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Zeng, K., Dong, H., Chen, H., Chen, Z., Li, B., & Zhou, Q. (2014). Wrist-ankle acupuncture for pain after transcatheter arterial chemoembolization in patients with liver cancer: A randomized controlled trial. American Journal of Chinese Medicine, 42, 289–302. 

Study Purpose

To evaluate the effects of wrist and ankle acupuncture for analgesia after transcatheter arterial chemoembolization

Intervention Characteristics/Basic Study Process

Patients receiving transcatheter arterial embolizations (TACEs) for primary liver cancer were randomized to receive acupuncture or opioids for pain management after the procedure. Pain scoring was done immediately after the procedure, and interventions were initiated after initial pain scoring. Pain scoring was repeated at one, two, four, and six hours after the intervention. Patients receiving opioids were given a single dose of MS Contin after the procedure. Those given acupuncture had needles remaining in subcutaneous tissue for six hours and did not receive analgesics during that time.

Sample Characteristics

  • N = 60  
  • MEAN AGE = 51.4 years
  • MALES: 91.6%, FEMALES: 8.4%
  • KEY DISEASE CHARACTERISTICS: Liver cancer

Setting

  • SITE: Single site  
  • SETTING TYPE: Inpatient    
  • LOCATION: China

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Randomized, controlled trial with active control

Measurement Instruments/Methods

  • Visual Analog Scale (VAS) for pain severity
  • Pain remission was used in the statistical analysis (complete remission, partial, mild, or no remission). Pain intensity difference was calculated to create a pain relief variable (PAR) where PAR = intensity difference/pretreatment pain score. A PAR > 50% was considered partial remission, and a PAR < 50% was considered mild.

Results

At one, two, and four hours postprocedure, both groups experienced similar pain relief. After six hours, the acupuncture group experienced significantly better pain relief (p < 0.05) as indicated by the proportion that obtained complete and partial remission. There were no differences between groups in adverse events.  

Conclusions

Wrist and ankle acupuncture was effective for the reduction of acute pain in this group of patients after TACE.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Other limitations/explanation: Limited duration of follow up; measures ended at six hours although postprocedural pain can persist for a few days

Nursing Implications

The findings of this study suggested that wrist and ankle acupuncture can provide effective analgesia for acute pain related to TACE. Wrist and ankle acupuncture is a technique that differs in practice and theory from traditional acupuncture in that it does not create a needling sensation. Acupuncture may be helpful for some patients to manage acute pain, and it may be a useful alternative for postprocedural pain control for patients who should avoid medication and medication side effects.

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Zeng, Y., Luo, T., Finnegan-John, J., & Cheng, A.S. (2013). Meta-analysis of randomized controlled trials of acupuncture for cancer-related fatigue. Integrative Cancer Therapies, 13, 193–200.

Purpose

STUDY PURPOSE: To examine effects of acupuncture on cancer-related fatigue

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: Medline, CINAHL®, Scopus, Cochrane Library, and CAJ full-text database
 
KEYWORDS: acupuncture, acupuncture therapy, fatigue, cancer-fatigue, cancer, carcinoma, tumour or tumor, malignance
 
INCLUSION CRITERIA: Articles published in English or Chinese, RCTs of acupuncture for the treatment of cancer-related fatigue; initially cancer survivors expanded to patients with cancer undergoing treatment
 
EXCLUSION CRITERIA: Studies of acupuncture that did not involve needle insertion, such as laser acupuncture or electro-acupuncture

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 488 records screened; 349 records excluded; 139 full-text articles assessed for eligibility
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Data extracted by two authors; methodological quality of included studies assessed by two authors independently; risk of bias of methodological quality assessed using the Cochrane Assessment Tool

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 7
  • TOTAL PATIENTS INCLUDED IN REVIEW = 689
  • SAMPLE RANGE ACROSS STUDIES: 12–302
  • KEY SAMPLE CHARACTERISTICS: 568 were female; 121 unknown; primarily diagnosed with breast cancer. No other demographic information provided.

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Elder care

Results

Three of seven trials had high risk of bias; one trial (combination of acupuncture with educational interventions compared to usual care) showed significant differences but could not parse out if acupuncture or education caused the effects; pooled analysis showed no difference in acupuncture compared to sham acupuncture or usual care in cancer-related fatigue, although forest plots indicate in favor of acupuncture; pooled analysis also showed no significant difference in quality of life and functioning.

Conclusions

The meta-analysis did not provide evidence to support the use of acupuncture in reducing cancer-related fatigue. There was no evidence that acupuncture was harmful.

Limitations

  • Small number of studies
  • Primarily women with breast cancer
  • Methodological bias in many studies

Nursing Implications

No evidence to recommend acupuncture for cancer-related fatigue, although no evidence indicates that it is harmful either. Rigorously designed RCTs are needed.

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Zenda, S., Ishi, S., Kawashima, M., Arahira, S., Tahara, M., Hayashi, R., . . . Ichihashi, T. (2013). A Dermatitis Control Program (DeCoP) for head and neck cancer patients receiving radiotherapy: A prospective phase II study. International Journal of Clinical Oncology, 18, 350–355. 

Study Purpose

To clarify the benefit of using a dermatitis control program without using corticosteroids

Intervention Characteristics/Basic Study Process

Patients with head and neck cancer undergoing radiotherapy followed a three-step protocol using gentle washing alone (step one), moistened wound environment with Vaseline® or dimethyl isopropyl-azulene (step two), or infection prevention with antibiotics (step three) for dermatitis grades 1, 2, and 3. Patients with grade 1–3 dermatitis all performed gentle washing. Patients with grade 2 dermatitis covered the radiated area with Vaseline gauze or dimethyl isopropyl-azulene, and patients with grade 3 dermatitis warranted antibiotics for infection.

Sample Characteristics

  • N = 113    
  • MEDIAN AGE = 63 years
  • AGE RANGE = 22–87 years
  • MALES: 82% (93 patients), FEMALES: 18% (20 patients)
  • KEY DISEASE CHARACTERISTICS: Patients with head and neck cancer (squamous cell carcinoma) aged 22–87 years undergoing radiation therapy (RT) (80 patients: RT as initial approach; 33 patients: postoperative RT)
  • OTHER KEY SAMPLE CHARACTERISTICS: Median radiation dose was 70 Gy with a range of 54–70 Gy. Chemotherapy regimen: cisplatin alone in 53 patients; cisplatin plus 5-FU in 11 patients. Primary site was larynx: 33 patients; oropharynx: 23 patients; hypopharynx: 18 patients; tongue/oral cavity: 12 patients, and unknown primary site: 14 patients

Setting

  • SITE: Single site  
  • SETTING TYPE: Multiple settings  
  • LOCATION: Outpatient and inpatient

Phase of Care and Clinical Applications

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

Study Design

  • Prospective phase II

Measurement Instruments/Methods

  • Descriptive statistics, statistical analysis with 90% power and one-sided type-I error 5%
  • Physicians and nurses used Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 to grade dermatitis.

Results

Following the dermatitis control program, grade 2 dermatitis was evident in 63 patients (56%), and grade 3 dermatitis was evident in 11 patients (less than 10%). There was no evidence of grade 4 dermatitis. Median time to onset of grade 2 dermatitis was 43.5 days. Seventy-one patients (63%) used step two or three for dermatitis during RT, and by two weeks after the completion of RT, 21 patients used step two or three. One month after RT completion, two patients were using step two or three for dermatitis. All patients were able to have their planned radiation without dose reduction. The rate of unplanned treatment breaks (10.6%) was low.

Conclusions

The dermatitis control protocol for patients with head and neck cancer undergoing RT described in this study was useful and effective at controlling severe radiodermatitis according to CTCAE version 3.0. Studies using larger numbers of patients and randomization could provide more evidence-based support for the use of a standardized protocol.

Limitations

  • Risk of bias (no random assignment)
  • Risk of bias(sample characteristics)—only patients with squamous cell carcinoma of the head and neck were studied
  • Other limitations/explanation: Without comparison with corticosteroids in the treatment protocol, there is no way to determine whether corticosteroids should or should not be used in preventing/treating radiation dermatitis. Dosing, route, and type of antibiotic regarding step three are not described. Further, the authors reported that a limitation of their study included that they could not mention the prevention of dermatitis.

Nursing Implications

A treatment program including gentle cleansing of the radiation field followed by moist, protective barriers (Vaseline gauze or dimethyl isopropyl-azulene), depending on the grade of dermatitis, could offer standardized care and better patient outcomes in terms of lessened skin irritation and fewer unplanned treatment breaks due to compromised skin integrity.

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Zavotsky, K.E., Banavage, A., James, P., Easter, K., Pontieri-Lewis, V., & Lutwin, L. (2014). The effects of music on pain and anxiety during screening mammography. Clinical Journal of Oncology Nursing, 18, E45–E49.

Study Purpose

To test whether women who listened to music during screening mammography report lower levels of pain and anxiety than women who did not listen to music

Intervention Characteristics/Basic Study Process

On three days of the week, patients listened to music during screening mammorgraphy, and on two days of the week, music was not provided. An MP3 player was preloaded with various types of music. Patients who were part of the music group were asked to select the music of their choice. Patients rated pain and anxiety immediately after completing the mammography.

Sample Characteristics

  • N = 100
  • MEAN AGE = 54.1 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Most were Caucasian. About 45% had had 13 or more previous mammographies.
     

Setting

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

Phase of Care and Clinical Applications

  • PHASE OF CARE: Diagnostic

Study Design

  • Non-random, two-group comparison

Measurement Instruments/Methods

  • 10-point Likert-type scale for pain and anxiety

Results

No significant differences in pain or anxiety were seen between groups.

Conclusions

This study did not show an effect of listening to music during mammography on pain or anxiety.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement validity/reliability questionable
  • No baseline anxiety measures—if patients were not anxious to begin with, they unlikely would have a result.

Nursing Implications

This study did not show an effect of listening to music during screening mammography, but evidence has shown effectiveness of music in reducing anxiety during invasive procedures. Listening to music during mammography is a low-cost and low-risk intervention that may be helpful to some patients. This study had multiple limitations.

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Zanin, T., Zanin, F., Carvalhosa, A.A., Castro, P.H., Pacheco, M.T., Zanin, I.C., … Brugnera, Jr., A.  (2010). Use of 660-nm diode laser in the prevention and treatment of human oral mucositis induced by radiotherapy and chemotherapy. Photomedicine and Laser Surgery, 28, 233–237.

Study Purpose

To evaluate the qualitative and quantitative effects of the 660-nm diode laser in the prevention and treatment of oral mucositis in patients with head and neck cancer being treated with chemotherapy and radiation

Intervention Characteristics/Basic Study Process

Seventy-two patients were divided into two groups. One group was the control, and the other group received low-level laser therapy twice weekly. Teeth were protected using a silicone tray containing neutral fluoride gel. Daily physical intraoral evaluations were performed. Patients were followed for seven weeks during radiation treatment.

Sample Characteristics

  • The study reported on 72 patients with head and neck cancer receiving treatment that included 1.8 gy radiation and 70 mg/mcisplatin weekly.
  • The sample had an age range of 34–80 years.
  • The sample was 83% male and 17% female.

Setting

This was a single-site study conducted at the Cancer Hospital of Mato-Grasso, Cuiaba, MT, Brazil.

Study Design

The study was a prospective clinical trial.

Measurement Instruments/Methods

  • A visual analog scale (VAS) was used to measure severity of oral pain.
  • The Brown scale was used to evaluate incidence of oral mucositis.
  • The National Cancer Institute (NCI) Common Toxicity Criteria (CTC) was used.
  • Patients received daily physical intraoral exams.

Results

  • Patients in the laser group had significantly lower NCI mucositis scores throughout the study period (p < 0.001).
  • Patients in the laser groups reported absence of pain during treatment, and controls reported increasing pain from weeks 1–4. Overall differences were significant (p = 0.05).

Conclusions

This study found that 660-nm diode laser therapy was effective in the prevention and treatment of oral mucositis in patients being treated with chemotherapy and radiation for head and neck carcinoma.

Limitations

  • The sample size was small with fewer than 100 patients.
  • The control group was not adequately described, including whether they received sham treatment.
  • A risk of bias exists because the patients were not randomly assigned to groups. Addtionally, the study was not blinded.
  • The report did not include a discussion of other oral care or medications used.

Nursing Implications

Low level laser therapy may be effective in the prevention of mucositis. However, this treatment is highly technical and requires special equipment and highly trained personnel.

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Zang, J., Hou, M., Gou, H.F., Qiu, M., Wang, J., Zhou, X.J., … Yi, C. (2011). Antiemetic activity of megestrol acetate in patients receiving chemotherapy. Supportive Care in Cancer, 19, 667–673.

Study Purpose

To evaluate the antiemetic properties of megestrol acetate (MA) in patients receiving moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC)

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to receive either MA or placebo combined with routine antiemetic medications during the first cycle of chemotherapy and used the alternative during the second cycle. Patients were given oral MA or a placebo tablet prior to the start of chemotherapy then daily on days 1–4 of the chemotherapy. All patients were given granisetron and metoclopramide daily on days 1–4 of chemotherapy. Patients received either MEC or HEC for one day. Patients recorded nausea, vomiting, and adverse experiences daily on diary cards during days 1–5 of chemotherapy.

Sample Characteristics

  • The sample consisted of 100 patients.
  • Mean age was 51.6 years (SD = 10 years).
  • The sample was 39% female and 61% male.
  • Cancer diagnoses were 67% alimentary tract cancer (including esophageal cancer, gastric cancer, colorectal cancer) and 33% lung cancer.
  • Slightly more than half (56%) of patients received HEC, and 44% received MEC.
  • Patients were not eligible for the study if they experienced nausea or vomiting before the start of chemotherapy or if they used antiemetic agents within 72 hours of the study.

Setting

The study was conducted at a single cancer center in China.

Phase of Care and Clinical Applications

All patients were in active treatment.

Study Design

This was a randomized, single-blind, placebo-controlled, crossover study.

Measurement Instruments/Methods

Patients recorded each emetic episode, their assessment of nausea and global satisfaction, and occurrence of any adverse effects on diary cards.

Results

  • MA combined with granisetron and metoclopramide provided higher protection of chemotherapy-induced nausea and vomiting (CINV) (p = 0.000) than no MA.
  • HEC patients who received MA had less CINV in comparison to patients with no MA (p = 0.001).
  • MEC patients who received MA had less CINV than patients with no MA (p = 0.002).
  • In the acute phase, nausea was higher (p = 0.039) and vomiting was more frequent (p = 0.003) without MA than with MA.
  • In the delayed phase, nausea (p = 0.000) and vomiting (p = 0.000) were lower with MA than without.
  • All adverse events were mild and did not cause patients to discontinue the drug.

Conclusions

MA provides higher rates of CINV protection in the acute and delayed phase of chemotherapy, especially the delayed phase. MA is effective in patients receiving HEC and MEC.

Limitations

  • This was a single institution study.
  • Demographic characteristics were not reported between the two different groups of subjects (MA versus placebo); therefore, it is unclear if characteristic differences may have influenced outcomes.

Nursing Implications

MA may have some antiemetic activity in patients receiving moderate to highly emetic chemotherapy and should be considered as part of an antiemetic regimen.

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Zachariah, B., Gwede, C.K., James, J., Ajani, J., Chin, L.J., Donath, D., … Kachnic, L.A. (2010). Octreotide acetate in prevention of chemoradiation-induced diarrhea in anorectal cancer: Randomized RTOG trial 0315. Journal of the National Cancer Institute, 102(8), 547-556.

Study Purpose

To assess the ability of long-acting octerotide (LAO) to prevent acute diarrhea in patients undergoing concurrent chemoradiation for rectal or anal cancer

Intervention Characteristics/Basic Study Process

Patients were randomized to either receive two 30 mg intramuscular injections of LAO or placebo. A “test” dose of 100 µg LAO was administered. Patients who tolerated the test dose then received a 30-mg dose of study drug between days 4–7 before the start of radiation and a second dose on day 22 (+ 3 days) of radiation. Patients received concurrent chemotherapy and radiation therapy to the pelvis. Radiation and chemotherapy regimens varied by institution. The plan was for a minimal dose of 45 Gy with a portal of 10x10 cm to the whole pelvis and a boost to the tumor bed. Follow-up evaluations were performed 3, 6, 9, and 15 months from start of radiation therapy.

Sample Characteristics

  • The study reported on 215 patients.
  • The mean age of patients in the LAO group was 61 years with a range of 27–83 years. The mean age of patients in the placebo group was 61 years with a range of 37–85 years.
  • The LAO sample was 38% female and 62% male. The placebo group was 36% female and 64% male.
  • The majority (80%) of patients had rectal cancer.

Setting

The study was conducted at multiple outpatient settings in the United States.

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

This was a randomized, double-blinded, placebo-controlled trial.

Measurement Instruments/Methods

The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (version 3.0) (CTCAE), Qualify of Life–Radiation Therapy Instrument (QOL-RTI), 14-item Expanded Prostate Cancer Index (EPIC)–Bowel, 7-item Functional Alterations due to Changes in Elimination–Bowel (FACE-Bowel), and 4-item Diarrhea Assessment Scale (DAS) were used.

Results

  • Prophylactic use of LAO is not beneficial in reducing the severity or preventing the incidence of diarrhea in patients receiving concurrent chemotherapy and radiation therapy for rectal or anal cancer.
  • Incidence of grade 2–4 acute diarrhea was similar in both groups (49% in the placebo group versus 44% in the LAO group).
  • LAO did not reduce the number of hospitalizations required (p = 0.55) or eliminate the need for additional standard antidiarrheal agents (p = 0.67).
  • LAO did not prevent modifications, delays, or interruptions in chemotherapy (p = 0.27) or radiation therapy (p = 0.95).

Conclusions

LAO did not demonstrate a statistically significant reduction in the incidence or severity of diarrhea or change in patient-reported bowel function and QOL in patients with rectal or anal cancer undergoing chemotherapy and radiation therapy.

Limitations

  • No intention-to-treat analysis was performed.
  • This study had a short follow-up timeframe with a median follow-up of only 9.64 months. Further long-term assessment should be conducted to evaluate QOL.

Nursing Implications

More clinical research is needed to evaluate interventions for the prevention of diarrhea in patients receiving chemotherapy and radiation therapy concurrently for rectal or anal cancer. LAO does not appear to reduce the incidence or severity of diarrhea or change patient-reported bowel function or QOL. Other studies have reported similar results. LAO should not be used to prevent diarrhea in patients receiving combined chemotherapy and radiation therapy outside of a controlled clinical research setting.

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Yu, Z., Liu, W., Wang, L., Liang, H., Huang, Y., Si, X., … Zhang, H. (2009). The efficacy and safety of palonosetron compared with granisetron in preventing highly emetogenic chemotherapy-induced vomiting in the Chinese cancer patients: A phase II, multicenter, randomized, double-blind, parallel, comparative clinical trial. Supportive Care in Cancer, 17, 99–102. 

Study Purpose

To evaluate the safety and efficacy of palonosetron versus granisetron for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving emetogenic chemotherapy

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to receive a single IV dose of either palonosetron 0.25 mg or granisetron 3 mg as a bolus dose, 30 minutes before receiving chemotherapy. Patients were evaluated daily from study days 1–7, and investigators were responsible for recording emetic episodes, rescue medication, and adverse events. Complete response was defined as no emetic episodes and no rescue medication for the first 24-hour interval after chemotherapy and during successive 24-hour time periods.

Sample Characteristics

  • The study consisted of 208 participants.
  • Mean age was 51.5 years.
  • The study group was 36.54% female and 63.46% male.
  • The most common cancer types were non-small cell lung, gastric, and breast cancers. A variety of other types were included.
  • The majority of the palonosetron group (92%) and the granisetron group (87%) were receiving cisplatin-containing chemotherapy; 17% in the granisetron and 19% in the palonosetron group were receiving epirubicin-containing therapy.
  • Approximately half of the sample was chemotherapy naïve.

Setting

The study was conducted at multiple sites in China.

Phase of Care and Clinical Applications

All patients were in active treatment.

Study Design

This was a double-blind, randomized, parallel comparative study.

Measurement Instruments/Methods

Evaluation was based on the World Health Organization's evaluation criteria of emesis. Emetic episodes and use of rescue medication were recorded.

 

Results

  • No significant differences were reported between groups in complete response rates.
  • In the granisetron group, 72% of patients had complete response in the 0–24 hour period compared to 83% in the palonosetron group.
  • Response rates declined in both groups from 24–96 hours.
  • No clinically relevant differences were reported between groups in overall incidence of adverse events.
  • No serious adverse events were found to be associated with the study drugs.
  • The most frequent adverse events were headache and constipation.

Conclusions

Palonosetron and granisetron appeared to provide similar results in control of CINV in the immediate, acute phase.

Limitations

  • The level and distribution of emetogenicity of chemotherapeutic regimens was not described, and no subgroup analysis based on this was done.
  • Nausea was not measured.
  • Methods of blinding were not described.
  • Reliability of recording vomiting and nausea episodes was unclear.
  • The authors did not report if the study was conducted in an inpatient setting.
  • The study only looked at single dose adminiatration, and the study had a short duration.

Nursing Implications

  • Palonosetron and granisetron appear to have similar efficacy and tolerability for the management of CINV in the immediate acute period.
  • Most patients (70%–80%) in the study population had an effective short-term response.
  • Response was less in the delayed phase.
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Yun, Y. H., Lee, K. S., Kim, Y. W., Park, S. Y., Lee, E. S., Noh, D. Y., . . . Park, S. (2012). Web-based tailored education program for disease-free cancer survivors with cancer-related fatigue: a randomized controlled trial. Journal of Clinical Oncology, 30, 1296–1303.

Study Purpose

To determine if an internet-based, tailored, psychoeducational program was effective in the management of fatigue and other symptoms for patients with cancer-related fatigue.

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to a tailored, web-based, health navigation program or usual care. The 12-week intervention program covered energy conservation, physical activity, nutrition, sleep hygiene, pain control, and distress management. The program included online education, health advice, message services, caregiver monitoring, and support and educational sessions. Principles of cognitive-behavioral therapy were used in the program design. The program was provided via a health navigation web site. Study measures were obtained at baseline and at the end of 12 weeks. Intention-to-treat (ITT) analysis was performed using the last observation carried forward for missing values.

Sample Characteristics

  • In total, 243 patients (23% male, 77% female) were included.    
  • Mean age was not provided; 53.5% of the patients were 45 years or older. 
  • Multiple tumor sites were included, with 38.6% being breast cancer.
  • Slightly greater than 94% of the patients had completed high school or higher education. 
  • Global Brief Fatigue Inventory (BFI) scores at baseline were an average of 4.13 across the study groups. 
  • At baseline, mean anxiety score was 6.46 and mean depression score was 5.7. 
  • All patients had fatigue scores at baseline of 4 or greater for at least one week and had completed primary treatment within the past 24 months.

Setting

  • Single site 
  • Home 
  • South Korea

Study Design

The study was a randomized, controlled trial with a wait-list control.

Measurement Instruments/Methods

  • BFI
  • Health-related quality of life (HRQOL)
  • European Organization for Research and Treatment of Cancer Quality of Life Questionnare (EORTC QLQ-C30)
  • Hospital Anxiety and Depression Scale (HADS)
  • Brief Pain Inventory (BPI)
  • Mini Nutritional Assessment (MNA)
  • Medical Outcomes Study (MOS) Sleep Scale

Results

The intervention group had a significantly larger reduction in fatigue scores (p = 0.0011), with an effect size of 0.29 (Cohen’s d). The intervention group also had a greater improvement in anxiety score and several quality of life–related scale scores (p < 0.05). Multiple variables were statistically significant predictors of change in fatigue scores.

Conclusions

Health navigation, the psychoeducational intervention used here, had a slight to moderate positive effect in reducing fatigue.

Limitations

  • The study had risks of bias due to no blinding and no appropriate attentional control condition.
  • Key sample group differences could have influenced the results.
  • Patient withdrawals were 10% or greater. The patient withdrawal rate was 29% overall and 31% in the intervention group.
  • At baseline, BFI scores were lower in the intervention group, so the method of ITT analysis may have overestimated the lower fatigue scores at follow-up for this group.
  • The withdrawal and loss to follow-up rate in the intervention group suggested that the intervention may not be well received by several patients.

Nursing Implications

The findings suggested that a psychoeducational program delivered via a web-based program may be helpful for some patients for the management of fatigue. Although the study was limited by a high withdrawal rate in the intervention group, the majority of patients continued with the program. This may be a practical approach that is helpful to some patients. Further research in the area of facilitating and encouraging patient participation in such programs would be useful.

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Yun, Y.H., Lee, M.K., Park, S., Lee, J.L., Park, J., Choi, Y.S., . . . Hong, Y.S. (2011). Use of a decision aid to help caregivers discuss terminal disease status with a family member with cancer: A randomized controlled trial. Journal of Clinical Oncology, 29, 4811–4819.

Study Purpose

To test whether a decision aid (DA) consisting of a videotape and workbook focused on explaining how to discuss death with family members is more effective than a videotape and workbook on patient pain control for caregivers of patients with cancer

Intervention Characteristics/Basic Study Process

A computerized random number generator blindly assigned caregivers to either a study treatment arm or a control arm with stratification according to caregiver age and patients’ awareness of their terminal status. The treatment group received a DA consisting of a 20-minute take-home educational DVD and a companion 43-page workbook, Patients Want to Know the Truth, for family members’ disclosure of terminal status to patients intended to facilitate decision making of patient–caregiver dyads. The authors developed and rigorously tested the DA, based on the transtheoretical model, in several earlier studies that appear in refereed journals to support its current study use. The control group received a National Cancer Institute–developed, Korean language DVD of similar length and a 29-page educational booklet developed by the Korean Ministry of Health and Welfare on cancer pain control. Both treatment and control groups were observed and assessed at the same intervals: zero, one, three, and six months.

Sample Characteristics

  • The sample (N = 119) included 63 participants in the intervention group and 56 participants in the control group. 
  • Patient mean age was 61.9 years (SD = 12.9); caregiver mean age was 45.6 years (SD = 11.8).
  • The patient sample was 57.2% male and 42.8% female; the caregiver sample was 33.2% male and 66.8% female.
  • Patients were diagnosed with breast cancer (18.5%), lung cancer (15.1%), terminal stomach cancer (14.6%), colon cancer (12%), liver cancer (7.4%), and “other\" cancers (42.5%).
  • All patients were defined as terminally ill and nonresponsive to conventional cancer therapy.
  • All caregivers were a spouse, parent, or child of the patient, 80% were married, 40% had college education or higher, 69% believed in a religion, and most were urban dwellers who had a monthly household income of $2,000 or more.

Setting

  • Multisite
  • Inpatient and outpatient settings
  • Korea

Phase of Care and Clinical Applications

  • End-of-life phase
  • End-of-life and palliative care; education; quality of life

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

  • Decision Conflict Scale (DCS): Used to assess caregiver perceptions of decisional conflict (uncertainty in making choices, feeling informed, clarity of personal values, and receipt of decision-making support) and satisfaction with choice; five-point Likert scale with 0.90 Cronbach’s alpha; administered to caregivers at zero, one, three, and six months   
  • Hospital Anxiety and Depression Scale (HADS): Used to measure caregiver psychological distress; Cronbach’s alphas for two factors ranged from 0.81 to 0.85; administered to caregivers at zero, one, three, and six months     
  • Caregiver Quality of Life Index–Cancer (CQOL): Used to measure caregiver quality of life with cancer; five-point Likert scale and Cronbach’s alpha of 0.89; administered to caregivers at zero, one, three, and six months
  • Decision Regret Scale (DRS): Used to measure caregiver regret with decision to discuss terminal diagnosis with patient; five-point Likert scale and Cronbach’s alpha of 0.89; administered to caregivers at one, three, and six months

Results

Sociodemographic and clinical characteristics of the treatment and control groups did not differ significantly, nor were there significant between-group differences in baseline DCS, HADS, or CQOL-C scores. By six-month assessment, only 26.8% of the total sample remained. Decisional conflict and satisfaction total score and conflict, uncertainty, and value clarity subscale scores significantly improved from baseline to one month for the treatment group as compared to the control group. Over six months, significant between-group differences continued for the DCS total score (p = 0.40) and subscales for conflict (p = 0.031), uncertainty (p = 0.014), and value clarity (p = 0.039). Depression scores improved significantly more in the treatment group than in the control group, and this was sustained over six months (p = 0.008). In the caregiver groups in which patients knew their terminal diagnosis, at six months, DCS uncertainty and depression scores (p = 0.029 and p = 0.031, respectively) showed significant improvement in the treatment (DA) group as opposed to the control group. In the caregiver groups in which patients did not know their terminal status, only the value clarity and depression subscale scores (p = 0.037 and p = 0.032, respectively) showed significance, with greater improvement in the treatment group at six months.

Conclusions

Theoretically based DAs appear to help caregivers of patients with cancer communicate with terminally patients if trained professionals assist those caregivers in the process of using them. This study found that the use of a DA did not improve the decision to discuss terminal prognosis but did reduce caregivers’ decisional conflict and depression, which is congruent with other literature. The caregivers in the treatment group did not have a decrease in anxiety.

Limitations

  • The sample included Koreans only. The DA needs to be tested with other diverse groups and illness populations. 
  • There was high attrition of the sample over the duration of the study (more than 70% in both the control and intervention groups); hence, this was a low-powered study despite the authors’ early determination of needed sample for statistically significant results.

Nursing Implications

Nurses have a primary role in assisting patients and caregivers in making treatment decisions to improve the quality of decision making for both groups. Helping patients become involved in decision making is an important facet of patient-centered care. Face-to-face discussions among nurses, patients, and caregivers often facilitate family coping when nurses engage in astute assessment and establish a trusting relationship with patients and their caregivers to understand their concerns. Use of DAs may provide an additional way to educate and empower patients and caregivers for difficult conversations, including those surrounding end-of-life prognosis and decisions. Nursing support and conversations about the efficacy of DAs for both patients and caregivers can offer greater insight into needed components of care to meet goals for quality patient and caregiver care during the cancer trajectory.

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