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Jepson, C., McCorkle, R., Adler, D., Nuamah, I., & Lusk, E. (1999). Effects of home care on caregivers’ psychosocial status. Journal of Nursing Scholarship, 31, 115–120.

Intervention Characteristics/Basic Study Process

The intervention was directed at patients and caregivers (primarily at patients). The standardized nursing intervention protocol included three home visits and six telephone calls over four weeks from an oncology clinical nurse specialist. Intervention activities included

  • Problem assessment and monitoring
  • Symptom management and teaching of self-care behaviors
  • Coordination of resources.

Sample Characteristics

  • The sample was comprised of 161 family caregivers of patients older than 60 years.
  • Patients
    • Were newly diagnosed (in the past two months) with solid-tumor cancers
    • Were currently hospitalized for surgical cancer treatment
    • Had a prognosis of six months or greater
    • Lived within 50 miles of the study center
    • Had a complex problem at the time of discharge.

Setting

Home setting

Study Design

A controlled trial design was used, with a major limitation.

Measurement Instruments/Methods

  • Caregiver reaction assessment
  • Center for Epidemiologic Studies–depression

Results

No significant differences existed on any outcome measure. No effect on caregiver esteem was found. Among caregivers with physical problems, those in the treatment group had an increase in lack of family support between interviews 1 and 2 followed by a decrease between interviews 2 and 3. Control group subjects displayed the opposite pattern. Caregivers with physical problems had greater decreases in difficulty with finances than those with no physical problems. Caregivers in the control group had a decrease, whereas those in treatment group did not. No significant effect on depression was found. Caregivers in the control group had a decrease in the effect of providing care on physical health between interviews 1 and 2 and then remained constant between interviews 2 and 3. Caregivers in the treatment group displayed the opposite pattern. The analyses are based on some caregivers who had received nonprotocol home care and were dropped from analyses.

Limitations

Little information is presented on the details of the intervention. The control group had some contamination (32.4% of the control group and 32.2% of the intervention group received referrals for home care that were not connected with the study). Findings were difficult to interpret.

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Jeppesen, E., Pedersen, C.M., Larsen, K.R., Rehl, A., Bartholdy, K., Walsted, E.S., & Backer, V. (2016). Music does not alter anxiety in patients with suspected lung cancer undergoing bronchoscopy: A randomised controlled trial. European Clinical Respiratory Journal, 3, 33472.

Study Purpose

To measure the effect of a music intervention on anxiety related to bronchoscopy

Intervention Characteristics/Basic Study Process

Patients undergoing bronchoscopy were randomly assigned to listen to music via earbuds during the procedures or use earplugs with no sound. On admission to the hospital, patients completed a study questionnaire, and blood cortisol samples were obtained. On admission to the operating area, baseline vital signs were taken, and actigraph sensors were applied to the patients' wrists, ankles, head, and hips. After 10 minutes, study measures were obtained again. About 60 minutes after bronchoscopy, the study measures were repeated.

Sample Characteristics

  • N = 135   
  • MEAN AGE = 63.7 years (SD = 11.6 years)
  • MALES: 51.7%, FEMALES: 48.3%
  • CURRENT TREATMENT: Other

Setting

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

Phase of Care and Clinical Applications

PHASE OF CARE: Diagnostic

Study Design

Single-blind, randomized, controlled trial

Measurement Instruments/Methods

  • State-Trait Anxiety Inventory (STAI) 
  • Vital signs

Results

Prior to bronchoscopy, the music group had lower STAI scores. After the bronchoscopy, anxiety was lower in both groups, with no difference between groups. No differences in duration of the procedure, sedatives, or amount of patient movement during the procedure were reported.

Conclusions

Music was not shown to reduce anxiety associated with bronchoscopy.

Limitations

  • Risk of bias (no blinding)
  • Measurement validity/reliability questionable
  • Subject withdrawals ≥ 10%

Nursing Implications

Music during bronchoscopy was not shown to affect patients' level of anxiety. Measurement of anxiety immediately prior to or during a procedure to perform this type of research is difficult and questionable.

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Jeong, J.H., & Yoo, W.G. (2015). Effects of pulmonary rehabilitation education for caregivers on pulmonary function and pain in patients with lung cancer following lung resection. Journal of Physical Therapy Science, 27, 489–490.

Study Purpose

To evaluate the effects of a pulmonary rehabilitation education program for caregivers on pain and pulmonary function in patients after lung resection

Intervention Characteristics/Basic Study Process

Patients were assigned to experiment and control groups. The control group received usual care including education on pain management, general postoperative care, incentive spirometer use, trunk and limb mobilization, and nebulizer instructions. In addition, caregivers in the experimental group received 30 minutes per week of instruction in splint coughing, airway clearance techniques, diaphragmatic breathing, and various exercises. Assessments were done at baseline (two weeks after surgery) and at four weeks after surgery.

Sample Characteristics

  • N = 41
  • AGE = Not provided
  • MALES: Not provided        
  • FEMALES: Not provided
  • KEY DISEASE CHARACTERISTICS: All had lung cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Not provided

Setting

  • SITE: Single site  
  • SETTING TYPE: Not specified  
  • LOCATION: Republic of Korea

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Prospective trial

Measurement Instruments/Methods

  • Visual Analog Scale (VAS)
  • Pulmonary Function Testing (PFT)

Results

Forced expiratory volume in one second was higher in the experimental group at baseline and at four weeks (p < 0.01). There was no difference between the groups in pain scores after the intervention.

Conclusions

Pulmonary rehabilitation education may improve pulmonary function in patients after lung resection.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment) 
  • Risk of bias (no appropriate attentional control condition)  
  • Key sample group differences that could influence results
  • Measurement/methods not well described 
  • Other limitations/explanation: It was not clear whether patients were randomized. There were significant differences between groups in outcome measures at baseline. It was not clear how the VAS for pain was administered.
 

 

Nursing Implications

Pulmonary rehabilitation education provided to caregivers was not shown to reduce postoperative pain scores, but it may have been beneficial in terms of pulmonary function testing results.

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Jeong, Y.J., Park, Y.S., Kwon, H.J., Shin, I.H., Bong, J.G., & Park, S.H. (2013). Acupuncture for the treatment of hot flashes in patients with breast cancer receiving antiestrogen therapy: A pilot study in Korean women. Journal of Alternative and Complementary Medicine, 19, 690–696. 

Study Purpose

To determine if acupuncture administered to Korean women receiving tamoxifen or anastrozole for breast cancer can be safe and feasible in controlling their hot flashes during eight weeks of intervention

Intervention Characteristics/Basic Study Process

Each intervention session lasted 40 minutes and consisted of 20 ± 5 minutes of acupuncture. Patients received three sessions per week for four weeks for a total of 12 sessions. The following acupuncture points were selected for the intervention: GV 20, M-HN-3, HT 8, KI 10, and LV 2. Acupuncture was administered by a physician with three years of experience.  After appropriate skin preparation, eight needles were inserted 10-20 mm deep into the skin and were manipulated to obtain De Qi.  Needles were rotated after 10 minutes.  Data were recorded at baseline, weekly during the intervention (visits 5, 8, 11, and 13), and four weeks post study.

Sample Characteristics

  • N = 10 
  • MEAN AGE = 46.60 years ± 4.93 (range = 38–53 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer diagnosis; pre-menopause = 80% and post-menopause = 20%
  • OTHER KEY SAMPLE CHARACTERISTICS: Previous treatments were surgery, radiotherapy, and chemotherapy in different proportions; any participant took dietary supplements concomitant to the study.

Setting

  • SITE: Single site  
  • SETTING TYPE: Not specified  
  • LOCATION: East-West Medical Center at Daegu Catholic University Center in Daegu, Korea

Phase of Care and Clinical Applications

  • PHASE OF CARE: Late effects and survivorship
  • APPLICATIONS: Elder care, palliative care, and supportive care

Study Design

Interventional study in a nonrandomized series of cases enrolled prospectively

Measurement Instruments/Methods

Data was self-reported using a hot-flash diary to record number and severity of hot flashes. A visual analogue scale was used to record severity of hot flashes. A total score was calculated by multiplying the severity and frequency of hot flashes.

Results

ANOVA was performed to analyze the differences from initial to final scores for hot flashes severity, frequency, and total hot flash score. 
 
The 10 women participants reported a significant decrease from initial to the last measure (F = 30.261, p < 0,001) in their mean VAS severity score of their hot flashes, and the benefit persists for four weeks after finalizing acupuncture intervention. Hot flashes frequency mean per day also shows a significant detriment from initial means 9.30 ± 9.72 to 2.80 ± 0.79 at final point. 
 
Facial temperature scores are not reported in the study, although authors describe this in the intervention. 

Conclusions

Findings are limited in explaining completely the efficacy of acupuncture to decrease hot flashes in women receiving tamoxifen or anastrozole to treat breast cancer. Although safety and statistical significance result from the study, the sample size, the lack of a random design, and the lack of a control group limit the generalization of data.

Limitations

  • Small sample of < 30
  • Baseline sample/group differences of import
  • Risk of bias from no control group
  • Risk of bias from no blinding
  • Risk of bias from no random assignment
  • Risk of bias from no appropriate attentional control condition
  • Risk of bias related to sample characteristics
  • Selective outcomes reporting
  • Key sample group differences that could influence results 
  • Findings not generalizable
  • Other limitations/explanation: Previous cancer treatments in the sample group, such as chemotherapy or radiotherapy, can also affect the final outcome. Pre- and post-menopausal women should not be in the same group in the sample. No control group is the main limitation. Follow-up described to eight weeks is limited. Subjective measures self-reported by participants may differ from other objective ways of measuring the symptom. Comparison with other references in the literature shows that Korean technic and Chinese technic are performed differently.

Nursing Implications

Implications for cancer nurses are limited since applying this intervention requires professional training. However, oncology nurses are vital in providing information to patients about complementary treatments that are safe and feasible in controlling hot flashes related to hormone cancer treatments. No related adverse events were described.

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Jeong, J. S., Ryu, B. H., Kim, J. S., Park, J. W., Choi, W. C., & Yoon, S. W. (2010). Bojungikki-tang for cancer-related fatigue: a pilot randomized clinical trial. Integrative Cancer Therapies, 9, 331–338.

Study Purpose

To evaluate whether Bojungikki-tang has beneficial effects on fatigue and overall quality of life in patients with cancer.

Intervention Characteristics/Basic Study Process

Patients were randomized to the experimental group or the wait-list control group. The experimental group received Bojungikki-tang for two weeks. Bojungikki-tang was administered as granules containing a mixture of 10 medicinal plants given three times daily. Patients were randomized through computer generation. Patients were recruited through newspaper and hospital advertisements.

Sample Characteristics

  • The final sample included 36 patients (37.5% male).
  • Mean age was 52.6 years. 
  • Diagnoses included breast cancer (27.5%), stomach cancer (12.5%), lung cancer (12.5%), colon cancer (12.5%), and other (35%).

Setting

Unknown

Study Design

The study was a randomized, controlled trial.

Measurement Instruments/Methods

  • Evaluation forms included the Visual Analogue Scale of Global Fatigue, which was used as the primary outcome variable.
  • The secondary outcome was measured using the Functional Assessment of Cancer Therapy–General (FACT-G), the FACT-Fatigue (FACT-F), and the Trial Outcome Index–Fatigue (TOI-F).

Results

The experimental group had statistically significant improvements in VAS-F scores, as well as FACT-G, FACT-F, and TOI-F (p < 0.05) at week 2.

Conclusions

The study had a possible effect from the study drug, although p-values were on the edge of significance. The benefit shown suggests additional study is required in a larger, placebo-controlled trial.

Limitations

  • The study had no placebo in place, and the treatment time was short.
  • The plant mixture was not controlled for variability.
  • One patient experienced an increase in BUN and creatinine above the reference ranges, and other adverse effects were reported (flatulence and dyspepsia); therefore, the potential for harm needs to be considered and the risks weighed versus potential benefits if additional study is to be performed with a larger population.
  • Exclusion criteria for patients needs to be more rigorous and include consideration of antihypertensive medication and other drug interactions and baseline renal function.

Nursing Implications

Patients pursuing this treatment should be educated on the current need for additional research.

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Jeon, Y.S., Lee, J.A., Choi, J.W., Kang, E.G., Jung, H.S., Kim, H. K., … Joo, J.D. (2012). Efficacy of epidural analgesia in patients with cancer pain: A retrospective observational study. Yonsei Medical Journal, 53, 649–653.

Study Purpose

To evaluate the efficacy and complications of continuous epidural analgesia to improve its efficacy for control of cancer-related pain

Intervention Characteristics/Basic Study Process

Most patients received morphine, bupivacaine, and ketamine via continuous epidural infusion. Dosing was determined by converting the daily total opioid dose to an IV morphine equivalent. The epidural morphine was delivered at 25%–17% of the IV morphine dose. Bupivacaine 12.5–25 mg per day and ketamine 10–20 mg per day were administered at 2 mL/h and varied according to pain location, severity, and type, as well as progression of disease. Additional adjuvant therapies were used and included antiepileptic drugs, antidepressants, anti-inflammatory drugs, and steroids. Pain levels were evaluated at baseline and at two weeks postepidural.

Sample Characteristics

  • The study reported on 96 patients.
  • Nine patients were 40 years old or younger, 35 patients were 41–59 years old, and 52 patients were 60 years or older.
  • Patients had been diagnosed with terminal lung, upper genitourinary, hepatobiliary, pancreatic, rectosigmoidal, urogenital, or other (10.4%) cancers.
  • The majority of patients (91.6%) had pain in the chest, abdomen, back, sacral, or lower extremity, and 8.3% had pain in the head, neck, and upper extremity.

Setting

The study was conducted at a single site in Korea. The setting type was not specified.

Phase of Care and Clinical Applications

  • Patients were at the end-of-life phase of care.
  • This study has clinical applicability for elder care and palliative care.

Study Design

The study design was a retrospective chart analysis.

Measurement Instruments/Methods

  • Paired sample t-tests were used to evaluate the morphine-equivalent drug dose (MEDD).
  • Statistical analysis was performed using SPSS software version 13.0.

Results

The MEDD decreased from 213.4 mg (SD = 221.7 mg) per day to 94.1 mg (SD = 145.0 mg) per day at two weeks follow up. Prior to receiving the epidural, 78.1% of patients reported severe pain; at the two-week follow up, only 19.6% reported severe pain (p < 0.05). Mild catheter complications occurred in 15.6% of patients. Moderate complications occurred in 14.6% of patients, including infection that had to be controlled with antibiotics or removal of the catheter.

Conclusions

Continuous epidural anesthesia is an effective pain control method for patients with cancer at the end of life. However, risk of infection and complications exist because of catheter placement.

Limitations

  • The sample size was small, with fewer than 100 patients.
  • A risk of bias exists because of the lack of a control group, blinding, and appropriate attentional control condition.
  • The subject withdrawal rate was 10% or greater. The study had an extremely high attrition rate because of patient death (over a two-week span, the sample was reduced from 96 to 56 patients).
  • Variations in documentation practices within the medical record were a weakness of this study.
  • This was a retrospective study.

Nursing Implications

For patients seeking more pain control, continuous epidural infusions may be an option for pain relief. The charts reviewed cited inappropriate pain control (78.1%) and intolerable side effects (21.9%) as the reasons for placing the epidural, which are key factors in working to improve comfort in patients with terminal cancer.  Risks of complications include infection, occlusion, catheter removal, risk of respiratory depression, motor block, hypotension, sensory deficits, and gastrointestinal and genitourinary function that must be evaluated while the catheter is in place. In patients with terminal cancer, patient and caregiver education is important.

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Jensen, J.M., Gau, T., Schultze, J., Lemmnitz, G., Folster-Holst, R., May, T., . . . Proksch, E. (2011). Treatment of acute radiodermatitis with an oil-in-water emulsion following radiation therapy for breast cancer: A controlled, randomized trial. Strahlentherapie Und Onkologie, 187(6), 378–384.

Study Purpose

To test the hypothesis that treatment with an oil-in-water emulsion (WO1932) leads to more rapid skin hydration, improves skin barrier function, and reduces pruritus in patients after radiation therapy

Intervention Characteristics/Basic Study Process

Patients were randomized to a treatment group or control group. In the treatment group, the oil-in-water emulsion was applied twice a day over six to eight weeks, starting after radiation therapy was completed. Sauna, swimming, and use of any other skin care product were not allowed. Clinical assessment was done after week one and at the end of the study.

Sample Characteristics

  • N = 64
  • AGE: Not provided
  • MALES: 0%, FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: All were experiencing radiodermatitis with an ONS score of 0–3
     

Setting

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

Phase of Care and Clinical Applications

  • PHASE OF CARE: Transition phase after active treatment

Study Design

  •  Open-label RCT

Measurement Instruments/Methods

  • ONS skin reaction scoring (not described)
  • Transepidermal water loss
  • Visual analog scale (VAS) for pruritus
     

Results

Pruritus decreased in all patients but more in the treatment group in weeks one, two, three, and five (p < .04). There was no significant difference between groups in skin scores overall. There was no difference between groups in transepidermal water loss.

Conclusions

This study does not provide strong evidence in favor of the oil-in-water emulsion tested here. Findings suggest the emulsion was helpful in reducing pruritus compared to no treatment at all.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding) 
  • Risk of bias(sample characteristics)
  • Measurement/methods not described
  • Other limitations/explanation: In one place, authors report that measures were done after week one and eight yet provide data for multiple other weeks. No demographic information is provided. Inclusion criteria state that patients had 0–3 skin scores, which means, at 0, there was no radiodermatitis. No clear baseline data or comparison of skin scores are provided.

Nursing Implications

This study does not provide strong evidence for evaluation of effectiveness of the oil-in-water emulsion tested here.

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Jensen, S.B., Jarvis, V., Zadik, Y., Barasch, A., Ariyawardana, A., Hovan, A., . . . Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO). (2013). Systematic review of miscellaneous agents for the management of oral mucositis in cancer patients. Supportive Care in Cancer, 21(11), 3223–3232.

Purpose

To analyze the available literature and define clinical practice guidelines for the use of the following agents for the prevention and treatment of oral mucositis (OM): allopurinol, midline mucosa-sparing radiation blocks, payayor, pentoxifylline, timing of radiation therapy (morning versus afternoon), pilocarpine, bethanechol, chewing gum, propantheline, and tetrachlorodecaoxide

Search Strategy

  • DATABASES USED: MEDLINE
  • KEYWORDS: Oral mucositis, cancer therapy, supportive, palliative, prevention, treatment, and saliva
  • Inclusion and exclusion criteria were not listed in this report, but, rather, were referenced from the criteria listed in another referenced study.

Literature Evaluated

A total of 99 references were retrieved. Of these, 18 were excluded based on the inclusion/exclusion criteria (which was not stated in the article). Of the remaining 81 papers, 49 pertained to agents of natural origin and the results on those agents were reported separately. This manuscript reported the results of the review of the remaining 32 papers that tested interventions that did not fit in any of the other categories and were classified as miscellaneous agents.

Studies were evaluated based on the list of major and minor flaws published by Hadorn. Level of evidence was assigned for each intervention based on the Somerfield criteria. A well-designed study was defined as a study with no major flaws per the Hadorn criteria. Findings from the reviewed studies were integrated into guidelines based on the overall level of evidence for each intervention.

Sample Characteristics

  • A final sample of 32 papers addressing 10 interventions were included in the report.
  • The numbers of patients and sample ranges across all studies were not reported.
  • Patient populations included patients receiving high-dose chemotherapy before stem cell transplantation, patients receiving radiation therapy (RT) for head and neck cancer, and patients receiving bone marrow transplantation.

Phase of Care and Clinical Applications

PHASE OF CARE: Active treatment

Results

Suggestions were made against the use of systemic pilocarpine administered orally for prevention of OM during RT in patients with head and neck cancer and in patients receiving high-dose chemotherapy with or without total body irradiation, prior to hematopoietic stem cell transplantation as well as against the use of systemic pentoxifylline administered orally for the prevention of OM in patients undergoing bone marrow transplantation. No guideline was possible for any other agent reviewed because of inadequate or conflicting evidence.

Conclusions

None of the agents reviewed was determined to be effective for the prevention or treatment of OM. This review was inadequate and difficult for the reader to understand. The methods section was missing needed information to assess the interventions and the associated recommendations.

Limitations

  • The scope of the analysis was too large, as 32 studies were included from which the review panel attempted to make recommendations about 10 different interventions.
  • The level of evidence was not explained to the reader, making it difficult to assess the results obtained and impossible to know if the study selection was biased.
  • The authors stated that the criteria for a well-designed study was no major flaws per the Hadorn criteria but did not tell the reader what the criteria were.
  • The authors were not clear if only well-designed studies were used exclusively.

Nursing Implications

Many products on the market claim to prevent or treat OM. Nurses need to be well informed before recommending any products or interventions to patients. Further research is needed. 

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Jensen, B.T., Jensen, J.B., Laustsen, S., Petersen, A.K., Søndergaard, I., & Borre, M. (2014). Multidisciplinary rehabilitation can impact on health-related quality of life outcome in radical cystectomy: Secondary reported outcome of a randomized controlled trial. Journal of Multidisciplinary Healthcare, 7, 301.

Study Purpose

To evaluate whether pre- and postoperative physical exercise affect quality of life and symptoms in patients undergoing radical cystectomy

Intervention Characteristics/Basic Study Process

Patients were randomized to a standard care or intervention group. Standard care included preoperative nutritional screening counseling and the use of oral supplements as needed, patient education, and standard mobilization postoperatively by walking during each shift with supervision once daily. The intervention included all aspects of standard care plus a preoperative exercise program and a more comprehensive postoperative exercise program with related patient education 14 days prior to surgery. Prior to surgery, a phone call after one week was done to promote adherence to the program. Postsurgery, the intervention group had physical therapy sessions two times per day including progressive muscle strength and endurance training. The difference between groups at four months after the intervention were reported.

Sample Characteristics

  • N = 100
  • MEAN AGE = 70 years (range = 46–91 years)
  • MALES: 66%, FEMALES: 34%
  • KEY DISEASE CHARACTERISTICS: All had surgery for urinary diversion
  • OTHER KEY SAMPLE CHARACTERISTICS: 57% married and living with a partner

Setting

  • SITE: Single-site  
  • SETTING TYPE: Multiple settings  
  • LOCATION: Denmark

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ)
  • Charlson Comorbidity Index (CCI)
  • Nutritional risk screening tool

Results

Those in the intervention group reported reduced symptoms of constipation and flatulence. Compared to the intervention group, those in the standard care group reported reduced insomnia (p = 0.04) and a clinically relevant, but not statistically significant, reduction in fatigue. There were no other differences between groups in symptoms.

Conclusions

The perioperative multicomponent rehabilitation program studied here did not result in reduced fatigue or improvement in overall quality of life compared to those who received standard care.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Subject withdrawals ≥ 10%
  • Other limitations/explanation: Patient adherence to exercises preoperatively was not described.

Nursing Implications

A more intensive exercise and educational counseling program provided perioperatively did not result in better patient outcomes related to fatigue four months after surgery for this group of patients. The lack of information about patients’ adherence to both pre- and postoperative exercise recommendations is a limitation of this report. Additional research on the impact of perioperative rehabilitation therapies in various patient groups would be of benefit.

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Jensen, W., Baumann, F.T., Stein, A., Bloch, W., Bokemeyer, C., de Wit, M., & Oechsle, K. (2014). Exercise training in patients with advanced gastrointestinal cancer undergoing palliative chemotherapy: A pilot study. Supportive Care in Cancer, 22, 1797–1806.

Study Purpose

To investigate the feasibility of two different training programs including resistance and aerobic exercise in a small cohort of patients with advanced gastrointestinal cancer undergoing palliative chemotherapy; the study aimed to investigate potential effects of these programs on quality of life according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) as well as on physical performance, biological parameters, and activities of daily living

Intervention Characteristics/Basic Study Process

The resistance exercise training (RET) group of large muscles received supervised training sessions over 45 minutes, including warm-up and cool-down periods, twice per week until a total of 24 sessions over a period of 12 weeks was achieved/completed. The aerobic exercise training (AET) group received supervised sessions lasting 45 minutes on a bicycle ergometer twice a week for 12 weeks. Starting at 60% of patients' predetermined pulse rate in weeks one through four, the work load was intensified to 70%–80% in weeks 5–12. The exercise duration started with 10 minutes in week one and was increased up to 30 minutes in week 12.

Sample Characteristics

  • N = 26 randomized (21 completed)  
  • AVERAGE AGE = 55 years
  • MALES: 10, FEMALES: 11
  • KEY DISEASE CHARACTERISTICS: Gastrointestinal (GI) tumors with advanced disease; 48% new diagnosis; varied treatment modalities
  • OTHER KEY SAMPLE CHARACTERISTICS: Some patients had a history of operation or radio-chemotherapy at initial diagnosis and were undergoing palliative chemotherapy.

Setting

  • SITE: Single-site    
  • SETTING TYPE: Not specified    
  • LOCATION: Supervised exercise (does not specify)

Phase of Care and Clinical Applications

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

Study Design

Two-group randomized trial

Measurement Instruments/Methods

  • Quality of Life (QOL): European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
  • Physical Performance: Muscular strength and cardiorespiratory fitness
  • Daily Physical Activity: Wearing a SenseWear® wristband; Freiburg Questionnaire of Physical Activity
  • Biologic Parameters: Peripheral venous blood parameters
  • Exercise preference

Results

Relevant to fatigue and QOL: In the AET arm, relevant improvements of the EORTC scores could be observed for global health status (58 preintervention to 71 postintervention, p = 0.045) and role functioning (from 53 to 75). The fatigue score decreased in both subgroups from 66 to 43 in the pre/postintervention analysis (p < 0.05). All other scores showed no change from baseline assessment to postintervention. A greater number of steps in daily living after the training intervention measured by the SenseWear® wristband seemed to be associated with higher physical (r = 0.51) and social functioning levels (r = 0.56) as well as lower scores for pain (r = −0.53) and fatigue (r = −0.54) after 12 weeks. Higher levels of physical (r = 0.70) and role functioning (r = 0.46), as well as lower scores for pain (r = −0.47) and fatigue (r = −0.59), were observed in patients with a higher level of postinterventional total activity per week.

Conclusions

The postinterventional fatigue level decreased in both subgroups, suggesting that both programs seem to have positive effects on fatigue in patients undergoing palliative chemotherapy.

Limitations

  • Small sample (< 30)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)

 

Nursing Implications

Further prospective, controlled trials with larger sample sizes are needed to adequately analyze the efficacy of these programs in patients with advanced gastrointestinal cancer currently undergoing palliative chemotherapy.

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