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Ferguson, R.J., Ahles, T.A., Saykin, A.J., McDonald, B.C., Furstenberg, C.T., Cole, B.F., & Mott, L.A. (2007). Cogntive-behavioral management of chemotherapy-related cognitive change. Psycho-Oncology, 16, 772–777.

Study Purpose

The study was conducted to examine Memory and Attention Training (MAAT) as a possible intervention for cognitive dysfunction. MAAT consists of four cognitive-behavioral components.

  1. Education on memory and attention
  2. Self-awareness training
  3. Self-regulation emphasizing arousal reduction through relaxation training, activity scheduling, and pacing
  4. Cognitive compensatory strategies training, which consists of self-instructional training, verbal rehearsal of auditory information, schedule-making, external cueing, and outlining written material

Intervention Characteristics/Basic Study Process

The MAAT intervention contained

  1. Workbooks with written information about chemotherapy and memory difficulty, and step-by-step guides on how to practice and apply compensatory strategies
  2. Four monthly visits, lasting 30–50 minutes, that focused on knowledge of chemotherapy-associated memory problems, identification of at-risk situations where memory failures arise, and learned and rehearsed compensatory strategies relevant to participants' difficulties
  3. Three interim phone calls to assist participants in applying compensatory strategies
  4. Homework between phone calls to further apply the compensatory strategies.

Sample Characteristics

  • The number of participants was 29.
  • All participants were Caucasian and female.
  • All participants had breast cancer.
  • The average participant age was 56.
  • Participants had an average of 15.40 years of education, and their mean IQ was 112.82.
  • Participants were an average of 8 years post-chemotherapy and had reported memory and attention problems.
  • Telephone screenings were completed for psychiatric disorders using PRIME-MD.
  • Participants who had previous central nervous system (CNS) radiation or intrathecal therapy were excluded from the study. Those who had psychiatric mental health issues or neurologic, CNS-related, or neuroehavioral risk factors were also excluded.

Setting

  • Rural
  • Regional academic cancer center (Dartmouth-Hitchcock Medical Center)
  • Private oncology offices in Northern New England

Study Design

This was a prospective, longitudinal, single-arm pilot study.

Measurement Instruments/Methods

  • California Verbal Learning Test-II (CVLT-II) for verbal memory
  • Logical Memory I and II for memory
  • Digit Symbol for graphomotor skills
  • Trail Making Test (TMT), Parts A and B, for visual attention, motor speed, and cognitive flexibility
  • Stroop Color-Word Interference Task for executive function
  • Center for Epidemiologic Studies Depression Scale for depression
  • State-Trait Anxiety Inventory for anxiety
  • Quality of Life-Cancer Survivors (QOL-CS) for cancer-related quality of life
  • Multiple Ability Self-Report Questionnaire (MASQ)

Results

Participants rated the MAAT program with high levels of general satisfaction post-treatment, and reported that it was helpful with improving memory, attention, and compensatory skills.

Neuropsychological test results revealed improvement on verbal memory (p = 0.001), executive functioning (p < 0.001), and psychomotor functioning (p = 0.001). Moderate to large treatment effect sizes (0.47 to 0.67) were observed in the MASQ total score and subscales immediately post-treatment, and the visual perceptual scale (0.63) was significant at the two month follow-up. Self-report in cognitive function in participants’ daily lives improved significantly over baseline and was sustained across all follow-up periods (p = 0.001). Similar patterns of improvement were observed on MASQ subscales of attention and concentration, spatial memory, verbal memory, and language. 

Conclusions

MAAT is a feasible and possibly effective cognitive-behavioral, non-pharmacologic management approach to a common problem for many cancer survivors.

Limitations

  • The sample size was small and lacked diversity. 
  • The study had no comparison control group or randomization. 
  • Participants were highly educated, limiting the generalizability of study findings.
  • Neuropsychiatric scores fell within normal range after conversion of the raw scores to standardized scores, despite patient complaints of cognitive issues. This may reflect the measure’s insensitivity or specificity or imply that the participants did not have mild impairments in their memory or attention.
  • Measurements were not acquired before chemotherapy treatments for a true baseline measure.
  • Differences in chemotherapies or other treatments for the participants were not reported.
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Fenton-Kerimian, M., Cartwright, F., Peat, E., Florentino, R., Maisonet, O., Budin, W., . . . Formenti, S. (2015). Optimal topical agent for radiation dermatitis during breast radiotherapy: A pilot study. Clinical Journal of Oncology Nursing, 19, 451–455. 

Study Purpose

To assess which of the three topical emollients commonly used for the skin care of patients undergoing whole breast radiation therapy minimizes the grade of dermatitis and cost of product, and to evaluate their effect on quality of life.

Intervention Characteristics/Basic Study Process

A total of 30 patients were randomized to three groups of 10 patients each and received one of three different skin care products to apply during radiation therapy to the whole breast (Calendula cream twice daily, RadiaPlex (hydrogel cream) twice daily, or mometasone twice weekly during the first and second weeks of radiation and daily during week three, plus Aquaphor daily). Weekly skin evaluations were conducted by a medical doctor or a nurse practitioner and RN. Another skin assessment was conducted at one week, one month, and three months post radiation therapy. Life quality index forms were completed by the patients at during visits.

Sample Characteristics

  • N = 30   
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Women with stage I–II node-negative breast cancer. Post lumpectomy or partial mastectomy with negative margins. At least two weeks post breast surgery.
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients who were scheduled to receive 4256 cGy to the whole breast in 16 fractions. Patients were excluded if they were undergoing concomitant chemotherapy or were less than two weeks post chemotherapy. Other exclusion criteria included patients with connective tissue disorders, such as lupus or rheumatoid arthritis.

Setting

  • SITE: Single site    
  • SETTING TYPE: Not specified  
  • LOCATION: New York University (NYU) Clinical Cancer Center

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Randomized, controlled trial using three commonly used topical emollients

Measurement Instruments/Methods

Weekly skin assessment by a medical doctor or a nurse practitioner and RN at one-week follow-up, one-month follow-up, and three-month follow-up visits. Completion of a Dermatology Life Quality Index (DLQI) (visual analog survey) or DLQI upon enrollment to study, during enrollment, and after radiation.

Results

Skin assessment findings and quality of life index scores showed no significant difference based on the product used. All patients experienced grade 1–2 (maximum) dermatitis. Patients did not report a significant decline in their quality of life scores based on the amount of radiation dermatitis they experienced. The maximum grade of dermatitis occurred the first week after completing treatment. Time to maximum skin reaction and time to resolution of the skin reaction for each of the three study arms were equal. A difference in cost existed between the three products (the Calendula cream was the least expensive at approximately $11 per 6.7 oz tube, the mometasone was approximately $48 per unknown dose size, and the RadiaPlex was the most expensive agent at $59 per 6 oz tube).

Conclusions

In this small pilot study, no significant difference was observed between three commonly used topical emollients on the occurrence or severity of radiation dermatitis among patients undergoing whole breast radiation. A cost difference existed between the three products.

Limitations

  • Small sample (< 30)
  • After equivocal findings regarding skin reaction and life quality measures, is it justifiable to recommend more costly topical agents instead of the most cost-effective one?

Nursing Implications

Future research involving multicenter trials and larger sample size could support standard of care recommendations for the most cost-effective product (Calendula cream). The findings show no significant difference in the effectiveness of the three tested agents in terms of severity of radiation dermatitis or decrease in quality of life.

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Fenlon, D.R., Corner, J.L., & Haviland, J.S. (2008). A randomized controlled trial of relaxation training to reduce hot flashes in women with primary breast cancer. Journal of Pain and Symptom Management, 35, 397–405.

Study Purpose

The study sought to assess the efficacy of relaxation training in reducing the incidence of hot flashes in women with primary breast cancer.

Intervention Characteristics/Basic Study Process

The intervention group received a single relaxation training session and was instructed to use practice tapes on a daily basis at home for one month; the control group received no intervention.

Sample Characteristics

The study enrolled150 women from three breast cancer centers in England.

  • Inclusion criteria: Postmenopausal women diagnosed with primary breast cancer and suffering from menopausal hot flashes. Any level of severity was accepted for inclusion in the trial as long as the women found the flashes to be troublesome. Postmenopausal was defined as six months without menstruation.

Study Design

The study was a randomized controlled trial.

Measurement Instruments/Methods

The incidence of flashes was measured using a diary, kept by the women, of every flash as it occurred over the period of one week. The women also gave a measure of the severity of each flash using four predefined categories: (a) length of flash, (b) physical manifestation, (c) emotional response, and (d) behavioral response. For each of these domains, four levels of severity (graded 1–4) were assigned, using the Hunter Menopause Scale.

Results

Of 150 women recruited to the trial, 104 women completed it to the primary endpoint at one month, and 97 completed all three months. The incidence and severity of hot flashes, as recorded by diaries, significantly declined over one month (p < 0.001 and p < 0.01, respectively), compared with the control group. Distress caused by flashes also significantly declined in the treatment group over one month (p < 0.01), compared with the contro.l No significant differences between the treatment group and the control group at three months and no changes in anxiety or QOL were reported.

Limitations

A large amount of attrition marred the trial.

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Fenig, E., Brenner, B., Katz, A., Sulkes, J., Lapidot, M., Schachter, J., . . . Gutman, H. (2001). Topical Biafine and Lipiderm for the prevention of radiation dermatitis: A randomized prospective trial. Oncology Reports, 8, 305–309.

Study Purpose

To evaluate of the use of Biafine or Lipiderm to prevent radiodermatitis

Intervention Characteristics/Basic Study Process

Participants were randomized to one of three trial arms: Biafine, Lipiderm, or control (no prophylactic treatment). Study preparations were applied twice daily, starting 10 days prior to the beginning of radiation therapy and continuing until 10 days after treatment. Skin treatment was upgraded if necessary to steroids (grade 3 reaction), antibiotics (grade 4 reaction) or pause in therapy (grade 5 reaction).

Sample Characteristics

  • The study sample (N = 74) was comprised of female patients with breast cancer.
  • Mean age was 69 years, with a range of 42–85 years.
  • Of patients in the study, 63% were receiving concomitant tamoxifen.

Setting

The study took place at a single site.

Study Design

The study used a randomized controlled trial design.

Measurement Instruments/Methods

  • The Radiation Therapy Oncology Group and European Organisation for the Research and Treatment of Cancer skin toxicity scale was used
  • Overall treatment success was determined by maximal treatment grade, total number of radiation treatment gaps needed, the patients’ weekly impression, the radiotherapists clinical impression, and the study nurses’ impression.
  • Impressions were measured by an evaluation questionnaire using the same criteria. Relevant data were reported as a grade of reaction.
  • Pearson correlation, Chi-square or Fisher’s exact tests were used to analyze relationships among the three study arms.

Results

  • No objective data revealed an advantage in the Biafine or Lipiderm arm.
  • The maximum skin treatment level was lower in the two intervention arms, but was not significant.
  • Patients in both intervention arms reported a high level of satisfaction (Biafine 86% and Lipiderm 85%).

 

Conclusions

The study does not refute or support use of these products for an existing skin reaction and did not show a radioprotective effect.

Limitations

  • The study groups were too small to demonstrate any differences among study arms.
  • Rubbing effects may have cause tissue damage.
  • Radiation therapists, nurses, and patients were all responsible for granding, which affects the reliability of data.
  • There was no mention of whether addition treatments were used as allowed.
Print

Fenig, E., Brenner, B., Katz, A., Sulkes, J., Lapidot, M., Schachter, J., … Gutman, H. (2001). Topical Biafine and Lipiderm for the prevention of radiation dermatitis: a randomized prospective trial. Oncology Reports, 8, 305–309.

Study Purpose

To evaluate the use of Biafine or Lipiderm to prevent radiodermatitis.

Intervention Characteristics/Basic Study Process

Participants were randomized to one of three trial arms:  (a) Biafine, (b) Lipiderm, or the (c) control (no prophylactic treatment).

Study preparations were applied twice daily, staring 10 days prior to the beginning of radiation therapy (RT) and continuing until 10 days after treatment. Skin treatment was upgraded if necessary to steroids for grade 3 reaction antibiotics for grade 4 reactions or pause in therapy for grade 5 reactions.

Sample Characteristics

  • The sample was comprised of 74 women.
  • Mean age was 69 years (range 42–85).
  • Patients had T1-T2N0M0 breast cancer.
  • Of the patients, 63% received concomitant tamoxifen.
  • Patients with a complicated surgical wound or history of skin conditions were excluded.

Setting

Single site

Study Design

The study was a randomized, controlled trial.

Measurement Instruments/Methods

  • The Radiation Therapy Oncology Group (RTOG) skin toxicity scale was used.
  • Impressions were measured by an evaluation questionnaire using the same criteria. Relevant data were reported as a grade of reaction.
  • Overall treatment success was determined by maximal treatment grade, total number of RT gaps needed, the patients’ weekly impressions, the radiotherapists' clinical impressions, and the study nurses’ impressions.
  • Pearson correlation, chi-square, or Fisher exact tests were used to analyze the relationships between the three study arms.

Results

  • No objective data revealed an advantage in the Biafine or Lipiderm arms.
  • Maximum skin treatment level was lower in the two intervention arms but was not significant.
  • Patients in both intervention arms reported high levels of satisfaction (Biafine 86%, Lipiderm 85%).

Conclusions

The study neither refutes nor supports use of these products for existing reactions. These products did not show radioprotective effects.

Limitations

  • The study groups were too small to demonstrate any differences among study arms.
  • Rubbing effects may have caused tissue damage.
  • There were several responsible graders:  radiation therapist, nurses, and patients. Interrater reliability of the measurements was not addressed.
Print

Feng, Y., Wang, X. Y., Li, S. D., Zhang, Y., Wang, H. M., Li, M., . . . Zhang, Z. (2011). Clinical research of acupuncture on malignant tumor patients for improving depression and sleep quality. Journal of Traditional Chinese Medicine, 31, 199–202.

Study Purpose

To study the effect of acupuncture on depression and insomnia in patients with malignant tumors. 

Intervention Characteristics/Basic Study Process

One time per day for 20 to 30 minutes, over a course of 30 days, patients in the intervention group received acupuncture on these acupoints:  Fenglon (ST-40), Yinlingquan (SP-9), Xuehai (SP-10), Sanyinjiao (SP-6), Yintant (EX-HN3), Baihui (DU-20), Sishencong (EX-HN1), Neiguan (PC-6), and Shenmen (TF-4). Patients in the control group received fluoxetine, 20 mg/day. Depression scores and sleep ratings were collected before and after the three-day treatment.

Sample Characteristics

  • The sample was comprised of 80 patients (66% male, 34% female) with malignant tumors:  40 patients were in the treatment group, which received acupuncture, and 40 were in the control group, which received 20 mg of fluoxetine daily.
  • Mean age was 63.8 years (standard deviation [SD] = 5.47 years; range 18–75 years).
  • All patients had a malignant tumor. Seven types of cancer were represented in the sample:  lung, gastric, breast, colorectal, lymphoma, cervical, and ovarian cancer. 
  • Depression was assessed according to the Chinese Classification of Mental Disorders, third edition (CCMD-3).
  • Patients with a functional disorder of the heart, liver, kidney, or spinal cord were excluded, as were those currently taking antidepressant medications.

Setting

  • Single site
  • Beijing, China

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

The study was a randomized, controlled trial with intervention and control groups.

Measurement Instruments/Methods

  • Zung Self-Rating Depression Scale (SDS)    
  • Hamilton Rating Scale for Depression (HRSD)
  • Pittsburgh Sleep Quality Index (PSQI)

Results

Pretreatment SDS scores of the treatment and control groups were 64.12 (SD = 5.34) and 64.24 (SD = 4.98), respectively, with no significant difference (p > 0.05). After treatment, SDS scores of the treatment and control groups were 43.64 (SD = 5.28) and 50.76 (SD = 5.42), which showed significant difference (p < 0.05). HRSD scores of both groups showed no significant difference before treatment (p > 0.05); however, after-treatment scores were 9.88 (SD = 1.27) in the treatment group and 13.72 (SD = 2.05) in the control group (p < 0.05). These results indicate that both acupuncture and fluoxetine were effective in reducing depression scores in these patients, with acupuncture showing greater effectiveness. PSQI scores of the treatment group, before and after treatment, were 14.48 (SD = 1.71) and 7.92 (SD = 1.22), respectively, with a significant difference (p < 0.001). The control group's PSQI scores, 13.92 (SD = 2.59) and 11.44 (SD = 1.89), did not reach significance (p > 0.05). Results indicate that acupuncture improved sleep quality in more patients than did fluoxetine.

Conclusions

Both acupuncture and fluoxetine were associated with reduced depression scores and some improvement in sleep. Due to the lack of a real control group and no control over cancer type and treatment phase, drawing a conclusion about the effectiveness of the intervention is difficult.

Limitations

  • The study had a small sample size, with less than 100 patients.
  • The age range was small.
  • The study was conducted at a single site, and the measurement tools were self-report instruments.
  • Fluoxetine may take more than 30 days to reach therapeutic effectiveness.
  • The study compared a fluoxetine-using group to an acupuncture-using group; the study included no real control group.
  • The sample included diverse cancer types, and patients were at different phases of treatment. These factors may confound the findings.
  • The authors did not analyze the differences between groups in regard to posttreatment PSQI scores. 
  • The study did not include an attentional control or consider the possible placebo effect of acupuncture.
     

Nursing Implications

Acupuncture is a nonpharmacologic intervention that shows promise in reducing depression and improving sleep quality in patients with cancer and depression.

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Feng, X., Ruan, Y., He, Y., Zhang, Y., Wu, X., Liu, H., . . . Li, C. (2014). Prophylactic first-line antibiotics reduce infectious fever and shorten hospital stay during chemotherapy-induced agranulocytosis in childhood acute myeloid leukemia. Acta Haematologica, 132, 112–117. 

Study Purpose

To study the efficacy of prophylactic antibiotics in pediatric patients with agranulocytosis and to investigate the efficacy and safety of different prophylactic protocols

Intervention Characteristics/Basic Study Process

Antibiotics included the combination of vancomycin and cefepime or single-use piperacillin/tazobactam. Control patients did not receive antibiotics prophylactically. Both groups were given oral voriconazole to prevent invasive fungal infections.

Sample Characteristics

  • N = 38  
  • MEAN AGE: 8.3 years
  • MALES: 63%, FEMALES: 37%
  • KEY DISEASE CHARACTERISTICS: All had Acute myeloid leukemia (AML) and agranulocytosis after high-intensity chemotherapy

Setting

  • SITE: Single-site    
  • SETTING TYPE: Not specified    
  • LOCATION: China

Phase of Care and Clinical Applications

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

Study Design

Nonrandomized, observational trial

Measurement Instruments/Methods

  • Febrile events defined as a single-axillary temperature > 38.3° centigrade
  • Cultures

Results

There were no differences found between the two preventive protocols used. The prophylactic group had less frequent fever (p < .001), a longer interval to fever (p = .007), and an average of seven fewer hospital days (p < .001). Pulmonary and oral infection were most common. In the prophylactic group, three patients had diarrhea and one patient developed a rash. There were no other antibiotic-related side effects.

Conclusions

There were no differences found between the two preventive protocols used. The prophylactic group had less frequent fever (p < .001), a longer interval to fever (p = .007), and an average of seven fewer hospital days (p < .001). Pulmonary and oral infection were most common. In the prophylactic group, three patients had diarrhea and one patient developed a rash. There were no other antibiotic-related side effects.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement validity/reliability questionable
  • Other limitations/explanation: The main outcome measure was a single episode of fever.

Nursing Implications

The findings showed that prophylactic antibiotics after high-intensity chemotherapy can be effective in children with minimal side effects. Findings should be considered with some caution given the study's limitations.

Print

Fellowes, D., Barnes, K., & Wilkinson, S. (2004). Aromatherapy and massage for symptom relief in patients with cancer. Cochrane Database of Systematic Reviews 2004, Issue 3. Art. No.: CD002287.

Search Strategy

DATABASES USED: MEDLINE, CINAHL, British Nursing Index, EMBASE, AMED, PsycINFO, SIGLE, and CancerLit were searched, as well as Dissertation Abstracts International.

Literature Evaluated

COMMENTS ON LITERATURE USED: From 1966–2002

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED = 8 RCTs, 10 reports

Results

The most consistent effect was on anxiety. Only one reported an effect on depression.

Conclusions

Insufficient evidence

Print

Fellowes, D., Barnes, K., & Wilkinson, S. (2005). Aromatherapy and massage for symptom relief in patients with cancer. Cochrane Database of Systematic Reviews 2005, Art. No.: CD002287.

Search Strategy

Databases searched were CENTRAL (Cochrane Library, Issue 1, 2002), MEDLINE (1966-May 2002), CINAHL (1982-April 2002), British Nursing Index (1994-April 2002), EMBASE (1980-week 25, 2002), AMED (1985-April, 2002), PsycINFO (1887-April, 2002), SIGLE (1980-March, 2002), CancerLit (1975-April, 2002), and Dissertation Abstracts International (1861-March, 2002). Reference lists of relevant articles were searched for additional studies.

Literature Evaluated

Reviews were included if they

  • Were randomized controlled trials (RCTs).
  • Were controlled before-and-after studies or interrupted time-series studies.
  • Studied aromatherapy or massage for patients with cancer.
  • Measured changes in patient-reported levels of physical or psychological distress or quality of life (QOL) using reliable and valid tools.

Sample Characteristics

  • A total of 10 reports met inclusion criteria. Of these, 8 were RCTs, representing 357 patients.
  • Most studies measured anxiety, depression, and pain; two demonstrated a reduction in nausea.

Results

Two studies assessed the symptom of nausea. Both studies showed a reduction in nausea in hospitalized patients.

Limitations

  • Although the studies were RCTs, the sample sizes were small.
  • Assessing the effect of aromatherapy was difficult because different essential oils were used.
  • The degree to which variation in massage style affects outcomes is not known.

Nursing Implications

  • Longer follow-up studies are needed with larger samples.
  • No harm was involved, but evidence was mixed as to effect of aromatherapy enhancement to massage to a clinically significant level.
Print

Fellowes, D., Barnes, K., & Wilkinson, S. (2004). Aromatherapy and massage for symptom relief in patients with cancer. Cochrane Database of Systematic Reviews, Issue 3. Art. No.: CD002287.

Purpose

To evaluate the effectiveness of massage and aromatherapy for symptom relief in patients with cancer

Search Strategy

The search used the following sources from 1966–2002: MEDLINE, CINAHL, British Nursing Index, EMBASE, AMED, PsycINFO, and CancerLit.

Literature Evaluated

  • A total of 1,322 references were initially retrieved.
  • Two reviewers independently assessed trials for inclusion in the review, assessing study quality and extracted data.

Sample Characteristics

Ten reports met the inclusion criteria; eight randomized controlled trials that included 357 patients were reviewed.

Results

  • The most consistently found effect of massage or aromatherapy massage was on anxiety.
  • Four trials (207 patients total) detected a reduction in anxiety postintervention.
  • There was no reported decrease in anxiety with the addition of aromatherapy.

Conclusions

While there is sufficient evidence to support the effectiveness of massage in decreasing anxiety in patients with cancer, there is insufficient evidence to draw conclusions about the effectiveness of aromatherapy massage for patients with cancer. Further research is needed.

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