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Vilela, L. D., Nicolau, B., Mahmud, S., Edgar, L., Hier, M., Black, M., . . . Allison, P. J. (2006). Comparison of psychosocial outcomes in head and neck cancer patients receiving a coping strategies intervention and control subjects receiving no intervention. Journal of Otolaryngology, 35, 88–96.

Intervention Characteristics/Basic Study Process

The Nucare program was a short-term psychoeducational coping strategies intervention. Three delivery formats were offered:  (1) small group, (2) one-to-one, and (3) a home format with didactic material. The didactic material comprised a workbook, cassette or CD containing spoken instruction to guide the individual through the workbook, and music to accompany the relaxation training component. Outcomes were quality of life (QOL) and depressive symptoms.

Sample Characteristics

  • The sample was comprised of 101 patients.
  • Patients were included if they had head and neck primary cancer, were up to 36 months following diagnosis, had finished their cancer treatment, and were able to understand and complete the study questionnaires.

Setting

Outpatient oncology clinic at the Jewish General Hospital Montreal, Canada

Phase of Care and Clinical Applications

Patients were undergoing the long-term follow-up phase of care.

Study Design

This was a feasibility study with a prospective, nonrandomized design, two groups, and repeated measures at baseline and three and four months.

Measurement Instruments/Methods

  • European Organisation for Research and Treatment of Cancer Core QOL Questionnaire (EORTC QLQ-C30) to measure health-related QOL
  • Hospital Anxiety and Depression Scale (HADS) to measure depression and anxiety

Results

Compared with their baseline scores, the intervention group had improved physical and social functioning, global QOL, fatigue, sleep disturbance, and depressive symptoms. The control group showed no changes in QOL or depressive symptoms.

Limitations

  • The sample was a convenience one, and a significant number of people refused to participate, thereby reducing generalizibility.
  • Sample size was not based on any calculation or hypothesis; rather, it was determined by logistical and financial constraints, so some differences may have been missed owing to insufficient power.
  • Loss to follow-up was greater in the test group than in the control group.
Print

Vilela, L. D., Nicolau, B., Mahmud, S., Edgar, L., Hier, M., Black, M., . . .Allison, P. J. (2006). Comparison of psychosocial outcomes in head and neck cancer patients receiving a coping strategies intervention and control subjects receiving no intervention. Journal of Otolaryngology, 35, 88–96.

Intervention Characteristics/Basic Study Process

The aim of the Nucare program intervention was to educate individuals with cancer on how to cope with the disease. Didactic materials consisted of a workbook, a cassette/CD guide to supplement the workbook material, and music to accompany the relaxation training component. The following eight components were emphasized in the Nucare program:  good coping, ways of thinking, communication, effective use of social support, problem-solving techniques, goal setting, healthy lifestyle, and relaxation training. The intervention was delivered in three formats:  (1) small-group (three to four participants with a trained therapist), (2) one-to-one (a participant and a therapist); or (3) home (the participant was provided with didactic material to use at home with no therapist). Data were collected at baseline and three to four months later.

Sample Characteristics

Patients were included if they 

  • Had primary head and neck cancer
  • Were up to 36 months following diagnosis
  • Were posttreatment.

Baseline

  • Sixty-six participants (78.8% male) were included.
  • Mean age was 56.7 years (range 30–84).
  • Of the participants, 78.8% were male, 63.6% were retired or working, 65.2% had high school education or less, 69.7% were with a partner or relative, 56% were late stage, the majority (30.3%) had larynx cancer, 48.5% had received combination radiotherapy (RT) and surgery, 90.9% had no history of cancer, and 87.9% had no recurrence.

Follow-up

  • Forty-five participants (80% male) were included.
  • Mean age was 57.3 years (range 30–84).
  • Of the participants, 70.1% were retired or working, 57.8% had high school education or less, 84.1% were with a partner or relative, 66.7% were late stage, 40% had pharyngeal cancer, 55.6% had received combination RT and surgery, 91.1% had no history of cancer, and 91.1% had no recurrence.

Patients who were in palliative or terminal care or who were unable to complete the outcomes questionnaires were excluded.

Setting

Outpatient clinic at the Jewish General Hospital in Montreal

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

The study used a feasibility, prospective, nonrandomized design.

Measurement Instruments/Methods

European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30)

Results

On the EORTC QLQ-C30, a statistically significant improvement was observed in fatigue (p < 0.05) in the intervention group. The control group showed deterioration at follow-up, but it was not significant.

Limitations

  • The study design lacked randomization, and age/gender distributions were dissimilar between the intervention and control groups.
  • The sample size was determined by logistical and financial restraints.
  • The study had a small sample size.
Print

Vilela, L.D., Nicolau, B., Mahmud, S., Edgar, L., Hier, M., Black, M., ... Allison, P.J. (2006). Comparison of psychosocial outcomes in head and neck cancer patients receiving a coping strategies intervention and control subjects receiving no intervention. Journal of Otolaryngology, 35(2), 88–96.

Study Purpose

To show the effectiveness of the Nucare program, a short-term psychoeducational intervention for patients with a cancer diagnosis, on the ability of individuals with cancer to cope with their disease

Intervention Characteristics/Basic Study Process

  • Three different delivery means were available, and participants chose the means they preferred. Delivery means were small-group format, one-to-one format, and home format.
  • Outcomes were quality of life and symptoms of depression. Outcomes were evaluated at baseline and at three to four months after baseline.
  • A control group received no intervention.
  • The Nucare psychoeducational program provided a workbook describing effective coping, ways of thinking, communication, uses of social support, problem-solving techniques, and goal setting; healthful lifestyle; and relaxation training.

Sample Characteristics

The sample was composed of 101 participants. The sample consisted of a convenience sample of patients with head or neck cancer. Participants had completed cancer treatment. The control group was matched to the internvention group in terms of length of time since diagnosis and stage of cancer.

Setting

  • Outpatient clinic
  • One hospital
  • Montreal, Quebec, Canada

Study Design

Feasibility study using a prospective, nonrandomized design

Measurement Instruments/Methods

  • European Organization for Research and Treatment of Cancer Core Quality of Life (EORTC QLQ-C30)
  • Hospital Anxiety and Depression Scale (HADS)

 

Results

From baseline to follow-up, the test group showed improvement in most quality-of-life scores and statistically significant improvement of depression (1.2 points, p < 0.05). The control group showed deterioration in most of the EORTC QLQ-C30 and HADS scores at follow-up. However, none of the changes was statistically significant at the 5% level.

Conclusions

Intervention delivery is feasible.

Limitations

  • The study used a prospective, quasiexperimental design without randomization.
  • The study employed a convenience sample, and many patients refused to participate. These factors reduce generalizability.
  • Authors did not compare the three delivery formats.
  • At baseline, the characteristics of the test and control groups were significantly different. Therefore, outcomes may not have been the result of the intervention.
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Vignes, S., Porcher, R., Arrault, M., & Dupuy, A. (2007). Long-term management of breast cancer-related lymphedema after intensive decongestive physiotherapy. Breast Cancer Research and Treatment, 101(3), 285–290.

Intervention Characteristics/Basic Study Process

Patients were followed for 12 months. Lymphedema volume was recorded prior to and at the end of intensive treatment and at 6- and 12-month follow-up visits. Multivariate models analyzed the role of three components of complete decongestive therapy (CDT): manual lymph drainage (MLD), low-stretch bandage, and elastic sleeve on lymphedema volume during one-year maintenance (after intensive CDT). Lymphedema treatment was managed with an 11-day hospital stay for intensive therapy. The second maintenance phase was carried out by the patient and family at home. At the hospital, patient education on implementing self-management was an important goal. Patients and families were taught the self-bandaging technique throughout the intensive phase.

Sample Characteristics

  • The sample (N = 537) was comprised of patients with secondary arm lymphedema who were recruited in a single lymphology unit.
  • Four hundred and twenty-six patients presented at 6-month follow up and 356 patients at 12 months.
  • The final study sample was 426 female patients referred to the center dedicated to lymphedema management from January 2001 to December 2004.
  • Patients were excluded from the study if they had a past history of lymph reduction by any method.

Study Design

The study used a prospective cohort design.

Measurement Instruments/Methods

  • Lymphedema volume was calculated for each 5 cm segment by truncated cone formula.
  • Lymphedema was defined as the difference between the lymphedematous limb and the healthy limb.
  • Upper-limb volumes were measured by the same operator at each of the four measurements.
  • Included at each ffollow-up visit was a recording of treatments applied, including MLD, self-bandages and the number per week, and elastic sleeve.
  • Breast cancer stage and treatment (age at cancer diagnosis, mastectomy and lumpectomy, radiotherapy, chemotherapy, and anti-estrogens), complications, patient characteristics, body mass index, date of onset of lymphedema, and lymphedema volume at inclusion were also recorded.

Results

  • Data collection was lost for 2 patients and 24 died during follow up.
  • Mean volume of lymphedema was 1054 +/- 633 ml prior to and 647 +/- 351 after intensive decongestive physiotherapy.
  • During the one-year maintenance phase therapy, the mean lymphedema volume increased by 84 ml.
  • Increased volume of more than 10% was experienced by 52% of patients.
  • Noncompliance to low-stretch bandage and elastic sleeve were risk factors for increased lymphedema after one year of maintenance treatment (p < 0.0001 and p = 0.002).
  • Non-compliance to MLD was not a risk factor (p = 0.91).
  • Multivariable covariance analysis model for the use of low-stretch self-bandages allowed a 99 ml additional volume reduction during maintenance therapy, compared to no use of bandages.
  • Use of an elastic sleeve allowed for a 118 ml additional volume reduction during maintenance therapy, compared to no use of elastic sleeve.
  • Effects of self-bandages and an elastic sleeve were independent from each other (p = 0.49) or interaction. The effects did not depend on the magnitude of lymphedema volume.
  • During the maintenance phase, compliance to the use of an elastic sleeve and low-stretch bandage should be encouraged to stabilize lymphedema volume.
  • MLD did not have an additional independent effect on post-treatment lymphedema.

Conclusions

Researchers concluded that bandages and an elastic sleeve are significant factors for maintenance if the sleeve is worn daily and self -bandages are worn nightly three times per week.

Limitations

  • Interventions were not randomized so there is no control and confounding factors cannot be identified.
  • A large number of patients was lost at 12-month follow up.
  • Assessment of compliance not very accurate and only full compliance was noted.
  • Study did not define maintenance MLD.
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Vignes, S., Blanchard, M., Arrault, M., & Porcher, R. (2013). Intensive complete decongestive physiotherapy for cancer-related upper-limb lymphedema: 11 days achieved greater volume reduction than 4. Gynecologic Oncology, 131, 127–130. 

Study Purpose

To determine the optimal complete decongestive physiotherapy (CDP) duration for reduction of lymphedema volume, as well as factors that will predict its success, optimally reducing it from 11 to 4 days

Intervention Characteristics/Basic Study Process

Patients were hospitalized in a rehabilitation center for 11 days for CDP. Lymphedema volume was evaluated initially and after 4 and 9 bandages.

Sample Characteristics

  • N = 129  
  • MEDIAN AGE = 64 (range = 42–88)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer-related lymphedema

Setting

LOCATION: Paris, France

Study Design

  • Observational

Measurement Instruments/Methods

  • Wilcoxon’s rank test 
  • Holm’s
  • Logistic regression models 
  • R statistical software, version 2.13.2

Results

Initial lymphedema volume was 907 mL at inclusion, with a significant mean decrease to 712 mL after four days, and 606 mL after 11 days. This corresponds to a 33% total lymphedema volume reduction.

Conclusions

CDP for 11 days had a significantly greater volume reduction of breast cancer-related lymphedema volume than after 4 days.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)

 

Nursing Implications

CDP for 11 days may be more effective than only four days and will more significantly improve patients' breast cancer-related lymphedema and may improve patients' overall quality of life more.

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Vignes, S., Porcher, R., Arrault, M., & Dupuy, A. (2011). Factors influencing breast cancer-related lymphedema volume after intensive decongestive physiotherapy. Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer, 19(7), 935–940.

Study Purpose

To analyze factors associated with treatment failure and success in lymphedema

Intervention Characteristics/Basic Study Process

All patients underwent complete decongestive therapy (CDT) with manual drainage, multilayer low-stretch bandages and specific exercises and skin care as recommended in international consensus guidelines. Patients were followed at 6 and 12 months and then yearly.  At each patients were questioned about actual treatments used and responses were recorded

Sample Characteristics

  • The sample (N = 682) was comprised of female patients with lymphedema.
  • Of the sample, 47.8% had mastectomy and 97.4% had radiation therapy.
  • Median time to lymphedema onset was 22 months and duration was 32 months.
  • All patients had initial lymphedema volume of more than 250 ml. 

 

Study Design

The study used a descriptive design.

Measurement Instruments/Methods

  • Arm circumference was measured.
  • Treatment failure was defined as a lymphedema volume increase of more than or equal to 50% of total reduction obtained during the first intensive CDT.
     

Results

  • Median lymphedema volume was 936 ml prior to therapy and 335 ml after CDT (p < 0.0001).
  • Median duration of follow up was 28 months.
  • Volume increased after initial intensive phase CDT throughout the first year.
  • Analysis gave hazard ratios of: MLD alone = 1.91, p = 0.03; elastic sleeve alone = 0.65, p = 0.1; MLD and elastic sleeve = 1.09, p = 0.73; bandage and elastic sleeve = 0.53, p = 0.004; MLD, bandage, and elastic sleeve = 0.73, p = 0.14. 
  • Lymphedema volume mainly reflected treatment compliance.
  • MLD alone was associated with increased risk of failure and adding MLD did not reduce the risk of failure. 
  • Being overweight was associated with increased risk of failure.
  • Compression therapy with an elastic sleeve during the day and bandaging at night were the main means to stabilize lymphedema volume. 
  • Body mass index was associated with higher risk of treatment failure.

Conclusions

MLD did not appear to reduce the risk of treatment failure for lymphedema. Compression therapy appears to be the main factor in stabilizing lymphedema volume.

Limitations

  • The study did not have a control group, blinding, or random assignment. 
  • Measurement and methods were not well described.
  • It is unclear if multiple people did measurement.
  • Measurement validity and reliability were questionable.
  • Patient self-report of compliance is not well described.
  • How relevant data was coded for analysis is not described.

Nursing Implications

Findings add to the growing body of evidence pointing to the critical nature of patient compliance with compression sleeves and bandaging over time for ongoing effective management of lymphedema. Findings suggested that being overweight may also contribute to potential for treatment failure. Nursing measures to provide support for treatment adherence and weight control are important areas for patient care.  Interventions to facilitate adherence to compression therapy should be researched.

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Vig, S., Seibert, L., & Green, M.R. (2014). Olanzapine is effective for refractory chemotherapy-induced nausea and vomiting irrespective of chemotherapy emetogenicity. Journal of Cancer Research and Clinical Oncology, 140(1), 77–82.

Study Purpose

To retrospectively evaluate the efficacy of the addition of olanzapine in adults experiencing refractory chemotherapy-induced nausea and vomiting (CINV) stratified by chemotherapy emetogenicity

Intervention Characteristics/Basic Study Process

This was a retrospective chart review of adults receiving chemotherapy between January 2008 and January 2012. Inclusion criteria required that patients received one or more daily doses of olanzapine 10 mg per dose for the indication of refractory CINV during the same admission. Each patient must have received antiemetic prophylaxis and first-line rescue antiemetics appropriate for the emetogenicity level of the chemotherapy regimen according to National Comprehensive Cancer Network guidelines at the time of chemotherapy administration. Patients were excluded if olanzapine was used for anything other than refractory CINV.

Sample Characteristics

  • N = 33
  • MEDIAN AGE = 49 years (range = 19–77 years)
  • MALES: 20, FEMALES: 13
  • KEY DISEASE CHARACTERISTICS: The most common oncologic diagnoses were advanced melanoma (36%) and Hodgkin lymphoma (34%).
  • OTHER KEY SAMPLE CHARACTERISTICS: Most subjects were Caucasian (58%) or Hispanic (24%).

Setting

  • SITE: Single site  
  • SETTING TYPE: Inpatient  
  • LOCATION: Southwest United States

Phase of Care and Clinical Applications

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

Study Design

  • Retrospective chart review

Measurement Instruments/Methods

Researchers measured the number of rescue antiemetics received following the first dose of olanzapine. Patients were stratified by chemotherapy emetogenicity level, age, gender, and number of prophylactic antiemetics received.

Results

Thirteen women and 10 men were included in this study, the majority of whom were Caucasian (58%) and were most frequently being treated for advanced melanoma (36%) and non-Hodgkin lymphoma (24%). The addition of olanzapine was successful for 65% of patients receiving regimens with low to moderate emetogenicity (n = 23) and 70% of patients receiving regimens with high emetogenicity (n = 10). For these cohorts, olanzapine 5–10 mg was administered for one to eight days (median four days). More women (85%) than men (55%) were successfully treated with the addition of olanzapine. For patients receiving a serotonin antagonist, glucocorticoid, and aprepitant as prophylaxis, the addition of olanzapine was successful for controlling breakthrough nausea 68% of the time. Patients who received a prophylactic serotonin antagonist alone were treated successfully 63% of the time for breakthrough nausea with olanzapine. Cohorts 18 to 50 years old (n = 12) and over 50 years (n = 15) received relief with the addition of olanzapine 67% of the time.

Conclusions

Adding olanzapine contributed to the success of CINV management, particularly for women more often than men. Findings suggest that the addition of olanzapine for refractory to prophylactic and breakthrough antiemetic regimens in all levels of emetogenicity may be beneficial.

Limitations

  • Small sample (< 100)
  • Risk of bias (no random assignment)
  • Risk of bias (no appropriate attentional control condition)
  • Unintended interventions or applicable interventions not described that would influence results
  • Findings not generalizable
  • Retrospective design

Nursing Implications

Nurses who assess and administer chemotherapy with low to moderate or high levels of emetogenicity should consider the addition of olanzapine for refractory CINV.

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Vidal-Casariego, A., Calleja-Fernandez, A., Ballesteros-Pomar, M. D., & Cano-Rodriguez, I. (2013). Efficacy of glutamine in the prevention of oral mucositis and acute radiation-induced esophagitis: a retrospective study. Nutrition and Cancer, 65, 424-429.

Study Purpose

To evaluate the effect of oral glutamine on the prevalence and severity of acute radiation-induced oral and esophageal mucositis

Intervention Characteristics/Basic Study Process

Data were collected retrospectively for patients receiving radiation therapy. Findings were compared between those who did and did not receive glutamine. Outcomes between those who were given glutamine early (prior to radiation therapy) versus late (after radiation therapy was begun) in the course of radiation therapy were compared. Data on nutritional status and interruptions in treatment were evaluated.

Sample Characteristics

  • The sample was composed of 117 patients, including 79 cases with oral mucositis.
  • Mean patient age was 62.2 years (SD = 13.6 years) in the experimental group.
  • The sample was 81.2% male and 10.8% female.
  • Diagnoses were head and neck, lung, esophageal, and lymphoma.
  • The majority of patients (73.5%) were also receiving chemotherapy.

Setting

The study was conducted at a single site outpatient setting in Spain.

Phase of Care and Clinical Applications

Patients were undergoing the active antitumor treatment phase of care.

Study Design

This was a retrospective study.

Measurement Instruments/Methods

The World Health Oragnization (WHO) mucositis grading scale was used.

Results

  • In the final sample, 27.4% of patients received early glutamine, 49.5% received glutamine late, and 23.1% of patients did not receive glutamine.
  • Analysis showed that prevalence of mucositis was lower among patients who received early glutamine compared to those who either did not receive glutamine or were given glutamine late (p ≤ 0.02).
  • After correction for sex, age, chemotherapy, radiation dose, and previous surgery, only glutamine use was predictive of risk for development of oral mucositis (risk difference = -9.0%; 95% CI = -18%, -1%).
  • For patients receiving radiation to the head and neck region, severity of oral mucositis was higher among those who did not receive early glutamine (p = 0.039).

Conclusions

Provision of oral glutamine prior to the beginning radiation therapy may be of benefit in the prevention of oral mucositis. Firm conclusions cannot be made because of multiple study limitations.

Limitations

  • Differences in the baseline sample group and variations in chemotherapy regimens, which could have affected the development of mucositis, could have influenced results.
  • A risk of bias exists because of the lack of a control group, blinding, and random assignment.
  • Unintended interventions or applicable interventions that were not described could have influenced results.
  • Measurement and methods were not well described.
  • No information about the oral care used was provided.
  • The timing of mucositis evaluation and how evaluations were done was not reported. 

Nursing Implications

This study has numerous limitations and risks of bias, and it attempted to draw conclusions across a very heterogenous population of patients. Findings suggest that oral glutamine may be helpful in preventing oral mucositis in patients receiving radiation to the head and neck area, and it appears that glutamine treatment may be most beneficial if treatment is begun prior to the initiation of radiation therapy.

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Vickers, A. J., Straus, D. J., Fearon, B., & Cassileth, B. R. (2004). Acupuncture for postchemotherapy fatigue: a phase II study. Journal of Clinical Oncology, 22, 1731–1735.

Intervention Characteristics/Basic Study Process

Traditional Chinese acupuncture was performed twice per week for four weeks or once per week for six weeks. The acupuncturists used points commonly used for fatigue.

Sample Characteristics

  • Thirty-seven adults (68% female) were included.
  • Mean age was 61 years (range 43–78).
  • Patients were ambulatory.
  • Patients were at least three weeks posttreatment.
  • Patients had a Brief Fatigue Inventory (BFI) score of 4 or greater. 
  • Race/ethnicity were not reported.
  • Patients were excluded if they had severe anemia, a Karnofsky Performance Status (KPS) score of less than 70, or an anticipated survival of less than 3 months.

Setting

Acupuncture was delivered in an Integrative Medicine clinic.

Study Design

The study used a single-arm, phase II, pilot design.

Measurement Instruments/Methods

  • BFI was measured at baseline pretreatment and one and two weeks posttreatment.
  • Anxiety and depression were covariates, not outcomes.

Results

Mean improvement was 31.1% (confidence interval [CI] [20.6%, 41.5%]); 39% of patients improved by greater than 40%. Younger and less depressed patients showed a greater response.

Conclusions

Acupuncture may affect serotonin pathways. No adverse events occurred.

Limitations

  • No control group or randomization was used.
  • There was no control for exercise.
  • Travel to the site was a barrier.

Nursing Implications

Certified acupuncturists are needed. Once weekly treatment was preferable. The intervention seemed to show benefits that suggest it is worthy of further study.

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Vickers, A.J., Feinstein, M.B., Deng, G.E., & Cassileth, B.R. (2005). Acupuncture for dyspnea in advanced cancer: A randomized, placebo-controlled pilot trial [ISRCTN89462491]. BMC Palliative Care, 4, 5.

Intervention Characteristics/Basic Study Process

Treatment consisted of two phases: acupuncture and acupressure. Patients were randomized to receive a single session of true or placebo acupuncture. Semi-permanent acupuncture studs then were inserted, and patients applied pressure to the studs twice a day to provide ongoing stimulation to acupuncture points.

Sample Characteristics

  • N = 47 (25 randomized to acupuncture and 22 to placebo)
  • KEY DISEASE CHARACTERISTICS: Patients with lung or breast cancer presenting with dyspnea 

Setting

  • SETTING TYPE: Inpatient and outpatient
  • LOCATION: Memorial Sloan-Kettering Cancer Center

Study Design

  • Randomized, placebo-controlled pilot trial

Measurement Instruments/Methods

  • Dyspnea was assessed with a 0–10 numerical rating scale immediately before and after acupuncture treatment and daily for a week thereafter.

Results

Dyspnea scores were slightly higher for patients receiving true versus placebo acupuncture immediately after and for the one week daily follow-up, but the difference was not statistically significant.

Conclusions

Acupuncture technique as used in this trial is unlikely to have an effect on dyspnea. 

Limitations

  • Two modifications of the trial existed: the first was to only include patients with non-zero dyspnea scores and the second changed one acupoint on the wrist, which caused pain in several patients. Protocol changes are problematic to the conclusion about the intervention.
  • Patients only received one acupuncture treatment as opposed to several, which may be more effective.
  • Accrual to the study was slow and limited by refusal by patients who deemed themselves too ill to participate.
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