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Tummel, E., Ochoa, D., Korourian, S., Betzold, R., Adkins, L., McCarthy, M., . . . Klimberg, V.S. (2016). Does axillary reverse mapping prevent lymphedema after lymphadenectomy? Annals of Surgery. Advance online publication.

Study Purpose

To further validate previous findings that an axillary reverse mapping (ARM) technique enabling the preservation of arm lymphatics can reduce the postoperative lymphedema rate in women having sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND)

Intervention Characteristics/Basic Study Process

ARM was conducted intraoperatively with technetium in the breast and blue dye in the arm. Arm volume displacement measures were conducted preoperatively and every six months. Follow-up ranged from 3–54 months, with an average of 20 months. Lymphedema rates of sample cases were compared to those of a group that did not have ARM.

Sample Characteristics

  • N = 504   
  • MEAN AGE = 57 years (SD = 13) 
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Of the participants, 90.6% had invasive cancer.

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Single-arm, phase-II

Measurement Instruments/Methods

  • Arm water displacement

Results

SNLB mapping was successful in 98.5% of the patients, and ALND lymphatics or blue nodes were identified in 71.8% of the procedures. After SLND, 0.8% had findings of lymphedema, and 6.5% had lymphedema after ALND. In cases where blue lymphatics were identified and able to be preserved, the SLNB lymphedema rate was 1.2%; the lymphedema rate in ALND cases was 6.9%. These rates were compared to reported rates with SLNB ranging from 0%–13%.

Conclusions

ARM may help preserve lymphatic structures and reduce the rates of postoperative lymphedema.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Unintended interventions or applicable interventions not described that would influence results
  • Measurement/methods not well described
  • No other interventions for the prevention or treatment of lymphedema were reported.
  • Actual measurements used for rate determination were not clear.

Nursing Implications

A variety of surgical techniques aimed at reducing postoperative lymphedema are being examined. This study describes one method of ARM that may be beneficial. Further research is needed to determine efficacy with concurrent comparison, the techniques that are most effective, and the role of ARM in overall lymphedema prevention and management.

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Tulipani, C., Morelli, F., Spedicato, M.R., Maiello, E., Todarello, O., & Porcelli, P. (2010). Alexithymia and cancer pain: The effect of psychological intervention. Psychotherapy and Psychosomatics, 79(3), 156–163.

Study Purpose

To evaluate the impact of psychological intervention on pain perception and levels of alexithymia in patients with cancer

Intervention Characteristics/Basic Study Process

For six months, patients were randomly included in a psychological intervention or control group. The intervention consisted of biweekly 90-minute sessions provided by a clinical psychologist trained in psychotherapy and psycho-oncology. Main aspects included psychoeducation regarding mechanisms of pain, daily management of cancer-related issues, emotional reaction to illness, problem solving, cognitive restructuring of dysfunctional illness-related concerns and beliefs, stress management, and progressive relaxation. Investigators assessed outcomes at baseline and at the end of the study. Authors did not describe the control condition.

Sample Characteristics

  • The sample was composed of 104 patients.
  • Mean patient age was 47.4 years.
  • Of all patients, 55.8% were female and 44.2% were male.
  • Subjects had a variety of cancer types. Gastrointestinal was the most frequent. Of all patients, 37.5% had metastatic disease. The average length of education was fewer than 10 years. Of all patients, 79.8% were married and 90% were receiving chemotherapy with or without radiation therapy.

Setting

  • Single site
  • Outpatient
  • Italy

Study Design

Randomized controlled trial

Measurement Instruments/Methods

  • Brief Pain Inventory
  • Toronto Alexithymia Scale (TAS-20)
  • Mental Adjustment to Cancer Scale
  • Illness Behavior Questionnaire
  • Hospital Anxiety and Depression Scale subscales for anxiety and depression
  • SF-12

Results

Control patients were significantly younger and had more progressive cancer than those in the intervention group (p = 0.01). In multiple regression analysis, only alexithymia and scores from the physical component of the SF-12 were predictive of pain intensity (p < 0.001). Patients with progressive disease had higher pain intensity, more interference with daily living, and worse pain (p < 0.001). At the end of six months, compared to controls, patients who received the intervention had significantly lower scores relating to pain intensity (p = 0.03), alexithymia (p < 0.001), hypochondriasis (p = 0.016), and disease perception (p = .013) and showed improvement in these problems from baseline (p < 0.007).

Conclusions

Findings of this study showed that the psychological intervention tested seemed to have a positive effect on pain and alexithymia in patients with cancer. Alexithymia was predictive of pain intensity.

Limitations

  • The study had risks of bias due to no appropriate control group, no attentional control, and no blinding. Authors did not describe the control condition.
  • Authors did not discuss other interventions provided to manage pain, so whether differences and changes in medical management of pain influenced results is unknown.
  • The control group had more progressive cancer and was younger. Both factors could have influenced pain and other outcomes.
  • Authors did not state whether patients in the intervention group attended all sessions.
     

Nursing Implications

Findings suggest that psychological intervention, including cognitive behavioral techniques and progressive relaxation, can be helpful to patients in regard to management of pain; however, limitations of the study design must be considered when interpreting results. The intervention provided was time-consuming and would be associated with cost, which was not discussed. Future researchers should construct well-designed studies to determine the most helpful type and dosage of interventions of this type.

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Tuca, A. (2010). Use of granisetron transdermal system in the prevention of chemotherapy-induced nausea and vomiting: a review. Cancer Management and Research, 2, 1–12.

Study Purpose

To evaluate the antiemetic efficacy of transdermal granisetron in chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately and highly emetogenic chemotherapy

Sample Characteristics

  • This article describes two clinical trials. The first, which was a phase II study, consisted of 210 patients with cancer. The second, which was a phase III study, consisted of 641 patients with cancer.
  • Ages, gender, and key disease characteristics were not specified.

Setting

This was a multisite study conducted in the inpatient setting. The phase II trial was conducted in Germany. The phase III trial was conducted in nine countries.

Phase of Care and Clinical Applications

All patients were in active treatment. Clinical applications of these studies are late effects and survivorship.

Study Design

  • The first clinical trial was a double-blind, double-dummy, randomized, multicenter study.
  • The second trial was a randomized, active control, double-blind, double-dummy, parallel group, multicenter, multinational study.

Measurement Instruments/Methods

In the first trial, patients used a Likert-type scale and visual analog scale (VAS) to measure CINV.

Results

  • No statistically significant differences were found in severity of nausea and vomiting, number of emetic episodes, or patient satisfaction between the two trial groups.
  • Constipation was more common in patients treated with the granisetron patch compared with patients who were treated with oral granisetron.

Conclusions

Transdermal granisetron is effective and safe in controlling acute emesis induced by chemotherapy with moderate and high emetogenic potential; its efficacy and safety are fully comparable with those of oral granisetron.

Limitations

Age, gender, cancer type, and stage were not mentioned.

Nursing Implications

The transdermal route may bring more comfort to patients. The patch is simple to apply and is maintained throughout chemotherapy without skin problems in most patients. The use of transdermal patch can avoid one of the many venous manipulations necessary in chemotherapy. Also, patches could be helpful in patients with swallowing problems.  Nurses need to consider obstacles, including cost and insurance coverage, when selecting antiemetics.

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Tsukuda, M., Ishitoya, J., Mikami, Y., Matsuda, H., Katori, H., Horiuchi, C., … Toth, G. (2009). Antiemetic effects of granisetron and dexamethasone combination therapy during cisplatin-containing chemotherapy for head and neck cancer: Dexamethasone dosage verification trial. International Journal of Clinical Oncology, 14, 337–343.

Study Purpose

To determine the optimal dose of dexamethasone in combination with granisetron for chemotherapy-induced nausea and vomiting (CINV) control with cisplatin-containing chemotherapy

Intervention Characteristics/Basic Study Process

Patients were randomized to either receive 8 mg dexamethasone before chemotherapy and 24, 48, and 72 hours after chemotherapy during cycle 1, and 16 mg dexamethasone at the same time periods with cycle 2 of chemotherapy (8 mg antecedent group), or dosing of dexamethasone in the opposite sequence. All patients also received 3 mg granisetron with each dexamethasone administration. Physicians had discretion to provide addition treatment in cases of extreme nausea or vomiting. Symptoms were evaluated daily for 5 days.

Sample Characteristics

  • The study consisted of 36 participants.
  • Age was not reported.
  • The sample was 33% female and 77% male.
  • All patients had head and neck cancers, with the most prevalent being hypopharyngeal.
  • The majority of patients (83%) were chemotherapy naïve.

Setting

The study was conducted at a single site in Japan.

Phase of Care and Clinical Applications

All patients were in active treatment.

Study Design

This was a randomized crossover trial.

Measurement Instruments/Methods

  • The National Cancer Institute's (NCI) Common Terminology Criteria (CTC) version 2.0 for appetite loss was used.
  • Nausea grade was defined in terms of number of vomiting episodes and ability to ingest liquids.
  • Complete response was defined as no occurrence of nausea and zero instances of vomiting or retching.

Results

Overall efficacy rates ranged from 47.2% on day 5 to 88.9% on day 1. No differences were found at any time point between groups.

Conclusions

No difference was found in antiemetic effect between 8 mg and 16 mg dexamethasone dosing.

Limitations

  • The sample size was small.
  • The antiemetic regimen did not contain all recommended medications.
  • Use of rescue medications was not discussed nor included in the definition of complete response.
  • Whether the study team conducted nausea grading or it was based on patient reports was not clear.
  • Nausea was defined in terms of vomiting rather than a symptom itself.

Nursing Implications

The study suggests that lower dosages of dexamethasone may be as effective as higher doses for CINV management. Further research in this area is needed. Lower dosing may help to reduce potential side effects of steroids.

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Tsukahara, K., Nakamura, K., Motohashi, R., Sato, H., Endo, M., Katsube, Y., . . . Suzuki, M. (2014). Antiemetic therapy of fosaprepitant, palonosetron, and dexamethasone combined with cisplatin-based chemotherapy for head and neck carcinomas. Acta Oto-Laryngologica, 134, 1198–1204. 

Study Purpose

To determine the effects of triple-drug therapy on chemotherapy-induced nausea and vomiting (CINV) in patients with head and neck cancer

Intervention Characteristics/Basic Study Process

Thirty men received 53 cycles of chemotherapy, and 11 women 18 cycles of chemotherapy consisting of cisplatin, docetaxel, and ​5-fluorouracil. Patients received concomitant radiation therapy except in the induction phase. Prior to each cycle, patients received fosaprepitant at 150 mg/kg, palonosetron at 0.75 mg/kg, and dexamethasone at 10 mg/kg. They also received dexamethasone at 6.6 mg/kg daily for three days after chemotherapy. Each patient received a diary to record their experiences of nausea and vomiting with each cycle.

Sample Characteristics

  • N = 41
  • MEAN AGE = 59 years (range = 31–75 years)
  • MALES: 73%, FEMALES: 27%
  • KEY DISEASE CHARACTERISTICS: Head and neck cancers including laryngeal, oral cavity, nasopharyngeal, mesopharyngeal, and hypopharyngeal among others
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients received cisplatin-based regimens.

Setting

  • SITE: Not stated
  • SETTING TYPE: Not specified    
  • LOCATION: Tokyo Medical University Hachioji Medical Center in Japan

Phase of Care and Clinical Applications

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

Study Design

Prospective, quantitative, nonrandomized, nonblinded trial

Measurement Instruments/Methods

  • A 0–100 mm Visual Analog Scale (VAS) was used to measure nausea (0 = no nausea, ≥ 0 and < 30 = slight nausea, ≥ 30 and < 70 = moderate nausea, ≥ 70 and < 100 = severe nausea, and 100 = very severe nausea).
  • Patient diary with multiple choice questions
  • Acute phase was day of administration
  • The delayed phase was day of administration to day 5

Results

A complete response (CR) was defined as no vomiting and no rescue therapy. In the overall phase, 69% (49 of 71) of courses achieved CR. The rate of no vomiting in the overall phase was 90.1%. Nausea in acute phase was reported as no nausea or slight nausea in 91.5% of patients. 87.3% of patients experienced no changes in or slightly reduced food intake, and 85.9% of patients reported good or relatively good general condition in the acute phase. In the delayed phase, no nausea to slight nausea was reported in 56.3% of patients, and 43.7% reported no changes in or slightly reduced food intake. 53.5% reported good to relatively good general condition.

Conclusions

In the overall phase, the majority of patients achieved a CR and reported no nausea or slight nausea. More patients experienced some nausea during the delayed phase than during the overall phase.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment) 
  • Risk of bias (no appropriate attentional control condition)
  • Measurement validity/reliability questionable 
  • Findings not generalizable
  • Questionable protocol fidelity
  • Other limitations/explanation: The diary used to measure outcomes was not validated as a research tool. The findings were not generalizable because of the variation in cisplatin dosing, postoperative status of patients, and doses of radiotherapy.
 

 

Nursing Implications

Triple-drug therapy should be considered during prophylaxis for CINV in patients with head and neck cancer receiving chemotherapy. Although the majority of patients experienced CR during the overall phase, more patients experienced nausea in the delayed phase. Additional interventions to prevent and treat CINV in the delayed phase may be necessary.

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Tsujimoto, T., Yamamoto, Y., Wasa, M., Takenaka, Y., Nakahara, S., Takagi, T., . . . Ito, T. (2014). L-glutamine decreases the severity of mucositis induced by chemoradiotherapy in patients with locally advanced head and neck cancer: A double-blind, randomized, placebo-controlled trial. Oncology Reports, 33, 33–39.

Study Purpose

To investigate whether L-glutamine (glutamine) decreases the severity of mucositis in the oral cavity, pharynx, and larynx induced by chemoradiotherapy (CRT)

Intervention Characteristics/Basic Study Process

Patients with squamous cell carcinoma of the nasopharynx, oropharynx, hypopharynx, or larynx (HNC) receiving CRT were randomized to orally receive either glutamine (group G) or placebo (group P) at a dose of 10 g three times per day throughout the CRT course.

Sample Characteristics

  • N = 40
  • AGE RANGE = 38–77 years
  • MALES: 34 (85%), FEMALES: 6 (15%)
  • KEY DISEASE CHARACTERISTICS: Primary squamous cell carcinoma of the nasopharynx, oropharynx, hypopharynx, or larynx

Setting

  • SITE: Single-site    
  • SETTING TYPE: Inpatient  
  • LOCATION: Osaka University Hospital, Japan

Phase of Care and Clinical Applications

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

Study Design

Double-blinded, randomized, placebo-controlled trial that excluded patients with active mouth or throat soreness before treatment, uncontrolled diabetes mellitus, or severe renal or hepatic insufficiency.

Measurement Instruments/Methods

  • Images of laryngoscope using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3
  • Hematologic and blood chemistry tests were performed at baseline, once per week during the study treatment (weeks one to six), and after treatment (weeks seven to nine) or until patient discharge, whichever occurred first.
  • Pain score according to a numerical rating scale (NRS) 
  • The primary treatment outcome was evaluated 10 weeks after the completion of treatment using computed tomography (CT), positron emission tomography-CT (PET-CT), and biopsy.

Results

The study demonstrated that glutamine significantly decreased the severity of CRT-induced mucositis in patients with HNC. Patients (group G) receiving glutamine had a decreased the incidence of grade 4 mucositis. The mean duration of supplemental nutrition because of severe mucositis was significantly shorter in group G than in group P (group G, 18 ± 13; group P, 27 ± 11; p = .046). Treatment delay caused by mucositis was observed in zero patients in group G and in 15% of patients in group P. In addition, NRS scores were significantly lower in group G than in group P at weeks 4, 5, and 6 (p = .049, p = .019, p = .032, respectively).

Conclusions

The study showed that glutamine significantly decreases the severity of CRT-induced mucositis in patients with cancer, which in turn will improve quality of life for patients.

Limitations

  • Small sample (< 100)

 

Nursing Implications

This study could not provide conclusive results of glutamine in the prevention and treatment of oral mucositis. The study indicated the need for an integrative and multidisciplinary approach in patient care, which could result in substantial advances in the outcomes of cancer therapy and the improvement in patient quality of life. However, there is no known specific dose for glutamine, and it has not been approved by the U.S. Food and Drug Administration for the treatment of mucositis during chemoradiotherapy.

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Tsuji, D., Kim, Y.I., Taku, K., Nakagaki, S., Ikematsu, Y., Tsubota, H., … Daimon, T. (2011). Comparative trial of two intravenous doses of granisetron (1 versus 3 mg) in the prevention of chemotherapy-induced acute emesis: a double-blind, randomized, non-inferiority trial. Supportive Care in Cancer, 20, 1057–1064.

Study Purpose

To determine the optimal IV granisetron dose, 1 or 3 mg, in patients with cancer receiving moderately emetogenic chemotherapy (MEC) or high emetogenic chemothrerapy (HEC)

Intervention Characteristics/Basic Study Process

Patients received 1 mg or 3 mg granisetron with adequate dosing of dexamethasone (20 mg IV dexamethasone on day 1 for patients receiving cisplatin-, anthracycline-, and cyclophosphamide-based regimens and 10 mg IV dexamethasone prior to chemotherapy for patients receiving MEC regimens). Granisetron and dexamethasone were diluted and administered 10-30 minutes before chemotherapy. Rescue antiemetic medication was possible, and the usage was recorded. Nausea and vomiting were recorded for seven days.

Sample Characteristics

  • This study reported on 359 patients.
  • The age range of patients randomized to 1 mg granisetron group was 26–89 years old. The age range of patients randomized to 3 mg group was 22–84 years old.
  • MALES (%)  overall 162 (45%); 3 mg cohort: n=25%; 1 mg cohort: n=21%   FEMALES (%) overall 197 (55%);  3 mg cohort: n=26%; 1 mg cohort: n=29%
  • Cancer diagnoses were gastrointestinal, breast, lung, and other malignancies.

Setting

This was a multisite study conducted at 10 centers located throughout Japan. The setting type was not specified.

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

This was a double-blind, randomized, noninferiority trial.

Measurement Instruments/Methods

Patient diaries were used to record episodes of acute and delayed nausea, vomiting, use of rescue antiemetics, and bowel patterns.

Results

Results indicated that 1 mg of granisetron was not inferior in effect to a 3-mg dose. The primary endpoint was the proportion of patients with a complete response during the first 24 hours after chemotherapy. For the primary endpoint, 359 patients were evaluable according to the modified intention-to-treat (ITT) analysis. Complete protection was achieved in the modified ITT population, 90.6% and 88.8% for the 3- and 1-mg groups, respectively (p < 0.0001); however, results met the stated margin to demonstrate noninferiority. The secondary efficacy analysis showed that the maximum grade of nausea in the acute phase was similar in both groups (p = 0.61). In addition, no significant difference was found between the two groups in the number of vomiting episodes (p = 0.62). No statistically significant differences were observed in the maximum grade of nausea in the delayed phase (from day 2 to 7; p = 0.67). Adverse events on day 1 as well as on days 2–7 after chemotherapy were mild and not significantly different in both groups. No severe or unexpected adverse events were reported.

Conclusions

This study showed that 1 mg granisetron is not inferior to 3 mg when both doses are combined with dexamethasone, assuming that a 15% difference in complete response rate is accepted.

Limitations

  • The authors reported a limitation because of a wide delta margin (15%), however, a 95% confidence interval (CI) existed.
  • Variation in chemotherapy regimens and diagnosis existed; these were not stratified to the two cohorts. Gender should have been stratified to the two cohorts as it is known that females experience nausea more often than males. Patients should also have been stratified according to the severity of their previous experience of CINV.

Nursing Implications

Findings suggest that lower dose granisetron may be effective for control of acute and delayed CINV.

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Tsivian, M., Qi, P., Kimura, M., Chen, V.H., Chen, S.H., Gan, T.J., & Polascik, T.J. (2012). The effect of noise-cancelling headphones or music on pain perception and anxiety in men undergoing transrectal prostate biopsy. Urology, 79, 32–36.

Study Purpose

To assess the effect of noise-canceling headphones, with or without music, on patient pain and anxiety associated with routine, office-based transrectal ultrasound-guided prostate biopsy  

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to one of three groups: control group (no noise-canceling headphones), headphones group (patients wore noise-canceling headphones), or music group (which listened to Bach's Brandenburg Concertos through noise-canceling headphones). Patients donned headphones immediately before the procedure, after hearing a thorough description of the procedure and getting into position for the procedure.

Sample Characteristics

  • The study reported on a sample of 88 patients: 28 in the control group, 29 in the headphones group, and 31 in the music group.  
  • Mean patient age was 62.5 years: 60 years in the control group, 68 in the headphones group, and 61.4 years in the music group.
  • The sample was 100% male.
  • Patients had an elevated prostate-specific antigen level or abnormal findings as revealed by a digital rectal examination.
  • The sample was predominantly white.

Setting

  • Site was unspecified.
  • Office-type setting, although authors did not state the location of the office site or whether practitioners in more than one office participated in the study. (Authors are from the Duke University Medical Center, in Durham, N.C.)

Study Design

Randomized controlled trial

Measurement Instruments/Methods

  • Verbal response scale (VRS), to measure pain
  • Visual analog scale (VAS), to measure pain
  • McGill Pain Questionnaire
  • State-Trait Anxiety Inventory
  • Physiologic measures: systolic blood pressure, diastolic blood pressure, differential blood pressure, heart rate, and respiratory rate

Results

Mean VRS scores showed that pain significantly increased from baseline to postprocedure for all groups (control group, 0.79–2.49, p = 0.001; headphones group, 0.89–2.29, p = 0.009; music group, 0.52–2.13, p < 0.001). In no group did anxiety level change from baseline to postprocedure. The music group had the lowest overall mean State-Trait Anxiety score. Blood pressure levels remained fairly stable from baseline to postprocedure. The control group’s mean diastolic blood pressure increased from 82.3 to 88.4, the headphones group’s mean diastolic blood pressure increased from 79.38 to 81.9, and the music group’s mean diastolic blood pressure increased from 82.5 to 84.9. Authors reported that these changes were not statistically significant.

Conclusions

According to this study, music or noise-canceling headphones do not appear to relieve pain perception and anxiety during transrectal prostate biopsy; however, further research is warranted due to the small sample size.

Limitations

  • The study had a small sample size, with fewer than 100 patients.
  • The patients and physician were not blinded.
  • The volume setting (the music played at a comfortable level) and genre of music may have been a limitation; because the biopsy gun was quite loud, those in the noise-canceling headphones group could hear the biopsy gun.

Nursing Implications

Although this study did not find music or noise-canceling headphones to be effective in decreasing pain perception and anxiety, nurses may want to ask patients if they would like to listen to music in the circumstances outlined. Listening to music may be a distraction and potentially mitigate pain.

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Tsimberidou, A.M., Giles, F.J., Khouri, I., Bueso-Ramos, C., Pilat, S., Thomas, D.A., . . . Kurzrock, R. (2005). Low-dose interleukin-11 in patients with bone marrow failure: Update of the MD Anderson Cancer Center experience. Annals of Oncology, 16, 139–145.

Intervention Characteristics/Basic Study Process

Interleukin-11 (IL-11) 10 mcg/kg subcutaneous was given daily for two weeks followed by a two-week rest period for two induction courses. Patients with grade 0–1 toxicity during a course could have a 5 mcg/kg/day dose increase in subsequent courses. If grade 3 toxicity was reached, the dose was decreased by 50%. If grade 4 toxicity was reached, therapy was stopped. Responders could receive maintenance therapy of the same daily dose used in induction (10 mcg/kg) given on alternate days or daily. For grade 3 or lower toxicity, the dose could increase by 5 mcg/kg. Therapy continued as long as there was hematologic improvement without grade 3 or 4 toxicity.

 

Sample Characteristics

  • N = 33
  • AGE: 5–85 years
  • MALES: 25, FEMALES: 8             
  • OTHER KEY SAMPLE CHARACTERISTICS: Bone marrow failure because of myelodysplastic syndrome (MDS), graft failure, aplastic anemia (AA), or chemotherapy. Platelet count 20 or less, or a platelet of less than 50 with an absolute neutrophil count less than 1 or hemoglobin less than 10 g/dl. No chemotherapy for more than two months and no disease progression. Patients with AA, no anti-thymocyte globulin for three months prior. Bone marrow biopsy and aspirate prior to treatment, at time of response, and post-therapy for those who lost their response.

Measurement Instruments/Methods

  • Assess toxicity, safety, response, and efficacy.

Results

Twenty-seven percent (nine patients—eight patients at 10 mcg dose, one patient at 15 mcg dose) responded. Patients were 56–78 years of age. The median time to response was 0.9 months (higher response rate with patients older than 50 years [P = 0.008], MDS versus AA [P=0.025], and creatinine greater than 1 mg/dl [P = 0.0004]). Lower baseline platelet counts (less than five) took months to respond. The median response duration was three months. Among responders, the median maximum post-treatment platelet count was 137. Five patients showed multilineage response; three were treated with IL-11 alone, and two were treated with IL-11 plus erythropoietin and granulocyte colony-stimulating factor. The most common side effects for grade 1–2 were lower extremity edema, conjunctiva infection, and fatigue. Grade 3 toxicities were arrhythmia and transient ischemic attack. Ten patients had no side effects. Patients on maintenance therapy received a range of 35–70 mg/kg weekly cumulative.
 

Limitations

  • What was the alternate dosing schedule?
  • Small subgroup of patients
  • Wide variety of maintenance dosing
  • No control
  • Age range of participants
     
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Tsianakas, V., Robert, G., Richardson, A., Verity, R., Oakley, C., Murrells, T., . . . Ream, E. (2015). Enhancing the experience of carers in the chemotherapy outpatient setting: An exploratory randomised controlled trial to test impact, acceptability and feasibility of a complex intervention co-designed by carers and staff. Supportive Care in Cancer, 23, 3069–3080. 

Study Purpose

To test the feasibility and acceptability of a codesigned (caregiver and healthcare provider) Take Care intervention, and to measure caregiver knowledge, information needs, confidence, and emotional well-being related to intervention efficacy

Intervention Characteristics/Basic Study Process

The Take Care intervention included a 19-minute DVD designed to offer education, information, and support to the caregivers of patients starting chemotherapy. It also included a booklet and a one-hour protocol-guided group (≤ 5) consultation offered prior to the delivery of the first cycle of IV chemotherapy.

Sample Characteristics

  • N = 47  
  • MEAN AGE = 52.77 years (range = 24–76 years)
  • MALES: 35%, FEMALES: 65%
  • KEY DISEASE CHARACTERISTICS: Caregivers of chemotherapy-naïve patients with breast, colon, or lung cancer scheduled to begin IV chemotherapy; all patients aged 18 years or older
  • OTHER KEY SAMPLE CHARACTERISTICS: Caregivers were nominated by patients as providing most support; aged greater than 18 years; married; spouse; and half were employed

Setting

  • SITE: Single site    
  • SETTING TYPE: Outpatient    
  • LOCATION: London teaching hospital

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Two-phase, mixed-method, pilot randomized, controlled trial with a later purposive subsample of the Take Care group gaining variation in caregiver characteristics and data on intervention feasibility and acceptability (focus groups of six healthcare providers also served later purpose)

Measurement Instruments/Methods

  • Visual Analog Scale (VAS) for knowledge of chemotherapy and side effects 
  • Supportive Care Needs Survey for Partners' and Caregivers' unmet needs (SCNS-P)
  • Experience of care (investigator-designed 11-item Likert scale)
  • Perceived confidence in supporting friend/relative (investigator-designed six-item numerical rating)
  • General Health Questionnaire 12 (GHQ-12) for emotional well being

Results

There were statistically significant improvements in intervention group caregiver knowledge of chemotherapy and side effects (all nine areas ≤ 0.012), their satisfaction with care in (five of seven items), and in the number of caregivers who felt they had the information they needed or that their informational needs had been met (p < 0.001). No difference between the intervention and control groups was demonstrated in emotional well-being or in caregivers' experience of care except for one item involving the time that staff members spent with care, which was higher for the intervention group (p = 0.014). Confidence in coping showed a trend towards significance after the intervention. In addition, focus group data showed that the intervention was feasible, acceptable, and useful.

Conclusions

The Take Care intervention for the caregivers of patients starting IV chemotherapy showed promise as an acceptable and feasible approach to support and educate caregivers.

Limitations

  • Small sample (< 100)
  • Risk of bias (no appropriate attentional control condition)
  • Unintended interventions or applicable interventions not described that would influence results
  • Measurement/methods not well described
  • Measurement validity/reliability questionable
  • Findings not generalizable
  • Other limitations/explanation: The five instruments used in study lacked reliability and validity information (three were developed by an investigator, not clear which author). The definition of feasibility and acceptability was not clear enough to aptly interpret findings. Some concern about intervention acceptability existed with the 41% participation refusal rate. Only 33% of caregivers who were invited to focus groups participated (four of 12). The caregiver convenience sample was 70% Caucasian British. Only one author analyzed the qualitative data, and it was unclear who moderated the group to avoid bias. It was unclear how the NHS in the United Kingtom may have influenced findings.

Nursing Implications

The Take Care intervention may provide an acceptable, useful, and feasible approach to meet the educational and support needs of the caregivers of patients receiving chemotherapy the first time. Additional studies reflecting methodologic rigor with United States population groups are warranted to determine if the intervention may be effective in improving caregiver knowledge of chemotherapy and side effects, meeting educational and support needs, and improving caregiver emotional well-being and role satisfaction.

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