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Heinrichs, N., Zimmermann, T., Huber, B., Herschbach, P., Russell, D.W., & Baucom, D.H. (2012). Cancer distress reduction with a couple-based skills training: A randomized controlled trial. Annals of Behavioral Medicine, 43, 239–252.

Study Purpose

To investigate the short- and long-term effects of a psychosocial side-by-side couple's intervention on disease distress, post-traumatic growth, communication, and dyadic coping among women with breast and gynecologic cancers and their partners

Intervention Characteristics/Basic Study Process

The side-by-side intervention consisted of four meeting sessions between a participating couple and a therapist on a biweekly, face-to-face basis at the couple’s home. Each meeting session lasted two hours. Each of the four sessions focused on a certain theme and had specific objectives.

The Couples Control Program was the control group. Control group couples received only one two-hour session where they were given written educational materials about breast and gynecological cancers. The therapist used a structured protocol when interacting with participants.

Sample Characteristics

  • The sample included 72 participants.
  • Age range of participants was 25–80 years, with a median age of 52 for the combined sample of women and their partners.
  • Males (partners) represented 50% of the sample; mean age of partners (all men) was 52.2 years (SD = 11.3).
  • The study involved women with breast or gynecologic cancers and their partners. Patients’ treatments for their disease included surgery (90%), radiation therapy (72%), chemotherapy (69%), and hormone therapy (60%).
  • There were significant differences between groups for cancer-specific distress (F (1,71) = 6.2, p = 0.02) and fear of progression (F (1,71) = 8.6, p = 0.005) at pretesting.

Setting

  • Multisite
  • Outpatient setting
  • Couples were recruited in three regional hospitals in Germany.

Phase of Care and Clinical Applications

Active antitumor treatment phase

Study Design

 A two-site, controlled, parallel-group study with random assignment (balanced randomization [1:1]) was used.

Measurement Instruments/Methods

Psychosocial distress:

  • Questionnaire on Stress in Cancer Patients (QSC-R23) was used to assess cancer-specific distress. This questionnaire was given to the women only (patients). Internal reliability was good (alpha 0.87).
  • Fear of Progression Questionnaire (FoP-Q) was used to assess fear of cancer progression in both the women and their partners. Internal reliability was good (alpha 0.87).
  • Avoidance-Defense Scale, which is a subscale of the Dealing With Illness Inventory–Revised, assessed how much women and their partners used avoidant behaviors in dealing with the disease. Internal consistency was alpha 0.54 and 0.51 for women and men, respectively.

Benefit finding:

  • Post-Traumatic Growth Inventory was used to assess an individual finding meaning and benefit from the experience of severe life events; this inventory was done for women and their partners.  Reliability was good (alpha 0.92 and 0.91 for women and men, respectively).

Relationship satisfaction:

  • Quality of Marriage Index (QMI) was used to assess marital satisfaction for women and their partners. Reliability was good (alpha 0.95).

Communication:

  • Communication subscale of the Partnership Questionnaire was used to assess communication quality for both women and their partners. Reliability was good (alpha 0.86 and 0.82 for women and men, respectively).

Dyadic coping:

  • Dyadic Coping Inventory was used to assess how partners cope with stress in their relationship; they report on their own behavior, their perceived partner’s behaviors, and their perceived behavior on themselves as a couple. This was measured for women and their partners. Reliability was not reported.

Results

Sample description and differences:

  • Baseline data showed that women in both groups (intervention and control) were somewhat distressed and that both men and women showed high average dyadic coping at baseline in both groups. Furthermore, participants in the intervention group showed significantly higher levels of fear of disease progression than their control group counterparts (M = 39 [SD = 9.2] versus M = 32.8 [SD = 8.6], F (1, 71) = 8.6, p =0.005).
  • The only significant difference between groups was in their continuation with the long-term assessments at 12-month assessment: More couples dropped from the control group (45%) compared with the intervention group (17%) X2 (df) = 1) = 6.7, p < 0.001. In addition, women who dropped in the control group after the post-treatment had lower communication quality (M = 16 [SD = 3.6]) at baseline than those who continued in the study (M = 19.9 [SD = 4.9], F (1, 25) = 4.6, p = 0.04.  

The following changes were observed in the outcome variables:

  • Women in the intervention group showed less avoidant behavior over time compared to women in the control group who showed an increase in avoidant behavior. The interaction between intervention, time, and gender was a significant predictor t (395) = 2.56, p = 0.011 (β = 0.31 [SD=0.12]). Males in the intervention group had an increase in avoidance from pre to first follow-up (third assessment ), whereas males in the control group maintained a high level of avoidance across time.
  • Couples in the intervention group showed a higher level of dyadic coping at all assessments (pre, post, follow-up 1, and follow-up 2), whereas couples in the control group showed decline across post through follow-up 1, with an increase in dyadic coping at follow-up 2.

Conclusions

Side-by-side intervention showed clear benefit compared to the control group in fear of disease progression and avoidant behavior. This benefit was short-term and did not carry through to long-term assessments. There was also clear benefit in dyadic coping and communication, but both were also short-term. 

Side-by-side intervention has shown potential benefit in faster post-traumatic growth compared to control group.

Limitations

  • The sample was small, with less than 100 participants.
  • There were baseline sample/group differences of import.
  • The study had risk of bias due to no blinding and no random assignment, as well as the sample characteristics.*
  • The intervention was expensive, impractical, and/or required training needs.*
  • Subject withdrawals were 10% or higher.
  • Other limitations/*explanation: The study was too complex to be readily comprehensible. Based on the descriptions in the study, it is not clear when the different sessions of intervention occurred, and the timeline was confusing. The reporting was too detailed and presented in a way that loses the reader in the detail. The study design required assessments over time (about 16 months), which leads to attrition challenges. The attrition affected, and possibly contributed to, some bias in the results. The study was thorough but also a case where too much was done. In short, the study was far from parsimony.

Nursing Implications

The findings indirectly indicate that the interdisciplinary team caring for women with cancer should involve the services of psychologists, family therapists, or advanced practice nurses with specialized training in mental and relationship wellness for patients and their partners.

Nursing care should include an assessment of a couple's distress level and communication patterns over the trajectory of a breast or gynecologic cancer illness.  

Attrition and recruitment in long-term studies involving caregivers remain serious threats, and future research designs and methodologies should include clear plans to manage these challenging aspects.

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Heiney, S.P., Reavis, K., Tavakoli, A.S., Adams, S.A., Hayne, P.D., & Weinrich, S.P. (2015). The impact of STORY on depression and fatigue in African-American women with breast cancer. Journal of National Black Nurses' Association, 26, 1–7.

Study Purpose

To test the hypothesis that depression and fatigue would be decreased more in the Sisters Tell Others and Revive Yourself (STORY) intervention group than in controls

Intervention Characteristics/Basic Study Process

The STORY intervention was a therapeutic activity delivered to a group via teleconference, using information and storytelling to increase social connections among African American women with breast cancer. A series to teleconferences was facilitated by two social workers with groups of 10 patients. The series was done weekly for eight weeks, and every other week for two weeks. Participants received small stipends during the study. Patients were randomly assigned to the STORY intervention or usual care. This particular report used secondary analysis to determine the impact of this intervention on depression and fatigue.

Sample Characteristics

  • N = 168
  • MEAN AGE: 56.7 years
  • RANGE: 32-83 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: All had breast cancer.

Setting

  • SITE: Single site
  • SETTING TYPE: Not specified
  • LOCATION: Southeastern United States

Study Design

  • Randomized, controlled trial

Measurement Instruments/Methods

  • Profile of Mood States Short Form (POMS-SF)

Results

There was no significant difference in fatigue or depression between study groups.

Conclusions

The psychoeducational intervention delivered via teleconference as tested here did not demonstrate an effect on fatigue or depression.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Unintended interventions or applicable interventions not described that would influence results
  • Measurement validity/reliability questionable
  • The single instrument used may not have been the best for measurement of these symptoms.
  • The educational content regarding how to manage fatigue and depression are not described, and from the description that is provided, it is not clear that patients were educated about evidence-based approaches to combat fatigue.
  • It is unclear whether levels of fatigue and depression were high enough to expect to see a reduction with an intervention.

Nursing Implications

The psychoeducational and supportive intervention tested did not show an effect on depression or fatigue. This report does provide information regarding using a teleconference approach to provision of a group intervention, which might be applicable in a number of situations to facilitate patient involvement in this type of activity. Further research regarding the most effective methods of delivery of educational and supportive interventions is needed.

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Heim, M.E., v d Malsburg, M.L., & Niklas, A. (2007). Randomized controlled trial of a structured training program in breast cancer patients with tumor-related chronic fatigue. Onkologie, 30, 429–434.

Intervention Characteristics/Basic Study Process

Intervention consisted of physiotherapy, group exercises, and psycho-oncologic interventions. Patients received a brochure with instructions for nine muscle strength and nine stretching exercises for large muscle groups. Outcomes were assessed at baseline, start of intervention (T1), end of intervention (T2), and at a three-month follow-up (T3).

Sample Characteristics

  • N = 63
  • AGE: In the intervention group, 56% were aged 51–70 years
  • KEY DISEASE CHARACTERISTICS: Patients with breast cancer with cancer-related chronic fatigue
  • OTHER KEY SAMPLE CHARACTERISTICS: Control group patients were slightly younger, but otherwise both groups were well balanced. Intervention group: 56% married, 59% working, most patients had received chemotherapy (66%) and radiation therapy (81%), and 78% received hormonal therapy
  • EXCLUSION CRITERIA: Evidence of psychiatric disease or patients who were less than six weeks to preceding surgery or chemotherapy

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active treatment, inpatient rehabilitation

Study Design

  • Randomized controlled trial
    • Structured physical training intervention (N = 32)
    • Control (N = 31)

Measurement Instruments/Methods

  • Linear analogue scale (LASA)
  • Multidimensional Fatigue Inventory (MFI)
  • Functional Assessment of Cancer Treatment (FACT)

Results

Trial outcome index for fatigue in the FACT-F questionnaire showed improvement in fatigue from T1–T3. The interaction of time and group were statistically significant (p = 0.003). For MFI measures, interaction between group and time effects was significant for physical fatigue between T2–T3 (p = 0.028). The mean MFI total score was higher for both the control and intervention group in comparison to the mean MFI total score for healthy women in the age group of 40–50 years at the three-month follow-up.

Limitations

  • Small sample size

Nursing Implications

Future research should incorporate better measures for the intensity of the exercise.

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Hegg, R., Mattar, A., Matos-Neto, J.N., Pedrini, J.L., Aleixo, S.B., Rocha, R.O., . . . van-Eyll-Rocha, S. (2016). A phase III, randomized, non-inferiority study comparing the efficacy and safety of biosimilar filgrastim versus originator filgrastim for chemotherapy-induced neutropenia in breast cancer patients. Clinics, 71, 586–592.

Study Purpose

To compare the efficacy and safety of two filgrastim formulations for controlling chemotherapy-induced neutropenia and to evaluate the noninferiority of the test drug against the original

Intervention Characteristics/Basic Study Process

Patients with grade 4 neutropenia were randomized 1:1 to Eurofarma filgrastim or Roche filgrastim. Doses were administered subcutaneously daily 5 mg/kg until absolute neutrophil count was 10,000/mm3 or greater or until the 15th day of the chemotherapy cycle (V14). Only a single event of febrile neutropenia was considered during the study period per patient. Neutrophil counts were drawn every two days.

Sample Characteristics

  • N = 219   
  • AGE = 49–51 years
  • MALES: Not specified
  • FEMALES: Not specified
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Breast cancer stages II–IV
  • OTHER KEY SAMPLE CHARACTERISTICS: Full dose of TAC or AT chemotherapy

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Not specified    
  • LOCATION: Brazil

Phase of Care and Clinical Applications

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

Study Design

Phase III, open-label, noninferiority, randomized, two-group trial

Measurement Instruments/Methods

  • Kolmogorov-Smirnov test with Lilliefors correction used to evaluate standard distribution of the outcome variables
  • Lillifors correction also used to adjust the estimated population parameters (mean and variance, standard deviation)

Results

To assess the noninferiority of the test drug to the original the 90% confidence interval for the difference in the rates of grade 4 neutropenia between the two groups were initially calculated.

Conclusions

No significant difference (p = 0.9971) in the rate of grade 4 neutropenia existed in the total number of patients in each group during the first chemotherapy cycle.

Limitations

Risk of bias (no blinding)

 

Nursing Implications

The increased surveillance of patients’ neutrophils may have produced better outcomes. The difference between the two drugs was negligible. Strong patient teaching is warranted, regardless of the process of events during the chemotherapy cycle.

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Heggie, S., Bryant, G. P., Tripcony, L., Keller, J., Rose, P., Glendenning, M., & Heath, J. (2002). A phase III study on the efficacy of topical aloe vera gel on irradiated breast tissue. Cancer Nursing, 25, 442–451.

Study Purpose

To see if topical aloe vera gel would be beneficial in reducing the skin side effects of radiation therapy (RT).

Intervention Characteristics/Basic Study Process

Participants were stratified according to bra cup size, history of lymphocele drainage, and smoking. Participants were randomized to use of aloe vera or an aqueous cream for control.

Sample Characteristics

  • The sample was comprised of 208 participants with breast cancer.
  • Median age was 57.5 years (range 28–89).
  • Patients had undergone lumpectomy or partial mastectomy.
  • Median radiation dose was 60.15 Gy.

Setting

Mater Centre, Australia, and the Royal Brisbane Hospital Centre, Australia

Study Design

The study was a randomized, controlled, double-blind trial.

Measurement Instruments/Methods

  • Weekly assessment form based on Dische’s Morbidity Rating Scale was used to record skin reactions.
  • Researchers observed for erythema, itching, pain, and extent of treatment area affected by dry or moist desquamation. The areas affected by moist desquamation were identified according to site.
  • Weight, skin type, tumor stage, and previous skin cancer were also recorded.
  • Weekly assessments were performed using the Radiation Therapy Oncology Group (RTOG) scale.
  • Skin changes recorded were itching, skin texture, tanning, erythema, time to skin change, and dose at first skin change.

Results

Aqueous cream was significantly better than aloe vera gel in reducing the incidence of dry desquamation and moderate or higher pain (p < 0.001). Participants with cup size D or more in either treatment arm experienced a significantly greater incidence of moderate or higher erythema compared with smaller-breasted women (p < 0.02). For non-chemotherapy participants, the aloe vera arm experienced a significantly reduced incidence of moderate or higher erythema (p = 0.02). The control group arm experienced a significantly reduced incidence of moderate or higher pain (p = 0.03). The most important predictors of development of skin reaction were radiation dose, breast size, patient smoking, and damage to the lymphatic system manifested by one or more lymphocele drainage. Cumulative dose was greater than 2,700 cGy, and there was a delay to onset of erythema (p = 0.013).

Conclusions

Aqueous cream is superior to aloe vera in reducing the acute RT skin reactions of dry desquamation and pain.

Limitations

  • The consistency and appearance of the two study preparations were quite dissimilar, so participants may have guessed the identity of their study preparation.
  • Ninety percent of the final skin assessments were conducted over the telephone, so the research nurse was not able to view the participant’s skin and had to rely on the subjective assessment.
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Hegarty, F., & Wong, M. (2014). Polymeric membrane dressing for radiotherapy-induced skin reactions. British Journal of Nursing, 23, S38–S46.

Study Purpose

To clinically evaluate the use of a polymeric membrane for the management of radiodermatitis in terms of skin integrity, management of desquamation, relief of pain and inflammation, and healing time

Intervention Characteristics/Basic Study Process

Patients with Radiation Therapy Oncology Group (RTOG) scores of 1–3 and early signs of skin reactions were followed for four weeks during treatment. Study data and patient assessments were obtained weekly. The polymeric dressing provided a mild cleansing agent activated by exudate that supported natural debridement. The dressing also contained glycerine, which provided moisture, and surfactant, which has been reported to reduce tension between healthy and unhealthy tissue.

Sample Characteristics

  • N = 23  
  • MEAN AGE = 63.6 years (range = 38–82 years)
  • MALES: 32%, FEMALES: 68%
  • KEY DISEASE CHARACTERISTICS: Various tumor types including breast, head and neck, and prostate
  • OTHER KEY SAMPLE CHARACTERISTICS: Highest radiotherapy dosage was 74 Gy in 37 fractions

Setting

  • SITE: Single-site  
  • SETTING TYPE: Outpatient    
  • LOCATION: United Kingdom

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Observational

Measurement Instruments/Methods

  • Numeric pain scale
  • Wong and Baker FACES® scale
  • Patient diary
  • RTOG skin rating

Results

From baseline to week 3, RTOG scores improved. Diary pain scoring showed an overall reduction in pain from an average of 6.5 to 1.6. Fixation of the dressing was a challenge, particularly among patients with breast and gynecologic cancers. Themes from a qualitative analysis of patient diaries identified skin improvement, a cooling effect of the dressing, and pain reduction.

Conclusions

Polymeric dressing use may be helpful for the prevention and treatment of radiodermatitis.

Limitations

  • Small sample (< 30)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement/methods not well described
  • Other limitations/explanation: The frequency and timing of dressing changes was not described. The way in which data were presented did not enable the reader to determine how many patients had a significant improvement or decline in skin condition, though group trends were shown. Who measured skin condition and how it was measured was not clear.

Nursing Implications

Polymeric dressings may be helpful for the prevention and treatment of radiodermatitis. Additional, well designed, clearly reported studies are warranted. Keeping this specific dressing in place was found to be a challenge for some patients.

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Kim, Y.H., Kim, H.J., Ahn, S.D., Seo, Y.J., & Kim, S.H. (2013). Effects of meditation on anxiety, depression, fatigue, and quality of life of women undergoing radiation therapy for breast cancer. Complementary Therapies in Medicine, 21(4), 379–387. 

Study Purpose

Investigate the effects of meditation on the symptoms of anxiety, depression, and fatigue in women who were receiving radiation therapy for breast cancer

Intervention Characteristics/Basic Study Process

The intervention group received a total of 12 meditation therapy sessions during its six-week radiation therapy period. The control group received only conventional radiation therapy. The meditation intervention was Brain Wave Vibration meditation, which is based on a Korean traditional exercise, simple movements, music, and positive messages (changing weekly). This focuses on the senses of the body, relaxing the body and mind and relieving negative thoughts through natural rhythmic movements.

Sample Characteristics

  • N = 83    
  • MEAN AGE = 47 years
  • MALES: 0%, FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Female patients with breast cancer undergoing breast conservation and radiation therapy with curative intent
  • OTHER KEY SAMPLE CHARACTERISTICS: Primarily married, primarily financially stable, primarily HER-2/neu negative

Setting

  • SITE: Single site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Asan Cancer Center, Seoul, Korea

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active anti-tumor treatment
  • APPLICATIONS: Elder care

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • Hospital Anxiety and Depression Scale (HADS)
  • Revised Piper Fatigue Scale
  • The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30

Results

Patients who received meditation therapy saw mild improvements, with a reduction in anxiety and fatigue. Patients in the control group also showed significant reduction in fatigue and anxiety, and post-intervention scores actually were lower for both of these in the control group. No effect was seen for depression.

Conclusions

The study states that an “affirmation” can be made that meditation can be used as a non-invasive intervention for improving fatigue and anxiety. However, results showed significant reductions in these symptoms for patients in the control group as well. This provides minimal support for effectiveness of the approach used here.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Unintended interventions or applicable interventions not described that would influence results
  • Findings not generalizable
  • Intervention expensive, impractical, or training needs
  • Subject withdrawals ≥ 10%
  • Korean study, using a Korean meditation technique; likely not generalizable to the United States
  • Big impact on time
  • Not a billable service; great staff time and training involved
  • Unclear whether the meditation was in a group setting or individual; what relation did group dynamics play in a group of patients who may have met together 12 times and formed an effective peer-to-peer support group?
  • The study was underpowered by the author's calculations.
  • An intent to treat analysis was used, but how this was applied was not stated.

Nursing Implications

Nurses likely would not have any options of referral to meditation resources. Something more generalizable, like relaxation or mindfulness, would have been a better option for a study. The study is Korean; typically educated Korean women may have had previous exposure to meditation, and the intervention would be more acceptable to them than to American women.

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Heckman, K.D., Weiner, G.J., Davis, C.S., Strauss, R.G., Jones, M.P., & Burns, C.P. (1997). Randomized study of prophylactic platelet transfusion threshold during induction therapy for adult acute leukemia: 10,000/microL versus 20,000/microL. Journal of Clinical Oncology, 15, 1143–1149.

Study Purpose

To compare two common prophylactic platelet transfusion thresholds for patients receiving induction chemotherapy for acute leukemia

Intervention Characteristics/Basic Study Process

Patients were divided into four groups: new diagnosis of leukemia in patients aged less than 60 years; new diagnosis in patients 60 years or greater; relapsed disease in patients aged less than 60 years; and relapsed disease in patients aged 60 years or greater. Patients were randomized by selecting cards from an envelope to receive platelets when their morning platelet counts were either 10,000 microliters or 20,000 microliters. All platelet apheresis product transfusions were given according to the same transfusion orders. Controls for failure to respond to platelet transfusion for all participants were included in the study as well as guidelines for removing patients if warranted. For serious and life threatening bleeding, and as otherwise directed by the treating physician, therapeutic platelets were administered to study participants.

Sample Characteristics

  • N = 78  
  • AGE RANGE = 19–82 years
  • MALES: 64%, FEMALES: 36%
  • KEY DISEASE CHARACTERISTICS: Patients were treated with one of three commonly used induction therapies. These included cytarabine x 7 days and daunorubicin x 3 days; cytarabine 2–3 Gm/m2 every 12 hours x 12 doses; or mitoxantrone 12 mg/m2 x 3 days with etoposide 150 mg/m2 CI x 5 days. 
  • OTHER KEY SAMPLE CHARACTERISTICS: None

Setting

  • SITE: Single-site    
  • SETTING TYPE: Inpatient    
  • LOCATION: University of Iowa Hospital

 

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Pediatrics, elder care, and palliative care 

Study Design

Prospective, randomized trial

Measurement Instruments/Methods

  • Bleeding toxicity scale
  • Number of bleeding episodes (calculated by documentation in patient chart or observation by investigator) 

Results

The study found that there was no statistical difference in the total number of bleeding episodes between the two groups of patients (p = .12). Of note, there was a significant increase in platelet reactions in the platelet group receiving ≤ 20,000 microliters (p = 0.005).

Conclusions

Administration of prophylactic platelets at a threshold of 10,000 microliters can cut back the utilization of platelets and reduce the incidence of viral exposure without a statistically significant effect on morbidity.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Findings not generalizable

Nursing Implications

Nurses need to be familiar with professional guidelines and institutional policies regarding platelet transfusions. This would include the use of premedications, post-transfusion blood drawing, and reporting of platelet reactions. For those institutions that use platelet thresholds higher than 10,000 microliters, it may be time to revisit practice based on the findings of this study.

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Heckler, C.E., Garland, S.N., Peoples, A.R., Perlis, M.L., Shayne, M., Morrow, G.R., . . . Roscoe, J.A. (2016). Cognitive behavioral therapy for insomnia, but not armodafinil, improves fatigue in cancer survivors with insomnia: A randomized placebo-controlled trial. Supportive Care in Cancer, 24, 2059–2066.

Study Purpose

To assess the combined and comparative effect of cognitive behavioral therapy (CBT) and armodafinil to improve sleep and daytime functioning in survivors of cancer.

Intervention Characteristics/Basic Study Process

Participants were randomized to (a) CBT-I and placebo, (b) CBT-I and armodafinil 50 mg b.i.d., (c) placebo BID, or (d) armodafinil 50 mg BID. All received written sleep hygiene guidelines. Participants had CBT-I in 30–60-minute individual, in-person sessions during weeks 1, 2, and 4; and had 15–30-minute phone sessions during weeks 3, 5, and 7. Study medicine was taken for 47 days from 7 am to 9 am and 12 pm to 2 pm.

Sample Characteristics

  • N = 88  
  • MEAN AGE = 56 years 
  • MALES: 12%, FEMALES: 88%
  • KEY DISEASE CHARACTERISTICS: Patients with any cancer who completed chemotherapy and/or radiation not less than one month prior and had no measurable disease
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients discontinued any prescribed or OTC sleep medications one week prior to the study and for the duration of the study

Setting

  • SITE: Not stated/unknown    
  • SETTING TYPE: Not specified  
  • LOCATION: United States and Canada

Phase of Care and Clinical Applications

  • PHASE OF CARE: Transition phase after active treatment

Study Design

  • Four am factorial
  • Randomized and blinded trials for medications but not for CBT-I

Measurement Instruments/Methods

  • Quantitative data of fatigue assessment using brief fatigue inventory (BFT)
  • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale

Results

Improvement in fatigue was noted with CBT for insomnia (p = 0.002 on BFI;  p < 0.001 on FACIT-F). No improvement in fatigue was noted with placebo, on armodafinil alone, or on armodafinil with CBT-I.

Conclusions

CBT for insomnia appears to improve fatigue in patients with insomnia, and armodafinil was not shown to improve fatigue in patients with insomnia and fatigue.

Limitations

  • Small sample (less than 100)
  • Study was a secondary aim of a previous trial.

Nursing Implications

This study shows that CBT for insomnia may be beneficial to patients with fatigue and that armodafinil does not improve fatigue.

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Hecht, J.R., Pillai, M., Gollard, R., Heim, W., Swan, F., Patel, R., . . . Malik, I. (2010). A randomized, placebo-controlled phase ii study evaluating the reduction of neutropenia and febrile neutropenia in patients with colorectal cancer receiving pegfilgrastim with every-2-week chemotherapy. Clinical Colorectal Cancer, 9, 95–101.

Study Purpose

The purpose of this study is to evaluate whether prophylactic pegfilgrastim administered with first- or second-line chemotherapy was feasible and reduced the incidence of grade 3/4 neutropenia and neutropenia-related complications in patients receiving 14-day oxaliplatin- or irinotecan-containing 5-FU–based chemotherapy regimens for advanced or metastatic colorectal cancer (CRC). 

Intervention Characteristics/Basic Study Process

One of three chemotherapy regimens (FOLFOX 4, FOLFIRI, or FOIL) was selected by physician discretion. Patients were randomized to receive either pegfilgrastim 6 mg or placebo on day 4 of each 14-day regimen. During the study period (the first four cycles of chemotherapy), the incidence of grade 3/4 neutropenia and febrile neutropenia were compared between the pegfilgrastim and placebo groups.

Sample Characteristics

  • The sample size was 241 at baseline; 135 completed the study.  
  • All were adults aged 18 years or older.
  • Men made up 67% of the sample; women made up 33%.
  • A key disease characteristic was locally advanced or metastatic CRC not curable by surgery and not amenable to curative radiation therapy

Setting

  • Multi-site (54 sites) 
  • Outpatient settings  
  • United States
     

Phase of Care and Clinical Applications

Active treatment

Study Design

Randomized, controlled trial, double-blinded. The control group received placebo.

Measurement Instruments/Methods

  • Laboratory results (complete blood count with five-part differential)    
  • Patient temperatures, either reported or taken by healthcare provider
  • Adverse events (nausea, diarrhea, fatigue, anemia, vomiting, anorexia, dehydration, abdominal pain, asthenia, pyrexia, decreased weight, hypokalemia, insomnia, neutropenia, constipation, alopecia, bone pain, dyspnea, pain, and febrile neutropenia)
     

Results

Patients treated with pegfilgrastim were significantly less likely (13%) to develop grade 3/4 neutropenia than those who received a placebo (43%) (p < 0.05). The pegfilgrastim group also experienced significantly fewer dose delays or dose reductions (33.4% versus 45%) (p < 0.05).

Conclusions

The study compares pegfilgrastim versus placebo, but does not consider pegfilgrastim versus filgrastim, which may have similar efficacy at reduced expense. Additional study is warranted, including a cost-benefit analysis.

Limitations

  •  The study authors disclosed potential conflicts of interest, including owning stock in Amgen, the company that produces pegfilgrastim.
  •  Amgen also provided writing assistance for this article, which raises questions of bias.

Nursing Implications

Patients with CRC receiving every-two-week chemotherapy regimens may benefit from supportive medications to stimulate neutrophil production.

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