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Poonawalla, I.B., Piller, L.B., Lairson, D.R., Chan, W., & Du, X.L. (2016). Impact of hematopoietic growth factors on blood transfusion needs, incidence of neutropenia, and overall survival among elderly advanced ovarian cancer patients treated with chemotherapy. International Journal of Gynecological Cancer, 26, 95–103. 

Study Purpose

To determine the effectives of an erythropoietin-stimulating agent (ESA) and granulocyte–colony-stimulating factor (G-CSF) in reducing blood transfusion needs and neutropenia incidence in community-dwelling older adults with ovarian cancer

Intervention Characteristics/Basic Study Process

Woman aged older than 65 years diagnosed with stage III–IV epithelial ovarian cancer (from January 2000–December 2009) were identified as having received chemotherapy by procedure codes in Medicare within nine months of diagnosis. Cox models were used for analysis and included time-dependent covariates. ESAs and G-CSFs were identified by Healthcare Common Procedure Coding System codes for epoetin-alfa/darbepoetin-alfa and filgrastim/pegfilgrastim. Blood transfusion need was measured from the time of diagnosis to first Medicare claim indicating the receipt of blood transfusion. Neutropenia incidence was measured from the time of the first chemotherapy administration to the first claim of neutropenia. Patients who did not receive a blood transfusion or did not develop neutropenia were censored at the date of death or last date in Medicare claims (i.e., December 31, 2010), whichever occurred first. Overall survival was measured from the time of first chemotherapy administration until death or the end of the follow-up period (December 31, 2011). Patients not experiencing the event (death) by this date were censored.

Sample Characteristics

  • N = 5,572   
  • AGE = Older than 65 years
  • FEMALES: 100%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Stage III–IV epithelial ovarian cancer 
  • OTHER KEY SAMPLE CHARACTERISTICS: Sociodemographics

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Not specified

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care

Study Design

Retrospective cohort study using SEER Medicare linked database

Measurement Instruments/Methods

  • Cox Model
  • Kaplan-Meier curves
  • Propensity scores
  • Logistic regression model
  • Propensity score distribution plots

Results

ESAa were effective in reducing blood transfusion need. G-CSFs were effective in lowering neutropenia incidence and were associated with improved survival in older adults with ovarian cancer. The interaction between ESA time and CSF time was significant (p = 0.0001).

Conclusions

The findings demonstrated that using epoetin-alfa or darbepoetin-alfa effectively lowers the blood transfusion needs by 48%–78% in patients receiving chemotherapy, which is comparable to prior randomized trials of patients with gynecologic and ovarian cancer. The use of a G-CSF was associated with a longer survival compared to those who received at least three doses of a G-CSF. The findings showed that patients who received fewer than three prophylactic G-CSF administrations did not experience better outcomes.

Limitations

  • Risk of bias (no random assignment)
  • Findings not generalizable
  • No ability to look at laboratory data that triggered the use of ESAs and G-CSFs
  • No ability to look at intensity of chemotherapy
  • Potential risk of ESAs or G-CSFs in relation to thrombocytopenia and bleeding events

Nursing Implications

This was a good study; however, it had a very focused patient population and may not be reproducible in the younger population. In addition, no information was provided regarding adverse events related to the use of ESAs or G-CSFs. Prior studies have shown a possible higher risk for mortality with the use of ESAs and G-CSFs. It is important to continue to look at established guidelines (Oncology Nursing Society, American Society for Clinical Oncology, National Comprehensive Cancer Network, Food and Drug Administration) for the use of ESAs and G-CSFs in the cancer population.

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Pommier, P., Gomez, F., Sunyach, M.P., D’Hombres, A., Carrie, C., & Montbarbon, X. (2004). Phase III randomized trial of calendula officinalis compared with trolamine for the prevention of acute dermatitis during irradiation for breast cancer. Journal of Clinical Oncology, 22(8), 1447–1453.

Study Purpose

To assess effectiveness of calendula for prevention of acute radiation-induced dermatitis of grade 2 or higher during radiation therapy compared with trolamine

Intervention Characteristics/Basic Study Process

Patients were randomly allocated to application of trolamine or calendula on irradiated fields after each session. Patients started topical application of ointment at onset of radiation therapy, twice a day or more, depending on occurrence of dermatitis and pain, until completion. Patients were instructed not to use the agent two hours or less before an irradiation session or before treatment evaluation. No other prophylactic creams, lotions, or gels were allowed. Physicians were free to treat established dermatitis grade 2 or higher or allergy as considered appropriate. Clinicians were blinded to the treatment used

Sample Characteristics

  • The study sample was comprised of 254 female patients who were randomized to trolamine (n = 128) or calendula (n = 126) treatment.
  • Age ranged from 26.5–74.5 years; mean age was 56.5 years in calendula arm and 55.1 years in trolamine arm.
  • All patients were post-lumpectomy or post-mastectomy for nonmetastatic breast cancer.
  • Patients received treatment with or without adjuvant postoperative chemotherapy or hormonal treatment.
  • Standard irradiation fractionation (2 Gy per session, five sessions per week) was used.

Setting

The study took place at Centre Leon Berard in Lyon, France.

Study Design

The study used a randomized, blinded controlled trial design.

Measurement Instruments/Methods

  • Acute dermal toxicity was evaluated according to the Radiation Therapy Oncology Group scale.
  • Pain was assessed weekly on a 10 cm visual analog scale.
  • The occurrence, duration, and reasons for interruption of radiation therapy or of allocated cream application were registered, as were allergic reactions and quantity of agents used.
  • At the end of the study, patients completed a questionnaire to assess satisfaction with ease of application, pain, and dermatitis relief.
  • Qualitative measures were compared using Chi Square or Fisher’s exact test, as appropriate.
  • For quantitative measures, the Student’s t test or Wilcoxon-Mann-Whitney tests were used.

Results

The occurrence of acute dermatitis of grade 2 or higher was significantly lower (41% versus 63%; p < .001) with use of calendula versus trolamine. Benefits were most marked at sites at risk of maceration (submammary fold, armpit, and tangential area) and sites with thin skin. Patients receiving calendula had less frequent interruption of radiation therapy. Mean length of treatment interruption was 10 days (range 2–22 days). Fifteen treatment interruptions were observed in trolamine group, 12 due to skin toxicity. No allergic reactions were observed in the calendula group, whereas four patients in the trolamine group developed allergic-type reactions of pruritus and urticaria. Patients receiving calendula had significantly reduced radiation-induced pain. Mean maximal pain evaluated in calendula group was 1.54 and 2.10 in the trolamine group (p = 0.03). Self-assessed satisfaction was greater with calendula. Prevention of erythema was 69% in the calendula arm versus 39% in the trolamine arm. Prevention of pain was 65% with calendula versus 46% with trolamine. Calendula was considered more difficult to apply as noted by 30% of the calendula group versus 5% of trolamine group. The risk of skin toxicity of grade 2 or higher was significantly increased for women whose body mass index was 25 or higher (p < 0.001), who had received chemotherapy before radiation therapy after a lumpectomy (p = 0.01), and who were using trolamine (p < 0.001).

Conclusions

Calendula was shown to be effective in reducing skin toxicity of radiation compared to trolamine.

Limitations

Because of differences in texture, color, and smell, it was not possible to perform a double-blind randomized study.

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Pommier, P., Gomez, F., Sunyach, M. P., D’Hombres, A., Carrie, C., & Montbarbon, X. (2004). Phase III randomized trial of Calendula officinalis compared with trolamine for the prevention of acute dermatitis during irradiation for breast cancer. Journal of Clinical Oncology, 22, 1447–1453.

Study Purpose

To assess the effectiveness of Calendula for the prevention of acute radiation (RT)-induced dermatitis of grade 2 or higher during RT compared with trolamine (Biafine).

Intervention Characteristics/Basic Study Process

  • Patients were randomly allocated to application of trolamine (n = 128) or Calendula (n = 126) on irradiated fields after each session.
  • Patients started topical application of ointment on irradiated skin at onset of RT, twice a day or more, depending on the occurrence of dermatitis and pain, until completion of RT.
  • Patients were instructed not to use agents two hours or less before an irradiation session or before treatment evaluation.
  • No other prophylactic creams, lotions, or gels were allowed.
  • Physicians were free to treat established dermatitis, grade 2 or higher, or allergy as considered appropriate.
  • Clinicians were blinded to the treatment used.

Sample Characteristics

  • The sample was comprised of 254 women (Calendula, 128; trolamine, 126).
  • Mean age was 56.5 years in the Calendula arm and 55.1 years in the trolamine arm (range 26.5–74.5). 
  • Patients were post lumpectomy or mastectomy for nonmetastatic breast cancer.
  • Patients were undergoing treatment with or without adjuvant postoperative chemotherapy or hormonal treatment.
  • Standard irradiation fractionation (2 Gy per session, five sessions per week) was used.
  • Patients who underwent lumpectomy received 52 Gy from two tangential fields to the whole breast with 10 Gy boost to the tumor bed.
  • Patients who underwent mastectomy received 46 Gy to the chest wall.
  • If relevant, internal mammary and supraclavicular nodes were irradiated.

Setting

  • Single site
  • Centre Leon Berard, Lyon, France

Study Design

The study was a randomized, blinded, controlled trial.

Measurement Instruments/Methods

  • Once weekly acute dermal toxicity was evaluated according to the Radiaton Therapy Oncology Group (RTOG) scale.
  • Pain was assessed weekly on a 10-cm visual analog scale (VAS). The occurrence, duration, and reasons for interruption of RT or of allocated cream application were registered, as were allergic reactions and quantity of agents used, until completion of RT.
  • At study end, patients completed a questionnaire to assess satisfaction with respect to ease of application, pain, and dermatitis relief.
  • Qualitative measures were compared to the chi-square test or Fisher exact test, as appropriate.
  • For quantitative measures, Student’s t-test or Wilcoxon-Mann-Whitney test was used.

Results

  • The occurrence of acute dermatitis of grade 2 or higher was significantly lower (41% versus 63%; p < 0.001) with the use of Calendula versus trolamine.
  • Twenty patients given trolamine presented with grade 3 toxicity (p = 0.034).
  • Benefits were most marked at sites at risk of maceration (submammary fold, armpit, and tangential area) and sites with thin skin.
  • Patients receiving Calendula had less frequent interruption of RT. Mean length of treatment interruption was 10 days (range 2–22 days). Fifteen treatment interruptions were observed in the trolamine group; 12 were due to skin toxicity.
  • No allergic reactions were observed in the Calendula group, whereas four patients in the trolamine group developed the allergic-type reactions of pruritus and urticaria.
  • Patients receiving Calendula had significantly reduced RT-induced pain.
  • Mean maximal pain evaluated in the Calendula group was 1.54 and 2.10 in the trolamine group (p = 0.03).
  • Self-assessed satisfaction was greater with Calendula.
  • Prevention of erythema:  69% Calendula versus 39% trolamine.
  • Prevention of pain:  65% with Calendula versus 46% trolamine.
  • Calendula was considered more difficult to apply as noted by 30% of the calendula group versus 5% of the trolamine group.
  • The risk of skin toxicity of grade 2 or higher was significantly increased for women whose body mass index was ≥25 kg/m2 (p < 0.001) and for women who had received chemotherapy before RT after a lumpectomy (p = 0.01), and for those using trolamine (p < 0.001).

Limitations

  • A delivered dose of 61 Gy or less was not identical in the treatment groups, favoring the Calendula group over the trolamine group.
  • Because of differences in texture, color, and smell, it was not possible to perform a double-blind, randomized study. Simple blinding of the clinician removed bias with respect to the main objective of the study.
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Pollak, J.S., Burdge, C.M., Rosenblatt, M., Houston, J.P., Hwu, W.J., & Murren, J. (2001). Treatment of malignant pleural effusions with tunneled long-term drainage catheters. Journal of Vascular and Interventional Radiology: JVIR, 12(2), 201-208.

Study Purpose

The objective of the study was to assess the effectiveness of tunneled pleural catheters in the treatment of malignant pleural effusions.

Intervention Characteristics/Basic Study Process

Initial enrollment of the first one-third of patients (n = 9) involved 2:1 randomization to the newly available and not U.S. Food and Drug Administration (FDA)-licensed PleurX® catheter or chest tube-administered chemical pleurodesis with doxycycline. The remaining 19 patients after October 1997 all were treated with the PleurX® catheter.

Sample Characteristics

  • The study reported on a sample of 28 patients with malignant pleural effusion for a total of 31 hemithoraces (three patients had bilateral hemothoraces) who entered on the study over 53 months.
  • The mean age was 60 years, with a range of 31–85 years.
  • Of the sample, 46% were males and 54% were females.
  • All patients had a moderate-sized, free-flowing pleural effusion without contralateral effusion or previous sclerotherapy or local radiation therapy.
  • Patients must have shown previous improvement with thoracenteses, adequate performance scale (Karnofsky at least 50), absence of chylous effusion, HIV positivity, mediastinal shift, infection in pleural space, prior lobectomy or pneumonectomy on affected side, and presence of hemostatic disorder.
  • Inclusion criteria were loosened to include anyone with symptomatic effusion after the randomization stopped and the Denver PleurX catheter was commercially available.
  • Two patients who had attempted chemical pleurodesis previously and two with loculated effusions were allowed to participate after the Denver PleurX catheter was licensed by the FDA.

Setting

  • The single-site study was conducted in both the inpatient and outpatient setting.
  • All patients were treated by the Interventional Radiology Department.
     

Phase of Care and Clinical Applications

  • Patients were underging the transitional phase of care after initial treatment.
  • The study has clinical applicability for end-of-life and palliative care.
     

Study Design

The study had a prospective convenience sample, with randomization of the initial one-third of patients. The study for the remaining two-thirds of the patients had a nonrandomized prospective design.

Measurement Instruments/Methods

  • Measurement of the type, extent, and response of pleural effusion was validated by computed tomography or frontal, lateral, and decubitus chest radiographs.    
  • Assessment of dyspnea is described, but the instrument or measurement criteria are not described.
  • Complication rate was calculated based upon a researcher-designed list of complications.
  • Need for hospitalization related to placing the catheter was measured.
  • Catheter-related discomfort was measured by patient report of pain.
     

Results

  • All catheters were placed successfully without procedural complication; however, two patients (10.7%) had three late complications. They included external catheter migration (1), tumor tracking along catheter route (1), and infection (1).
  • Follow-up time with catheters ranged from 3–618 days, with a median of 51 days.
  • Dyspnea improvement was seen in 26 of 28 patients (93%), and when including patients with more than one procedure, improvement was 93%. This symptom improvement was enduring and present in 20 of 22 patients (91%) alive at 30 days post-procedure.
  • Persistent control of pleural effusions with a defined drainage regimen based upon the prior drainage was effective in 90% of catheters placed.
  • Spontaneous pleurodesis was achieved in 42% of hemithoraces, with a median time of 19 days (range 7–96 days). Only one patient developed recurrent pleural effusion, and this patient had only one locule of his effusion treated with catheter insertion.
  • Five of 28 patients required additional pleural interventions (successful treatment in 23 of 28 patients [82%]).
  • Five patients required additional procedures to achieve control of the pleural effusion, but the number of complex, chylous, or loculated effusions was limited.

Conclusions

This small, single-site, prospective study of the effectiveness of tunneled pleural catheters showed effective pleural drainage, spontaneous pleurodesis equivalent to chest catheter pleurodesis, reduced days of hospitalization (as the procedure can be safely performed outpatient), reduced distressing symptoms, and rare complications.

Limitations

  • The study had a small sample size of less than 30 patients.
  • Short survival after catheter insertion did not permit complete evaluation of efficacy.

Nursing Implications

Its use in patients with refractory effusions could be advantageous, as it represents patients who have received other therapies prior to catheter insertion. The average life expectancy of patients with malignant pleural effusions is only 6–12 months, with as many as half of patients dying within 30 days. Patients with malignant pleural effusions represent a group who experience significant symptoms that affect quality of life. Interventions that are low-intensity, can be performed quickly and with limited recovery time, and can be managed in the ambulatory or home setting are optimal. Nurses can act as advocates for innovative management of malignant pleural effusions that enhance patient independence. Nurses are key patient and family educators who provide guidance, support, and hands-on instruction in management of tunneled pleural catheters. Their follow-up with patients and caregivers assist in the detection of complications, as well as evaluation of efficacy. Follow-up nursing assessment for symptom relief and spontaneous pleurodesis or the need for additional interventions may be especially important for these patients receiving end-of-life care with limited contact with physicians.

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Pockaj, B.A., Gallagher, J.G., Loprinzi, C.L., Stella, P.J., Barton, D.L., Sloan, J.A., … Fauq, A.H. (2006). Phase III double-blind, randomized, placebo-controlled crossover trial of black cohosh in the management of hot flashes: NCCTG trial N01CC1. Journal of Clinical Oncology, 24, 2836–2841.

Study Purpose

The purpose of the study was to measure the efficacy of black cohosh (one capsule, Cimicifuga racemosa 20 mg twice daily) for the treatment of hot flashes in women with and without a history of breast cancer.

Intervention Characteristics/Basic Study Process

Participants received four weeks of therapy with black cohosh or an identical appearing placebo. The black cohosh or placebo was given as one tablet twice per day. After completing the first four weeks, participants were crossed over to the alternative treatment arm.

Sample Characteristics

  • The study randomized 132 participants. 107 participants (81%) completed the first five weeks of hot flash diaries; 99 participants (75%) completed the entire nine weeks of therapy. The mean age was 56 years.
  • Inclusion criteria:
    • History of breast cancer, a perceived increased risk of breast cancer, or did not want to take estrogen due to the increased risk of breast cancer.
    • Participants experienced bothersome hot flashes (14 or more per week) for at least one month.
    • Concomitant therapy with tamoxifen, raloxifene, or an aromatase inhibitor was allowed as long as patient had been on the therapy for one month.
    • Use of vitamin E and/or soy was allowed if the patient had been on a stable dose for one month or more and planned to continue the same dose during the entire study period.
  • Exclusion criteria:
    • Receiving concomitant chemotherapy, androgens, or estrogens.
    • Any prior use of black cohosh; use of antidepressants within the prior two weeks (or planned use during the next nine weeks); or current or planned use of other agents for treating hot flashes (e.g., clonidine, belladonna alkaloids, dehydroepiandrosterone) 
    • Other oral herbal therapies, therapeutic herbal teas, or tinctures during the study period were not allowed because of potential interactions with black cohosh.

Study Design

This was a double-blind, randomized, cross-over clinical trial with two four-week periods.

Measurement Instruments/Methods

Participants completed a prospective, daily hot flash diary during the baseline week and then during the two four-week crossover treatment periods. Hot flash scores were measured by assigning points to each hot flash based on severity (1 for mild to 4 for very severe) and then adding the points for a given time period.

Results

The primary end point was the average intrapatient hot flash score (which is a construct of average daily hot flash severity and frequency) difference between the baseline week and the last study week of the first treatment period. Hot flash activity was analyzed in a number of ways. The difference between treatment week 4 (study week 5) and baseline  hot flash score (study week 1) was compared between placebo and black cohosh arms by standard two-sided Wilcoxon procedures. Confidence intervals were constructed for median reductions in hot flash frequency and score. Patients receiving black cohosh reported a mean decrease in hot flash score of 20% (comparing the fourth treatment week to the baseline week) compared with a 27% decrease for patients on placebo (p = .53). Mean hot flash frequency was reduced 17% on black cohosh and 26% on placebo (p = .36). Patient treatment preferences were measured after completion of both treatment periods. Thirty-four percent of patients preferred the black cohosh treatment, 38% preferred the placebo, and 28% did not prefer either treatment. Toxicity was minimal across both groups.

Conclusions

This trial failed to provide any evidence that black cohosh reduced hot flashes more than the placebo.

Limitations

Limitations of the study included using a subset of participants did not have a diagnosis of breast cancer but met the eligibility criteria of a perceived increased risk of breast cancer, or did not want to take estrogen because of the increased risk of breast cancer. The numbers of participants with and without a breast cancer diagnosis were not specified.

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Poage, E.G., Rodrick, J.R., Wanchai, A., Stewart, B.R., Cormier, J.N., & Armer, J.M. (2014). Exploring the usefulness of botanicals as an adjunctive treatment for lymphedema: A systematic search and review. PM&R, 7, 296–310.

Purpose

STUDY PURPOSE: To review and critique the evidence of published studies that investigated the use of botanicals in the treatment of lymphedema
 
TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: PubMed, CINAHL, the Cochrane Database of Systematic Reviews, the Cochrane Controlled Trials Register, PapersFirst, ProceedignsFirst, WorldCat, PEDro, National Guidelines Clearing House, ACP Journal Club, DARE, and articles sent to authors
 
KEYWORDS: Terms used by the International Lymphoedema Framework in 2006 for the Best Practice for the Management of Lymphoedema
 
INCLUSION CRITERIA: Not clearly stated; English language, evidence-based, lymphedema, complimentary and alternative therapies, 2004–2012
 
EXCLUSION CRITERIA: Not clearly stated; inadequate sample (not defined), insufficient level of evidence due to study design (not defined), not a complimentary and alternative medicine study

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 5,927
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Articles were categorized according to the Oncology Nursing Society's Putting Evidence Into Practice levels of evidence guidelines. A limited number of randomized, controlled trials were found; sample sizes were small, and studies had design flaws.

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED = 11 
 
TOTAL PATIENTS INCLUDED IN REVIEW = Not stated
 
SAMPLE RANGE ACROSS STUDIES: Not stated
 
KEY SAMPLE CHARACTERISTICS: Patients with lymphedema

Phase of Care and Clinical Applications

PHASE OF CARE: Late effects and survivorship

Results

  • No botanicals reviewed were recommended for practice. 
  • The benefits of alpha benzopyrones are balanced with harms.
  • The effectiveness of gamma benzopyrones is not established
  • The effectiveness of saponin is not established.
  • The effectiveness of horse chestnut seed extract in combination therapies is not established
  • The effectiveness of pine bark extract versus gama benzopyrone is not established.
  • The effectiveness of selenium is not established.

Conclusions

One botanical intervention, alpha benzopyrones, had benefits that were balanced with harms, but the effectiveness of all other botanical interventions was not established. At this time, botanical supplements cannot be recommended as part of a therapeutic protocol to manage lymphedema in patients with cancer.

Limitations

At this time, there is limited high-quality evidence investigating the potential use of botanicals in the treatment of cancer-related lymphedema. The number of studies using botanical interventions is small, and most possess significant design flaws. This review did not clearly state the inclusion and exclusion criteria used to select literature, and patient demographics were not described.

Nursing Implications

At this time, botanical supplements should not be considered as part of routine care in the treatment of cancer-related lymphedema. Nurses must be knowledgeable about the various botanical supplements patients may be using, and they must always assess patients for the use of any botanical supplements. Nurses should council patients who are taking or who ask about botanical supplements on the current state of the research.

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Pitten, F.A., Kiefer, T., Buth, C., Doelken, G., & Kramer, A. (2003). Do cancer patients with chemotherapy-induced leukopenia benefit from an antiseptic chlorhexidine-based oral rinse? A double-blind, block-randomized, controlled study. Journal of Hospital Infection, 53(4), 283–291.

Study Purpose

To assess the benefit of antiseptic mouthwash in patients with leukopenia because of a decrease in micro-organisms

Intervention Characteristics/Basic Study Process

  • Patients were randomized to chlorhexidine or fluoride rinse (control group).
  • Patients rinsed three times per day for 30 seconds from the start of chemotherapy to the end of leukopenia.
  • Pre-rinsing during and after leukopenia, aerobic and anaerobic bacteria in oral cavity were counted.
  • Patients were assessed for oral mucositis.
  • Patients did not brush teeth when leukopenic.

Sample Characteristics

  • The sample consisted of 47 patients.
  • Patients had solid tumor and hematologic diagnoses.

Measurement Instruments/Methods

  • Bacterial swabs were taken pre-, during and post-treatment.
  • Clinician assessment and mucositis scores were taken.
  • C-reactive protein was measured.

Results

  • In the chlorhexidine group, a significant decrease in aerobic (p = 0.042) and anaerobic (p = 0.008) bacterial flora were identified.
  • In the control group, the numbers of bacteria were unchanged (p > 0.05).
  • More patients in the chlorhexidine group had severe mucositis and inflammation, but this was not significant.

Conclusions

Chlorhexidine did not provide a clinical benefit against mucositis.

Limitations

  • The study had a small sample.
  • The oral assessment was unclear.
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Pitceathly, C., Maguire, P., Fletcher, I., Parle, M., Tomenson, B., & Creed, F. (2009). Can a brief psychological intervention prevent anxiety or depressive disorders in cancer patients? A randomised controlled trial. Annals of Oncology, 20, 928–934.

Study Purpose

To determine if baseline intervention in persons free of depression and anxiety can prevent development of depression or anxiety at 6 and 12 months after diagnosis

Intervention Characteristics/Basic Study Process

Subjects were randomized to either the immediate-intervention or delayed-intervention groups. Intervention consisted of a 90-minute face-to-face interview followed by two telephone interviews (45 minutes each) at two weeks and six weeks after the initial interview. Therapeutic intervention included storytelling about initial experiences with diagnosis, exploration of thoughts about cancer-related events and concerns, and use of a booklet for examples of ineffective coping strategies.

Sample Characteristics

  • At 6 months, 355 patients were evaluated for the outcome variable; at 12 months, 313 patients were evaluated for the outcome variable.
  • Mean patient age was 51.4 years; age range was 18.6–70.9 years.
  • Female: 321; male: 144. There were 48 men in each of the three groups. (Assignment of women and men was randomized, final sample was not described.) 
  • Participants:
    • Had various cancer diagnoses.
    • Were newly diagnosed with first episode of cancer.
    • Had a judged life expectancy of at least two years.

Setting

  • Single site
  • Outpatient
  • Manchester, Greater Manchester, England

Phase of Care and Clinical Applications

Active treatment

Study Design

Randomized controlled trial

Measurement Instruments/Methods

  • A concerns checklist, a 14-item checklist to measure level of concern (0–5) regarding the physical, practical, relationship, or existential aspects of cancer and its treatment. A score of 8 or above indicated risk of developing depression.
  • Structured Clinical Interview for DSM-IIIR (SCID), administered by trained interviewers at 6 and 12 months.
  • Hospital Anxiety and Depression Scale (HADS).

Results

  • At the 6- or 12-month follow-up, 71 patients were diagnosed with an anxiety or depression disorder. At both follow-up evaluations, 13 were diagnosed with such a disorder.
  • The six-month evaluation revealed no difference between anxiety or depression development in the immediate intervention group (14.3%) and the delayed intervention group (12.3%). Therefore, the two groups were evaluated as one group in the final analysis.
  • Patients in the high-risk group who received the intervention showed odds of developing anxiety or depression that were lower than those of patients in the usual-care group (p = 0.05).

Conclusions

The therapeutic psychological intervention demonstrated the potential to prevent disorders relating to depression and anxiety in cancer patients at high risk for development of depression.

Limitations

  • The study did not include an appropriate control group.
  • The study confirmed inter-rater reliability of the two therapists but presented no external confirmation of the proficiency with which each adhered to the protocol.
  • A large proportion of the initial sample was lost to follow-up.
  • Risks of bias were due to no attentional control and an unblended design.

Nursing Implications

In-person or by-telephone cognitive behavioral intervention delivered by nurses trained in intervention delivery could help to reduce the prevalence of depression and anxiety in newly diagnosed cancer patients. Initial determination of risk for development of clinical depression and anxiety can be useful to identify those patients who may benefit most from such an intervention.

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Pitceathly, C., Maguire, P., Fletcher, I., Parle, M., Tomenson, B., & Creed, F. (2009). Can a brief psychological intervention prevent anxiety or depressive disorders in cancer patients? A randomised controlled trial. Annals of Oncology, 20, 928–934.

Study Purpose

To test the hypothesis that a brief intervention would be superior to usual care to prevent anxiety or depressive disorders among newly diagnosed patients with cancer

Intervention Characteristics/Basic Study Process

The structured intervention was based on cognitive behavioral therapy geared toward coping and exploring beliefs and thoughts about illness. The first session was 90 minutes in person with a therapist, followed by two 45-minute sessions two and six weeks later via telephone.

Sample Characteristics

  • The sample was comprised of 465 patients with cancer.
  • Mean patient age was 51.4 years ± 13.04.
  • The sample was 69% female and 31% male.
  • The most common diagnoses were breast cancer, lymphoma, and gynecologic cancers.
  • Patients were excluded if they had an anxiety or depressive disorder, were taking antidepressant or anxiolytic medication, or were receiving psychological intervention.
  • At baseline, 59.6% of patients were deemed to be at high risk for development of anxiety or depressive disorders.
  • The majority of patients were receiving either chemotherapy or radiotherapy alone.
  • Most (70%–77%) patients were married or cohabitating.

Setting

  • Single site
  • Outpatient setting
  • Manchester, England, United Kingdom

Phase of Care and Clinical Applications

Active treatment phase

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

  • Structured clinical interview for DSM-III-R (SCII) to identify any episode of anxiety or depressive disorder
  • Hospital Anxiety and Depression Scale (HADS)
  • Concerns checklist: 14-item checklist of physical, practical, relationship, and existential concerns rated on a five-point scale

Results

By the six-month time point, approximately 27% of participants were lost to follow-up or had dropped out of the study for various reasons. Those variables found to predict drop-out were age, gender, previous psychiatric history, and concerns score, some of which were the same variables reported to be predictive of developing an anxiety or depressive disorder.

At the 12-month follow-up, there was no difference between groups. In patients at high risk for developing an anxiety or depressive disorder, those in the intervention group were less likely to develop a disorder (p = 0.05). There was no difference in findings based on the timing of the intervention (immediate – within one week of starting treatment, versus delayed – eight weeks after starting treatment).

Conclusions

The brief intervention studied may have potential for preventing development of anxiety or depressive disorders only in those patients who were at initial high risk for development of those disorders.

Limitations

  • The study had no attentional control.
  • The study had increased risk of bias because patients self-selected to either the intervention or control group.
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Pirl, W.F. (2004). Evidence report on the occurrence, assessment, and treatment of depression in cancer patients. Journal of the National Cancer Institute Monographs, 32, 32–39.

Purpose

To produce an evidence-based report that reviews empirical literature about depression in patients with cancer and focuses on occurrence, assessment, and treatment

Search Strategy

Authors examined literature published January 1966–September 2000. Authors found literature by searching PubMed, PsycINFO, CINAHL, and BiOSIS Citation Index.

Literature Evaluated

The most common intervention for depression is behavioral/cognitive counseling. Because hundreds of articles exist on this topic, the review was limited to several meta-analyses of psychosocial interventions; some measured emotional adjustment or distress rather than depression. All studies cited were conducted prior to 1998. Tools for measuring depression included the Hamilton Rating Scale for Depression, Clinical Global Impression, Hospital Anxiety and Depression Scale, and Montgomery-Asberg Depression Rating Scale. Descriptive reports were found on complementary treatments but no randomized controlled trials (RCTs).

 

Sample Characteristics

Authors identified 11 RCTs of medication treatment for depression in patients with cancer. The RCTs included data about 755 patients, an average of 58 patients per study.

Conclusions

Some data support the efficacy of psychosocial and pharmacologic treatments for depression in people with cancer. Studies, using antidepressant medications, that conformed to usual practices for antidepressant trials did demonstrate benefit. (The studies that lasted for fewer than five weeks tended to show less benefit than did longer studies.)

Limitations

RCTs of alternative or complementary interventions were not found.

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