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Xin'an, L., Jianying, Z., Lizhi, N., Fei, Y., Xiaohua, W., Jibing, C., . . . Kecheng, X. (2014). P0079 alleviating the pain of unresectable hepatic tumours by percutaneous cryoablation: Experience in 73 patients. European Journal of Cancer, 50(Suppl. 4), E31. 

Study Purpose

To review the changes in the severity of pain before and after percutaneous cryoablation of hepatic tumors

Intervention Characteristics/Basic Study Process

Patients with large tumors (major diameter P5 cm) underwent transarterial chemoembolization (TACE) first and then cryoablation. Cryosurgeries of hepatic tumors were performed on all 73 patients using an argon gas-based cryosurgical unit with two freeze/thaw cycles. Maximal freezing time was 15 minutes followed by natural thawing for 5 minutes x 2. A margin of at least 1 cm of normal hepatic tissue was frozen circumferentially around the tumor.

Sample Characteristics

  • N = 73  
  • AGE RANG = 25–80 years (mean not noted)
  • MALES: 40, FEMALES: 33
  • KEY DISEASE CHARACTERISTICS: 29 patients had hepatocellular carcinoma; 44 patients had metastatic lesions in the liver; cancer was not invading major vessels; only 17 patients had pain.
  • OTHER KEY SAMPLE CHARACTERISTICS: KPS > 70%, platelet count ≥ 80,000, white blood cell count ≥ 3x109/l, neutrophil count ≥ 2x109/ l, hemoglobin ≥ 9 g/l, prothrombin time international normalized ratio ≥ 1.5, adequate hepatic and liver function 

Setting

  • SITE: Single-site    
  • SETTING TYPE: Outpatient    
  • LOCATION: China

Phase of Care and Clinical Applications

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

Study Design

  • Intervention study: One-group design

Measurement Instruments/Methods

  • Pain intensity scale 0–10 (0 indicating no pain and 10 indicating worst pain imaginable) with severe pain classified as 5–10

Results

Six patients had an immediate relief of severe pain, 11 had relief within 15 days of cryosurgery (these were of the 17 patients with pain prior to the procedure), 39 were always pain-free, and 17 had new pain with the procedure but total relief within 15 days.

Conclusions

The pain-relieving effect of cryosurgery was immediate for some patients but all eventually experienced the complete disappearance of pain for at least eight weeks. Pain relief was delayed for some patients due to edema, which resulted from the treatment.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding) 
  • Risk of bias (no random assignment) 
  • Risk of bias (no appropriate attentional control condition)  
  • Intervention expensive, impractical, or training needs

Nursing Implications

Cryoablation is a potential pain-relieving treatment for primary and metastatic tumors of the liver, but more studies are needed before this can be recommended as a modality to manage pain. Evidence to support long-term results beyond eight weeks also is lacking.

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Xie, J., Chen, L.H., Ning, Z.Y., Zhang, C.Y., Chen, H., Chen, Z., . . . Zhu, X.Y. (2017). Effect of transcutaneous electrical acupoint stimulation combined with palonosetron on chemotherapy-induced nausea and vomiting: A single-blind, randomized, controlled trial. Chinese Journal of Cancer, 36, 6-016-0176-1.

Study Purpose

To investigate the effects of transcutaneous electrical acupoint stimulation (TEAS) on chemotherapy-induced nausea and vomiting (CINV)

Intervention Characteristics/Basic Study Process

Patients receiving chemotherapy via an infusion to transcatheter arterial chemoembolization were randomized to an active or placebo acupuncture group. Prior to chemotherapy, all patients received IV palonosetron. Patients received acupuncture 1–2 hours before chemotherapy, and more just after chemotherapy. Acupuncture was continued twice daily for six days. In the sham acupuncture group, electrodes were placed on the same acupoints for the same length of time and frequency, but no electrical stimulation was given. Severity and frequency of nausea and vomiting were recorded in patient diaries daily. P6, L14, and ST36 acupoints were used.

Sample Characteristics

  • N = 142   
  • MEAN AGE = 56.5 years
  • AGE RANGE = 30–77
  • MALES: 68.3%, FEMALES: 41.7%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Primary or metastatic liver cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: All were on cisplatin-based regimens.

Setting

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

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Double-blind, sham-controlled, randomized, controlled trial

Measurement Instruments/Methods

  • Visual analog scale (VAS) 0–10 for anorexia
  • MD Anderson Symptoms Inventory

Results

No significant differences in CINV existed between groups. Anorexia was lower in the active acupuncture group from the second day onward (p < 0.0002).

Conclusions

Electroacupuncture was not shown to have an effect on CINV but appeared to have benefit for reducing anorexia.

Limitations

  • Measurement/methods not well described
  • Of daily CINV scoring, values used in analysis were not described.

Nursing Implications

Electroacupuncture was not effective in reducing CINV in this study but appeared to have a positive effect on appetite. Additional research is needed to determine any potential role of acupuncture for anorexia in patients with cancer.

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Xiao, F., Song, X., Chen, Q., Dai, Y., Xu, R., Qiu, C., & Guo, Q. (2016). Effectiveness of psychological interventions on depression in patients after breast cancer surgery: A meta-analysis of randomized controlled trials. Clinical Breast Cancer. Advance online publication. 

Purpose

STUDY PURPOSE: To assess the effectiveness of Cognitive Behavioral Therapy (CBT) or CBT approach interventions for improving depressive symptoms

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: Medline, PubMed, Cochrane Collaboration, WANFANG, CNKI database
 
INCLUSION CRITERIA: Randomized, controlled trials; comparison of an individual CBT intervention to a control group; women with breast cancer
 
EXCLUSION CRITERIA: None specified

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 1,882
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Jadad scale for methodologic study quality

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 13 
  • TOTAL PATIENTS INCLUDED IN REVIEW = 966
  • SAMPLE RANGE ACROSS STUDIES: Not provided
  • KEY SAMPLE CHARACTERISTICS: Women with breast cancer who had undergone surgery

Phase of Care and Clinical Applications

PHASE OF CARE: Not specified or not applicable

Results

Analysis was conducted for each type of outcome measurement instrument used in the research. Across eight studies using the Self-Rating Depression Scale (SDS), the effect of the intervention was seen to be beneficial (standard mean difference [SMD] = –0.87, p < 0.0001). The pooled results of three studies for effects using the Hospital Anxiety and Depression Score (HADS) was also in favor of the intervention (SMD = –0.50, p = 0.04). Across all studies, the SMD comparing CBT to control was –0.92 (p < 0.00001).

Conclusions

Individually delivered CBT was shown to be effective in reducing the symptoms of depression among women with breast cancer.

Limitations

In some studies, different cognitive behavioral approaches were used, and some delivered the intervention via a combination of face-to-face and telephonic contact. The results of the study quality evaluation were not reported. All studies excluded patients with major depression diagnoses.

Nursing Implications

Interventions using cognitive behavioral approaches can be effective to reduce the symptoms of depression in women having undergone surgery for breast cancer. Although full CBT is generally delivered by trained therapists, nurses can incorporate many of these principles into general patient teaching, counseling, and support. Patients with significant depression should be referred for appropriate management as needed.

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Xiao, Y., Liu, J., Liu, Y.C., Huang, X.E., Guo, J.X., & Wei, W. (2014). Phase II study on EANI combined with hydrochloride palonosetron for prevention of chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy. Asian Pacific Journal of Cancer Prevention, 15, 3951–3954.

Study Purpose

To evaluate the effects of an electronic antinausea instrument (EANI) combined with hydrochloride palonosetron versus hydrochloride palonosetron alone on nausea and vomiting during the administration of highly emetogenic chemotherapy

Intervention Characteristics/Basic Study Process

The treatment group received 0.25 mg of hydrochloride palonosetron injected five minutes before chemotherapy while wearing an EANI (no report of how long the patients wore the instrument). The control group received 0.25 mg of hydrochloride palonosetron injected five minutes before chemotherapy alone.

Sample Characteristics

  • N = 120 (60 in control, 60 in treatment)
  • AGE RANGE = 23–74 years (no sample characteristics provided)
  • MALES: Not reported, FEMALES: Not reported
  • KEY DISEASE CHARACTERISTICS: Not reported
  • OTHER KEY SAMPLE CHARACTERISTICS: No sample characteristics were reported, but eligibility criteria included patients being treated with highly emetogenic chemotherapy (adriamycin, cisplatin, and epirubicin) with no nausea or vomiting 24 hours before chemotherapy.

Setting

  • SITE: Not stated
  • SETTING TYPE: Not specified    
  • LOCATION: People’s Hospital of Taixing City, China

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • Vomiting degree was measured and reported as 0 (no vomiting), 1 (one to two emesis events per day), 2 (three to five emesis events per day), or 3 (greater than five emesis events per day).
  • Nausea level was measured and reported as 0 (no change), 1 (no change in eating), 2 (obvious reduction in food intake), or 3 (couldn't eat and needed IV nutritional support).  
  • Response rate was defined as the degree of vomiting plus the level of nausea divided by the total number of cases.
  • There was no report of who recorded nausea and vomiting or how often.

Results

There was a significant difference in the response rate for nausea (90% response in treatment group and 76.7% response in control group, p < 0.05), and there was a significant difference in the response rate for vomiting (95% response in treatment group and 78.3% response in control group, p < 0.05). No significant differences in adverse reactions between the groups and no severe adverse reactions were reported.

Conclusions

The use of an electronic antinausea instrument along with hydrochloride palonosetron appeared to be more effective than hydrochloride palonosetron alone for the treatment of acute nausea and vomiting associated with highly emetogenic chemotherapy.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Measurement/methods not well described
  • Measurement validity/reliability questionable
  • Other limitations/explanation: The study lacked a great deal of information, which calls into question its validity. There was no information how the randomization was performed, no information on sample characteristics was provided, no information on the EANI device was given, vomiting and nausea classifications were not validated, who determined the vomiting and nausea classifications for each patient was not stated, and there was no report of a statistical analysis. Adverse reactions were reported in the results but were not part of the purpose statement, and it was not described how the information was obtained.

Nursing Implications

Electronic antinausea instruments may be effective for treating chemotherapy-induced nausea and vomiting, but additional studies are needed to confirm these findings.

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Xiao, Y., Liu, J., Huang, X. E., Ca, L.H., Ma, Y.M., Wei, W., . . . Wu, Y.J. (2014). Clinical study on fluvoxamine combined with oxycodone prolonged-release tablets in treating patients with moderate to severe cancer pain. Asian Pacific Journal of Cancer Prevention, 15, 10445–10449.

Study Purpose

To assess the safety and efficacy of fluvoxamine combined with prolonged-release oxycodone for the management of cancer-related chronic pain

Intervention Characteristics/Basic Study Process

Patients with moderate to severe cancer-related pain were randomized to either the control group, which was treated with only prolonged-release oxycodone, or the prolonged-release oxycodone combined with fluvoxamine group. A daily maintenance dose of oxycodone was determined per patient after two weeks. Fluvoxamine began at 50 mg per day and increased by 50–100 mg per day to a maximum of 150 mg twice daily. Patients were assessed three times daily for pain response and dosage adjustment.

Sample Characteristics

  • N = 120
  • AGE = Not provided
  • MALES: Not provided, FEMALES: Not provided
  • KEY DISEASE CHARACTERISTICS: Not provided
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients had a life expectancy of at least two months at study entry.

Setting

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

Study Design

Randomized, open-label trial

Measurement Instruments/Methods

  • Numeric Rating Scale (NRS)
  • Opioid consumption

Results

Pain severity declined in both groups. There were no reported significant differences between groups for pain severity or opioid consumption.

Conclusions

The findings of this study did not demonstrate the efficacy of fluvoxamine for chronic pain management.

Limitations

  • Risk of bias (no blinding)
  • Measurement/methods not well described
  • Measurement validity/reliability questionable
  • Other limitations/explanation: The timing of measurement and duration were not well described. Although pain was measured every three hours, the exact measure used in the analysis was not stated. There was no information about the duration of the study, total opioid dosages in both groups before and after the intervention, or demographic information. The sample numbers differed between the tables and the body of the article, calling into question the overall validity of the results.

Nursing Implications

This study did not show any benefit from the addition of fluvoxamine to prolonged-release opioids in the management of moderate to severe chronic cancer-related pain.

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Xiangyong, Y., Zhongsheng, Y., Wenchao, L., Hui, D., Shuzhou, Q., Gang, C., . . . Lian, Z. (2016). External application of traditional Chinese medicine in the treatment of bone cancer pain: A meta-analysis. Supportive Care in Cancer, 24, 11–17. 

Purpose

STUDY PURPOSE:  Assess efficacy of external application of traditional Chinese medicine for cancer-related bone pain
 
TYPE OF STUDY:  Meta analysis and systematic review

Search Strategy

DATABASES USED: MEDLINE, EMBASE, Cochrane Collaboration and four Chinese databases
 
KEYWORDS: bone cancer pain, metastatic bone, external treatment, traditional Chinese medicine, herbal medicine
 
INCLUSION CRITERIA: RCT
 
EXCLUSION CRITERIA: Not stated

Literature Evaluated

TOTAL REFERENCES RETRIEVED: N = 439
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED:  Cochrane risk of bias assessment

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED: N =  5
 
SAMPLE RANGE ACROSS STUDIES: Sample sizes for each study not provided
 
TOTAL PATIENTS INCLUDED IN REVIEW: 534
 
KEY SAMPLE CHARACTERISTICS: Not provided

Phase of Care and Clinical Applications

Applications: Palliative care

Results

Analysis showed improved partial pain response with Chinese medicine compared to sustained release morphine or bisphosphonates (RR = 1.18, p = 0.02)

Conclusions

External application of traditional Chinese herbal medicine was shown here to improve pain response rate in patients with metastatic bone pain; however, the quality of the evidence is insufficient to draw firm conclusions

Limitations

All studies were deemed to be of low quality. The authors noted that included studies were mainly from Chinese publications, and that it is known that negative results are not published in China. This suggests important publication bias.

Nursing Implications

There is currently insufficient good quality evidence to demonstrate efficacy of traditional Chinese herbal medicine for pain management. Findings of this meta analysis suggest promise for this type of intervention as adjunctive treatment; however, well-designed research is needed for evaluation of the evidence.

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Wysocki, W.M., Mitus, J., Komorowski, A.L., & Karolewski, K. (2012). Impact of preoperative information on anxiety and disease-related knowledge in women undergoing mastectomy for breast cancer: A randomized clinical trial. Acta Chirurgica Belgica, 112, 111–115.

Study Purpose

To evaluate the impact of information, provided preoperatively, on the anxiety and knowledge of women undergoing mastectomy for breast cancer; to assess the specific impact of additional, structured preoperative information (delivered by means of educational/informational video) on perioperative anxiety and treatment- and disease-related knowledge in women undergoing mastectomy for breast cancer

Intervention Characteristics/Basic Study Process

Routine information was delivered to both arms of the study. Information was not standardized and included the typical conversation with the attending surgeon, surgical informed consent, and practical information from nurses. The treatment arm provided additional information delivered preoperatively via video; the information was recorded by a breast cancer survivor. Information in the video was obtained from the National Cancer Institute’s website. All patients were prospectively followed for one month (further follow-up was performed according to local treatment protocols) at 24–36 hours, 7 days, and 30 days postoperatively.

Sample Characteristics

  • The study reported on a sample of 58 female patients.
  • Mean patient age was 60 years in the intervention group and 55 years in the control group.
  • Patients had a diagnosis of breast cancer needing mastectomy, with cytologically or histologically proven invasive breast cancer. More than 80% in both arms had IIA and IIB stage disease, and 76% were diagnosed with ductal carcinoma.
  • Women were older than 18 years of age and had the physical and psychological ability to use a visual analog scale and to complete requested questionnaires.
  • Women were excluded from the study if they were admitted for breast-conserving therapy, neoadjuvant treatment for breast cancer, disseminated breast cancer, vision and/or hearing impairment, previous treatment for other malignancies, medical education, and other factors (geographical and familial) that would interfere with the protocol requirements.

Setting

  • Inpatient
  • Department of Surgical Oncology, Maria Sklodowska-Curie Memorial Institute of Oncology, Krakow, Poland

Phase of Care and Clinical Applications

  • Phase of care: active treatment
  • Clinical applications: late effects and survivorship

Study Design

Open-labeled, randomized controlled trial

Measurement Instruments/Methods

  • To measure anxiety: A visual analog scale (VAS) for anxiety was validated and shown to be the clinical equivalent of the Hospital Anxiety and Depression Scale (HADS) and the State-Trait Anxiety Inventory (STAI).  
  • To measure level of knowledge: Investigators used a VAS (a subjective measure) as well as a self-administered questionnaire (an objective measure) containing specific questions about breast cancer treatment and familial risk.

Results

  • Authors noted no significant differences in anxiety levels between the intervention and control arms over all four time points.
  • Authors noted no significant differences in subjective or objective knowledge between the intervention and control arms over all four time points.
  • The number of patients confirming the association of the participant’s disease with an elevated risk for breast cancer in children or close blood relatives increased in the intervention arm from 40% preoperatively to 70% postoperatively.

Conclusions

Patients who participated in the study showed no evident or significant improvement in perioperative anxiety or treatment- and disease-related knowledge, with the exception of knowledge concerning available primary treatment modalities.

Limitations

  • The study had a small sample size, with fewer than than 100 participants.
  • The outcomes of this study may result from having no a priori sample size estimation or power analysis. Interpreting results was difficult.

Nursing Implications

Patient education, as well as emotional support, should always be important preoperatively and must continue postoperatively.

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Wyse, J.M., Carone, M., Paquin, S.C., Usatii, M., & Sahai, A.V. (2011). Randomized, double-blind, controlled trial of early endoscopic ultrasound-guided celiac plexus neurolysis to prevent pain progression in patients with newly diagnosed, painful, inoperable pancreatic cancer. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology, 29(26), 3541–3546.

Study Purpose

To determine if early ultrasound-guided celiac plexus neurolysis (EUS-CPN) prevents pain progression in and reduces narcotic use by patients with painful inoperable pancreatic cancer

Intervention Characteristics/Basic Study Process

Eligible for the study were patients referred for endoscopic ultrasound for the diagnosis and staging of suspected pancreatic cancer with new onset of suspected cancer-related pain. If onsite cytopathology results confirmed the diagnosis of adenocarcinoma and the lesion was deemed inoperable, consenting patients were randomly assigned to EUS-CPN or no EUS-CPN. Celiac plexus neurolysis (CPN) was performed during the endoscopic procedure. After the procedure patients returned to the referring physician for ongoing pain management. One month after randomization, a patient could undergo open-label CPN at the physician’s discretion. Investigators assessed outcomes at one and three months after randomization.

Sample Characteristics

  • The sample was composed of 98 patients.
  • Mean patient age was 66.6 years.
  • Of all patients, 52% were female and 48% were male.
  • All patients had inoperable pancreatic cancer. Investigators performed subgroup analysis of patients who received chemotherapy and/or radiation therapy for pain management. On average, patients had a pain-duration history of nine weeks. Average pain intensity score at baseline was 4.7 on an 11-point scale.

Setting

  • Single site
  • Outpatient
  • Canada

Study Design

Double-blind randomized controlled trial

Measurement Instruments/Methods

  • Numeric pain intensity rating scale 0–10
  • Total morphine consumption
  • Digestive Disease Quality-of-Life Questionnaire-15 (DDQ-15)

Results

  • Sixty patients survived to the three-month follow-up point. All subjects randomized were included in intention-to-treat analysis. Pain relief with EUS-CPN was greater at one month (mean difference [MD] of pain scores: –28.9, 95% CI –67 through –2.8, p = 0.09) and three months (MD: –60.7, 95% CI –86.6 through –25.5, p = 0.01). However, the difference in mean change from baseline was significantly lower in the EUS-CPN group after one month (p = 0.01) and three months (p < 0.001).
  • Change in morphine consumption was not different between groups at any time point.
  • Authors noted no differences between groups in regard to survival or quality of life.
  • Secondary analysis related to patients who received chemotherapy or radiation therapy.
    • Among patients who did not undergo chemotherapy or radiation therapy, EUS-CPN was associated with significantly better pain relief at one month and three months (p < 0.001).
    • In patients who underwent chemotherapy or radiation therapy, pain control with EUS-CPN was not significantly different from pain control in patients who did not undergo EUS-CPN.
    • In patients undergoing chemotherapy or radiation therapy, authors noted no difference between groups in morphine consumption.
    • In patients who did not have chemotherapy or radiation therapy, EUS-CPN patients had lower morphine consumption at three months (p = 0.05).

Conclusions

Results show that, compared to pain management with narcotics alone, early EUS-CPN provides greater pain relief. In the sudied patients, this approach was not better than chemotherapy or radiation therapy for pain control. 

Limitations

  • The study had a small sample, with fewer than 100 patients.
  • Pain intensity measures used for analysis are unclear. Methods describe use of an 11-point scale and analysis of percentage of change. However, results are reported as mean differences. Presumably the differences are differences in mean percentage of change, but that is not clear.
  • Timing of pain intensity measures is not entirely clear. Whether pain measures represent least, average, and worst pain is unclear.
  • Authors do not discuss breakthrough pain or its management.

Nursing Implications

For patients with painful inoperable pancreatic cancer, early EUS-CPN may provide better pain control than do opioids alone. However, this study does not show any difference in overall morphine consumption associated with EUS-CPN. In this group of patients, palliative chemotherapy or radiation therapy appears to achieve pain control similar to the pain control that EUS-CPN achieves. EUS-CPN has not been associated with early or late complications; it may produce fewer side effects and symptoms than chemotherapy or radiation therapy. For this group of patients, nurses can advocate for consideration of EUS-CPN for adjuvant pain management. The advantage of early EUS-CPN is that the procedure can be done at the same time as a staging procedure, limiting the number of invasive procedures that the patient has to undergo.

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Wyatt, G., Sikorskii, A., Rahbar, M. H., Victorson, D., & You, M. (2012). Health-related quality-of-life outcomes: a reflexology trial with patients with advanced-stage breast cancer. Oncology Nursing Forum, 39, 568–577.

Study Purpose

To evaluate the safety and efficacy of reflexology.

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to one of three groups:  reflexology, lay foot manipulation, or the control. Certified reflexology providers administered the reflexology intervention in four weekly, 30-minute sessions. Foot manipulation providers were laywomen trained in the procedure. The laywomen delivered foot manipulation according to the relexology schedule. The control group received standard care. Study data were collected at baseline and at 5 and 11 weeks after randomization. Reflexologists and foot manipulation providers collected data after sessions at the planned time points.

Sample Characteristics

  • The study was comprised of 243 women with breast cancer.
  • Mean age was 55.7 years.
  • Most patients had stage III or IV breast cancer, and 79.67% had metastatic disease.
  • The majority (83%) of patients were Caucasian, 65% were married or partnered, and 35% were employed. Educational level varied across the groups.
  • Patients were excluded if they were in hospice care at the time of study entry.

Setting

  • Multisite
  • United States

Phase of Care and Clinical Applications

The study has clinical applicability for late effects and survivorship.

Study Design

The study was a three-group, single-blind, randomized, controlled trial.

Measurement Instruments/Methods

  • Short Form Health Survey (SF-36) Physical Functioning Subscale
  • Functional Assessment of Cancer Therapy–Breast (FACT-B)
  • Brief Fatigue Inventory (BFI)
  • Brief Pain Inventory (BPI)
  • State-Trait Anxiety Inventory (STAI)

Results

At baseline, scores regarding anxiety and depression, according to the Center for Epidemiologic Studies Depression Scale (CESD), differed significantly (p < 0.01) across study groups. No differences were found regarding quality of life and symptoms of depression, anxiety, pain, or nausea. Those receiving reflexology reported lower levels of dyspnea than did the other two groups (p ≤ 0.02). Patients getting foot manipulation from laywomen had lower fatigue scores than did the controls (p < 0.01). Further analysis showed that the effect on fatigue was mediated by changes in dyspnea. Eleven percent of those in the foot manipulation group and 10% of those in the reflexology group did not complete all the sessions. The intervention had no adverse effects.

Conclusions

The findings suggested that reflexology may improve the symptoms of dyspnea and that foot manipulation may help reduce fatigue in women with advanced-stage breast cancer. The authors noted no effect of reflexology or foot manipulation on pain, anxiety, symptoms of depression, or nausea.

Limitations

  • The study had important baseline sample and group differences.
  • The study had a risk of bias due to the lack of blinding.
  • The findings were not generalizable; the study was underpowered in regard to detecting planned differences in patient outcomes.

Nursing Implications

The findings did not indicate that reflexology and foot manipulation affected pain, anxiety, symptoms of depression, or nausea among women with advanced breast cancer. The study demonstrated that these interventions are safe for the type of patients who participated. Reflexology and foot manipulation are low-risk interventions that may be helpful to some patients. Laypeople and caregivers could be taught these techniques, which may provide a meaningful way for these people to be involved in symptom management.

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Wu, H., Dodd, M. J., & Cho, M. H. (2008). Patterns of fatigue and effect of exercise in patients receiving chemotherapy for breast cancer. Oncology Nursing Forum, 35, E90-E99.

Study Purpose

To examine daily fatigue patterns during the third cycle of chemotherapy in women with breast cancer and predict whether fatigue trajectories differ by exercise or chemotherapy regimens.

Intervention Characteristics/Basic Study Process

Patients completed a daily fatigue diary that included a fatigue rating and items to determine whether they were exercisers or nonexercisers. Patients were asked to complete the diary daily. Weekly telephone calls from an exercise physiologist were used to determine exercise adherence.  Adherence was determined as either a yes or no based on whether the patient exercised at least three days per week for 20 minutes per session and at a “somewhat hard” intensity. Measures obtained during the third course of chemotherapy were used in this analysis.

Sample Characteristics

  • Ninety-eight patients (all female) were included.
  • Mean age was 49.5 years (standard deviation = 9.3; range 28–72).
  • Patients had breast cancer stage III and less.
  • Of the patients, 72% were married/partnered, 28% were single, 74% were Caucasian, and 89% were educated more than 12 years.
  • Patients were undergoing chemotherapy, with the majority (79%) receiving chemotherapy.

Setting

  • Multisite  
  • Outpatient
  • Five cancer centers in the San Fransisco Bay area

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

This was a prospective, longitudinal, repeated-measure design primary study; a secondary analysis of these data was performed.

Measurement Instruments/Methods

  • The fatigue diary had two standard questions, each measured on an 11-point rating scale ranging from 0 (no fatigue/tiredness) to 10 (overwhelming fatigue/tiredness). 
  • Determination of exerciser versus nonexerciser status, the Surgeon General’s Guideline for Physical Activity, was used (described as at least three days a week for 20 minutes per session at an intensity of “somewhat hard”).

Results

Average levels of fatigue reported were moderate for the first eight days and mild for the rest of the cycle. Highest levels of fatigue were observed on days 1 to 3 for average and worst fatigue. Five distinct trajectory patterns of cancer-related fatigue (CRF) were identified:  immediate and sharp increase followed by a gradual decline; early peak, a decline, and a sharp increase toward the end of the cycle; small variations among daily scores; chaotic pattern; and step-up evaluation followed by a gradual decline. Nonexercisers had higher average and worst fatigue (p < 0.01). In exercisers and nonexercisers, fatigue declined in severity over time, and the rate of decline was not significantly different between the two groups; however, fatigue levels were consistently higher among nonexercisers.

Conclusions

CRF peaked in the days immediately after intravenous chemotherapy and declined gradually over time. Fatigue tended to be lower in those who exercised as described.

Limitations

  • The study had a small sample size, with less than 100 patients.
  • The sample consisted of female outpatients with breast cancer.
  • Fatigue was not measured at different times during the day.
  • No baseline of fatigue was established prior to chemotherapy.
  • The length of the chemotherapy cycle varied depending on the regime.

Nursing Implications

Nurses should provide anticipatory guidance to patients so that they can plan for the days when they are at most risk for fatigue. Continued exercise during the course of chemotherapy may be helpful in mitigating the severity of fatigue.

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