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Karaca, H., Bozkurt, O., Ozaslan, E., Baldane, S., Berk, V., Inanc, M., ... Ozkan, M. (2014). Positive effects of oral beta-glucan on mucositis and leukopenia in colorectal cancer patients receiving adjuvant FOLFOX-4 combination chemotherapy. Asian Pacific Journal of Cancer Prevention, 15(8), 3641–3644. 

Study Purpose

To examine the effect of oral beta-glucan on leukocytes, neutrophils, platelets, oral mucositis, and diarrhea in a group of patients with colorectal cancer who received adjuvant FOLFOX-4 and were at high risk for these side effects

Intervention Characteristics/Basic Study Process

Sixty-two consecutive patients admitted with colorectal cancer and treated with FOLFOX-4 between July 2009 and July 2010 were divided into two equal groups to receive beta-glucan 50 mg per day for at least one week with FOLFOX-4 for the first cycle or only FOLFOX-4. Leukocyte, neutrophil, and platelet counts were obtained, and oral mucositis and diarrhea were graded one day before and one week after chemotherapy.

Sample Characteristics

  • N = 62  
  • MEDIAN AGE = 61 years (treatment); 55 years (control – no statistical difference) (range = 30–78 years)
  • MALES: 61%, FEMALES: 39%
  • KEY DISEASE CHARACTERISTICS: Colorectal cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients treated with FOLFOX-4

Setting

  • SITE: Single-site    
  • SETTING TYPE: Inpatient  
  • LOCATION: Turkey

Phase of Care and Clinical Applications

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

Study Design

A retrospective study of consecutively-admitted patients.

Measurement Instruments/Methods

  • The National Cancer Institute's Common Toxicity Criteria (NCI, CTC) were used for grading oral mucositis and diarrhea.
  • Cell counts were measured using a Siemens Advia® 2120i hemogram device.

Results

Oral mucositis and diarrhea were observed in six (19%) patients in the treatment group and in 13 (42%) patients in the control group. Statistical analysis could not be done because of the limited number of patients. There were no beta-glucan-induced side effects reported. There was no difference in the leukocyte and neutrophil counts before and after chemotherapy in the treatment group. The platelet count difference before and after chemotherapy was significant (p = 0.048). The difference between baseline and after chemotherapy was significant (p = < 0.01) for median leukocyte, neutrophil, and platelet counts in the control group.

Conclusions

Oral beta-glucan showed some effectiveness in reducing oral mucositis or diarrhea in patients receiving FOLFOX-4. Results are difficult to interpret because no statistical analysis could be performed comparing the two groups.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Measurement/methods not well described
  • Other limitations/explanation: The sample description was very brief. The discussion of quality of life when it was not measured was problematic. The study did not differentiate between patients who experienced diarrhea from those who had mucositis.

Nursing Implications

In this study, beta-glucan showed some relief of oral mucositis and diarrhea in participants. The study, however, was small, and statistical analysis was not possible due the number of participants enrolled. Additionally, all patients enrolled in this study were diagnosed with colorectal cancer and received FOLFOX-4 treatment, so the results may not be generalizable to other populations. At this time, other interventions should be considered to relieve symptoms associated with oral mucositis and diarrhea corresponding to chemotherapy treatment.

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Kara, I., Apiliogullari, S., Oc, B., Celik, J.B., Duman, A., Celik, C., & Dogan, N.U. (2012). The effects of intrathecal morphine on patient-controlled analgesia, morphine consumption, postoperative pain and satisfaction scores in patients undergoing gynaecological oncological surgery. Journal of International Medical Research, 40, 666–672.

Study Purpose

To compare the impact of intrathecal morphine (ITM) plus patient-controlled analgesia (PCA) versus PCA alone on morphine consumption, pain relief, and patient satisfaction after gynecologic-oncologic surgery (GOS)

Intervention Characteristics/Basic Study Process

Patients were randomized to an ITM plus PCA group or a PCA-only control group. Study patients received 0.3 mg ITM at the L3-L4 or L4-L4 vertebral level, and control patients received a needle puncture only. The same anesthesiologist performed all procedures. All patients received an initial morphine bolus of 0.05 mg/kg if pain was > 60 (0–100) on a Visual Analog Scale in the postanesthesia care unit. The PCA was reprogrammed for all patients to deliver a 1.5 mg bolus with a seven-minute lockout after patients were discharged from the postanesthesia care unit. Measurements were taken at 30 minutes and at one, three, six, 12, 24, and 48 hours.

Sample Characteristics

  • N = 56
  • MEAN AGE = 73.13 years (SD = 7.25 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Gynecologic malignancies (uterine, ovarian, cervix, and other)

Setting

  • SITE: Selcuk University, Department of Obstetrics and Gynaecology
  • SETTING TYPE: Hospital
  • LOCATION: Konya, Turkey

Phase of Care and Clinical Applications

  • PHASE OF CARE: Adult patients receiving active treatment 
  • APPLICATIONS: Elder care and palliative care

Study Design

Prospective, randomized, double-blinded study

Measurement Instruments/Methods

Primary Measures

Pain scores were assessed using a 100 mm Visual Analog Scale (VAS, 0 mm = no pain, and 100 mm = worst pain imaginable). Patient satisfaction was measured using a 100 mm VAS (0 = very unsatisfied, and 100 = very satisfied), and cumulative PCA morphine consumption (mg) was calculated.

Secondary Measures

Patients were directly asked if they experienced nausea, vomiting, or pruritus. Rescue medication was administered for nausea and vomiting. The number of patients who verbally reported secondary measures and who received rescue medications were recorded.

Sedation was assessed using a five-point scoring scale (0 = fully awake, 1 = drowsy, closed eyes, 2 = asleep but easily aroused with light tactile stimulation or simple verbal command, 3 = asleep and aroused only by strong physical stimulation, and 4 = could not be aroused. Fatigue also was assessed on a four-point scale (0 = none, and 4 = severe). Respiratory depression was defined by a rate of less than 10 breaths per minute and was reversed by administering 0.1 mg of IV naloxone every five minutes until adequate respiration was restored.

Results

Primary Outcomes

Patients in the ITM plus PCA group had a lower consumption of morphine (p < 0.0001 at all time points). There was no statistic difference in pain or patient satisfaction scores.

Secondary Outcomes

There was no statistic difference in sedation, nausea, pruritus, or fatigue between the two groups.

Conclusions

ITM plus PCA significantly reduced morphine consumption compared to PCA alone in the first 48 hours after GOS. The intervention, however, did not decrease pain scores or improve patient satisfaction. Both the intervention and the control group reported similar levels of the secondary side effects measured in this study.

Limitations

  • Small sample (< 100)
  • Risk of bias (sample characteristics)
  • Findings not generalizable
  • Intervention expensive, impractical, or training needs

Nursing Implications

ITM plus PCA may be a viable option to decrease overall morphine consumption for patients in whom this is a desired outcome as it did not increase adverse side effects. However, the addition of ITM did not improve postoperative pain scores or overall patient satisfaction in patients receiving GOS.

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Kapoor, N., Naufahu, J., Tewfik, S., Bhatnagar, S., Garg, R., & Tewfik, I. (2016). A prospective randomized controlled trial to study the impact of a nutrition-sensitive intervention on adult women with cancer cachexia undergoing palliative care in India. Integrative Cancer Therapies. Advance online publication. 

Study Purpose

To assess the efficacy of a whole wheat flour mix along with local ingredients (IATTA) with counseling to enhance dietary intake, physical activity, and quality of life (QOL)

Intervention Characteristics/Basic Study Process

Patients in the intervention group received 14 packets of IATTA every two weeks during appointments along with 30 minutes of counseling by a qualified nutritionist at each visit. They were advised to eat the contents of one whole packet along with their daily diet. Physical activity, such as walking, was also encouraged during counseling sessions. Patients in the control group received 30 minutes of counseling only by a qualified nutritionist at each visit.

Sample Characteristics

  • N = 63 (30 in intervention group and 33 in control group)
  • MEDIAN AGE = 44 years (intervention group), 47.8 years (control group)
  • FEMALES: 100%
  • CURRENT TREATMENT: Chemotherapy, radiation, combination radiation, chemotherapy
  • KEY DISEASE CHARACTERISTICS: Loss of more than 5% from pretreatment, body mass index less than 20 kg/m2, hemoglobin less than 12g/dl, energy intake less than 1,500 kcl/d 
  • OTHER KEY SAMPLE CHARACTERISTICS: Exclusions: Patients with gastrointestinal disorders who were on anabolic steroids, taking synthetic oral supplements, and/or had a life expectancy of less than three months

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: India

Phase of Care and Clinical Applications

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

Study Design

  • Prospective, randomized, controlled trial

Measurement Instruments/Methods

Anthropometric measurements of nutritional status, physical activity, and QOL measurements:

  • Body weight
  • Mid-upper arm circumference (MUAC)
  • Dietary questionnaire: Patient Generated Subjective Global Assessment
  • Physical activity questionnaire: Indian Migrant Study Physical Activity Questionnaire
  • QOL assessment: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ-C30) questionnaire

Results

Fifty-one percent of patients completed the study. Patients in the intervention group tended to gain weight, but it was not statistically significant. Patients in the control group showed statistically significant weight loss (p = 0.003) and reduced MUAC (p = 0.006). Body fat increased significantly in the intervention group (p = 0.002) and decreased significantly in the control group (p = 0.032) at the end of the six-month intervention period from baseline. At the end of six months, significant energy intake increased in the intervention group (p = 0.001) with carbohydrates (p = 0.001), protein (p = 0.001), and fat (p = 0.006), respectively. Physical activity recall showed significantly reduced activity in the control group (p = 0.004). Patients in the intervention group did not show a change in physical activity. The intervention group showed a statistically significant improvement in QOL in factors such as fatigue (p = 0.002) and appetite loss (p = 0.006). The control group showed a statistically significant decrease in the domains of global health status (p = 0.018) and social functioning (p = 0.004). At the end of six months, global health status, social functioning, appetite, and fatigue showed significant differences between the two groups (p < 0.001).

Conclusions

Nutrition therapy and supplementation within palliative care may improve QOL and stabilize weight in patients with cancer and cachexia. Nearly 50% of patients did not complete the study, so further study is indicated.

Limitations

  • Small sample (< 100)
  • Risk of bias (sample characteristics)
  • Key sample group differences that could influence results
  • Findings not generalizable
  • Subject withdrawals ≥ 10%  
  • Female patients only
  • Homogeneous population—not diverse

Nursing Implications

Nutrition counseling is imperative through all phases of cancer care. Further study of nutrition counseling and intervention should include QOL measures, such as physical activity, social functioning, and pain status.

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Kapoor, A., Singhal, M.K., Bagri, P.K., Nirban, R.K., Maharia, S., Narayan, S., & Kumar, H.S. (2015). Comparison of single versus multiple fractions for palliative treatment of painful bone metastasis: First study from north west India. Indian Journal of Palliative Care, 21, 45–48. 

Study Purpose

To compare pain outcomes with two different radiotherapy dosing schedules for pain associated with bone metastases

Intervention Characteristics/Basic Study Process

Referred patients were allocated to two different dosage groups based on the discretion of the radiation oncologist. Pain was assessed at the end of treatment and on days 8, 15, and 30 in follow-up.

Sample Characteristics

  • N = 187
  • MALES: 64%, FEMALES: 36%
  • KEY DISEASE CHARACTERISTICS: Breast, lung, prostate, renal, and thyroid cancers; 71% had metastases only on vertebrae

Setting

  • SITE: Single site  
  • SETTING TYPE: Outpatient  
  • LOCATION: India

Phase of Care and Clinical Applications

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

Study Design

Prospective study

Measurement Instruments/Methods

  • Visual Analog Scale (VAS)

Results

In total, 62% of patients received a single fraction of 8 Gy and the rest had 10 fractions of 3 Gy. There were no significant differences between these groups in overall pain reduction.

Conclusions

Single and multiple fraction radiation therapy schedules provided similar results for the control of pain from bone metastases.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Subject withdrawals ≥ 10%
  • Other limitations/explanation: No information on analgesic or bone modifying agent use was provided. There was no intent to treat analysis for patients lost to follow-up. No sample demographics were provided.

Nursing Implications

Single fraction radiotherapy for pain control appeared to be as effective as multiple fraction dosing. Single fraction dosing may provide a more practical and convenient alternative for pain control. There could be differences in adverse effects, which were not discussed in this report.

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Kao, C.Y., Hu, W.Y., Chiu, T.Y., & Chen, C.Y. (2014). Effects of the hospital-based palliative care team on the care for cancer patients: An evaluation study. International Journal of Nursing Studies, 51(2), 226-235.

Study Purpose

To evaluate the effects of the hospital-based palliative care team on care for patients with cancer

Intervention Characteristics/Basic Study Process

The hospital-based palliative care team visited intervention patients “regularly” during the one-week study period. Team members including physicians, nurses, chaplains, and social workers provided advice about medications and taught patients and families skills to relieve physical symptoms, provided emotional support, and assisted with truth-telling and preparation for death. Data were collected at baseline and one week later.

Sample Characteristics

  • N = 60
  • MEAN AGE = 57.5 years (SD = 14.62)
  • MALES: 57%, FEMALES: 43%
  • KEY DISEASE CHARACTERISTICS: Patients with advanced cancer with palliative care needs
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients hospitalized in a medical center in Taiwan; unlikely to die or be discharged in 24 hours

Setting

  • SITE: Single site
  • SETTING TYPE: Inpatient   
  • LOCATION: Taipei, Taiwan

Phase of Care and Clinical Applications

  • PHASE OF CARE: End-of-life care
  • APPLICATIONS: Palliative care

Study Design

Quasi-experimental study with a pretest-posttest design

Measurement Instruments/Methods

  • Symptom Distress Scale (SDS)
  • Hospital Anxiety and Depression Scale (HADS)
  • Spiritual Well-Being Scale
  • Social Support Scale

Results

No significant difference was seen in anxiety and depression between the control and intervention groups after one week of palliative care. Improvement was seen in edema, fatigue, dry mouth, and abdominal distention.

Conclusions

Nurse interventions improved symptom management for the intervention group; however, in the short timeframe of this study emotional disturbances were not affected. Cultural implications are important here; death is a taboo topic in Chinese culture, and patients' understanding of their terminal disease is low and rarely discussed.

Limitations

  • Small sample (< 100)
  • Risk of bias (no random assignment)
  • Unintended interventions or applicable interventions not described that would influence results
  • Patients were given the choice of usual care plus visits from the palliative care team versus usual care alone. The timeframe was only one week, and the number of visits and disciplines of the palliative care team were not clearly described. Nurse interventions for some physical symptoms are described very generally; no interventions for depression or anxiety are described.

Nursing Implications

Palliative care consultation may benefit many symptoms of patients with cancer, but without clear interventions for depression and in this short timespan, little effect is apparent.

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Kang, Y.K., Lee, S.S., Yoon, D.H., Lee, S.Y., Chun, Y.J., Kim, M.S., . . . Kim, T.W. (2010). Pyridoxine is not effective to prevent hand-foot syndrome associated with capecitabine therapy: Results of a randomized, double-blind, placebo-controlled study. Journal of Clinical Oncology, 28, 3824–3829.

Study Purpose

To determine whether concurrent pyridoxine therapy can prevent the development of hand-foot syndrome (HFS) in patients being treated with capecitabine. 

Intervention Characteristics/Basic Study Process

Chemotherapy-naïve patients with gastrointestinal (GI) tract cancers who were scheduled for capecitabine-containing chemotherapy were randomly assigned to concurrent oral pyridoxine (200 mg per day) or placebo. Patients were stratified by chemotherapy regimen and monitored until development of HFS with a National Cancer Institute (NCI) common toxicity criteria of grade 2 or worse, or capecitabine-containing chemotherapy ended. Patients in the placebo group who developed grade 2 or worse HFS were randomly assigned again to received pyridoxine or placebo in the next chemotherapy cycle to determine whether pyridoxine could improve HFS.

Sample Characteristics

  • The study reported on a sample of 360 patients with GI tract cancers.
  • Median patient age was 56 years.
  • The sample was 67% male and 33% female in the pyridoxine group, and 58% male and 42% female in the placebo group.
  • Most patients had colon cancer and were scheduled for adjuvant capecitabine monotherapy. The next largest group comprised patients with stomach cancer who were receiving palliative capecitabine and cisplatin, or docetaxel, capecitabine, and cisplatin.
  • Patients in both arms received a median of six cycles of chemotherapy.

Setting

The site and setting types were not specified.

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

This was a randomized, double-blinded, placebo-controlled trial.

Measurement Instruments/Methods

  •  Kaplan-Meier curves
  •  NCI Common Terminology Criteria for Adverse Events (CTCAE), version 2.0
     

Results

  • Fifty-seven of 180 pyridoxine-treated patients (32%) and 55 of 180 placebo-treated patients (31%) developed grade 2 or worse HFS.
  • Randomization of the 44 patients in the placebo group with grade 2 or worse HFS to placebo or pyridoxine for the next cycle resulted in no significant difference in the proportion showing improvement of HFS.

Conclusions

Pyridoxine is not effective in the prevention of capecitabine-associated HFS.

Limitations

This trial did not include pathophysiologic analysis, which could have provided additional information on the pathogenesis of capecitabine-induced HFS.

Nursing Implications

Pyridoxine prophylaxis was shown to have no effect on reducing the development or severity of HFS.

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Kangas, M., Bovbjerg, D.H., & Montgomery, G.H. (2008). Cancer-related fatigue: A systematic and meta-analytic review of non-pharmacological therapies for cancer patients. Psychological Bulletin, 134, 700–741.

Purpose

STUDY PURPOSE: To conduct a systematic review and meta-analysis on nonpharmacologic interventions (psychosocial and exercise) for cancer-related fatigue (CRF)

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: CANCERLIT, CINAHL, Embase, MEDLINE, PubMed, PsycINFO
 
INCLUSION CRITERIA: Published trials that met the following criteria: (a) published in a scientific peer-reviewed journal in full manuscript form; (b) written in the English language; (c) included a nonpharmacological intervention as one treatment arm of the study; (d) evaluated participants who were aged at least 18 years, had been diagnosed with cancer (any type or stage), and were at any phase of treatment or recovery; and (e) included a specific quantitative measure of fatigue or related symptom (comprising tiredness, lethargy, vigor, vitality or energy) as a primary or secondary outcome measure, in which the measure was administered minimally at preintervention (baseline) and postintervention. Randomized, controlled trial (RCTs) or non-RCTs (clinical trials without randomization) and single group design with baseline and post-intervention measures; only RCTs with sufficient statistical data to compute effect size were included in the meta-analysis.
 
EXCLUSION CRITERIA: Case reports and single case designs

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 119
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Criteria adapted from CONSORT guidelines and Delphi criteria list as well as four additional criteria: (a) whether the participant inclusion criteria for each identified study required individuals to be suffering from fatigue and/or related symptoms (e.g., low energy, vigor) prior to randomization; (b) whether the study was based on a specific CRF aim and/or CRF-related hypothesis (including predictions for effect of intervention[s] on fatigue, vigor and/or vitality); (c) whether the intervention was based on a specific fatigue-related theory, which the researchers made explicit in the publication; and (d) type of fatigue outcome measure used (i.e., unidimensional versus multidimensional). These four criteria were included in the moderator analyses. Two evaluators reviewed abstracts and articles. Duplicate studies were excluded from the analysis.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 57 RCTs included in the meta-analysis, 116 published articles for systematic review
  • TOTAL PATIENTS INCLUDED IN REVIEW = 4,621 in meta-analysis
  • SAMPLE RANGE ACROSS STUDIES: Not reported
  • KEY SAMPLE CHARACTERISTICS: Of the patients, 33%–45% had breast cancer and were in a mix of stages and treatment statuses.

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Results

Both psychosocial interventions and exercise showed benefit in CRF. Psychosocial interventions had a small to moderate effect on fatigue; exercise had a moderate effect. No significant differences existed in the effect of exercise on CRF between psychosocial interventions and exercise. Exercise showed a stronger effect during treatment than post-treatment, whereas psychosocial interventions showed a stronger effect post-treatment.

Conclusions

Both psychosocial interventions and exercise are beneficial in ameliorating CRF. A multimodal approach across all phases of treatment is best.

Limitations

  • Limited search
  • High heterogeneity
  • Somewhat dated review; latest published article included was 2006

Nursing Implications

Provides additional support for psychosocial interventions and exercise for CRF. Because of the heterogeneity of interventions, supporting one type of psychosocial intervention or exercise regime over another is difficult. Nurses can incorporate interventions acceptable to patients.

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Kangas, M., Milross, C., Taylor, A., & Bryant, R.A. (2013). A pilot randomized controlled trial of a brief early intervention for reducing posttraumatic stress disorder, anxiety and depressive symptoms in newly diagnosed head and neck cancer patients. Psycho-Oncology, 22,1665–1673.

Study Purpose

To conduct a controlled pilot trial evaluating the efficacy of a brief early cognitive behavior therapy intervention (CBT) to reduce symptoms of post-traumatic stress disorder (PTSD), depression, and anxiety and to prevent chronic psychological problems within the first year following diagnosis of head and neck cancer

Intervention Characteristics/Basic Study Process

Patients with elevated levels of PTSD, anxiety, or depression were randomized to seven individual sessions of either CBT or nondirective supportive counseling (SC). The interventions were concurrent with radiation therapy. The primary outcomes (PTSD, anxiety, and depression) and secondary outcomes (cancer-related appraisals, quality of life)  were assessed at baseline, one month, six months, and one year postintervention. Researchers assessed participants by using diagnostic clinical interviews and self-report questionnaires. Participants completed the screening assessment conducted by trained psychologists and were then randomized to either a CBT or SC group. Assessors blinded to treatment group conducted follow-up assessments. Researchers conducted a random evaluation of 25% of participants to ensure clinician adherence to protocol.

Sample Characteristics

  • The study reported on a sample of 35 participants.
  • Mean patient age was 54.8 years, with a range of 18–70 years.
  • The sample was 80% male and 20% female.
  • Patients had primary head and neck cancer, first onset.
  • Patients were recommended to receive primary radiation therapy (XRT) or adjuvant XRT, had an expected prognosis of more than 12 months, and were English speaking.
  • There were no differences in sociodemographic or medical variables.

Setting

  • Single site
  • Setting type unspecified
  • Royal Prince Alfred Hospital, Sydney, Australia

Phase of Care and Clinical Applications

  • Patients were undergoing active antitumor treatment.
  • The study has clinical applicability for elder care and palliative care.

Study Design

A pilot randomized controlled trial design was used.

Measurement Instruments/Methods

Assessors administered the following at each assessment:

  • Clinician-administered PTSD scale
  • Structured Clinical Interview for DSM-IV Axis IV disorders (SCID-IV)
  • Posttraumatic Stress Disorder Checklist (PCL), stress-specific version
  • Beck Depression Inventory (BDI)
  • Posttraumatic Cognitions Inventory (PTCI)
  • Functional Assessment of Cancer Therapy–General
  • Treatment Credibility Scale (TCS), adapted to measure patient’s beliefs about treatment efficacy contingent on the intervention to which patient was randomized (CBT or SC)

Results

In spite of randomization, the CBT group, compared to the SC group, had significantly elevated scores on the PTCI self-blame subscale. This finding was included as a covariate. Participants in both treatment interventions reported a decline in anxiety and symptoms of depression over time. The study found no significant interaction effects between the two groups in regard to world outlook and negative appraisals. However, a main effect of time was evident for the PTCI negative scale, with both groups reporting a reduction in negative self-referent appraisal scores at one and six months. Significant main effects of time were also evident for improvements in quality of life and on all four subscales in both treatment groups. This was most evident at 6 and 12 months post-therapy. There were no significant differences between groups, and effect size (Cohen’s d) was not significantly different for anxiety or depression outcomes.

Conclusions

The findings of this study indicate that early intervention with psychotherapy is useful in reducing anxiety and symptoms of depression and PTSD and for preventing chronic psychopathology in symptomatic patients with head and neck cancer.

Limitations

  • The study had a small sample size, with less than 100 participants.
  • The study had risks of bias due to no control group, no appropriate attentional control condition, and limiting sample characteristics.
  • Findings are not generalizable.
  • The intervention is expensive or impractical and is accompanied by need for training.
  • The study involved English-speaking patients only, and mainly Caucasian males.
  • Cancer type was limited to head and neck cancer.

Nursing Implications

Early identification and intervention for patients who are newly diagnosed with head and neck cancer may be beneficial in reducing symptoms resulting from PTSD, anxiety, and symptoms of depression related to diagnosis. Early identification and intervention may prevent chronic psychological issues in the patient population studied. This study showed that both CBT and SC had similar effects. Findings are limited by lack of a control group and the fact that, with or without treatment, all patients' anxiety levels tend to decline over time.

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Kang, H.C., Ahn, S.D., Choi, D.H., Kang, M.K., Chung, W.K., & Wu, H.G. (2014). The safety and efficacy of EGF-based cream for the prevention of radiotherapy-induced skin injury: Results from a multicenter observational study. Radiation Oncology Journal, 32, 156–162.

Study Purpose

To evaluate the efficacy and safety of topically applied recombinant human epidermal growth factor (rhEGF) for the prevention of radiation-induced dermatitis in patients with cancer

Intervention Characteristics/Basic Study Process

EasyDew CR cream (0.005% rhEGF, ceramide, hyaluronic acid, Inca omega oil, portulaca oleracea extract, mango butter, and meadowfoam oil) was applied to the radiation portal skin twice per day from day 1 to the last day of radiation treatment (RT). Patients were advised to wash the cream off prior to RT. No other prophylactic creams or lotions were allowed, and additional applications were ceased if an adverse reaction occurred because of the rhEGF-based cream. Compliance in applying the cream was evaluated weekly by the treating radiation oncologist.

Sample Characteristics

  • N = 1,138
  • MEAN AGE = 51 years (range = 18–90 years)
  • MALES: 17.6%, FEMALES: 82.4%
  • KEY DISEASE CHARACTERISTICS: Histologically-confirmed breast (73%), head & neck (13%), others combined (14%; cervical, soft tissue, esophagus, lung, rectum, and thymus)
  • OTHER KEY SAMPLE CHARACTERISTICS: All participants received > 50 Gy of external radiotherapy, but the mode varied (photons [51.8%], electrons [4.6%], and photons with electrons [43.6%]).

Setting

  • SITE: Multi-site
  • SETTING TYPE: Outpatient
  • LOCATION: Twenty-one cancer centers in Korea

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Multi-site, prospective, observational study of the efficacy and safety of rhEGF cream to prevent radiodermatitis (in patients receiving more than 50 Gy of external radiotherapy)

Measurement Instruments/Methods

  • Modified Radiation Therapy Oncology Group (RTOG) Acute Skin Toxicity Scale
    • The authors commented, “This scale of radiation dermatitis was modified with a representative sign to reduce interobserver variations.” The presence of edema, dry skin, and pruritus also were measured. The status of pruritus was scored using the following criteria: grade 0, no pruritus; grade 1, mild or localized, relieved spontaneously; grade 2, mild or localized, relieved by local measures; grade 3, intense or widespread, relieved by systemic measures; and grade 4, intense or widespread and poorly controlled despite treatment.

Results

SAFETY of CREAM: Adverse events related to the rhEGF-based cream developed in 49 patients (4%) with mild erythema being the most common side effect. Skin toxicity grades > 2 were observed in 5% of patients. Edema, dry skin, and pruritus grades ≥ 3 developed in 9%, 9%, and 1% of the patients, respectively. Safety was categorized in 99.2% of patients.
 
EFFICACY of CREAM: The percentage of radiation dermatitis with maximum grades of 0 and 1 was 19% and 58%, respectively, at the time of 50 Gy.

Conclusions

This study showed that the intervention used was not associated with any severe adverse reactions, but it provides no real evidence regarding the efficacy of the rhEGF cream.

Limitations

  • Baseline sample/group differences of import
  • Risk of bias (no control group)
  • Risk of bias (sample characteristics)
  • Other limitations/explanation: There were 21 centers and no mention of the number of raters used, how the raters were trained, or measurement of inter-rater reliability. The standard RTOG scale was modified. Skin toxicities had Common Terminology Criteria for Adverse Events (CTCAE) variations. RT doses were not surveyed using a method. The objective radiation dermatitis assessment tool needed improvement.

Nursing Implications

Additional studies of this cream are needed before considering the use of this cream in practice. The authors addressed pruritus and radiation toxicity as being potential adverse events; however, they do not stress the importance. Pruritus has been demonstrated to negatively impact quality of life.

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Kang, J.H., Kwon, J.H., Hui, D., Yennurajalingam, S., & Bruera, E. (2013). Changes in symptom intensity among cancer patients receiving outpatient palliative care. Journal of Pain and Symptom Management, 46, 652–660.

Study Purpose

To determine symptom changes after outpatient palliative care

Intervention Characteristics/Basic Study Process

Patients who were seen in outpatient palliative care and had completed a symptom assessment scale were included in retrospective review of medical records. Only patients who completed the assessment and had at least one follow-up visit were included. The outpatient palliative care service was provided by an interdisciplinary team. Baseline symptom severity was compared to findings on an initial follow-up—usually in 15 days—and compared to a group of patients not eligible for study inclusion.

Sample Characteristics

  • N = 1,612 
  • MEAN AGE = 59.2 years (SD = 13.2 years)
  • MALES: 52%, FEMALES: 48%
  • KEY DISEASE CHARACTERISTICS: Multiple disease types; lung, gastrointestinal, and genitourinary cancers were most frequent.
  • OTHER KEY SAMPLE CHARACTERISTICS: 73% were Caucasian.

Setting

  • SITE: Single site 
  • SETTING TYPE: Outpatient 
  • LOCATION: MD Anderson in Texas

Phase of Care and Clinical Applications

  • APPLICATIONS: Palliative care

Study Design

  • Retrospective, descriptive

Measurement Instruments/Methods

  • Edmonton Symptom Assessment Scale

Results

Of the patients, 52%–74% had improvement in intensity of symptoms of pain, fatigue, depression, anxiety, anorexia, shortness of breath, and sleep disruption. Overall, among patients who had no or mild symptoms at baseline, symptom intensity was worse at follow-up, and among those with moderate or severe symptoms, symptom intensity declined at follow-up. Of patients with moderate or severe symptoms, 48%–80% continued to have clinically significant symptom intensity at follow-up. Median scores for pain, fatigue, depression, anxiety, anorexia, dyspnea, and sleep disturbance improved by at least one point by the first follow-up (p < .001).

Conclusions

Outpatient palliative care services in this setting were associated with reduced symptom intensity among patients who had moderate to severe symptoms. Findings suggest that the timing of initial follow-up might not be sufficient to significantly reduce symptom burden quickly.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Selective outcomes reporting
  • Other limitations/explanation: Retrospective design; no information provided regarding disease stage or phase of cancer care involved; only a single follow-up time point

Nursing Implications

Findings suggest that provision of outpatient palliative care services can be beneficial in reducing symptom burden among patients with cancer. Because 48%–80% still had relatively high intensity of symptoms at follow-up after 15 days—and those with no or mild symptoms had exacerbation of symptoms at follow-up—a shorter initial follow-up period might achieve more rapid improvement and help to prevent exacerbation of symptoms. Findings also suggest that getting more severe symptoms under control may take longer, pointing to the need for nurses to consider involvement of palliative care specialists early in the course of cancer treatment.

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