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Heras, P., Hatzopoulos, A., Heras, V., Kritikos, N., Karagiannis, S., & Kritikos, K. (2011). A comparative study of intravenous ibandronate and pamidronate in patients with bone metastases from breast or lung cancer: Effect on metastatic bone pain. American Journal of Therapeutics, 18(5), 340–342.

Study Purpose

To compare the effects of ibandronate with those of pamidronate in patients with bone metastases from breast or lung cancer  

Intervention Characteristics/Basic Study Process

All patients were diagnosed with either breast or lung cancer and had scan-confirmed bone metastases. Patients were in one of two treatment groups, each receiving IV medication every four weeks for six months. Group A received 6 mg ibandronate. Group B received 90 mg pamidronate.

Sample Characteristics

  • The sample was composed of 25 patients.
  • Mean patient age was 60.9 years.
  • Of all patients, 28% were male and 72% were female.
  • Fifteen participants had a primary diagnosis of breast cancer. Ten participants had a primary diagnosis of lung cancer.

Setting

The authors are practitioners at three facilities in Greece: General Hospital of Nafplio, General Hospital of Kos, and the Hellenic Medical Society for the Study of Psychosomatic Problems, Athens. The report does not specify that these were locations used in the study, however.

Phase of Care and Clinical Applications

  • Phase of care: active treatment
  • Clinical applications: late effects, survivorship, end of life, palliative care
     

Study Design

Comparative study

Measurement Instruments/Methods

  • A linear analog scale, 0–10, to assess pain, mobility, and quality of life (QoL)
  • Patient's serum calcium-creatinine ratio, to measure bone resorption
     

Results

Patient demographics were similar in both groups. At baseline, linear analog scale scores were similar in both groups. Compared to the pamidronate group, the ibandronate group had lower pain scores, higher mobility and QoL scores, and lower serum calcium levels. Patients who were taking ibandronate needed fewer analgesics (p = 0.001). In regard to bone pain, patients taking ibandronate reported scores in the range 0–1 and patients taking pamidronate reported scores in the range 3–4.

Conclusions

Ibandronate may be superior to pamidronate in alleviating pain, improving mobility and QoL, and reducing bone resorption in patients with bone metastases from breast or lung cancer.

Limitations

  • The study had a small sample size, with fewer than 30 participants.
  • The study had a risk of bias due to no random assignment.
     

Nursing Implications

Evidence from this study strongly supported the effectiveness of bone-modifying agents in reducing the pain of patients with bone metastases. This study attempted to compare the effectiveness of different bisphosphonates. The size and limitations of the trial did not permit researchers to draw firm conclusions regarding the usefulness of one agent over another. Further research is needed to determine the relative efficacy of bone-modifying agents in pain control.

Print

Hensley, M.L., Hagerty, K.L., Kewalramani, T., Green, D.M., Meropol, N.J., Wasserman, T.H., . . . Schuchter, L.M. (2009). American Society of Clinical Oncology 2008 clinical practice guideline update: Use of chemotherapy and radiation therapy protectants. Journal of Clinical Oncology, 27(1), 127–145.

Purpose

STUDY PURPOSE: To update the American Society of Clinical Oncology (ASCO) guidelines on the use of chemotherapy and radiation therapy protectants for patients with cancer

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: MEDLINE, preMEDLINE, Cochrane Collaboration Library
 
KEYWORDS: Dexrazoxane, mesna, amifostine, and palifermin. These terms combined with neoplasms, cancer, malignancies, and tumors.
 
INCLUSION CRITERIA: Reviewers limited the search to randomized controlled trials, meta-analyses and systemic reviews. The specific criteria included participants with cancer receiving chemotherapy and/or radiation. Participants were randomly assigned to a protectant arm or a control arm and the outcomes reported included as least one of the following toxicities including but not limited to hemorrhagic cystitis, neurotoxicity, neutropenia, and mucositis. Inclusions looked at included compliance, quality of life, cost effectiveness, and disease-free survival. The main focus was to determine any chemotherapy/radiation therapy-induced toxicity.   
 
EXCLUSION CRITERIA: Prospective or retrospective cohort studies and phase I or phase II randomized trials

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 744
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Evidence summary tables were used to extract data. Originally, 744 studies were identified and reviewed for inclusion. After screening abstracts, 643 were eliminated, leaving 101 to undergo a full review for interventions and outcomes. Of that, 62 were excluded, leaving 39 articles left for inclusion. 

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED = 39
 
TOTAL PATIENTS INCLUDED IN REVIEW = Large volume of patients
 
KEY SAMPLE CHARACTERISTICS: Patients with non-small cell cancer, head and neck cancer, prostate cancer, ovarian cancer, Ewing’s sarcoma, and multiple blood cancers

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Results

All the 2002 recommendations were reviewed and addressed. New findings include recommendations against amifostine for the prevention of neutropenia in patients receiving chemotherapy/radiation therapy. Palifermin is recommended for patients undergoing an autologous stem cell transplant and allogeneic with hematologic malignancies to prevent mucositis. No other new evidence or change in guideline recommendation was discovered.
 
Mesna dosing with standard-dose ifosfamide—Recommended when the ifosfamide dose is less than 2.5 g/m2 per day.
 
Mesna dosing with high-dose ifosfamide—Evidence is not sufficient to recommend mesna with high-dose ifosfamide.
 
Mesna with cyclophosphamide—Mesna plus saline diuresis is recommended in the setting of stem cell transplantation.

Conclusions

Using various chemotherapy/radiotherapy protectants is useful in certain malignancies for prevention of toxicity related to therapy. Future trials need to be blinded with placebo-controlled arms to provide key evidence to ensure safe guideline recommendations. 

Limitations

Most of the trials lacked a placebo arm in the studies with the quality of the literature reviewed being limited. The panel found that different instruments and/or assessment tools varied for assessing the same outcome in multiple trials.

Nursing Implications

Nurses caring for this patient population need to be aware and understand that there are medications that can be given to prevent certain chemotherapy/radiation toxicities.

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Henke, M., Alfonsi, M., Foa, P., Giralt, J., Bardet, E., Cerezo, L., … Berger, D. (2011). Palifermin decreases severe oral mucositis of patients undergoing postoperative radiochemotherapy for head and neck cancer: a randomized, placebo-controlled trial. Journal of Clinical Oncology, 29, 2815–2820.

Study Purpose

To determine if palifermin reduces severe oral mucositis (OM), defined as grade 3 or 4 on the World Health Organization (WHO) Oral Mucositis Grading Scale, in patients undergoing postoperative radiochemotherapy for locally advanced head and neck cancer

Intervention Characteristics/Basic Study Process

  • This study had three arms. In arm 1, patients received 120 ug/kg palifermin per week during radiochemotherapy (at least seven doses). In arm 2, patients received 120 ug/kg palifermin per week for four doses, then placebo throughout the remainder of radiochemotherpy. In arm 3, patients received placebo throughout radiochemotherapy.
  • Radiation therapy consisted of conventional or three-dimensional radiation planning for standard fractionation (5 X 2 Gy per week), for a total dose 60 Gy to 66 Gy. Chemotherapy consisted of 100 mg/m2 cisplatin on days 1 and 22. Palifermin was administered once, three days prior to starting radiochemotherapy, followed by six once-weekly doses. 
  • Local supportive care of normal saline rinses, topical anesthetics, feeding tube, and hematopoietic growth factors were allowed. Anti-inflammatory, antifungal, or antibiotic mouthwash solutions were not permitted.

Sample Characteristics

  • The study reported on 186 patients with a mean age of 56.5 years.
  • The sample was 82% male and 18% female.
  • Patients were resected for pathohistologically documented, high-risk Stage II to IVB squamous cell cancer of the oral cavity, oropharynx, hypopharynx, or larynx and were expected to receive at least 50 Gy to at least two of the main areas of the oral or oropharyngeal mucosa.
  • Patients had European Cooperative Oncology Group (ECOG) performance status of 0–2, no history of pancreatitis or acute pancreatitis within the last year, and no prior radiation to the head and neck region or prior to chemotherapy.

Setting

This was a multisite study conducted in Australia, Canada, France, Germany, Italy, Spain, and United Kingdom.

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

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

Measurement Instruments/Methods

  • The WHO oral toxicity scale was used.
  • Trained evaluators conducted twice weekly assessments (at least 3±1 days apart throughout radiochemotherapy) until resolution of OM to WHO grade 2 or lower or until week 15.
  • If OM was not resolved by week 15, weekly assessments were continued until OM reached grade 0 or 1 or until week 24.
  • Evaluations immediately analyzed for data quality and accuracy by Clinical Assistance Programs.

Results

  • The four-arm palifermin arm was halted because of slow enrollment. Results for the 38 patients on this arm were analyzed separately and matched for the first 38 patients enrolled in the placebo arm.
  • Palifermin at 120 ug/kg reduced severe OM in patients with head and neck cancer undergoing concomitant postoperative radiochemotherapy.
  • Severe OM was observed in 47 (51%) in the palifermin arm and 63 (67%) in the placebo arm (p = 0.027). The median durations of severe OM were 4.5 days in the palifermin arm and 22.0 days in the placebo arm (p = 0.037). The median times to develop severe OM were 45 or 21 days (p = 0.022) in the palifermin and placeblo arms, respectively.

Conclusions

Palifermin administered prior to initiation of and weekly during concurrent chemotherapy-radiation therapy reduced OM incidence. The study also examined secondary endpoints (i.e., duration and onset, xerostomia, mouth and throat soreness (MTS) score) as well as radiation treatment breaks and chemotherapy delays. Patients receiving palifermin did not experience fewer breaks or lower average MTS  even though these patients did receive fewer opiod analgesics.

Limitations

This study was supported by Amgen, which manufactures paliferrmin.

Nursing Implications

Treatment-related OM is debilitating for patients with head and neck cancer undergoing concurrent chemotherapy-radiation therapy. This can significantly impact patient comfort, nutritional status, and response to therapy. Further research is needed to identify effective therapies to better protect the oral mucosa.

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Hendrix, C.C., Abernethy, A., Sloane, R., Misuraca, J., & Moore, J. (2009). A pilot study on the influence of an individualized and experiential training on cancer caregiver's self-efficacy in home care and symptom management. Home Healthcare Nurse, 27, 271–278.

Study Purpose

To formally evaluate whether a tailored and experiential training approach by an experienced nurse would enhance confidence (self-efficacy) of family cancer caregivers to provide home care and manage patients’ symptoms of illness

Intervention Characteristics/Basic Study Process

The study principal investigator (PI) provided a conceptually based, tailored, and patient-centered bedside intervention for family caregivers providing home care to patients with hematologic malignancies. Caregiver training included symptom management on prevention of infection, pain, poor nutrition, constipation/diarrhea, and management of medications for patient cancer symptoms. Interactive discussion on these topics occurred between interventionist (experienced nurse), caregiver, and patient. To encourage patient involvement in problem-solving symptoms, dyad participation was also incorporated into bedside training. Caregivers received an illustrated take-home manual on discussed topics. Discussion focused on nonpharmacologic interventions to improve patient comfort and meet other patient needs. Caregivers provided a return demonstration following nurse delivery of didactic teaching and skill performance (e.g., catheter care management) specific to patients’ home situation. Sufficient time was provided in the teaching encounter for patients and caregivers to ask questions and to allow satisfactory completion of the skills required for effective patient home care before patient discharge.

Assessment of the influence of the intervention occurred before and after PI training and one week following hospital discharge of the patients. Caregivers completed postintervention assessment within 24 hours of the PI’s didactic and skill performance presentation to caregivers.

Sample Characteristics

  • The sample (N = 16) was 15% male and 85% female.
  • Sample age range was 44–80 years.
  • Mean age was 62 years for both patients and caregivers.
  • All patients had hematologic cancers and were admitted for chemotherapy or treatment of cancer-related acute conditions.
  • Caregivers were connected to patients who were likely to be discharged soon and who were not actively dying; lived with patients in the same home and served as primary caregivers; and were English speaking and reading.
  • The majority of caregivers were white and did not work outside the home; almost half were educated at the associate degree level or higher.

Setting

  • Single site
  • Multiple settings
  • Southeastern U.S. regional medical center

Phase of Care and Clinical Applications

Active antitumor treatment phase

Study Design

A quasi-experimental, time-series design was used.

Measurement Instruments/Methods

  • Cancer Caregiver Self-Efficacy (Confidence) Questionnaire (CCSE): This 23-item tool was used three times in the study to assess caregiver confidence in completing a behavioral task or skill.
  • No prestudy reliability and validity indices were reported.
  • Cronbach’s alpha was 0.94 for the CCSE. Construct validity index of 0.77 (p < 0.001) was reported for the CCSE when the scores from the study sample of 16 were correlated with historical data including the Caregiving Preparedness Scale.

Results

Total caregiver CCSE scores were significantly higher immediately after caregiver training (z = 4.49, p < 0.001) and one week after hospital discharge of patients (z = 3.22, p < 0.001). These higher scores reflect higher and some sustained levels of caregiver confidence to provide needed home care to patients comprising the sample. Although unanticipated, four patients died within one week of hospital discharge (20% attrition for study), producing a total sample of 16 from the initial sample of 20 patient–caregiver dyads for the one-week assessment.

Conclusions

Timely assessment and nurse-led interventions relevant to assessment findings may increase caregiver confidence to assume home care for patients with hematologic malignancies. Based on Bandura’s (1986) conceptual self-efficacy framework, this pilot study suggests that nurse-led individualized teaching and modeling of homecare skills at the patient’s bedside prior to discharge can sustain caregiver confidence for up to one week postdischarge of the patient. Caregivers and patients believed the intervention to be highly beneficial based on a 1:1 relationship with the nurse-teacher.

Limitations

  • The sample was small, with less than 30 participants.    
  • Risk of bias existed because of no control group, no blinding, and no appropriate attentional control condition.
  • Unintended interventions or applicable interventions that would influence results are not described.
  • Findings are not generalizable.
  • Subject withdrawals were greater than 10%.
  • Involvement of the PI or study staff with the rounding oncologist during prerecruitment may have influenced individuals approached for the study (Were those with greatest needs referred for the study?)
  • The acuity level of the sample patients and the functional health of caregivers to support their ability to provide home care are unknown.
  • Whether training occurred the day of discharge or how variable the timing and length of the intervention was are unclear.
  • Whether data from the 20 subjects were used in the pre- and post-analysis and then from the 16 for the pre-one week, or whether the 16 were used for all analysis, is unclear. The analysis section suggests that a mixed-effects model was used, suggesting that all data were used and missing data were modeled. More manuscript details would aid in interpretation of the study findings.
  • Threats of maturation and selection also may affect internal validity of the study.

Nursing Implications

As part of their education, nurses learn about the teaching-learning process to optimally prepare patients, families, and communities about ways to improve personal and societal health. With early discharge of patients and the need for family members to often assume complex caregiving roles, there is a heightened need for nurses to use their knowledge of teaching-learning to assess and implement effective teaching to families during the cancer trajectory. Individualized and bedside teaching approaches, such as those found in this study, benefit patients and family members in both inpatient and outpatient settings. Study findings must be evaluated with caution due to the small sample size, one setting for data collection, and lack of control group. More specifically relative to sample size, additional replication of the study must occur to more clearly identify the influence of the individualized and experiential training program on diverse population groups related to ethnicity, clinic care type, education level, and gender (external validity). This would capture deeper understanding of needed components of tailored care in the healthcare team approach to efficiently meet caregiver and patient needs.

Print

Hendrix, C.C., Bailey, D.E. Jr., Steinhauser, K.E., Olsen, M.K., Stechuchak, K.M., Lowman, S.G., . . . Tulsky, J.A. (2015). Effects of enhanced caregiver training program on cancer caregiver's self-efficacy, preparedness, and psychological well-being. Supportive Care in Cancer, 24, 327–336. 

Study Purpose

To examine the effects of enhanced training on caregivers’ self-efficacy in managing patients' symptoms, stress, preparedness for caregiving, depression, and anxiety

Intervention Characteristics/Basic Study Process

Researchers structured and used enhanced caregiver training (CT) that taught caregivers how to manage patients’ symptoms and their own stress. This training added distress management to previously developed training that focused on managing patients' symptoms only. Training was done at the patients' bedside, one on one, with dyads (patients and their caregivers), and required one to two hours. Training on symptom management involved a manual process that started with a needs assessment to tailor the training to the patient’s situation, an interactive discussion that involved both the patient and the caregiver about how to manage symptoms, and concluded with a one-page hand out on each symptom. Training related to caregivers’ stress management involved a three-step behavioral rehearsal procedure. The nurse modeled how to implement the skill, and the caregiver practiced the skill and received constructive feedback. Finally, the caregiver practiced until she or he mastered the skill.

Sample Characteristics

  • N = 38 (intervention); 38 (control)
  • AVERAGE AGE = 55 years (caregivers)
  • MALES: 18%, FEMALES: 82%
  • OTHER KEY SAMPLE CHARACTERISTICS: The majority of caregivers were adults, Caucasian, married, had at least some college education, and were the spouses of patients. The majority had a high level of health literacy, and the average length of caregiving was 19 months. A dyad was excluded if a patient was under hospice care.

Setting

  • SITE: Single site    
  • SETTING TYPE: Inpatient  
  • LOCATION: Duke University Health System Oncology Units

Phase of Care and Clinical Applications

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

Study Design

Randomized, controlled trial in which the intervention arm received enhanced CT and the control group received information about community resources

Measurement Instruments/Methods

  • Modified Caregiver Self-Efficacy Scale (CaSES) to assess confidence in caregiving abilities (13 items) and in stress management (one item)
  • The Preparedness for Caregiving Scale (PCS), a subscale of the Family Caregiving Inventory (FCI)
  • Profile of Mood States (POMS) to assess anxiety
  • Center for Epidemiologic Studies–Depression (CES-D) scale
  • Caregiver Reaction Assessment (CRA) to assess caregiver burden
  • Rapid Estimate of Adult Literacy in Medicine (REALM-R) to assess health literacy

Results

Significant difference was identified between the intervention and control groups in self-efficacy for managing patients' symptoms, caregiver stress, preparedness for caregiving immediately after the intervention. The intervention group scored higher on the previous outcomes. No differences in other outcomes were found, and the differences initially observed after the intervention were not sustained at two and four weeks after discharge.

Conclusions

Enhanced CT improved caregivers’ self-efficacy, stress management, and preparedness for caregiving immediately after the intervention. However, it did not lead to significant changes in anxiety, depression, or burden. No sustained effects of the intervention were observed for any outcomes.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Intervention expensive, impractical, or training needs
  • Subject withdrawals ≥ 10%  
  • Other limitations/explanation: This was a well done trial despite the identified limitations.

Nursing Implications

Caregiver training given in a single dose may not be the best approach to improving caregiver outcomes. Training or interventions for caregivers should be tailored based on emerging needs after discharge, and they should not be exclusively based on the observed or anticipated needs prior to a patient's discharge from the hospital.

Print

Hendrix, C.C., Landerman, R., & Abernethy, A.P. (2013). Effects of an individualized caregiver training intervention on self-efficacy of cancer caregivers. Western Journal of Nursing Research, 35, 590–610.

 

Study Purpose

To (a) investigate the effects of an individualized caregiver training intervention on a caregiver’s self-efficacy in home care and symptom management, and (b) identify whether caregiver training would affect a caregiver’s psychological well-being (depression, anxiety, and quality of life)

Intervention Characteristics/Basic Study Process

After signing informed consent, dyads completed baseline questionnaires and were randomly assigned to either a treatment group or a control group. Interactive nurse–caregiver training for one to two sessions was offered when discharge was imminent. Immediately after caregiver training, caregivers completed questionnaires on self-efficacy. Follow-up questionnaires for caregivers and patients were completed at one week, two weeks, and four weeks after hospital discharge of patients.

The caregiver training intervention provided caregiver training for managing patients’ cancer symptoms with four major components: (a) prevention of infection, (b) pain control, (c) maintenance of nutrition, and (d) adequate elimination. The program was manualized, including a book for caregivers with “how to” pictures. Additional time and content were allocated to address specific homecare issues identified by caregivers. The training followed a consistent outline, but information shared was specific to needs of the patient and caregiver.

The control intervention consisted of an interactive nurse–caregiver standardized, manualized one-two session intervention focused on information about community resources for caregiving. This included but was not limited to home health agencies, respite care, and caregiver support services.

Sample Characteristics

  • The sample included 120 patient dyads (60 in treatment group and 60 in control group).
  • Of the caregivers, 48% were 46–64 years of age; of the patients, 54% were 60–69 years of age.
  • The caregiver sample was 17% male and 83% female; the patient sample was 71% male and 29% female.
  • Patients had hematologic malignancies.
  • Of the caregivers, 84% were white, 89% were married, 60% had education beyond high school, 64.6% were not working outside the home, and the patient for whom they cared was a spouse.
  • Of the patients, more than 80% were white, 88% were married, and almost 90% had education beyond high school.

Setting

  • Single site
  • Outpatient setting
  • Duke University Hospital in Durham, NC

Phase of Care and Clinical Applications

  • Multiple phases
  • Home care; after hospital discharge; survivorship

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

  • Lorig’s Self-Efficacy Scale: Noted prior assessed reliability (0.94) and validity
  • Hospital Anxiety and Depression Scale (HADS): No noted prior reliability and validity
  • Older Americans Resources and Services (OARS) Multidimensional Functional Assessment Questionnaire (Instrumental and Physical subscales): No noted reliability and validity
  • OARS Comorbidity Scale: No noted reliability and validity indices
  • Caregiver Quality of Life–Cancer Scale (CQOLC): Noted earlier assessed internal consistency of 0.91   
  • Memorial Symptom Assessment Scale (MSAS): No noted reliability and validity

Results

There was increased self-efficacy immediately following the caregiver training intervention and higher self-efficacy and symptom management at four weeks after the intervention when compared to the control group. A significant group-by-time interaction (p = 0.008) was present in the training intervention caregiver group that showed decreased depression scores from baseline to time 3 (one week). However, significant differences between treatment and control groups were not found after time 3. A similar result occurred when analyzing the effect of the intervention on caregiver anxiety. In terms of the effect of the caregiver intervention on patient’s physical symptoms, the overall intervention over time did not significantly improve symptoms. There was also no significant effect of the intervention on caregiver quality-of-life scores in both the control and caregiver training groups.

Conclusions

Caregivers have a major role in the outcome of a successful transition from hospital to home. This study provides information about caregiver training that improved their self-efficacy when addressing symptom management of a family member with cancer. More research is needed to determine the most effective caregiver training to manage patients’ symptoms at home.

Limitations

  • Nurses delivering the caregiver training intervention and the control intervention were not blinded.
  • Assessment of the delivery of control and caregiver training intervention did not occur.
  • The sample was mostly white, educated, and married.
  • Caregivers were not observed providing actual home care and symptom management interventions.

Nursing Implications

Caregiver training for the patient’s home care and symptom management is critical in bridging the transition for patients from hospital to outpatient care. Nurses play a key role in this caregiver training tailored to specific caregiver and patient needs. Evidence-based information about the most effective training, including decisions about frequency, dosing, timing, formatting of information, and preparation of the nurse, is needed to improve caregiver quality of life and psychological well-being.

Print

Hendriks, L.E., Hermans, B.C., van den Beuken-van Everdingen, M.H., Hochstenbag, M.M., & Dingemans, A.M. (2016). Effect of bisphosphonates, denosumab, and radioisotopes on bone pain and quality of life in patients with non-small cell lung cancer and bone metastases: A systematic review. Journal of Thoracic, 11, 155–173. 

Purpose

STUDY PURPOSE: To assess the evidence of effectiveness of these agents on bone pain and quality of life (QOL)

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: PubMed, Medline, EMBASE, Web of Science, Cochrane Collaboration, and manual search of study references
 
INCLUSION CRITERIA: English, German, or Dutch language; full article or conference proceeding; at least five patients with non-small cell lung cancer (NSCLC) in the sample; bone metastases; treatment with bisphosphonate, denosumab, radioisotopes, or a combination of these alone or combined with other treatment.
 
EXCLUSION CRITERIA: None specified

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 1,577
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: The review included 23 studies and 2 conference proceedings. The method for evaluation of study quality were not stated.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 25 
  • TOTAL PATIENTS INCLUDED IN REVIEW = 3,044 with bisphosphonates or denosumab, 762 with radioisotopes
  • SAMPLE RANGE ACROSS STUDIES: 22–1,597 patients
  • KEY SAMPLE CHARACTERISTICS: Multiple tumor types, including lung cancer

Phase of Care and Clinical Applications

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

Results

Thirteen studies examined use of bisphosphonates and/or denosumab. Twelve studies used various radioisotopes. No randomized studies using bone-modifying agents were found. One randomized study compared zoledronic acid versus ibandronate. Most of these studies were examining effects to prevent skeletal events. Overall for those with NSCLC, a mean of 67% of patients had a decrease in pain score (3 studies, 225 patients). Of patients given samarium, 60%-95% experienced a decrease in pain. Overall radioisotopes appeared to reduce pain with rapid onset, lasting one to three months. Data were limited for individuals specifically with NSCLC. Most studies did not include QOL measurement; in the five studies that did, only two showed improvement.

Conclusions

Limited evidence exists that bisphosphonates or denosumab reduce or prevent pain from bone metastases or impact QOL in patients with NSCLC . Radioisotopes appear to have a palliative effect on pain, but no high-level evidence for this was found.

Limitations

  • No quality evaluation

Nursing Implications

Although some evidence exists that bone-modifying agents prescribed to prevent skeletal events may reduce associated pain, the evidence is limited, particularly for patients with NCSLC. Radioisotopes appear to reduce pain for a limited amount of time, and repeated use can have significant adverse effects on bone marrow. Authors of this report suggest that efficacy for pain relief may be tumor dependent, and that, due to potential bone marrow suppression, radioisotopes should be reserved for patients who are not receiving active anticancer therapy and pain that is not appropriate for palliative radiotherapy.

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Hemati, S., Asnaashari, O., Sarvizadeh, M., Motlagh, B. N., Akbari, M., Tajvidi, M., & Gookizadeh, A. (2012). Topical silver sulfadiazine for the prevention of acute dermatitis during irradiation for breast cancer. Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer, 20(8), 1613–1618.

Study Purpose

To evaluate the effectiveness of topical silver sulfadiazine to prevent radiation dermatitis in women receiving radiotherapy for breast cancer

Intervention Characteristics/Basic Study Process

Patients were randomized to intervention and control groups and were matched by the investigator in terms of the flatness of the chest wall. Patients in the intervention group were instructed to apply 1% silver sulfadiazine cream to the irradiated field every eight hours for three consecutive days. No application was done on the days they received radiation therapy. Use of the cream was continued for one week after completion of radiotherapy. Both groups were educated in general skin care. No other creams were to be applied to the radiation field. Skin in the field was examined weekly by a random radiation oncologist who was not informed of patient group assignment.

Sample Characteristics

  • The study sample was comprised of 102 female patients with breast cancer.
  • Mean age was 48.4 years.
  • Chemotherapy had to be completed at least three weeks prior to study entry.  

 

Setting

The study took place in an outpatient setting in Iran.

Phase of Care and Clinical Applications

Patients were undergoing active antitumor treatment.

Study Design

The study used a single blind randomized controlled trial design.

Measurement Instruments/Methods

The Radiation Therapy Oncology Group scoring of skin toxicity was used.

Results

 From the second week onward, patients who received the silver sulfadiazine cream showed lower grades of skin injury (p < 0.002).

Conclusions

Silver sulfadiazine was more effective than no treatment in reducing the severity of radiation-induced dermatitis.

Limitations

  • The study had a risk of bias due to no blinding.
  • Measurement validityand reliability are questionable.
  • Patient adherence to use was not evaluated. 

Nursing Implications

Silver sulfadiazine was more effective than no skin treatment to reduce severity of radiation-induced dermatitis. It would be more helpful to determine the difference between this approach and other topical treatments, which have been shown to have some efficacy.

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Heller, L., Kowalski, A.M., Wei, C., & Butler, C.E. (2008). Prospective, randomized, double-blind trial of local anesthetic infusion and intravenous narcotic patient-controlled anesthesia pump for pain management after free TRAM flap breast reconstruction. Plastic and Reconstructive Surgery, 122(4), 1010–1018.

Study Purpose

To assess the efficacy of continuous infusion pump delivery of bupivacaine at TRAM flap donor site; to assess the safety of continuous infusion pump delivery of bupivacaine at TRAM flap donor site

Intervention Characteristics/Basic Study Process

Patients received 0.375% bupivacaine or isotonic saline through a continuous infusion pump in the suprapubic area and caudal to the donor site incision. All patients received narcotic via PCA programmed for demand-only mode, with no basal rate. Patients could receive oral narcotics. Pain at rest was evaluated four times per day while patients were awake. Overall satisfaction was assessed every four hours for the first three days.

Sample Characteristics

  • The sample was composed of 48 patients, 23 in the intervention group and 25 in the control group.
  • In the intervention group, mean patient age was 50.3 years; in the control group, 47.6 years.
  • All participants were female.
  • All participants were undergoing unilateral mastectomy with TRAM flap reconstruction.

Setting

  • Single site
  • Inpatient
  • M.D. Anderson Cancer Center, Houston, Texas

Study Design

Prospective randomized, double-blinded trial

Measurement Instruments/Methods

  • Amount of PCA narcotic used
  • Type and amount of oral narcotic used
  • Pain score, on a 10-point visual analog scale (VAS), measured four times daily when patient was at rest
  • Patient satisfaction as measured every four hours for three days

Results

  • During the first two postoperative days, total PCA use was lower in the continuous infusion group than in the control group. (In both groups, measures of the intensity of abdominal pain at rest reflected significantly lower pain with each postoperative day. Measures were not significantly different between groups.)
  • Patient satisfaction was higher in the continuous infusion versus the control group (P = 0.032).

Conclusions

Continuously infused bupivacaine reduced patients' need for PCA opioids early in the postoperative period.

 

Limitations

  • Pain from the mastectomy site may have been a confounding factor.
  • The study had a small sample size, with fewer than 100 patients.
  • Limitations may include individual differences regarding pain perception, pain threshold, and the appropriateness of requests for pain medication.

Nursing Implications

Postoperative mastectomy-TRAM patients may benefit from continuous infusion of anesthetic to an operative site. Ongoing research to determine the most effective dosage and the most effective anesthetics is warranted.

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Hejna, M., Kostler, W.J., Raderer, M., Steger, G.G., Brodowicz, T., Scheithauer, W., … Zielinski, C.C. (2001). Decrease of duration and symptoms in chemotherapy-induced oral mucositis by topical GM-CSF: Results of a prospective randomized trial. European Journal of Cancer, 37, 1971–1975.

Intervention Characteristics/Basic Study Process

Patients were randomized to one of two arms.

  • Arm A was given topical granulocyte-macrophage colony-stimulating factor (GM-CSF) (Leucomax) mouthwash three times per day. The mouthwash consisted of 400 mcg GM-CSF in 250 mL water. Patients were instructed to rinse with 25 mL for 3 minutes and repeat 10 times within 30 minutes. They were to repeat this process at three identical times each day.
  • Arm B was given a solution of 4 mL povidone-iodine in 125 ml water with amphotericin B. They were to rinse with 10 mg four times per day according to the same instructions as Arm A.

Both groups were instructed to continue using the respective mouthwashes until complete response (CR). A third, independent investigator randomized patients without knowing individual mucositis ratings.

Sample Characteristics

  • The study reported on 31 patients, with 15 in Arm A and 16 in Arm B.
  • Patients' ages ranged from 39–77 years, with a median age of 58 years.
  • All patients had solid tumor diagnoses.
  • The World Health Organization (WHO) oral mucositis scale was used to grade patients after they had received fluorouracil (5FU)-based chemotherapy. Two investigators independently rated mucositis severity.

Setting

The study was conducted between March 1998 and June 1999.

Study Design

This was a prospective, randomized, controlled study.

Measurement Instruments/Methods

Every three days, objective and subjective evaluations were conducted.

Results

  • Patients who received the GM-CSF treatment experienced shorter duration (5.3 versus 8.1 [p = 0.0008]) and quicker resolution (2.8 versus 4.1 [p = 0.0011]) of mucositis.
  • No side effects were reported, and the treatment was well tolerated.

Limitations

  • The sample size was small.
  • Application of mouthwash findings is complicated.
  • The treatment has a high cost.
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