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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.
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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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Ell, K., Aranda, M.P., Xie, B., Lee, P.J., & Chou, C.P. (2010). Collaborative depression treatment in older and younger adults with physical illness: Pooled comparative analysis of three randomized clinical trials. American Journal of Geriatric Psychiatry, 18(6), 520–530.

Purpose

To perform intent-to-treat meta-analyses on pooled data, to compare the effect of collaborative multidisciplinary care on depression in older adults to that received by younger adults

Search Strategy

  • This study did not involve database searches; authors analyzed three randomized trials. Search keywords were not provided.
  • Authors selected trials with similar designs (i.e., similar intervention and measurements).
  • The study provided no information about trial exclusion. One can note, however, that each of the three trials excluded participants for these factors: acute suicidality, high alcohol use scores, recent use of lithium or antipsychotic medications, life expectancy of fewer than six months, and significant cognitive impairment.
     

Literature Evaluated

  • Evaluation involved a no-scoring system applied to three clinical trials. Authors examined reanalyzed pooled data from the trials. The outcome measures were
    • Treatment responses (where a 50% reduction in the Patient Health Questionnaire-9 (PHQ-9) score from baseline was considered a clinically meaningful improvement in symptoms of depression).
    • Major depression (PHQ-9 ≥ 10).
    • Composite scores of quality-of-life subscales (the Short-Form Health Survey).
    • Health care utilization.
  • The three studies employed similar collaborative care as an intervention. The intervention included antidepressant medication, problem-solving therapy, and by-telephone symptom monitoring and relapse prevention by telephone over 12 months. The intervention incorporated personalized multidiscipline collaborative care based on the structured algorithm for stepped care. For example, a clinical specialist in depression communicated with an antidepressant prescriber in regard to a patient’s medication.
  • The control group in all three studies received enhanced usual care. The usual care included standard health system care, patient- and family-focused educational pamphlets on depression, and community resources. However, usual care in the studies differed slightly as the result of differences in setting.
  • In all three studies, data were collected at baseline, 6 or 8 months, and 12 months.
     

Sample Characteristics

  • Samples from the three randomized controlled trials consisted of 1,081 patients with major depressive symptoms and comorbid illness. When combining data, authors excluded patients with dysthymia alone or patients with no depression.
  • Sample range across studies:
    • Study 1: cancer trial, n = 472, age 18 and older
    • Study 2: diabetes trial, n = 387, age 18 and older
    • Study 3: homecare trial, n = 311, age 65 and older.
  • Key sample characteristics:
    • Total sample: age 60 and older, n = 440; age 18–59, n = 641.       
    • Patients had diverse multiple diseases (cancer, diabetes, hypertension, heart disease, kidney disease, etc.).
    • Sites were oncology and primary care safety-net clinics and diverse home healthcare programs.

Phase of Care and Clinical Applications

  • Phase of care: long-term follow-up
  • Clinical applications: late effects and survivorship, eldercare

Results

  • Comparing patients ≥ 60 years to patients 18–59 years revealed no significant differences with respect to reducing depression symptoms (p = 0.18–0.58) or improving quality of life (t = 1.86, df = 669, p = 0.07 for physical functioning at 12 months, and p = 0.23–0.99 for all others).
  • At six months in both age groups, intervention patients had significantly higher rates of a 50% reduction of the PHQ-9 score (older patients: Wald chi [df = 1] = 4.82, p = 0.03; younger patients: Wald chi [df = 1] = 6.47, p = 0.02) and  a greater reduction in major depression rates (older patients: Wald chi [df = 1] = 7.72, p = 0.01; younger patients: Wald chi [df = 1] = 4.0, p = 0.05) than did patients receiving enhanced usual care.
  • There was no significant age-group differences in treatment type or intensity.

Conclusions

Study findings indicate that collaborative depression care in individuals with diverse comorbid illness is as effective in reducing depression in older patients as it is in younger patients, including those in low-income, minority classifications.

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Elliott, E. A., Wright, J. R., Swann, R. S., Nguyen-Tân, F., Takita, C., Bucci, M. K., . . . Radiation Therapy Oncology Group Trial 99-13. (2006). Phase III trial of an emulsion containing trolamine for the prevention of radiation dermatitis in patients with advanced squamous cell carcinoma of the head and neck: results of Radiation Therapy Oncology Group Trial 99-13. Journal of Clinical Oncology, 24, 2092–2097.

Study Purpose

This phase 3 trial was designed to compare an emulsion containing trolamine against usual supportive care within each participating institution.

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to one of three treatment arms:  (a) prophylactic trolamine emulsion, (b) interventional trolamine emulsion, and (c) declared institutional preference.

In both trolamine arms, trolamine was applied at four-hour intervals. Patients were instructed to maintain at least four hours between trolamine and radiation therapy (RT).

Trolamine use was discontinued immediately if an allergic reaction occurred or if grade 3 dermatitis was reported in any area larger than 1.5 cm of confluent desquamation or bleeding in the treatment area.

Sample Characteristics

  • The sample was comprised of 547 patients (79% male).
  • Mean age was 59 years.
  • Patients had head and neck cancer.
  • Approximately 80% of the patients received an RT dose greater than 60 Gy.
  • Of the patients, 53% on study received combined-modality treatment.

Setting

Fifty-one institutions in various states in the United States

Study Design

The study was a randomized, controlled trial.

Measurement Instruments/Methods

  • The primary outcome was the reduction in grade 2 or higher skin toxicity, per National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 2 and the ONS toxicity scoring tool.
  • Secondary outcomes included patient-reported quality of life (QOL).
  • Skin assessments and QOL forms were completed before RT, weekly during RT, and weekly for four weeks after RT.
  • The Spitzer QOL Index (SQOLI) and the Head and Neck Radiotherapy Questionnaire (HNRQ) were used to measure QOL. A higher score indicated greater toxicity and poorer QOL.

Results

  • The rates of grade 2 or higher radiodermatitis were 79%, 77%, and 79% in the prophylactic, interventional, and institutional preference arms, respectively.
  • Rates of grade 3 or 4 dermatitis did not differ, with rates of 25%, 25%, and 23% in the three arms, respectively.
  • Confluent moist desquamation was observed in 7%, 10%, and 8% of patients in the prophylactic, interventional, and institutional preference arms, respectively.
  • Ulceration, hemorrhage, and necrosis were experienced in 2%, 3%, and 1% of the patients in the three arms, respectively.
  • The ONS toxicity score reported a small to moderate amount of moist desquamation in 31%, 28%, and 34% of patients in the prophylactic, interventional, and institutional preference arms, respectively.
  • No significant differences were found in QOL.
  • Fourteen products were reported as standard of care. The most commonly used product was Aquaphor, which was the institutional preference for 39% of the patients.
  • A slightly higher rate of treatment breaks was reported in the institutional arm than in both trolamine arms for current and former smokers, but the breaks on average were shorter.

Conclusions

The results demonstrate no advantage for the use of trolamine in reducing the incidence of grade 2 or higher radiodermatitis or improving patient-reported QOL.

Limitations

  • Absence of patient diaries to record compliance with application directions, the timing and number of applications, and the full amount of product used was a limitation. The product log for this trial was a record of the number of tubes supplied to each participant.
  • The study was not blinded or placebo-controlled, which introduced the possibility that the skin grading and QOL assessments were subject to reviewer and patient bias.
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Ell, K., Xie, B., Quon, B., Quinn, D.I., Dwight-Johnson, M., & Lee, P.J. (2008). Randomized controlled trial of collaborative care management of depression among low-income patients with cancer. Journal of Clinical Oncology, 26, 4488–4496.

Study Purpose

To determine the effectiveness of Alleviating Depression Among Patients with Cancer (ADAPt-C) collaborative care management for major depression or dysthymia

Intervention Characteristics/Basic Study Process

ADAPt-C is collaborative care management developed for low-income and minority patients. The control group received enhanced usual care (EUC). Data collection occurred at baseline, 6 months, and 12 months. The intervention involved semistructured assessment and patient and family education, navigation assistance, behavioral therapy components in weekly sessions, and patient homework. After treatment initiation, patients received monthly telephone contact for up to 12 months, for maintenance and relapse prevention. Medication was used as clinically indicated for psychiatric symptoms. Overall management was based on guidelines, from the National Comprehensive Cancer Care Network, for treatment of depression in cancer patients. 

Sample Characteristics

  • N = 472 participants (242 in the intervention group  and 230 in the control group).
  • Of participants, 49.4% was age 50 or older.
  • Female: 84.5%; male: 15.5%.
  • Participants had diverse cancer types at a variety of stages. Most participants (42.6%) had gynecologic cancer.
  • Adult patients showed evidence of depression or dysthymia after cancer diagnosis.
  • Of all participants, 87.9% were Hispanic.
  • Intervention and control groups differed at baseline in regard to emotional well-being and quality of life. Researchers noted lower well-being in the intervention group.
  • The two groups differed in regard to percentage of foreign-born participants. The greater percentage was in the intervention group (p = 0.04).

Setting

  • Single site
  • Outpatient
  • Southern California

Phase of Care and Clinical Applications

Active treatment and transition

Study Design

Prospective, randomized, controlled trial with simple blinding

Measurement Instruments/Methods

  • Patient Health Questionnaire-9 (PHQ-9) for the diagnosis of major depression and depression severity level
  • Functional Assessment of Cancer Therapy-General (FACT-G)
  • Medical Outcome Study 12-item Short-Form Health Survey (SF-12) for quality of life
  • Brief Pain Inventory (Short Form)

Results

  • From baseline to the 12-month follow-up, 63.2% of intervention patients had a 50% or greater reduction in depression symptoms as assessed by the PHQ-9 depression scale. In comparison, 50% of patients in the EUC group had a 50% or greater reduction (p = 0.01).
  • Researchers noted five-point reduction in the PHQ-9 score: 72.2% of intervention patients versus 59.7% of EUC (p = 0.02).
  • Intervention patients had significantly better quality-of-life outcomes (p < 0.05).
  • At the six-month follow-up, researchers found no difference between groups in regard to depression severity.
  • Intervention patients experienced greater rates of depression treatment (p < 0.0001).

Conclusions

ADAPt-C collaborative care may be a feasible and effective means of reducing symptoms of depression in some cancer patients.

Limitations

  • The study may have had risks of bias due to large attrition (214 participants, or 45% of participants), lack of control over the type of cancer treatments, and the range of time lapses since treatment.
  • The baseline differences in the emotional well-being subscale scores of the FACT-G and SF-12 mental component summary were not adjusted for the main analyses.
  • Cost will be involved in training the team members (e.g., a clinical specialist) and in hiring these personnel.

Nursing Implications

ADAPt-C is a time- and personnel-intensive intervention that requires significant commitment on the part of the patient.

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