single-site    
  • SETTING TYPE: Not specified    
  • LOCATION: India

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Pediatrics

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

Daily diary counted a number of observations including
  • Complete response = no nausea and vomiting
  • Partial response = one to two emetic episodes but no rescue therapy
  • No response = more than three emetic episodes or rescue therapy.

Results

In the acute phase, of the children who received the first regimen, 84.4% had a complete response rate compared to 90.3% who received the second regimen (95% CI: 0.78, 96, p = 0.37). Of the children who received regimen 1, 15.5% had a partial response, and 9.6% of those who received regimen 2 had a partial response. In the delayed phase, 64.4% of patients who received regimen 1 had a complete response compared to 51.6% who received regimen 2. Partial response rates were observed in 31.1% of patients in regimen 1 and 41.9% in regimen 2. Failure rates were 4.4% in regimen 1 and 6.45% in regimen 2. Children receiving regimen 2 had more adverse events including hypotension (two patients) and marked sedation (four patients).

Conclusions

The addition of midazolam and diphenhydramine does not improve CINV in children receiving HEC.

Limitations

  • Small sample (< 30)
  • Risk of bias (no blinding) 
  • Measurement/methods not well described

 

Nursing Implications

The addition of midazolam and diphenhydramine does not improve CINV associated with HEC in pediatric patients, and the addition increased the number of adverse side effects children experienced. Nurses should consider different interventions to help control CINV in pediatric patients who are receiving HEC.

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Ell, K., Xie, B., Kapetanovic, S., Quinn, D.I., Lee, P.J., Wells, A., & Chou, C.P. (2011). One-year follow-up of collaborative depression care for low-income, predominantly Hispanic patients with cancer. Psychiatric Services (Washington, D.C.), 62(2), 162–170.

Study Purpose

To examine 18- and 24-month outcomes for patients who participated in the Alleviating Depression Among Patients with Cancer (ADAPt-C) clinical trial, whose aim was to improve access to culturally adapted depression care among low-income, predominantly Hispanic women with cancer

Intervention Characteristics/Basic Study Process

The usual-care group received standard oncology care for patients with depression. Oncologists were free to prescribe antidepressants or mental health care to both groups, and patients were free to use community mental health services. The intervention is adapted from the Improving Mood-Promoting Access to Collaborative Treatment (IMPACT) intervention, which provided collaborative intervention focused on problem solving, health navigation, personalized treatment and monitoring, assessment, and follow-up and education by a specialist. Follow-up occurred by telephone monthly.

Sample Characteristics

  • N = 210 (patients who completed 24-month assessment, 44% of initial study).
  • Mean patient age was 48.7 years (SD = 12.9 years).
  • Males, 11%; females, 89%.
  • Of all patients in the study, 93% were Hispanic; 75% had been in the United States for more than 10 years.
  • Baseline data: 64% of cancers were gynecologic or breast cancers; 28%, stage III or IV recurrent cancer.
  • Mean depression score at baseline was 12.52 (SD = 3.36).
  • Included patients had received a cancer diagnosis at least 90 days prior to baseline and met criteria for having symptoms of depression as stated in eligibility.
  • Patients were excluded if they had suicidal ideation, had a life expectancy of fewer than six months, reported scores greater than or equal to 8 on the Alcohol Use Disorders Identification Test, had recently used lithium or antipsychotic medication, had a score of equal to or less than 2 on the Karnofsky Performance Status Score, or were unable to speak English or Spanish. 

Setting

  • Multisite
  • Outpatient
  • California and southern Florida

Phase of Care and Clinical Applications

  • Phase of care: long-term follow-up
  • Applications: late effects and survivorship
     

Study Design

Randomized control trial, longitudinal 

Measurement Instruments/Methods

  • Patient Health Questionnaire-9 (PHQ-9)
  • Functional Assessment of Cancer Therapy Scale
     

Results

  • The number of reports of receiving treatment for depression declined over time; however, reports of treatment were more numerous in the intervention group. At 12 months, researchers found significant differences (p < 0.001) between groups in regard to use of antidepressant medication, with the intervention group reporting greater use of antidepressant medications.
  • The intervention group reported greater use of counseling at 12 months (p < 0.001) and 18 months (p = 0.001), than did the other group.
  • The number of reports of having had any depression treatment was significantly different in the intervention group at 12 months (p < 0.001) and 18 months (p = 0.001).
  • The intervention group had a 46% decrease in PHQ-9 scores; the usual-care group had a 32% decrease, which was a significant decrease (p = 0.02). The intervention group was significantly more likely to have decreased its PHQ-9 score by 5 points since baseline at 12, 18, and 24 months (p = 0.01, p =0.03, p = 0.02, respectively).

Conclusions

The effectiveness of the psychoeducational components of the intervention is unclear because patients in the experimental group also used antidepressants to a greater degree and received more counseling than did patients in the other group. Evidence does support the conclusion that, in the intervention group, management of depression improved.

Limitations

  • The study had no appropriate attentional control condition.
  • The control group had no attention control, a fact that limits interpretation of between-group differences. 
  • This was a complex and multifaceted intervention; therefore, knowing which component of the intervention had the greatest influence is difficult.
     

Nursing Implications

Collaborative supportive care with symptom monitoring, support, and follow-up can help patients with depression improve their outcomes. Ongoing monitoring and involvement to address depression in patients appears to result in more treatment of depression. Future work is needed to understand which component of this intervention is most effective.

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