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Buragadda, S., Alhusaini, A.A., Melam, G.R., & Arora, N. (2015). Effect of complete decongestive therapy and a home program for patients with post mastectomy lymphedema. Journal of Physical Therapy Science, 27, 2743–2748. 

Study Purpose

To compare lymphedema-related outcomes between women receiving complete decongestive therapy (CDT) and a home program versus those receiving manual drainage and compression garments

Intervention Characteristics/Basic Study Process

Patients were divided into two groups. One group received manual drainage, compression garments, glenohumeral mobilization, and deep breathing exercises. The other received CDT including manual drainage, compression garments, and a home self-massage and exercise program. Participants received initial training for the home program to be completed daily. Both groups received treatment from a therapist five days per week for six weeks. Study assessments were done a baseline, week 4, and week 6.

Sample Characteristics

  • N = 60
  • MEAN AGE = 56.2 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: All participants had breast cancer, and 51% received a radical mastectomy.

Setting

  • SITE: Single site  
  • SETTING TYPE: Multiple settings  
  • LOCATION: Saudi Arabia

Phase of Care and Clinical Applications

  • PHASE OF CARE: Late effects and survivorship

Study Design

Pre- and post-test design

Measurement Instruments/Methods

  • Arm circumference measurements
  • Visual Analog Scale (VAS) for pain
  • Disabilities of the Arm Shoulder and Hand (DASH) questionnaire

Results

Subjects in both groups had significant reductions in arm volume, pain, and DASH scores.

Conclusions

Both CDT with a home program of manual drainage and exercise and standard manual lymphatic drainage with compression garments resulted in significant improvements in arm volume, associated pain, and disability scores.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement/methods not well described
  • Other limitations/explanation: The type of pain measured was not clear. The results reporting was unclear in the tables provided. It was not clear if patients were randomly assigned to groups.

Nursing Implications

Both the combination of manual lymphatic drainage with compression garment use and CDT with a daily home program were associated with significant improvements in lymphedema symptoms.

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Bundy, D.G., Gaur, A.H., Billett, A.L., He, B., Colantuoni, E.A., Miller, M.R., & Children's Hospital Association Hematology/Oncology CLABSI Collaborative. (2014). Preventing CLABSIs among pediatric hematology/oncology inpatients: National collaborative results. Pediatrics, 134, e1678-e1685. 

Study Purpose

To assess the feasibility of instituting a multicenter effort to standardize central line (CL) care and CL-associated bloodstream infection (CLABSI) tracking while quantifying the impact of standardizing these processes on CLABSI rates among pediatric patients

Intervention Characteristics/Basic Study Process

A CL maintenance bundle was developed using Centers for Disease control and Prevention guidelines and recommendations as well as best practices from previous pediatric CLABSI efforts. These guidelines included (a) a reduction in the number of CL manipulations and entries, (b) the maintenance of a sterile entry to CL (hand hygiene and sterilization of port), (c) and standardized CL care practices (date and time cap, tubing/dressing/needle changes, standardized procedure). Tubing changes were every 96 hours and every 24 hours for blood products and lipids. Staff members audited the CLABSI bundle practice monthly using a standard form and submitted unit profile information. Teams met in two-day learning sessions annually and interacted monthly via webinars.

Sample Characteristics

  • N = 28 separate units  
  • KEY DISEASE CHARACTERISTICS: 50% hematology or oncology and transplant; 36% hematology or oncology; 7.1% oncology and transplant; and 7.1% transplant only
  • OTHER KEY SAMPLE CHARACTERISTICS: Units varied in size (8–48 beds); two thirds of teams were Magnet hospitals; 93% of patients were afebrile, neutropenic, postintensive chemotherapy patients with acute myeloid leukemia in inpatient settings waiting for count recovery; none of the units used antimicrobial impregnated catheters; a third used chlorhexidine gluconate baths in at least some patients; half involved patients and families in daily rounds

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Inpatient    
  • LOCATION: United States

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Pediatrics

Study Design

Cohort comparison study

Measurement Instruments/Methods

Teams reported baseline data regarding CLABSI from January 2006 and October 2009. These data were compared to the intervention period from November 2009 to August 2012. CLABSIs were tracked as number per 1,000 CL days per month. CLABSIs occurring more than 48 hours after hospital admission and less than 48 hours prior to hospital discharge were deemed inpatient events and included in measurements.

Results

Across 46 months, precollaborative effort CLABSI rates were 2.85 per 1,000 CL days. During the first 34 months after the intervention, that rate was 2.04 per 1,000 CL days (p = 0.05). The odds for having no CLABSIs per unit per month was 2.59 higher during the collaborative intervention (p = 0.01). The compliance with recommended CL maintenance increased rapidly over the first year from 38% at baseline to 79% by the end of the first year. It remained at a rate of 81%–86% during the remainder of the intervention period.

Conclusions

The 28% reduction during the first 2.5 years suggested the elimination of about 290 CLABSIs over that period with an estimated reported cost savings of about $11 million. It was feasible to implement a standardized CL maintenance care bundle, track CL infections with standardized definitions, and generate benchmark data across a large network of centers. The implementation of a standardized catheter care bundle in a multi-instutituional collaborative effort was associated with reduced CLABSI rates.

Limitations

  • Risk of bias (no control group)
  • Measurement validity/reliability questionable
  • Other limitations/explanation: Retrospective study design; reliability of self-reported adherence to all aspects of the care protocol was not examined; patient characteristics in terms of infection risk were not described

Nursing Implications

Nurses are on the front lines when it comes to CLABSI prevention. This report demonstrated the effectiveness of a multisite collaborative initiative to reduce CLABSI rates. The implementation of a specific care bundle, monthly practice auditing, monthly webinars, and annual education of care teams involved was reported to be effective. This report provides suggested approaches for such initiatives and demonstrates associated improvement in quality and cost reduction.

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Bull, J., Wellman, C.V., Israel, R., Barrett, A.C., Paterson, C., & Forbes, W.P. (2015). Fixed-dose subcutaneous methylnaltrexone in patients with advanced illness and opioid-induced constipation: Results of a randomized, placebo-controlled study and open-label extension. Journal of Palliative Medicine, 18, 593–600. 

Study Purpose

To determine safety and efficacy of fixed doses of methylnaltrexone (MNTX) in patients with advanced disease

Intervention Characteristics/Basic Study Process

After participation in a two-week placebo randomized controlled trial (RCT), patients were eligible to enroll in a 10-week open-label extension study to evaluate the use of MNTX at a fixed dose based on weight using as-needed dosing. Patients were dosed at 8 mg SC for weight of 38 kg to less than 62 kg or, if 62 kg or greater, at a dose of 12 mg. Doses were administered as needed but not more often than daily. Rescue doses of other bowel medications were permitted if the MNTX was not effective. Patients were taking stable laxative regimens and a stable dose of opioids.

Sample Characteristics

  • N = 230  
  • MEAN AGE = 65.9 years
  • MALES: 50.9%-51.7%, FEMALES: 48.3%-49.1%
  • KEY DISEASE CHARACTERISTICS: Advanced illness, with 57%-66% having a cancer diagnosis

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Multiple settings  
  • LOCATION: United States

Phase of Care and Clinical Applications

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

Study Design

  • Open-label extension study following a prior clinical trial using MNTX for the management of opioid-induced constipation

Measurement Instruments/Methods

  • Diary of bowel function
  • Clinic visits

Results

MNTX was effective in the management of opioid-induced constipation in both the RCT and the open-label extension study. The results were based on rescue free bowel movements after doses of MNTX. For the MNTX arm in the RCT component, 62.9% of patients had bowel function compared with 9.6% of the placebo control group (p < 0.0001). Weight did not have an effect on outcome. Secondary end points were all in favor of MNTX, including time to bowel function after first dose. The most common side effects were abdominal pain and nausea.

Conclusions

A fixed dose of MNTX is safe and effective in the management of opioid-induced constipation in patients with advanced disease.

Limitations

  • Risk of bias (no blinding)
  • Patients under 38 kg were not eligible
  • Short study duration

Nursing Implications

This study adds support to the data that MNTX is safe and effective for opioid-induced constipation.

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Bulfone, T., Quattrin, R., Zanotti, R., Regattin, L., & Brusaferro, S. (2009). Effectiveness of music therapy for anxiety reduction in women with breast cancer in chemotherapy treatment. Holistic Nursing Practice, 23, 238–242.

Study Purpose

To evaluate the effect of musical therapy on anxiety in patients with breast cancer receiving conventional treatment

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to the music or control group. While in the waiting room for 30 minutes prior to chemotherapy treatment, those assigned to the music group had the opportunity to choose and listen to pretaped musical themes with a Walkman and earphones for 15 minutes. Control patients received standard care. Anxiety levels were measured at baseline and after 15 minutes.

Sample Characteristics

  • The study reported on a sample of 60 female patients (30 in each study group).
  • Mean patient age was 49.2 years +/- 6.9 in the experimental group and 52.7 years +/- 6.1 in the control group.
  • All patients had stage I or II breast cancer and were receiving adjuvant chemotherapy.
  • All patients had social support persons or family members present at the time of study.

Setting

  • Single site
  • Italy

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

Speilberger State and Trait Anxiety Inventories

Results

There were no differences between groups in pretreatment anxiety levels. Both groups demonstrated moderate pretreatment anxiety levels. Pretreatment state anxiety levels were higher than trait anxiety levels in both groups (p < 0.05). Post-test anxiety scores in the experimental group decreased by 9.9 (p < 0.001). In the control group, there was no significant change, although anxiety increased slightly after 15 minutes. There were no significant relationships between anxiety scores and demographic variables.

Conclusions

Listening to music may reduce anxiety related to chemotherapy administration. The levels of state anxiety compared to trait anxiety indicates that chemotherapy treatment is a stressful situation for patients.

Limitations

  • The study reported on a small sample, with less than 100 participants.
  • The study was a single brief intervention, and it is not clear if listening to music would always have an effect of reducing anxiety before treatment.
  • The study was limited to women with breast cancer and may not be readily applicable to patients with more advanced disease, those receiving treatments other than adjuvant chemotherapy, males, or those with other types of cancer.
  • Other potential symptoms were not evaluated, so it is unclear how music would impact anxiety in the setting of additional patient symptoms.

Nursing Implications

Chemotherapy administration can be stressful for patients, and listening to music prior to treatment may be helpful to them. Providing the opportunity to listen to music is a simple intervention that has no inherent risks to patients and could easily be incorporated into practice in healthcare settings.

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Bukki, J., Stanga, Z., Tellez, F.B., Duclos, K., Kolev, M., Krahenmann, P., . . . Juni, P. (2013). Omega-3 poly-unsaturated fatty acids for the prevention of severe neutropenic enterocolitis in patients with acute myeloid leukemia. Nutrition and Cancer, 65, 834–842.

Study Purpose

To explore the safety and effectiveness of omega-3 poly-unsaturated fatty acid (PUFA) added to parenteral nutrition in protecting patients with leukemia from severe enterocolitis

Intervention Characteristics/Basic Study Process

Fourteen patients with acute myeloid leukemia (AML) who received omega-3 PUFA in a phase II trial were compared with 66 consecutive control patients not getting this intervention. Total parenteral nutrition (TPN) was given as a standard emulsion containing the full supply of carbohydrates, amino acids, and lipids, with a total energy content of 2,215 kcal in a 1,875 mL volume via central venous catheter over 24 hours. Patients included in the phase II study additionally were administered 100 mL/d of a commercially available IV omega-3 PUFA formulation over four hours. TPN and omega-3 PUFA were given up to duration of four weeks.

Sample Characteristics

  • N = 14  
  • AGE: Unknown
  • MALES, FEMALES: Unknown
  • KEY DISEASE CHARACTERISTICS: De novo AML or high-risk myelodysplastic syndrome (MDS); planning to undergo chemotherapy
  • OTHER KEY SAMPLE CHARACTERISTICS: Eligible participants were any adults with cyto- or histopathologically confirmed de novo diagnosis of either AML or high-risk MDS (IPSS score of higher than 1.5). All participants had been considered for TPN and had an Eastern Cooperative Oncology Group performance status of 2 or less and were about to undergo myeloablative induction chemotherapy.

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient   
  • LOCATION: Bern, Switzerland

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Phase II trial with a historical control group of consecutive patients with AML

Measurement Instruments/Methods

  • Common Terminology Criteria for Adverse Events (CTCAE) v3.0

Results

Two out of 14 patients included in the phase II trial experienced grade 3 colitis after initiation of chemotherapy (14%), and none experienced grades 4 or 5. Conversely, 16 out of 66 control patients experienced grade 3 colitis (24%), 3 experienced grade 4 (5%), and 2 died of grade 5 colitis (3%). According to blind assessments, 3 out of 14 patients included in the phase II trial experienced grade 3 colitis after initiation of chemotherapy (21%), and 1 had grade 4 colitis (7%), whereas 7 out of 66 control patients experienced grade 3 colitis (11%), 4 experienced grade 4 (6%), and 4 died of grade 5 colitis (6%). Among the 13 patients who actually received omega-3 PUFA, two were deemed to have grade 3 colitis (15%) according to open assessment, whereas three were deemed to have grade 3 colitis (23%) and one was deemed to have grade 4 colitis (8%) according to blind assessment. Odds ratios of colitis were grades 3 and above. The benefit of omega-3 PUFA was more pronounced in adjusted as compared with crude analyses and more pronounced according to open as compared with blind assessments. Formal statistical significance at the conventional α level of 0.05 was reached only for the adjusted analyses of colitis grades as determined by the open assessor, with an odds ratio of 0.27 (95% CI 0.11–0.65). The IPT weighted analysis according to blind assessments yielded a non-significant odds ratio of 0.79 (95% CI 0.35–1.78).

Conclusions

The study showed little evidence to suggest that the addition of omega-3 PUFA to TPN in patients with AML undergoing myeloablative chemotherapy is effective in reducing the incidence of severe neutropenic enterocolitis. Results depended on the approach chosen in assessing colitis grades (open versus blind assessment), and the nature of the analysis (crude or adjusted using inverse probability of treatment weighting).

Limitations

  • Small sample (less than 30)
  • Risk of bias (no random assignment)
  • Measurement/methods not well described
  • Questionable protocol fidelity
  • Other limitations/explanation: The original study design was not carried out because of accrual problems.

Nursing Implications

Therapeutic interventions remain limited in neutropenic colitis. To truly answer the question of whether this intervention would benefit patients, trials should be centrally randomized with adequate placebo controls to blind patients, blind adjudication of colitis grades, and an intention-to-treat analysis.

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Buijs, C., Mom, C.H., Willemse, P.H., Marike Boezen, H., Maurer, J.M., Wymenga, A.N., … Mourits, M.J. (2009). Venlafaxine versus clonidine for the treatment of hot flashes in breast cancer patients: A double-blind, randomized cross-over study. Breast Cancer Research and Treatment, 115, 573–580.

Study Purpose

Comparison of venlafaxine versus clonidine for the treatment of hot flashes with regard to side effects, efficacy, QOL, and sexual functioning in patients with breast cancer.

Intervention Characteristics/Basic Study Process

Patients randomly assigned to receive venlafaxine for eight weeks, followed by a wash-out period of two weeks, then eight weeks of clonidine or vice versa

Sample Characteristics

N = 60 (30 assigned to venlafaxine and 30 to clonidine). Patients with a primary or metastatic breast cancer age 60 years or younger, allowed antitumor hormonal treatment if started one month prior and continued taking throughout treatment period.

Study Design

Double-blind, randomized, cross-over study.

Measurement Instruments/Methods

Assessment took place before the start of each drug, then at 2, 8, 12, 18 weeks after treatment began. Six questionnaires were used to compare the drugs' effects on adverse events, efficacy, QOL, and sexual functioning: daily diary on hot flashes, hot flash–related daily interface questionnaire, Medical Outcomes Study Short Form (SF-36), sexual activity questionnaire, and Zung Self-Rating Depression Scale.

Results

Forty patients completed all treatments, 12 patients only one treatment, 8 patients neither. Dropout rates during venlafaxine were 15 out of 59, versus clonidine, 5 out of 53. Withdrawal rateswere not affected by sequence of treatment. Efficacy: After eight weeks, no difference was seen between the two drugs in reduction of hot flash scores: median 49% for venlafaxine and 55% for clonidine. The drug that the patient received first caused the greatest reduction in hot flash score.

Limitations

Statistics: based on the testing used to calculate the number of patients needed to detect differences, the sample size was too small to detect difference, which may be the reason no statistical difference was  found between the interventions.

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Buffart, L.M., van Uffelen, J. G., Riphagen, I. I., Brug, J., van Mechelen, W., Brown, W. J., & Chinapaw, M. J. (2012). Physical and psychosocial benefits of yoga in cancer patients and survivors, a systematic review and meta-analysis of randomized controlled trials. BMC Cancer, 12, 559.

Purpose

STUDY PURPOSE: Evaluate effects of yoga on physical and psychosocial symptoms
TYPE OF STUDY:  Meta Analysis & Systematic Review

Search Strategy

DATABASES USED: AMED, CINAHL, British Nursing Index, CENTRAL, EMBASE, PEDro, psycINFO, PubMed and SPORT-Discus
KEYWORDS:  States detailed search profiles available on request
INCLUSION CRITERIA:  RCT, adults with any cancer diagnosis, yoga intervention including physical postures, control group non exercise
EXCLUSION CRITERIA:  Yoga included as part of a larger intervention such as mindfulness based stress reduction were excluded

Literature Evaluated

TOTAL REFERENCES RETRIEVED : N = 1909
EVALUATION METHOD AND COMMENTS ON LITERATURE USED Study method quality evaluated using a Delphi list previously developed and tested.  Low quality defined as <50% of possible total score.

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED; N(studies)  =  13
SAMPLE RANGE ACROSS STUDIES, TOTAL PATIENTS INCLUDED IN REVIEW:  Range 18-128
KEY SAMPLE CHARACTERISTICS:  12 studies involved breast cancer patients, 1 was in lymphoma

Phase of Care and Clinical Applications

PHASE OF CARE:  Multiple phases of care

Results

Physical outcomes: Pain was evaluated in 4 studies, meta analysis of 2 of these showed a large effect size (d=-0.63, 95% CI -0.98, -0.31)
Psychosocial outcomes: Reduced anxiety (d=-0.77; 095% CI -1.08, -0.46) fatigue (d=-.051, 95% CI -0.79,-0.22)  Effects on sleep disturbance were small and insignificant.
Dropout rates ranged from 0-38%
Interventions ranged from planned 6 -15 sessions.  Some studies involved supervised yoga classes, and some involved home practice only.  Studies involved patients in active treatment and others involved cancer survivors who had completed treatment.

Conclusions

Findings suggest that yoga may be helpful to reduce anxiety and fatigue in patients with cancer.

Limitations

States 3 studies included participant blinding or double blinding – it is unclear how a participant would not know they were receiving a yoga intervention.  Varied methods of measurement were used in the studies included – there is no description of how these were handled in meta analysis.  There is no report of heterogeneity findings.   Most studies were very small sample sizes.  There was a wide range of drop -out rates and no information about how this was handled in analysis.  Studies did not include attentional control conditions, so it is unclear how much effect was due to group support versus the actual yoga activity.  No differentiation was made between group session interventions versus patients who did home practice alone after instruction.

Nursing Implications

Findings do not provide strong support for effectiveness of yoga for sleep.  Findings do suggest that yoga may be helpful for patients to reduce anxiety and fatigue.  Nurses can support involvement in this type of activity for patients who are interested in participating in yoga.

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Buentzel, J., Micke, O., Adamietz, I.A., Monnier, A., Glatzel, M., & deVries, A. (2006). Intravenous amifostine during chemoradiotherapy for head-and-neck cancer: A randomized placebo-controlled phase III study. International Journal of Radiation Oncology, Biology, Physics, 64, 684–691.

Study Purpose

To evaluate the efficacy and safety of IV amifostine during radiochemotherapy for head-and-neck cancer

Intervention Characteristics/Basic Study Process

Patients in the study group received 300 mg/m2 IV amifostine on the days in which they received carboplatin and radiation therapy (RT). On the days in which they received only RT, they were given 200 mg/m2 IV amifostine.

Sample Characteristics

  • The study reported on 132 patients (67 in the amifostine group and 65 in the placebo group).
  • The median age of patients in the amifostine group was 57 years and the median age of patients in the placebo group was 58 years. Patients' ages ranged from 23–78 years.
  • This was a randomized, double-blind, placebo-controlled, phase III, multicenter study.
  • Patients had been diagnosed with stage III or IV head and neck cancer and were receiving RT and 70 mg/mcarboplatin.

Setting

The study was conducted between October 1996 and October 1999.

Measurement Instruments/Methods

  • Radiation Therapy Oncology Group (RTOG) scoring was used.
  • The Acute/Late Radiation Morbidity Scoring Criteria were used.

Results

  • Effectiveness not established; no statistical evidence was found to indicate that mucositis was improved with the use of amifostine versus placebo.
  • In the amifostine group, 39% of patients experienced grade 2 or higher xerostomia; in the placebo group, 35% of patients experienced grade 2 or higher xerostomia (p = 0.715).
  • In the amifostine group, 39% of patients experienced grade 3 or higher xerostomia; in the placebo group, 22% of patients experienced grade 3 or higher xerostomia (p = 0.055).
  • In the amifostine group, 47 patients completed the study; in the placebo group, 55 patients completed the study.
  • The most common reactions were nausea/vomiting, hypotension, allergic reaction, and rash.
  • In the amifostine group, 30% of patients discontinued treatment versus 11% in the placebo group.

Conclusions

The intervention was not found to be effective in the management of mucositis toxicity.

Limitations

This was the first randomized and placebo-controlled study of amifostine in the head and neck cancer population.

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Budin, W.C., Hoskins, C.N., Haber, J., Sherman, D.W., Maislin, G., Cater, J.R., . . . Shukla, S. (2008). Breast cancer: Education, counseling, and adjustment among patients and partners: A randomized clinical trial. Nursing Research, 57(3), 199–213.

Study Purpose

To determine the effects of care phase-specific psychoeducation and telephone counseling on emotional, physical, and social adjustment of patients and partners, compared to standard treatment of disease management

Intervention Characteristics/Basic Study Process

Patients and partners were randomly assigned to one of four groups in dyads.

  • The control group (group 1) received standard disease management (DM), which consisted of stated adherence of providers to evidence-based treatment protocols.
  • Group 2 received psychoeducation (SE) consisting of four phase-specific videos involving coping, recovering from surgery, and understanding adjuvant therapy.
  • Group 3 received DM plus telephone counseling (TC) using treatment phase-specific scripted telephone counseling interventions.
  • Group 4 consisted of combined SE and TC interventions.

The partner involved was the person the patient identified as most intimately involved in the breast cancer experience. Care phases were defined as Time 0 (T0) (upon study entry), T1 (diagnostic—when the diagnosis of breast cancer was determined), T2 (postsurgical phase—two days after surgery), T3 (adjuvant therapy phase—when making decisions about therapy), and T4 (ongoing recovery—two weeks after completion of chemotherapy or radiation, or six months after surgery if no adjuvant therapy was done).

Sample Characteristics

  • The sample consisted of 126 patients and 126 partners.
  • The average patient age was 53.8 ± 11.7. The average partner age was 51.6 ± 12.0.
  • Gender: (only reporting on partners; all patients were female.)
    • Females: 41.6%
    • Males: 58.4%
  • All patients had breast cancer.
    • Had a family history of breast cancer: 49.8%
    • Had lumpectomy or wide excision: 53.4%
    • Had radical mastectomy: 8.7%
    • Had stage 0 disease: 22.9%
    • Had stage 3 disease: 5.9%
  • Sixty percent of partners were spouses or live-in partners, 12% were daughters, 13% were sisters, 11% were friends, and 4% were mothers.
  • Seventy percent of partners were Caucasian, and 12.8% were African American.
  • Approximately 85% of partners had at least some college education.
  • Sixty percent of partners and 52.8% of patients were employed full time. 71.3% of partners reported a combined income greater than $50,000.
  • Seventy-seven percent of partners reported having children.

Setting

  • Multi-site
  • Outpatient
  • Medical centers in the New York metropolitan area

Measurement Instruments/Methods

  • Profile of adaptation to life clinical scale (PAL-C)
  • Breast cancer treatment response inventory (BCTRI)
  • Self-rated health subscale (SRHS)
  • Psychosocial adjustment to illness scale (PAIS)

Results

Patients' psychological well-being (p = 0.033) improved over time in all groups. There was also a significant difference in improvement over time depending on the study group assigned (group plus time effect) (p = 0.004). The TC group had the highest psychological well-being at the adjuvant therapy stage.

No significant effects were noted among partners. No significant effects related to distress from side effects among patients were noted in any group. For patients in the DM control group (group 1), significantly greater side-effect distress was noted compared to all treatment groups combined (p = 0.02). The side-effect severity for patients had a significant effect over time, and mean severity of side effects was significantly higher from baseline to T4 in the DM control group (p = 0.016). Partners in the SE and TC group (group 4) reported significantly fewer side effects than those in the TC-only group (group 3) (p = 0.017), and a significant overall effect of the intervention (p = 0.024) on physical symptoms was reported. Physical symptoms reported by partners did not demonstrate an effect from time. Partners' overall health scores were not affected, and patients' overall health improved over time for all groups (p < 0.0001). The intervention had no significant effect on vocational adjustment for patients, and in partners, both group assignment and time demonstrated significant main effects in analysis (p </= 0.05). Only time appeared to affect social adjustment.

Conclusions

Most outcomes for patients and partners improved over time, regardless of group assignment. The combination of standardized SE and TC as provided in the study was associated with improved psychological well-being across the timeframe of the study.

Limitations

  • No appropriate control group or attentional control was used.
  • It is not clear what patient education and counseling and amount of patient contact and attention was provided in the DM control group to differentiate fully between interventions. Standard or usual care was not clearly defined or applied.
  • Group assignment was not blinded.
  • The sample tended to be well-educated and of relatively high income levels, so findings may not be applicable to other socioeconomic and cultural groups.
  • All patients were women, and as other studies have shown, differences in variables associated with patient and caregiver gender may influence these outcomes producing findings that may not be applicable to other types of patient-partner groups.
  • Although some improvements were seen over time for both patients and partners, authors point out that higher than normal levels of adjustment problems were evident at the time of final data collection. The findings may have been biased by lack of blinding and the sample who chose to participate, as these patients may have been more motivated or more distressed than others in the total population.
  • It is not clear how outcomes actually changed over time in all groups. The authors provide graphic representation of predicted outcomes over time rather than actual mean results.
  • The time frame of interventions carried out might have influenced the findings. Specifically, the adjuvant therapy group was collected prior to adjuvant therapy, which may be misleading.

Nursing Implications

Both patient and partner reactions to breast cancer vary over time and tend to improve over time, and findings suggest that patient needs and issues vary at different phases in care, suggesting the need for different strategies and interventions according to the phase of care. SE and supportive counseling activities can be helpful to patients and caregivers in management of physical symptoms and side effects. TC intervention in combination with SE activities as provided by video, as in this study, may provide a practical alternative method to provide this type of intervention.

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Buda, A., Ghelardi, A., Fruscio, R., Guelfi, F., La Manna, M., Dell'Orto, F., & Milani, R. (2016). The contribution of a collagen-fibrin patch (Tachosil) to prevent the postoperative lymphatic complications after groin lymphadenectomy: A double institution observational study. European Journal of Obstetrics, Gynecology, and Reproductive Biology, 197, 156–158. 

Study Purpose

To describe the effects of using a collagen fibrin patch on complications after inguinofemoral lymphadenectomy for gynecologic cancer

Intervention Characteristics/Basic Study Process

Outcomes in consecutive women who underwent groin dissection using the fibrin patch were compared to historical controls who did not use the patch. The same surgical teams performed the procedures. The patch used contained a collagen matrix coated with coagulation factors that cause adhesion between the patch and wound surfaces. Short-term postoperative results and long-term complications, such as cellulitis and late lymphedema, were compared between groups.

Sample Characteristics

  • N = 49   
  • MEAN AGE = 74.3 years
  • AGE RANGE = 48–95 years
  • FEMALES: 100%
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: Most had vulvar primary tumors.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Multiple settings    
  • LOCATION: Italy

Study Design

Observational with historical control comparison

Measurement Instruments/Methods

Method of lymphedema determination or measurement is not described.

Results

In the control group, 24% developed late lymphedema, compared to 4% of patients in the group that did not use the patch. No significant differences were observed between groups in the proportion of those who had mono- or bilateral dissections or the number of lymph nodes removed, although the fibrin patch group had a slightly lower number of lymph nodes removed and fewer underwent adjuvant radiotherapy.

Conclusions

The findings suggest that the use of the fibrin patch may be helpful to prevent some complications of lymphadenectomy; however, stronger research evidence is needed for evaluation.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement/methods not well described

Nursing Implications

Various surgical techniques are being examined for their effects on lymphedema-related outcomes after lymph node resections. Ongoing research is needed to determine the overall effectiveness of various techniques. Limited evidence exists for interventions to prevent and manage lower limb lymphedema.

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