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Diedrich, B., Remberger, M., Shanwell, A., Svahn, B.M., & Ringden, O. (2005). A prospective randomized trial of a prophylactic platelet transfusion trigger of 10 x 109 per L versus 30 x 109 per L in allogeneic hematopoietic progenitor cell transplant recipients. Transfusion, 45, 1064–1072. 

Study Purpose

To compare differences in the number of platelet transfusions received and episodes of hemorrhagic bleeding, based upon a prophylactic transfusion trigger of either less than 10 x 109 per L or less than 30 x 109 per L, in patients undergoing allogeneic hematopoietic progenitor stem cell transplants

Intervention Characteristics/Basic Study Process

Patients were randomized (after stratification) to receive prophylactic platelet transfusions at either less than 10 x 109 or less than 30 x 109 per L. The number of transfusions received, the types of bleeding episodes, and the number of red blood cell transfusions were recorded 7 days pre- to 30 days post-transplantation. The results of the morning lab draws identified the need for transfusion based upon the trigger group (T 10 or T 30). In addition, patients were assessed daily (if inpatient) and twice weekly (if outpatient) by nurses blinded to the treatment arm. A special research nurse was used to collect study data. 

Sample Characteristics

  • N = 166  
  • AGE RANGE = 1–63 years
  • MALES: 52%, FEMALES: 48%
  • KEY DISEASE CHARACTERISTICS: Patients undergoing transplants for non-malignant, acute, or chronic leukemia, or other solid tumor malignancy. Exclusion criteria included known bleeding disorders or coagulopathy.

Setting

  • SITE: Single-site    
  • SETTING TYPE: Inpatient    
  • LOCATION: University Hospital in Sweden

Phase of Care and Clinical Applications

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

Study Design

Prospective, randomized trial

Measurement Instruments/Methods

  • World Health Organization (WHO) criteria

Results

There were no significant differences between the groups based upon donor type, origin of hematopoietic progenitor cells, age, or conditioning regime used. There was a significantly lower number of transfusions received in the T 10 group (median 4 versus 10, p < 0.001) without a significant difference in the episodes of bleeding between groups.

Conclusions

The evidence suggests that the trigger for prophylactic platelet transfusions in patients undergoing allogeneic hematopoietic progenitor stem cell transplants may be safely decreased from 30 x 109 to 10 x 109 per L.

Limitations

Note that the logistic regression multivariate analysis of factors associated with platelet transfusions before day 30 and before day 60 demonstrate wide confidence intervals (95% CI, 3.08–18.7 and 95% CI 1.82–9.67, respectively).

Nursing Implications

Nurses will care for patients at risk of life threatening bleeding and need to be aware of indications for platelet transfusion. A lower threshold for prophylactic transfusion may conserve the blood supply.

Print

Didem, A., Ayfer, E., & Ayse Ferda, O. (2014). The effect of chewing gum on oral mucositis in children receiving chemotherapy. Health Science Journal, 8, 373–382.

Study Purpose

To determine if chewing gum is efficacious in the prevention and treatment of oral mucositis in children receiving chemotherapy regimens

Intervention Characteristics/Basic Study Process

Procedure:
  • Permission from institution
  • Written informed consent obtained from parents of each child
  • Interview with parent and child to elicit demographic information
  • The study group consisted of children chewing nonsugary gum for 10 days three times daily for 20 minutes (abstaining from drinking water one hour before chewing gum).
  • Both study groups used Tantum® mouthwash for standard oral care and continued usual tooth brushing.
  • Children’s oral assessments were performed on day s1, 5, and 10 using the World Health Organization (WHO) Oral Mucositis Index (OMI). An Eilers’ Oral Assessment Guide with pH measurements was taken.
  • All assessments were performed by the same researcher.

Sample Characteristics

  • N = 60  
  • AGE RANGE = 6–18 years
  • MALES: 48.33%, FEMALES: 51.7%
  • KEY DISEASE CHARACTERISTICS: Acute myeloid leukemia, acute lymphoblastic leukemia, Hodgkin lymphoma, and Wilms tumor
  • OTHER KEY SAMPLE CHARACTERISTICS: Duration of hospitalization by day, number receiving chemotherapy, and duration of disease by year

Setting

  • SITE: Single site
  • SETTING TYPE: Inpatient pediatric oncology clinic at a university hospital
  • LOCATION: Istanbul

Phase of Care and Clinical Applications

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

Study Design

Quasi-experimental study with a control group

Measurement Instruments/Methods

  • World Health Organization (WHO) Oral Mucositis Index (OMI)
  • Eilers’ Oral Assessment Guide (EOAG)
  • Intraoral pH assessment measured by researchers within one minute after chewing using pH colormatic strips placed under the tongue for two minutes (values ranged from 4–9)

Results

  • Acute lymphoblastic leukemia was the most common diagnosis.
  • No statistical difference between demographic data in both control and study groups related to age, gender, or educational states was found.
  • At end of the study, significant difference (p < 0.5) in mucositis severity between the two groups existed.
  • At the start of study, the average pH value was 5.8 (SD = 0.6) for the study group and 5.9 (SD = 0.3) for the control group. At end of study (day 10), the average pH value was 6.4 (SD = 0.2) in the study group and 6 (SD = 0.3) in the control group. This was statistically significant (p < 0.5).

Conclusions

Chewing gum was an effective option for preventing and treating oral mucositis in pediatric patients with acute lymphoblastic leukemia, acute myeloid leukemia, Hodgkin lymphoma, and Wilms tumors.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Unintended interventions or applicable interventions not described that would influence results
  • Findings not generalizable
  • Other limitations/explanation: Unintended interventions such as avoiding certain foods or using ice chips at home were not described. Not all children had the same mucositis severity in this study. The type of gum was not described and its ingredients were not described.

Nursing Implications

  • This study indicated a potential treatment and prevention intervention for pediatric patients with cancer.
  • Its findings point to areas for additional nursing research.
  • The intervention was low-cost, accessible, and easy to administer.
Print

Didem, K., Ufuk, Y.S., Serdar, S., & Zumre, A. (2005). The comparison of two different physiotherapy methods in treatment of lymphedema after breast surgery. Breast Cancer Research and Treatment, 93(1), 49–54.

Intervention Characteristics/Basic Study Process

The experimental group underwent complete decongestive therapy that included lymph drainage using the Foldi method, multilayer compression bandage, elevation, remedial exercises, and skin care. The control group underwent standard physical therapy that included compression bandages, elevation, head-neck and shoulder exercises, and skin care. Both groups had a home program of bandaging, skin care, and walking. Therapy was three times per week for four weeks.

Sample Characteristics

  • The study sample (N = 53) was comprised of patients with lymphedema post-breast cancer treatment.
  • Patients were randomly assigned and blinded to the intervention in the experimental group (n = 27) or the control group (n = 26).
  • Average duration of lymphedema at the time of treatment was three years.
  • Patients were experiencing mild-to-moderate lymphedema; mild lymphedema (n = 21) was defined as a 2 cm circumference difference and moderate (n = 32) a difference of 2–5 cm.
  • Patients were excluded from the study if they had
    • Obvious psychiatric illness
    • Severe pain in the axillary region
    • Severe cardiac disease
    • Uncontrolled hypertension
    • Malignancy.
  • The average mean volume was 580 ml.
  • Patients were assessed for type of breast cancer procedures, but this was not used for characterizing the sample.
  • Of patients in the sample, 24.4% had lumpectomies, 64.2% had modified radical mastectomies, and 11.3% had radical mastectomies.
  • Nine patients had a history of cellulitis, and 44 had no infection.
  • All patients had axillary dissection with a range of 2–35 nodes removed.

Study Design

The study used a prospective trial design.

Measurement Instruments/Methods

  • Range of motion, circumference measurement, and volumetric measurement were assessed before and after treatment.
  • Circumference measurements were taken using a standard one inch, retractable, fiberglass tape measure.
  • Measurements were taken from 10, 15, and 20 cm above and below the olecranon process, at wrist, and at metacorpophalangial joints.
  • Measurements always were taken twice.
  • The same procedure was used for the unaffected arm of each participant.
  • The arm was placed in water-filled container and displaced water was measured.
  • Shoulder mobility was measured using goniometry.
  • Function was measured as the active mobility with extension-flexion, abduction-adduction, and external rotation.

Results

Mean percentage reduction in edema was 55.7% in the experiential group and 36% in control group (p < 0.05). Only 45% had limitation of range of motion to start. Reduction in shoulder mobility was 48.1% in the experiential group and 42.3% in control group before treatment. Shoulder flexion and abduction movements in both groups were increased after treatment (p < 0.05). No significant difference was found in shoulder external rotation in both groups (p > 0.05). No difference was found between groups in shoulder mobility.

Conclusions

Patients were similarly classified using circumferential and volumetric measurements; therefore, either of the methods can be used.

Limitations

  • The sample size was small, with less than 100 patients.
  • Patients had extensive disease of more than three years duration.
  • The tissue was not described.
  • Lymphedema was not staged.
Print

Didem, K., Ufuk, Y.S., Serdar, S., & Zumre, A. (2005). The comparison of two different physiotherapy methods in treatment of lymphedema after breast surgery. Breast Cancer Research and Treatment, 93(1), 49–54.

Intervention Characteristics/Basic Study Process

The study included an experimental group and a control group. The experimental group received complete decongestive therapy (CDT) that included lymph drainage (Foldi method), multilayer compression bandage, elevation, remedial exercises, and skin care. The control group received standard physical therapy that included compression bandages, elevation, head and neck and shoulder exercises, and skin care. Both groups had a home program of bandaging, skin care, and walking. Therapy was three times per week for four weeks.

Sample Characteristics

  • The study sample (N = 53) included 27 experimental group patients and 26 control group patients who were randomly assigned and blinded to the intervention.
  • All patients had mild (n = 32) or moderate (n = 21) lymphedema post-breast cancer treatment (2 cm circumference difference was defined as mild lymphedema, and 2–5 cm circumference difference was defined as moderate).
  • Average duration of lymphedema at the time of treatment was three years; all patients had experienced lymphedema for more than one year. 
  • Patients measuring 2–5 cm were excluded from the study based on obvious psychiatric illness, severe pain in axillary region, severe cardiac disease, uncontrolled hypertension, or malignancy.
  • The average mean volume was 580 ml. 
  • Patients were assessed for type of breast cancer procedures, but the sample was not characterized by them.
  • Of the 53 patients who were post-breast cancer treatment, 24.4% had lumpectomies, 64.2% modified radical mastectomies, and 11.3% radical mastectomies. In addition, 13.2% received chemotherapy and 49.1% hormonal therapy. 
  • All patients had axillary dissection with a range of 2–35 nodes removed and a mean of 24.2.

Setting

The study took place at a school of physical therapy.

Study Design

A prospective trial design was used.

Measurement Instruments/Methods

  • Range of motion, circumference measurement, and volumetric measurement were assessed before and after treatment.
  • Circumference was measured using a standard one-inch, retractable, fiberglass tape measure.
  • Measurements were taken from 10, 15, and 20 cm above and below the olecranon process, at wrist, and at metacorpophalangial joints.
  • Measurements always were taken twice.
  • The same procedure was used for the unaffected arm of each participant.
  • To measure volume, the arm was placed in a water-filled container and displaced water was measured.
  • Goniometry was used to determine shoulder mobility. 
  • Function was measured as the active mobility with extension-flexion, abduction-adduction, and external rotation.

Results

  • Mean percentage reduction in edema was 55.7% in the experimental group and 36% in the control group (p < 0.05).
  • Only 45% of patients had limited of range of motion to start. Reduction in shoulder mobility was 48.1% in the experimental group and 42.3% in control group before treatment.
  • Shoulder flexion, abduction movements in both groups were increased after treatment (p < 0.05).
  • No significant difference was found in shoulder external rotation in both groups (p > 0.05).
  • No difference between groups in shoulder mobility was found.
  • Similar patient classification was found using circumferential and volumetric measurements.

Conclusions

Either of the methods can be used.

Limitations

  • Patients had extensive disease of more than three years' duration.
  • No description of the tissue (pitting fibrotic) was provided.
  • Lymphedema was not staged.
  • The sample size was small.
Print

Dibble, S.L., Luce, J., Cooper, B.A., Israel, J., Cohen, M., Nussey, B., Rugo, H. (2007). Acupressure for chemotherapy-induced nausea and vomiting: A randomized clinical trial. Oncology Nursing Forum, 34, 813-820.

Study Purpose

To compare the differences in chemotherapy-induced nausea and vomiting (CINV) in women receiving chemotherapy for breast cancer among three groups: acupressure, acupressure placebo, and usual care

Intervention Characteristics/Basic Study Process

Subjects were randomized to one of three groups: acupressure to P6 point (active), acupressure to S13 point (placebo), or usual care. Participants in the acupressure groups were taught to apply acupressure wrist devices by research assistants unaware of the active pressure point. All participants completed daily logs for 21 days. Patients measured nausea and vomiting and recorded methods for controlling the symptoms, including antiemetics and acupressure. Research assistants, who had received two hours of training on the study protocol, instructed participants. In an examination or private room, the participants were taught to find a quiet place each morning to perform the acupressure treatment to both P6 points sequentially either as treatment or practice. During the day, participants in the acupressure groups were encouraged to apply digital pressure to one of the points whenever nausea occurred regardless of where they were. Each session was six minutes in the morning and three minutes each during the rest of the day. Self-ratings were completed on a daily basis prior to bedtime. All participants were called or seen on day eight for review of the log and coaching, if needed.

Sample Characteristics

  • The study consisted of 160 women beginning their second or third cycle of chemotherapy for breast cancer.
  • Participants had experienced moderate nausea intensity scores with previous cycles of chemotherapy, based on a score of at least 3 on the Morrow Assessment of Nausea and Emesis.
  • Participants were able to read and write in English.

Setting

The study was conducted in community oncology programs associated with M.D. Anderson Cancer Center and nine independent sites.

Study Design

This was a multicenter, longitudinal, randomized controlled trial.

Measurement Instruments/Methods

  • The Rhodes Index of Nausea and Vomiting (three-item nausea; single-item vomiting subscales) was used.
  • Nausea intensity also was rated with a descriptive, numeric rating scale, ranging from 0–10.
  • The State-Trait Anxiety Index also was used.

Results

  • No significant differences were found in demographic data, disease, or treatment variables among the groups.
  • No significant differences were identified in acute nausea and vomiting among the treatment groups.
  • With delayed nausea and vomiting, the acupressure group demonstrated a statistically significant reduction in the amount of vomiting and intensity of nausea over time when compared with the placebo or usual care groups.
  • No significant differences were found between the placebo and usual care groups.

Conclusions

In conjunction with pharmaceutical management, acupressure at P6 was  found to reduce the amount and intensity of delayed CINV in women undergoing treatment for breast cancer.

Limitations

  • The same research assistants and nurses taught both pressure points. Although most did not know which pressure point was active, a few referenced the Internet for the information.
  • Some patients with uncontrolled nausea also broke the blind by pursuing more information online.
  • Some participants had challenges finding the location consistently; some needed markings on their wrist. Two participants found application of pressure difficult because of long fingernails.
  • Staff training on the technique and return demonstration were not specifically described.
  • No men or children were included in the study population.

Nursing Implications

Acupressure is a safe and effective tool to be offered to women undergoing breast cancer chemotherapy treatment.

Print

Dibble, S.L., Chapman, J., Mack, K.A., & Shih, A. (2000). Acupressure for nausea: Results of a pilot study. Oncology Nursing Forum, 27, 41-47.

Study Purpose

To compare the effects of usual care (regular antiemetics) versus usual care plus acupressure training on nausea and its intensity in women receiving chemotherapy for breast cancer

Intervention Characteristics/Basic Study Process

The intervention involved finger acupressure bilaterally at the P6 and ST36 acupressure points located on the forearm and knee for a maximum of three minutes for each point every morning or as needed for nausea. Baseline and poststudy questionnaires and a daily log were used to collect data.

Sample Characteristics

  • The study consisted of 17 adult women undergoing chemotherapy for breast cancer (cyclophosphamide, methotrexate, and fluorouracil or doxorubicin-containing regimens). The control group had nine patients, and the experimental group had eight patients.
  • The mean age of both groups was 49 years old.
  • More than half (59%) of participants were Caucasian.

Setting

The study was conducted in two sites located in urban areas in the western United States: an outpatient oncology clinic in a major teaching medical center and a private outpatient oncology practice.

Measurement Instruments/Methods

  • Nausea was measured at baseline and poststudy via questionnaires and daily logs.
  • Nausea experience and its intensity were measured with the Rhodes Inventory of Nausea, Vomiting, and Retching.

Results

Significant differences existed between the two groups in regard to nausea experience (p < 0.01) and nausea intensity (p < 0.04) during the first 10 days of the chemotherapy cycle, with the acupressure group reporting less intensity and experience of nausea.

Limitations

  • The study only looked at a single cycle of treatment.
  • The sample size was small.
  • The sample was limited to women with breast cancer.
  • The ST36 acupressure point was difficult to reach.
Print

DiRenzo, N., Montanini, A., Mannina, D., Dondi, A., Muci, S., Mancuso, S., … Federico, M. (2011). Single-dose palonosetron for prevention of chemotherapy-induced nausea and vomiting in patients with aggressive non-Hodgkin's lymphoma receiving moderately emetogenic chemotherapy containing steroids: results of a phase II study from the Gruppo Italiano per lo Studio dei Linfomi (GISL). Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer, 19(10), 1505-1510.

Study Purpose

To evaluate the efficacy and safety of a single dose of palonosetron, a second-generation serotonin type 3 (5-HT3) receptor antagonist, in patients with aggressive non-Hodgkin lymphoma receiving moderately emetogenic chemotherapy (MEC)-containing steroids

Intervention Characteristics/Basic Study Process

Patients received a single IV bolus of palonosetron (0.25 mg) over 30 minutes before administration of chemotherapy (day 1), and patients were assessed from day 1 through day 5. The antiemetic response was evaluated during the acute, delayed, and overall phases, as well on each day.

Sample Characteristics

  • The study reported on 86 participants.
  • Median age was 65 years, with a range of 20–87.
  • The sample was 55% male and 45% female.
  • Patients had aggressive, stage I–IV, non-Hodgkin lymphoma (diffuse large B cell lymphoma = 78%).
  • Patients had European Cooperative Oncology Group (ECOG) status of 0–2, were receiving R-CHOP, CHOP, R-COMP, and other chemotherapy regimens. Dexamethasone or metoclopramide as rescue medication were available upon patient request.

Setting

This multisite was conducted in Italy.

Phase of Care and Clinical Applications

  • All patients were in active treatment.
  • This study has application for late effects and survivorship.

Study Design

This was a prospective, open label, nonrandomized, phase II study.

Measurement Instruments/Methods

  • Complete response (CR) was defined as no vomiting and no rescue therapy during overall phase (0–120 hours).    
  • Complete control was defined as CR and only mild nausea.
  • The percentage of patients experiencing emesis and nausea was recorded.
  • Patients completed diaries on days 1–5, recording the nausea occurrence; nausea severity on a 3-point, Likert-type scale; and use of rescue medication.
  • Patient global satisfaction with antiemetic therapy was measured using a visual analog scale (VAS).

Results

  • CR was observed in 86% of patients during the overall phase. CR during the acute phase was 90.7%, and CR during the delayed phase was 88.4%.
  • CC was 82.6% overall, 89.5% during the acute phase, and 82.6% in the delayed phase. During the overall study period, the emesis-free rate was 74.4%, the nausea-free rate was 74.4%, and no patients experienced severe nausea. The median global satisfaction with antiemetic therapy was 8.0 out of 10.
  • The treatment was well tolerated, and no patients experienced severe adverse events.
  • The most common, grade 1–2 adverse events were constipation (7.0%), headache (5.8%), asthenia (7.0%), and dizziness (1.2%). No grade 3–4 adverse events or significant changes in lab tests or vital signs were recorded during the study period.

Conclusions

A single dose of palonosetron is effective, tolerable, and safe in control of CINV in patients receiving MEC-regimen-containing steroids.

Limitations

  • No appropriate control group was included.
  • No control for risk factors for CINV other than gender and age. Although antiemetic regimen did not include dexamethasone, the chemotherapy regimen included prednisone.

Nursing Implications

A single dose palonosetron infusion is a tolerable and safe option for patients receiving MEC-containing steroids. A single-dose palonosetron infusion could be less expensive in comparison to multiple administration of IV infusions of the first generation 5-HT3 RAs, which also could save time and required workforce.

Print

Dhruva, A., Miaskowski, C., Abrams, D., Acree, M., Cooper, B., Goodman, S., & Hecht, F. M. (2012). Yoga breathing for cancer chemotherapy-associated symptoms and quality of life: results of a pilot randomized controlled trial. Journal of Alternative and Complementary Medicine, 18, 473–479.

Study Purpose

To assess the feasibility and effects of pranayama (regulation and expansion of breath) among patients receiving chemotherapy. To test the efficacy of pranayama in alleviating common chemotherapy-associated symptoms (fatigue, sleep disturbance, stress, anxiety, and depression) and improving quality of life (QOL). To evaluate patients' responses to the use of pranayama in alleviating common chemotherapy-associated symptoms affecting QOL.

Intervention Characteristics/Basic Study Process

Participants were randomized 1:1 in blocks of four. The allocation sequence was generated by the study statistician and then transferred to sealed numbered envelopes. The study staff enrolled participants and implemented the allocation sequence, which was concealed from the study staff until study assignment. Blinding of participants was impossible due to the intervention, which consisted of a 60-minute class once per week taught by yoga instructors and twice daily home practice that totaled 20 to 30 minutes per day, along with usual care during two cycles of chemotherapy. The control group received only usual care during the initial cycle of chemotherapy, and the pranayama intervention along with usual care during the second cycle of chemotherapy.

Sample Characteristics

  • The sample was comprised of 16 patients.
  • Mean age was 56 years (standard deviation [SD] = 11.9 years) in the control group and 52.4 years (SD = 14.6 years) in the treatment group.
  • The treatment group was 75% female and 25% male; the control group was 100% female.
  • Patients were receiving intravenous chemotherapy for cancer (50% of participants had breast cancer, 50% had some other type of cancer).
  • Patients were included in the study if they had a visual analog scale (VAS) score for fatigue of at least 4 out of 10 and a Karnofsky Performance Status (KPS) of 60 or higher.
  • Patients were excluded from the study if they participated in ongoing yoga practice; had severe chronic obstructive pulmonary disease (COPD), class III or IV heart failure, child class C cirrhosis, or end-stage renal disease; or had received more than three prior chemotherapy regimens.
  • The sample was 62.5% white, and 7 out of 16 were employed.

Setting

  • Single site
  • Outpatient
  • University medical center

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

The study was a randomized, controlled trial.

Measurement Instruments/Methods

  • Participants kept a daily diary in which they recorded the amount of time spent practicing pranayama.
  • At baseline, between the first and second cycle, and at the end of the study, the investigators took measures according to these instruments:
    • Piper Fatigue Scale (PFS)
    • General Sleep Disturbance Scale (GSDS)
    • Hospital Anxiety and Depression Scale (HADS)
    • Perceived Stress Scale (PSS)
    • Short Form 12 (SF-12 v1), to measure QOL.

Results

Sixteen of 18 participants completed all study measures:  eight from the control group and eight from the treatment group. The study intervention had no adverse effects. Increased yoga practice was associated with statistically significant reductions in sleep disturbance (p = 0.04) and anxiety (p = 0.04). The mental component of QOL approached statistical significance (p = 0.05).

Conclusions

This was the first study of a pure pranayama intervention for patients with cancer, and it demonstrated that yoga breathing is a feasible and safe intervention for this patient population. Any increase in the yoga breathing practice correlated with improvements of chemotherapy-associated symptoms and QOL. Researchers should confirm these findings by means of a larger study.

Limitations

  • The study had a small sample size, with less than 30 participants.
  • The study had risks of bias due to lack of an attentional control and due to selection bias:  those who would elect to participate in a study of this kind may be more likely than others to benefit from it. In addition, the study included self-reported outcomes.

Nursing Implications

Among patients with cancer who are undergoing chemotherapy, pranayama breathing techniques may help decrease sleep disturbance and anxiety and increase the mental component of QOL. Pranayama breathing, supplemented with reminders during and between treatments, seems to be an intervention that is feasible for this group of patients.

Print

Dhinakaran, M., Jain, K., Benjamin, K.E., Kaur, P., & Dhinakaran. (2014). Effect of complete decongestive therapy (CDT) in upper limb lymphedema in breast cancer patients. Indian Journal of Physiotherapy and Occupational Therapy, 8, 87–91. 

Study Purpose

To identify the long-term effect of complete decongestive therapy (CDT) to decrease lymphedema and enhance quality of life in patients after radical mastectomy with unilateral upper extremity lymphedema

Intervention Characteristics/Basic Study Process

Intensive phase of CDT for 10 days: Skin care, manual lymph drainage for 45 minutes (Vodder method), ComprezonTM low elastic compression stocking lymphedema arm sleeve with hand, shoulder cap and belt with a pressure of 23–32 mm Hg. Patients wore the garment 23 hours every day. Exercises twice a day up to 10 days: Active movement of the glenohumeral joint for five minutes; isometrics exercise, including the arm and shoulder, elbow, and wrist, 10 repetition each, with compression garments; and deep abdominal breathing exercise 3–5 times in between each isometric exercise. The same protocol was used in the home. Patients and their relatives were taught how to conduct self-care and self-management.
 
Maintenance phase: After a month with CDT isotonic exercise, including shoulder, elbow, and wrist muscles, for 50%–60% of 10 RM 8–10 times, two times a day, and stretching exercise, including stretching of the pectoralis major and minor latissimus dorsi. The patients were followed up with monthly for up to three months.

Sample Characteristics

  • N = 45   
  • AGE = 48.44 (SD = 6.5 years)
  • FEMALES: 100%
  • CURRENT TREATMENT: Immunotherapy
  • KEY DISEASE CHARACTERISTICS: Breast cancer survivors after radical mastectomy
  • OTHER KEY SAMPLE CHARACTERISTICS: History of unilateral post mastectomy lymphedema with more than 2 cm circumference than the normal side, aged older than 19 years, no neurological disorders, no untreated or unstable medical conditions, no edema in lower extremities

Setting

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

Phase of Care and Clinical Applications

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

Study Design

  • Pre-post design

Measurement Instruments/Methods

  • Modified truncated cone method
  • European Organization of Research and Treatment of Cancer Core Quality of Life (EORTC QLQ-C30) questionnaire
  • Upper limb lymphedema quality of life (ULL-QOL) questionnaire

Results

Volume of the affected limb was decreased by 80.22 (95% confidence interval [CI] [–96.71, –63.73]) from baseline to the third month (p < 0.0001). Mean change in quality of life at the second month as compared to baseline was significant (69.95, 95% CI [66.49, 73.42], p < 0.0001).

Conclusions

CDT may be effective in reducing the volume in the lymphedema limb and in enhancing breast cancer survivors’ quality of life.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement validity/reliability questionable
  • Findings not generalizable
  • Intervention expensive, impractical, or training needs
  • Single-site study

Nursing Implications

More rigorously designed studies are needed to examine the effectiveness of CDT in patients with lymphedema. Note that patients who underwent lumpectomy also developed lymphedema.

Print

Dharmawardene, M., Givens, J., Wachholtz, A., Makowski, S., & Tjia, J. (2015). A systematic review and meta-analysis of meditative interventions for informal caregivers and health professionals. BMJ Supportive and Palliative Care. Advance online publication.

Purpose

STUDY PURPOSE: To assess meditative intervention outcomes on physical and emotional markers of well-being, job satisfaction, and burnout among informal caregivers (ICG) and health professionals
 
TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: PubMed, EMBASE, CINAHL, and PsycINFO
 
KEYWORDS: Article text key words combined with medical subject heading (MeSH) terms for all assessed databases
 
INCLUSION CRITERIA: Studies used a form of meditation intervention defined by the study and included mantra meditation and mindfulness meditation defined by the Agency for Healthcare Research and Quality; studies with a randomized, controlled trial design or a pre/post assessment of the intervention; studies focused on health professional caregivers or ICGs
 
EXCLUSION CRITERIA: Studies involving movement-based practices such as yoga asana, tai chi or qigong; studies defined as dissertations, poster or conference presentations, or letters to the editor; studies in languages other than English; studies containing fewer than five participants or reporting on healthcare employees in general but not specifically on healthcare providers with direct patient care responsibilities; studies involving multicomponent interventions not separately reporting the effects of any meditative components

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 2,912
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: The authors used a consistent scoring process to assess study quality (criteria of Downs and Black) and factors potentially affecting bias (i.e., blinding, recruitment, randomization, analytic approach). A similar process was used to construct a meta-analysis of the two different groups assessed (ICGs and healthcare providers) and the negative and positive outcome domains of each group (e.g., depression, anxiety, fatigue, hope, satisfaction). The authors appropriately used the Q statistic and comprehensive meta-analysis (analysis package) to appropriately assess heterogeneity of effect estimates and random-effects models to predict mean differences for each outcome when included studies had sufficient information to do so.  

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED = 27; n = 15 focused on ICGs (seven randomized, controlled trials, one nonrandomized controlled trial, and seven pre/postintervention studies)
 
TOTAL PATIENTS INCLUDED IN REVIEW: 9-78; majority are female ICG.  Studies median quality score (based on Downs and Black) was 11, range typically 7-17
 
SAMPLE RANGE ACROSS STUDIES: 
 
KEY SAMPLE CHARACTERISTICS: The majority of studies involved the ICGs of patients with dementia; only one study involved ICGs of patients with cancer.

Phase of Care and Clinical Applications

PHASE OF CARE: End of life care, various stages of diseases (dementia, advanced disease including cancer, children chronic illness) care  
 
APPLICATIONS: Pediatrics, Elder care, Palliative care

Results

  • Reported only on the arm that involved informal caregivers
  • Eight of 15 ICG studies provided self-reported data on stress and anxiety. Seven of the 15 studies reported statistically significant improvements with informal caregiver use of meditative interventions. 
  • Twelve of 15 studies measured ICGs' mood or mental health. Eight of those reported statistically significant improvements in caregiver mental health after a mindfulness intervention.
  • Heterogeneity Q statistics were statistically significant for controlled trials of anxiety and for pre- and postintervention studies of ICG depression. 
  • The combined effect for controlled trial studies involving ICGs on depression, anxiety, stress, self-reported efficacy, and quality of life and mental health showed benefits from meditation. 
  • The combined effect for pre- and postintervention studies on depression, anxiety, stress, and caregiver burden showed meditation benefits.
  • An insufficient number of studies existed to examine combined effect for caregiver fatigue, sleep quality, confusion and grief, personal growth, hope, energy, and life satisfaction was included.  
  • Three out of the six studies that examined self-efficacy (a positive outcome) showed significant caregiver improvement, but the combined effect of the controlled trials suggested a meditation benefit but not for a reduction of caregiver burden. 
  • Six of the seven studies of ICGs that assessed physiological measures of stress showed a statistically significant change postintervention. 

Conclusions

Focusing on the outcomes for ICGs, the combined evidence from the controlled trials supports use of meditative interventions to minimize ICG’s depression, anxiety, and stress. Combined evidence from the pre- and postmeditative intervention studies supported their use in alleviating ICG burden. However, the insufficient study rigor and number prevent ed conclusions about the meditative interventions' effects on caregiver energy, fatigue, hope, confusion, and grief or life satisfaction. The insufficient number of studies prevents assessment of effect of meditation on caregivers’ capacity for decision making, patient advocacy, or resilience.

Limitations

  • Review of the ICGs of mostly patients without cancer limits the applicability for patients with cancer and their caregivers  
  • Insufficient studies exist to make conclusions about several caregiver-related outcomes (e.g., energy, fatigue, hope, confusion, grief or life satisfaction, capacity for decision making, patient advocacy or resilience).
  • The majority of female study participants minimized the generalizability of findings to male ICGs.
  • Many studies relied on self-report with a wide variability of assessed study qualities (Downs and Black criteria).
  • Study reviewed only English language studies

Nursing Implications

The effect of a meditative intervention on caregivers of patients with cancer should be explored with more studies using rigorous designs possessing higher statistical power. The initial data from this study indicate that a meditative intervention may benefit the ICGs of patients with various illnesses.

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