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Martire, L.M., Lustig, A.P., Schulz, R., Miller, G.E., & Helgeson, V.S. (2004). Is it beneficial to involve a family member? A meta-analysis of psychosocial interventions for chronic illness. Health Psychology, 23, 599–611.

Search Strategy

MEDLINE, PsycInfo, CancerLit, CINAHL, American College of Physicians Journal Club, Cochrane Controlled Trials Register, Cochrane Database of Systematic Reviews, and Database of Abstracts of Reviews of Effectiveness were searched using key words in groups (a) patient, ill, illness or health, (b) family, caregiver, caregiving, marriage, marital, spouse, spousal, couple, or partner, and (c) treatment, intervention, or support. ERIC, Social Work Abstracts, Expanded Academic ASAP, Academic Search Elite, PubMed, ISI Web of Knowledge and Web of Science, Economic and Social Research Council, Inter-University Consortium for Political and Social Research, and Physician Data Query/National Cancer Institute, as well as tables of contents of all Elsevier Publications medical journals, were searched using the key words family, caregiving or caregiver, and intervention or treatment.

Sample Characteristics

  • Seventy randomized trials comparing interventions with usual care were used.
  • The sample was a mixture of family caregivers of individuals with chronic illness (Alzheimer disease, dementia, stroke, cardiac disease, chronic pain, rheumatoid arthritis, brain injury, and cancer).
  • The sample included two large studies of 2,042 (Alzheimer) and 4,408 (post-myocardial infarction) participants.
  • Excluding those two large studies, the average sample size was 87 caregivers.

Conclusions

Overall, evidence suggested that interventions reduced depressive symptoms in family members when the intervention focused on illnesses other than dementia. Family interventions targeted to patients and family members (as a dyad) or to family members alone were effective in reducing caregiver burden. Interventions offered to spouses alone or to a combination of family members were effective in reducing caregiver burden. Interventions had a stronger effect in reducing burden, depression, and anxiety when relationship issues between patients and caregivers were addressed.

No evidence was found that psychosocial interventions relieved anxiety in family members (uniform across studies).

A family intervention demonstrated the strongest evidence for improving family burden and was uniform across studies for spouses and for mixed groups of family members.

Limitations

Only five studies included cancer populations.

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Martin, M.L., Hernandez, M.A., Avendano, C., Rodriguez, F., & Martinez, H. (2011). Manual lymphatic drainage therapy in patients with breast cancer related lymphoedema. BMC Cancer, 11, 94.

Study Purpose

To determine the effectiveness of manual lymph drainage (MLD) in reducing lymphedema in patients with breast cancer

Intervention Characteristics/Basic Study Process

Participants were randomly assigned to a control group and an experimental group. The control group received standard lymphedema treatment as well as a month of ambulatory treatment, daily bandaging from hand to shoulder for the first four weeks (removed at night), compression garments, and patient education regarding prevention guidelines and exercises to perform at home. The experimental group received the standard treatment plus MLD. MLD was performed before the bandaging occurred.

Sample Characteristics

  • The study sample (N = 58) was comprised of White female patients with breast cancer who had ipsilateral axillary lymphedema.
  • Al patients
    • Had prior mastectomy, tumerectomy, or quadrantectomy and axillary lymphadenectomy
    • Finished radiotherapy or chemotherapy six months prior to study
    • Did not have rehab within three months prior to recruitment.

Setting

The study took place at a rehabilitation facility in Brazil.

Phase of Care and Clinical Applications

Patients were undergoing active lymphedema treatment.

Study Design

The study used a randomized controlled trial design.

Measurement Instruments/Methods

  • The measurement used to determine the effectiveness of MLD was the percentage of volume reduction after treatment using the water-displacement method.
  • The investigators defined a good response to treatment as a 20% or more reduction in volume of the effected extremity.
  • Measurements were taken at baseline and one, three, and six months.
  • Patients also took a quality-of-life questionnaire for cancer in general and for breast cancer.

Results

At 12 months the incidence of lymphedema in the intervention group was very similar to the control group: 24% and 19%, respectively. This difference is not considered statistically significant. There were no incidence differences at three and six months. There was also no difference in the time taken to develop lymphedema, secondary outcome measures of arm circumference, health-related quality of life, and patient reports.

Conclusions

Because of the lack of statistically significant changes in lymphedema incidence between control and intervention groups, it can be concluded that MLD is not effective in preventing lymphedema in the first year post-operatively in patients with breast cancer.

Limitations

The study had a small sample size, with less than 100 participants.

Nursing Implications

The study indicates that MLD does not provide a statistically significant improvement in limb volume in patients with lymphedema. One of the greatest limitations of the study is the sample size. If the results of a repeated randomized controlled trial with a larger sample size yields similar results, MLD should not be taught to lymphedema patients because studies suggest it is unnecessary and ineffective.

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Martinez-Zapata, M.J., Roque, M., Alonso-Coello, P., & Catala, E. (2006). Calcitonin for metastatic bone pain. Cochrane Database of Systematic Reviews, 3, CD003223.

Search Strategy

Databases searched were MEDLINE (1966–2005), EMBASE (1974–2005), Cochrane Central Register of Controlled Trials (issue 2, 2005), and specialized registers of the Cochrane Cancer Network and the Cochrane Pain, Palliative and Supportive Care Group. Also searched were metaRegister of Controlled Trials, U.S. National Institutes of Health register, register of the Center for Clinical Trials and Evidence-Based Healthcare, and register of the European Organization for Research and Treatment of Cancer.

Registers of trials in progress also were assessed.

Studies were included in the review if they

  • Reported on calcitonin plus a rescue medication versus placebo plus a rescue medication
  • Used any comparison between different models and intervention doses of interest
  • Included use of steroids or analgesic radiotherapy if administration was equal in each treatment arm.

Studies where bisphosphonates were administered before patients were randomized to different treatment arms and studies where the efficacy of calcitonin in treating pain was measured over a short period (less than four weeks) were excluded.

Literature Evaluated

The review included two randomized, double-blind clinical trials of patients with metastatic bone pain for a total of 90 patients. The first study compared calcitonin (100 IU administered subcutaneously each day for 28 days) versus placebo administered to a group of 40 women with breast cancer and pain from bone metastasis. The second study compared calcitonin (100 IU administered subcutaneously each day for three months) versus placebo in 50 women with breast cancer and painful bone metastases.

Sample Characteristics

Of the two studies selected (90 patients), all patients had metastatic bone pain caused by any primary tumor, diagnosed by computed tomography, bone gammagraphy, nuclear magnetic resonance, or other radiographic process.

Conclusions

The limited available evidence does not support the use of calcitonin to control pain from bone metastases.

Limitations

Calcitonin has been assessed in studies with small sample sizes and too short-term evaluations.

Nursing Implications

More double-blind, parallel clinical trials using long-term evaluations are needed.

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Martinez, K.A., Aslakson, R.A., Wilson, R.F., Apostol, C.C., Fawole, O.A., Lau, B.D., . . . Dy, S.M. (2014). A systematic review of health care interventions for pain in patients with advanced cancer. American Journal of Hospice and Palliative Care, 31, 79–86.

Purpose

STUDY PURPOSE: To evaluate the effectiveness of healthcare interventions targeting pain in patients with cancer

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: PubMed, CINAHL, PsycINFO, DARE, and Cochrane Collaboration; reference lists were used to identify additional studies.

KEYWORDS: Search terms and strategy specifics are in an online appendix to this article.

INCLUSION CRITERIA: Random or nonrandom trials with a control group. Patient-centered and institutional change interventions were included in the definition of healthcare interventions. Pain was included as an outcome.

EXCLUSION CRITERIA: Not specified

Literature Evaluated

TOTAL REFERENCES RETRIEVED = 1,3014

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: GRADE system of quality evaluation; risk of bias was high in seven studies and moderate in another seven studies.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 19 
  • TOTAL PATIENTS INCLUDED IN REVIEW = 97
  • KEY SAMPLE CHARACTERISTICS: Mixed tumor types; median follow-up was 8 weeks (range was 2–24 weeks); all had advanced cancer.

Phase of Care and Clinical Applications

APPLICATIONS: Palliative care

Results

Of the studies, 89% examined patient educational activities. Two focused on provider-level interventions. Fifty-five percent of studies (11 studies) that measured knowledge and barriers found significant improvement in barriers to pain management. Five studies measured pain knowledge–two of these showed improvement. Forty-seven percent of the 19 studies showed significant improvement in pain outcomes compared to the control group. Findings varied by the type of intervention used, and results suggest that the use of multiple educational modalities may be more effective. The number of patient encounters in studies varied widely.

Conclusions

Psychoeducational interventions significantly can reduce barriers to pain management, improve pain knowledge, and improve pain outcomes.

Limitations

  • Many studies had small sample sizes and moderate to high risk of bias. 
  • The samples had little ethnic diversity. 
  • Although most used the Brief Pain Inventory, studies used different components of the tool and individual subscales only.

Nursing Implications

Psychoeducational interventions can reduce patient barriers to pain management, improve relevant knowledge, and have a positive impact on pain. Multimodal interventions combining various educational media and follow-up appear to be more effective than alternatives. Data are limited to show effects of institutional, provider-focused interventions, but results in this area are promising. A combination of provider- and patient-focused interventions should be evaluated.

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Martinez, J.M., Leite, L., França, D., Capela, R., Viterbo, L., Varajão, N., . . . Santo, A. (2015). Bundle approach to reduce bloodstream infections in neutropenic hematologic patients with a long-term central venous catheter. Acta Medica Portuguesa, 28, 474–479. 

Study Purpose

To use a bundle approach to reduce central line–associated bloodstream infections (CLABSI) in patients with hematologic malignancies and neutropenia with long-term central venous catheters (CVC)

Intervention Characteristics/Basic Study Process

Between 2010 and 2012, a bundle of interventions was introduced and outcomes were compared with the results from six months prior to the intervention. Interventions were the use of a different catheter (a neutral pressure mechanical valve connector versus a positive pressure mechanical valve connector), changing needless connectors twice weekly instead of weekly, and the replacement of a chlorhexidine solution to clean needless connectors rather than a solution with 70% alcohol. If blood cultures were obtained, patients were put on broad spectrum antibiotics. All patients were receiving prophylactic co-trimoxazole, itraconazole, and environmental neutropenic precautions.

Sample Characteristics

  • N = 116   
  • AGE = older than 18 years
  • MALES: Not provided  
  • FEMALES: Not provided
  • KEY DISEASE CHARACTERISTICS: Patients with acute leukemia, multiple myeloma, or non-Hodgkin lymphoma
  • OTHER KEY SAMPLE CHARACTERISTICS: All had tunneled catheters

Setting

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

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Prospective with historical cohort comparison

Measurement Instruments/Methods

Blood cultures were obtained for the presence of a fever for more than one hour or other signs of infection from peripheral veins and CVC lines.

Results

With the intervention, a 71% reduction in both CLABSIs (risk ratio [RR] = 0.29, p < 0.014) and overall bloodstream infections (RR = 0.28, p < 0.001) occurred. The reduction of gram-positive bacteria was most pronounced.

Conclusions

The institutional protocol changes related to catheter selection and IV access system care were associated with a reduction in CLABSIs.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Limited sample description.
  • Outcomes measured at 72 hours only
  • No information was provided regarding other aspects of care or techniques used in insertion.

Nursing Implications

The changes implemented here were associated with the reduced incidence of CLABSIs within 72 hours. The authors suggested that changing from a positive pressure valve catheter to a neutral pressure type catheter may have been most relevant, as positive pressure valves tend to develop a biofilm and cannot be cleaned well with routine flushing.

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Martin-Hirsch, P.P.L., and Bryant, A. (2013). Interventions for preventing blood loss during the treatment of cervical intraepithelial neoplasia. Cochrane Database of Systematic Reviews, 2013, CD001421. 

Purpose

STUDY PURPOSE: To assess safety and efficacy of interventions used to prevent blood loss during treatment of cervical intraepithelial neoplasia (CIN)

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: CENTRAL, MEDLINE, EMBASE
 
INCLUSION CRITERIA: Randomized, controlled trail; women with proven CIN undergoing surgical treatment
 
EXCLUSION CRITERIA: None specified

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 1,225
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Evaluated for risk of bias; no specific grading for quality is reported.

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED: 12 
 
TOTAL PATIENTS INCLUDED IN REVIEW: 1,512
 
SAMPLE RANGE ACROSS STUDIES: 48–230
 
KEY SAMPLE CHARACTERISTICS: Women with CIN undergoing excision or biopsy procedures

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Results

  • Vasopressin versus placebo: One trial showed significant reduction in blood loss (MD -100.9, p < 0.00001). One trial examined selective bleeding and showed a significant reduction with vasopressin (RR = 0.4, p < 0.0001)
  • Tranexamic acid (TA) versus placebo: One trial showed reduction in postoperative blood loss with TA (MD -55.6, p < 0.0001). Analysis of two trials showed no meaningful difference in the risk of primary hemorrhage (RR = 1.24), and across four trials, there was significantly reduced risk of secondary hemorrhage with TA (RR = 0.23, p = 0.00017).
  • Vaginal pack with Monsel’s solution: Vaginal packs were associated with significant reduction in perioperative blood loss and decreased risk of dysmennorhea compared with hemostatic sutures (p < 0.05).

Conclusions

Vasopressin, TA, and vaginal packs with Monsel’s solution appear to be helpful in reducing blood loss in women with CIN undergoing surgical procedures. Findings are limited because few studies exist comparing specific interventions.

Limitations

  • Limited number of studies included
  • Mostly low quality/high risk of bias studies

Nursing Implications

This review contains limited evidence; however, findings suggest that use of vasopressin, TA, and vaginal packs with Monsel’s solution may be helpful to reduce various types of procedure-related bleeding in women with CIN.

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Martin, A.C., & Keats, M.R. (2014). The impact of yoga on quality of life and psychological distress in caregivers for patients with cancer. Oncology Nursing Forum, 41, 257–264. 

Study Purpose

To evaluate the effects of a six-week yoga intervention on caregivers’ overall quality of life and psychological distress

Intervention Characteristics/Basic Study Process

Caregivers participated in a particular type of yoga called vinyasa yoga (VY) for 150 minutes per week, which was conducted in two 75-minute sessions for six weeks. Each VY session included breathing exercises, meditation, poses, and a particular subtype of VY called savasana that promotes relaxation and relieves stress.

Sample Characteristics

  • N = 12
  • AGE = 18–65 years
  • MALES: 8%, FEMALES: 92%
  • KEY DISEASE CHARACTERISTICS: Participants were the informal, unpaid caregivers of patients with cancer. No information is provided about the type of cancer. 
  • OTHER KEY SAMPLE CHARACTERISTICS: Caregivers who reported a level of distress that was disrupting their lives based on the National Comprehensive Cancer Center Distress Thermometer were included in the study. 

Setting

  • SITE: Single site  
  • SETTING TYPE: Other  
  • LOCATION: Dalhousie University public recreational facility, Canada

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care

Study Design

  • A single-group, pre- and post-test pilot study

Measurement Instruments/Methods

  • Profile of Mood States (POMS)
  • TMD = total mood disturbance or overall psychological distress
  • SF-36, version 2 to measure quality of life

Results

The overall attendance rate was 65%. Participants had a mean baseline distress score of 6.5 out of 10. A significant difference was seen in TMD scores from baseline to post-intervention (p = 0.002). Although no significant difference was seen in the physical component score of SF-36 from baseline to post-intervention, a significant difference was seen in the mental component scores of SF-36 from baseline to post-intervention (p = 0.018). The effect in the intended outcome for TMD scores and MCS was large.

Conclusions

Cancer caregivers may benefit mentally with reduction in psychological distress from VY.

Limitations

  • Small sample (less than 30)
  • 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)
  • Risk of bias(sample characteristics)
  • Findings not generalizable
  • Questionable protocol fidelity
  • Other limitations/explanation: Although this study shows some positive findings, including reduction in psychological distress and improvement in the mental component of quality of life, small sample size and the absence of a control group reduce the strength of this study. Also, the majority of the participants were women, which reduces the generalization of the findings to both genders. Details regarding who conducted the yoga teaching and whether they are trained in yoga are not provided in the study.
 

Nursing Implications

VY seems to be a cost-effective approach to improve the quality of life and psychological distress in cancer caregivers. Nurses can encourage caregivers to participate in VY programs. RCTs with larger sample size are needed to find the true effect of yoga on cancer caregivers in terms of reducing psychological distress and improving quality of life.

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Martin-Broto, J., Cleeland, C.S., Glare, P.A., Engellau, J., Skubitz, K.M., Blum, R.H., . . . Atchison, C. (2014). Effects of denosumab on pain and analgesic use in giant cell tumor of bone: Interim results from a phase II study. Acta Oncologica, 53, 1173–1179.

Study Purpose

To describe the effect of denosumab on pain and analgesic use in patients with giant cell tumor of bone (GCTB)

Intervention Characteristics/Basic Study Process

Patients were split into two groups, cohort 1, which contained patients with unresectable disease or multiple lesions, and cohort 2, which contained patients with resectable disease but for whom surgery was associated with high morbidity. Patients received denosumab every four weeks with additional doses on days 8 and 15. Pain was assessed with the Brief Pain Inventory Short Form at baseline and each visit for the first six months and every three months thereafter.

Sample Characteristics

  • N = 271  
  • AVERAGE AGE: 33.5 years
  • MALES: 41%, FEMALES: 59%
  • KEY DISEASE CHARACTERISTICS: Patients had either unresectable disease or had disease associated with high morbidity; ≥ 12 years old with active histologically confirmed GCTB

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Not specified    
  • LOCATION: Multiple international centers

Phase of Care and Clinical Applications

  • PHASE OF CARE: Mutliple phases of care
  • APPLICATIONS: Elder care and palliative care 

Study Design

  • Phase II, prospective clinical trial

Measurement Instruments/Methods

  • The Brief Pain Inventory Short Form (BPI-SF) was used to evaluate pain and minimally important differences.
  • The Analgesic Quantification Algorithm (AQA) was used to evaluate analgesic use at each visit.

Results

Cohort 1: Moderate to severe pain was reported in 45% of patients with strong opioid use in 33% of patients at baseline. The median time to a clinically relevant decrease in pain was 30 days (CI = 95%, SD = 16–57). The estimated median time to a clinically relevant pain worsening was 23.3 months, and 39% of patients (56) reduced strong opioid use to little or no use. Less than 5% of patients with no or low use at baseline (113) shifted to strong opioid use.
 
Cohort 2: Moderate to severe pain was report in 49% of patients with strong opioid use in 14% of patients at baseline. The median time to a clinically relevant decrease in pain was 30 days (CI = 95%, SD = 15–29). The estimated median time was not determined for worsening pain for cohort 2 because a small number of patients (16/89) experienced pain worsening during the study, with 40% of patients (14) reducing strong opioid use to little or no use. Less than 5.3% of patients with no or low use at baseline (86) shifted to strong opioid use.

Conclusions

Denosumab is a reasonable treatment choice for pain relief in patients with GCTB with unresectable disease, disease with multiple lesions, or for patients in whom resection would be associated with high morbidity. This treatment would reduce radiotherapy-related risks and provide a medical option for treating patients in who  surgical intervention (the treatment of choice) is not a option or is presented as a high-risk option.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)

Nursing Implications

Denosumab is an easy drug to administer that has few side effects. Education on the drug and its administration would be required to effectively treat patients limited to this option. Nurses could help advocate for patients with unresectable disease or disease associated with high morbidity with surgery. This could be an alternative to radiation if patients are unable to receive radiation or are concerned about the low but present risk of secondary tumors from radiation treatment.

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Marti-Carvajal, A.J., Anand, V., & Sola, I. (2015). Treatment for disseminated intravascular coagulation in patients with acute and chronic leukemia. Cochrane Database of Systematic Reviews, 6, CD008562.

Purpose

STUDY PURPOSE: To assess the benefits and harms of pharmacologic interventions for treating patients with leukemia experiencing disseminated intravascular coagulation (DIC) to update a prior systematic review

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: MEDLINE OVID, LILACS, CENTRAL, WHO International Clinical Trials
 
INCLUSION CRITERIA: Randomized, controlled trials (RCTs); patients of any age with acute or chronic leukemia; eligible RCTs had to compare confentional interventions with and without anticoagulants, procoagulants, or antifibrolynics
 
EXCLUSION CRITERIA: Not specified

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 9,027
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Cochrane risk of bias assessment; used GRADE criteria for strength of evidence; studies included were of low quality because of small sample sizes and study design.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 4 studies 
  • TOTAL PATIENTS INCLUDED IN REVIEW = 388
  • SAMPLE RANGE ACROSS STUDIES: 10–132

Phase of Care and Clinical Applications

PHASE OF CARE: Not specified or not applicable

Results

Interventions included human activated protein C versus heparin, recombinant human soluble thrombomodulin versus heparin, tanexamic acid versus placebo, and dermatan sulfate versus heparin. Only one study was found for each intervention. No significant differences in bleeding with protein C or dermatan sulfate existed. Recombinant human soluble thrombomodulin was associated with improvement in bleeding symptoms compared to heparin, and lower scoring of hemorrhagic problems with tranexamic acid compared to placebo.

Conclusions

Insufficient high quality evidence exists to fully evaluate these interventions.

Limitations

  • Limited number of studies included
  • Mostly low quality/high risk of bias studies
  • Low sample sizes
  • Some studies included patients with DIC from other causes, and the findings were not reported separately for patients with leukemia, further reducing the relevant samples for consideration.

Nursing Implications

Extremely limited evidence regarding the effects of pharmacologic interventions for the management of DIC and associated bleeding exists compared to usual practice using heparin.

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Martenson, J.A., Halyard, M.Y., Sloan, J.A., Proulx, G.M., Miller, R.C., Deming, R.L., … Atherton, P.J. (2008). Phase III, double-blind study of depot octreotide versus placebo in the prevention of acute diarrhea in patients receiving pelvic radiation therapy: Results of north central cancer treatment group N00CA. Journal of Clinical Oncology, 26, 5248-5253.

Study Purpose

To determine the effectiveness of octreotide in reducing treatment-related diarrhea during radiation therapy to the pelvis

Intervention Characteristics/Basic Study Process

Patients were randomized to receive octreotide acetate or placebo. Patients in the treatment group were given 100 µg subcutaneous octreotide acetate on day 1 followed by 20 mg intramuscular octreotide acetate on days 2 and 29. Patients in the control group received placebo by the same routes on the same days.

Sample Characteristics

  • The study reported on 125 patients.
  • Patients had histologic proof of cancer in the pelvis without distant metastases and were receiving radiation therapy, either as definitive treatment or adjuvantly.                           

Setting

This was a multisite, collaborative trial of North Central Cancer Treatment Group.

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

This was a double-blinded, randomized control trial.

Measurement Instruments/Methods

A Bowel Function Questionnaire and a Uniscale Quality of Life (QOL) measure were used.

Results

No statistically significant differences were found between groups. Octreotide did not reduce the severity or incidence of diarrhea during pelvic radiation therapy. Abdominal cramps were worse in patients on the octreotide arm, but the difference was not statistically significant (p = 0.053). Patients receiving octreotide experienced significantly more problems with nocturnal bowel movements (70% versus 45%, p = 0.004), clustering (90% versus 69%, p = 0.004), and blood with bowel movements (57% versus 35%, p = 0.01).

Conclusions

Octreotide did not result in improvement in diarrhea in this population and was associated with more problems. Octreotide did not have an effect on the severity or incidence of diarrhea during pelvic radiation therapy. Some gastroinstestinal (GI) symptoms were worse in patients receiving octreotide compared to placebo.

Limitations

  • The subjects in the treatment groups were different. More patients in the control group had histories of rectal surgery or primary rectal cancer.
  • Not all patients completed the day 29 dose of study medication. Only 49 (79%) of 62 of patients in the placebo arm and 43 (69%) of 62 of patients in the octreotide arm received a second dose.
  • No intention-to-treat analysis was conducted.

Nursing Implications

More clinical research is needed to evaluate the effective prevention of diarrhea during pelvic radiation therapy. Long-acting octreotide (LAO) should not be used outside of a controlled clinical trial setting.

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