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Wilcock, A., Corcoran, R., & Tattersfield, A. E. (1994). Safety and efficacy of nebulized lignocaine in patients with cancer and breathlessness. Palliative Medicine, 8, 35–38.

Intervention Characteristics/Basic Study Process

Patients were studied on three consecutive days and were given nebulized saline on day 1, lignocaine 100 mg on day 2, and then lignocaine 200 mg on day 3. Lignocaine is the same as lidocaine hydrochloride (name used in the United States).

Sample Characteristics

  • The sample was comprised of six patients with cancer (four with lung cancer and two with breast cancer); all patients were breathless at rest but had stable symptoms for two weeks. Four patients had coexisting lung disease.
  • Age ranged from 66 to 76 years.
  • Oxygen saturation ranged from 78% to 98%.

Measurement Instruments/Methods

Vital signs were measured and pulse oximetry was performed at baseline and 10, 20, and 30 minutes following treatment. Forced expiratory volume in the first second (FEV1) was measured before and 30 minutes after treatment. A visual analog scale (VAS) measured work of breathing and distress of breathing at baseline and 10, 20, 30, and 60 minutes following the intervention.

Results

No significant differences in vital signs or FEV1 existed between treatments. Two patients developed a wheeze after the 200-mg dose of lignocaine, but no bronchodilator was required. The rate of breathing effort decreased after all three treatments, with no significant differences between treatments. The distress of breathing decreased after saline and increased slightly but was statistically significantly (p < 0.025) with both doses of lignocaine. No benefit was seen with inhaled lignocaine.

Limitations

  • The study had a small sample size (N = 6).
  • The authors stated that the sample was limited because most patients were either too unhealthy or insufficiently stable to participate in the study.
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Wijayasinghe, N., Andersen, K.G., & Kehlet, H. (2014). Neural blockade for persistent pain after breast cancer surgery. Regional Anesthesia and Pain Medicine, 39, 272–278. 

Purpose

STUDY PURPOSE: To review the literature and determine the effects of neural blockades for persistent pain after breast cancer surgery (PPBCS)
 
TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: MEDLINE, PubMed, Scopus, and EMBASE
 
KEYWORDS: [breast neoplasms/surgery AND neural blockade] [breast neoplasms/surgery AND intercostobrachial] [breast cancer (MAJR topic) AND surgery (MAJR topic) AND pain (MAJR topic)] [breast cancer pain AND intercostobrachial nerve] and the following keywords in all three databases: [intercostobrachial], [(intercostobrachial AND breast cancer)], [(intercostobrachial) AND (breast cancer pain)], [(intercostobrachial) AND (blockade) AND (breast)], [(medial cutaneous nerve) AND (breast pain)], [(pectoral nerves)AND(breast pain)], [(long thoracic nerve) AND (breast pain)], [(thoracodorsal nerve) AND (breast pain)], [(intercostal nerves) AND (breast pain)] [(medial cutaneous nerve block) AND (breast cancer )], [(pectoral nerve block) AND (breast cancer)], [(long thoracic nerve block) AND (breast cancer)], [(thoracodorsal nerve block) AND (breast cancer)], [(intercostal nerve block) AND (breast cancer)]
 
INCLUSION CRITERIA: Studies written in English concerning patients who had undergone breast cancer surgery; patients developed persistent pain; and patients received a local anesthetic block in the course of treatment for their pain
 
EXCLUSION CRITERIA: Studies on phantom breast pain; the use of neural blockades in the perioperative period; and treatments for PPBCS that did not target nerves

Literature Evaluated

TOTAL REFERENCES RETRIEVED: Eight were eligible
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Grades of recommendation, assessment, development, and evaluation

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 7
  • TOTAL PATIENTS INCLUDED IN REVIEW = 135
  • SAMPLE RANGE ACROSS STUDIES: Not provided
  • KEY SAMPLE CHARACTERISTICS: Postmastectomy

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment
 
APPLICATIONS: Palliative care

Results

1) All of the four intercostal nerve block studies were performed in the case series (n = 15), and eight (53%) of 15 patients experienced complete pain relief from the local anesthetic blockade.
2) The two SGB studies showed statistically significant reductions in pain scores for as many as three months after the blocks, but eight (11%) of the 75 patients did not respond to the block.
3) In the PVB study, two (20%) of 10 patients were pain-free after five months.

Conclusions

This review demonstrated a lack of high-quality research on neural blockades for PPBCS, which is predominantly a neuropathic pain syndrome.

Limitations

  • This review found that the studies included for the analysis were of low quality because of the case studies included (n = 4; 56%).
  • Only two randomized, controlled trials were included.

Nursing Implications

Because of the low quality of the included studies and the small number of randomized, controlled studies of studies in this review, little evidence for neural blockades for PPBCS can be used for nursing at this time point.

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Wiffen, P.J., & McQuay, H.J. (2010). Oral morphine for cancer pain. Cochrane Database of Systematic Reviews 2010(8).

Purpose

To determine the efficacy of oral morphine in bringing relief from cancer pain; to assess the incidence and severity of side effects associated with oral opioids

Search Strategy

  • Databases searched were MEDLINE; EMBASE; Cochrane Central Register of Controlled Trials (CENTRAL); Cochrane Pain, Palliative and Supportive Care Group Trials Register; and Oxford Pain Relief Database. In addition, investigators performed manual searches of 40 key journals that list pain-related trials.
  • Search keywords were analgesics, opioid (*administration and dosage), morphine, (*administration and dosage), neoplasms (*complications) pain (*drug therapy, radiotherapy), randomized controlled trials (RCT). Investigators searched for studies relating to humans, adults, and children.
  • Studies were included if they
    • Were RCTs.
    • Had been published as full journal articles.
    • Compared an oral morphine preparation to placebo, active control, or alternative route of morphine.
    • Included adults or children with cancer pain that required opioids for treatment.
  • Studies were excluded if they were quasi-randomized studies, included 10 or fewer participants, did not assess pain as an outcome measure, focused on pain unrelated to cancer.

Literature Evaluated

The search retrieved 133 studies; 62 met inclusion criteria. After elimination of duplicates, the group for analysis included 54 studies. There were insufficient data to perform meta-analysis. Study quality was evaluated using the Jadad scale. Overall, the quality of studies was high, with a median score of 4 on a five-point scale. Studies included comparisons of modified- and immediate-release opioids, comparisons of morphine versus other drugs, and comparisons of the effects of morphine delivered by different routes and delivery mechanisms.

Sample Characteristics

The 54 studies involved a total sample of 3,749 participants. Sample range was 11–699.

Results

  • Fifteen studies compared modified-release morphine to immediate-release morphine. The trials showed that both forms were similar in terms of pain relief provided and adverse effects experienced.
  • Twelve studies compared various doses or dose intervals of modified-release morphine. The trials revealed no significant differences across products in terms of pain intensity, rescue analgesia, or adverse effects.
  • Thirteen studies compared modified-release morphine with other opioids, including oxycodone, hydromorphone, transdermal fentanyl, dextropropoxyphene, tramadol, and methadone.
    • Comparisons of modified-release morphine with oxycodone showed that both resulted in adequate analgesia. Studies revealed some differences in side-effect profiles.
    • In a comparison of modified-release hydromorphone and modified-release morphine, both achieved satisfactory pain control. Authors noted no difference regarding the use of rescue medications.
    • Comparisons of oral morphine and transdermal fentanyl showed no significant differences between treatments in regard to pain control. However, more patients receiving fentanyl required upward-dose titration and more rescue medication. Transdermal fentanyl was associated with less sedation and less constipation. Dose-equivalency determination appeared to be problematic in one trial.
    • One small study found that, compared with morphine, dextropropoxyphene was associated with fewer side effects and lower doses needed for pain relief
    • One study of tramadol versus morphine in opioid-naive patients revealed that both medications resulted in satisfactory analgesia but that tramadol was more effective in treating neuropathic pain.
    • One study, which compared methadone to oral morphine, showed that a greater number of adverse events were associated with methadone than with oral morphine.
  • Six studies compared immediate-release morphine to other opioids, including Brompton cocktail, methadone, tramadol, oxycodone, and oral transmucosal fentanyl citrate.
    • Comparisons of oral morphine to Brompton cocktail showed no difference between treatments and demonstrated that cocaine did not enhance analgesia.
    • One comparison involving morphine and methadone showed that both drugs achieved pain control but that more patients on morphine complained of dry mouth and that more patients on methadone complained of headache.
    • Tramadol and morphine use resulted in a pain decrease to similar intensities.
    • One study, which compared morphine to immediate-release oxycodone, revealed that the two achieved similar control of pain. The most frequent side effect of both was sedation. Oral morphine was associated with more nausea than was oxycodone.
    • In one study, patients could use either morphine capsules or oral transmucosal fentanyl (OTFC) for breakthrough pain. OTFC was more successful than morphine at reducing pain intensity, and the majority of patients preferred OTFC.
  • The studies showed no significant difference in pain control or adverse events between oral and rectal administration or between tablets and oral suspension.
  • Compared to naproxen, morphine was associated with greater use of rescue medication.
  • The studies showed that oral morphine and epidural morphine produced a similar level of pain relief. The epidural route was associated with fewer side effects but more technical problems.
  • Oral morphine and morphine suppositories provided a similar level of pain control. Studies showed no difference in the adverse effects associated with these two interventions.
  • Various studies compared different medication routes or morphine to nonopioids. Across studies there was a 6% withdrawal rate due to adverse effects.

Conclusions

The literature demonstrates the effectiveness of morphine with titration to effect. The range of doses used in studies varied widely, with the maximum dose recorded being 2000 mg/day. Mean daily dose was 110–250 mg/day. This shows effectiveness over a wide range and that oral morphine, at the correct dose for the individual, is as effective as other opioids and morphine adminstered through nonoral routes. Limited evidence shows that transdermal fentanyl is faster than oral morphine at dealing with breakthrough pain. Some evidence shows that transmucosal fentanyl may be superior to oral morphine in the treatment of breakthrough pain and that fentanyl patches are associated with fewer side effects at the same level of analgesia. Oxycodone, hydromorphone, and morphine provide comparable pain control and are associated with similar adverse events. A small number of patients appear to develop intolerable side effects as the result of using oral opioids. Findings support the effectiveness of various forms of opioids for pain control, and the appropriateness of dose titration across a wide range, with specific medication selected according to each patient's responses and preferences.

Nursing Implications

These findings show that titrating to pain relief, using modified-release opioids, is possible.

Print

Wiffen, P.J., Derry, S., Naessens, K., & Bell, R.F. (2015). Oral tapentadol for cancer pain. Cochrane Database of Systematic Reviews, 9, CD011460.

Purpose

STUDY PURPOSE: To assess the efficacy of tapentadol for relief of cancer pain

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: CENTRAL, EMBASE, MEDLINE, ClinicalTrials.gov, and WHO clinical trials registry platform
 
INCLUSION CRITERIA: Randomized, controlled trial comparing tapentadol with placebo or active control, adults with moderate to severe pain, sample size of at least 10, pain measurement using a validated instrument
 
EXCLUSION CRITERIA: None specified

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 209
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Criteria from the Cochrane Handbook for Systematic Reviews

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 4 
  • TOTAL PATIENTS INCLUDED IN REVIEW: 1,029
  • SAMPLE RANGE ACROSS STUDIES: 93–496 patients
  • KEY SAMPLE CHARACTERISTICS: Pain intensity of at least 4 on a 10-point scale, age range was 50–75 years

Phase of Care and Clinical Applications

PHASE OF CARE: Late effects and survivorship
 
APPLICATIONS: Palliative care

Results

Tapentadol was as effective as oxycodone or morphine in comparator studies. No substantial differences in side effects were seen between tapentadol and comparators.

Conclusions

Tapentadol is as effective as oxycodone or morphine for chronic pain management.

Limitations

  • Limited number of studies included
  • Mixed study quality

Nursing Implications

Tapentadol was shown to be effective for management of cancer-related pain, but little suggests that it should be considered above other opioids. Further research would be helpful. The authors suggest that a reduction of pain intensity of at least 50% should be used to establish treatment efficacy, and note that tapentadol, as with all opioids, presents challenges in terms of benefits and side effects of treatment.

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Wiese, C.H., Barrels, U.E., Graf, B.M., & Hanekop, G.G. (2009). Out-of-hospital opioid therapy of palliative care patients with \"acute dyspnoea\": A retrospective multicenter investigation. Journal of Opioid Management, 5(2), 115-122.

Study Purpose

The objective was to investigate and compare emergency medical treatment of acute dyspnea in palliative care patients with advanced-stage cancer on the basis of several emergency medical therapy schemes.

Intervention Characteristics/Basic Study Process

The study consisted of a retrospective evaluation of emergency medical treatment initiated in response to palliative client complaints of “acute dyspnea” over a 24-month period. Data collected were based on the emergency service protocol of four different German emergency medical services. Patients were categorized into five groups based on the intervention utilized by emergency physicians in the management of their dyspnea. Group 1 used therapy with morphine IV and oxygen; Group 2 used morphine IV, bronchodilator-effective drugs (IV and per inhalation), and oxygen; Group 3 used bronchodilator therapy (IV and per inhalation); Group 4 used oxygen therapy only; and Group 5 utilized no therapy. The extent to which the symptom was relieved was measured by patients’ numeric rating of intensity of dyspnea compared to extent of “vital sign normalization” on the basis of patients’ arterial oxygen saturation and respiratory rate.

Sample Characteristics

  • The sample was comprised of 116 patients.
  • Patients ranged in age from 49–91.
  • The median patient age in Group 1 was 77 years, Group 2 was 69 years, Group 3 was 73 years, Group 4 was 74 years, and Group 5 was 71 years.
  • Of the 116 patients, 47 were females and 69 were males.
  • Only patients diagnosed with advanced stage of disease (i.e., palliative stage with no feasible curative therapy alternative) were included in the current study.
  • Multiple cancer types were included.
  • Patients with advanced non-cancer disease and non-cancer related dyspnea (e.g., COPD) were excluded.
  • All 116 patients were pre-treated with opioids according to WHO III standards for symptomatic pain control. Fifty-six patients (48%) were also pre-treated with rescue opioid medication for breakthrough symptoms of acute dyspnea (estimated as 1/6 of pain opioid dose rate).

Setting

The study was conducted during multiple out-of-hospital emergency response/home visits by four emergency medical services in Germany.

Study Design

This was a retrospective, descriptive study.

Measurement Instruments/Methods

  • Numeric Rating Scale (NRS) to subjectively measure intensity of dyspnea (0 = very bad, 6 = very good)
  • Arterial oxygen saturation
  • Respiratory rate
  • Phone interview and directed survey of emergency physicians regarding expertise in emergency medical care and palliative medicine

Results

Based on improvement in respiratory rate, arterial oxygen saturation, and patient’s numeric rating of dyspnea, 47 patients (41%) experienced relief of dyspnea from emergency medical treatment. Dyspnea was relieved in 14 Group 1 patients (67%), 15 Group 2 patients (52%), 8 Group 3 patients (22%), 5 Group 4 patients (18%), and 5 Group 5 patients (71%). Though no significant differences regarding relief of dyspnea were noted between Groups 1 and 2 and between Groups 3 and 4 (P > 0.05), a statistically significant difference was noted when Groups 1 and 2 were compared to Groups 3 and 4 (P <  0.001), indicating a higher success among the two groups that utilized opioid therapy in the management of dyspnea. Only Group 5 experienced a correlation between subjective dyspnea ratings and objective measurements (i.e., oxygen saturation and respiratory rate). The high success rate in dyspnea alleviation observed in Group 5 (no medical treatment) was achieved by the transfer of a tracheostomy tube, which was the noted cause of dyspnea in five patients. Morphine was the only medication used during opioid therapy, and no respiratory sedation was noted by emergency physicians.

Conclusions

Significant relief of acute dyspnea was observed when IV opioid therapy was used as opposed to oxygen and bronchodilator therapy alone.

Limitations

The study was purely descriptive, with no structured study protocol with measures for comparison or randomization of subjects. Thoroughness and accuracy of each documented encounter analyzed is also questionable. The investigation was carried out on the basis of a German system of emergency/pre-hospital treatment options that are not wholly generalizable to the American paramedic emergency response system.

Nursing Implications

IV opioid therapy for the management of acute dyspnea in out-of-hospital encounters for palliative care patients appears to be more beneficial than use of oxygen therapy and bronchodilator (IV and per inhalation) alone. Integration of a palliative care team (preferably with 24-hour accessibility) in the subsequent alleviation of dyspnea in out-of-hospital emergency palliative encounters may prove beneficial. This study raises the question of how dyspnea among palliative care patients may be managed by pre-hospital services in the United States and pre-hospital service staff knowledge of symptom management for this group of patients.

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Wickham, R. (2010). Best practice management of CINV in oncology patients: II. Antiemetic guidelines and rationale for use. Journal of Supportive Oncology, 8(2, Suppl. 1), 10–15.

Type of Resource/Evidence-Based Process

The search strategy was not applicable or stated.

Results Provided in the Reference

This article discussed underlying shared principles in chemotherapy-induced nausea and vomiting (CINV) guidelines from the American Society of Clinical Oncology (ASCO), the Multinational Association for Supportive Care in Cancer (MASCC), and the National Comprehensive Cancer Network (NCCN).

  • Common goals among these guidelines are to prevent CINV and to identify the risk period for CINV asscociated with at least four days of moderate- and high-intensity emetogenic treatments.
  • The guidelines report that oral and IV formulations of 5-HT3 receptor antagonists are equally effective.
  • Selection of an antiemetic regimen should be based on the emetic risk of the chemotherapy being used as well as patient factors and experience.
  • Prophylactic antiemetics should be used when the risk of CINV is 10% or more.
  • A table of chemotherapeutic medications by emetogenic risk was provided. The author noted that such risk assignment does not provide for moving up the CINV risk ladder according to differing patient experience. Current guidelines are similar in terms of antiemetic regimens but only outline this for the first course of chemotherapy.
  • The article provided a brief review of current specific antiemetic recommendations provided in guidelines. Substantial differences exist between physician and nursing assignment of patient risk for delayed CINV, and limited evidence exists regarding the best approaches for breakthrough CINV.

Guidelines & Recommendations

Currently recommended agents for breakthrough CINV are prochlorperazine, metoclopramide with or without diphenhydramine, haloperidol, dexamethasone, dronabinol nabilone, lorazepam, alternating 5-HT3 receptor antagonists, olanzapine, and promethazine. The author noted that guidelines are useful, but guideline adherence can only go to a certain extent in preventing CINV, particularly with delayed symptoms, multiple-day chemotherapeutic regimens, high-dose chemotherapy, breakthrough CINV, and refractory CINV.

Nursing Implications

CINV guidelines are a good clinical tool to help clinicians implement evidence-based practice; however, their use needs to be accompanied by accurate patient assessments throughout the period of CINV risk. A standard guideline may not fit the needs of all patients and recommendations need to be viewed as a starting point for individualized patient care. More study and attention needs to be given to issues of delayed, breakthrough, and refractory CINV. This article is expert opinion-based and does not provide evidence for all information provided.

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White, V.M., Young, M., Farrelly, A., Meiser, B., Jefford, M., Williamson, E., . . . Winship, I. (2014). Randomized controlled trial of a telephone-based peer-support program for women carrying a BRCA1 or BRCA2 mutation: Impact on psychological distress. Journal of Clinical Oncology, 32, 4073–4080.

Study Purpose

To determine if peer telephone intervention would reduce distress among women with BRCA1/2.

Intervention Characteristics/Basic Study Process

Recruitment through familial cancer clinics; baseline questionnaire completed and then those who indicated interest in talking with a peer were randomly assigned to the intervention group (IG) or usual care group. Those in the IG received surveys four and six months after baseline. IG matched with peer to support. Peers were recruited and received a program manual and three days of training. Contact between peer and participant was to occur six times in a four-month period.

Sample Characteristics

  • N = 174
  • MEAN AGE: 43.56 for the IG and 43.18 for controls
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Women; BCRA1/2 mutation carriers; received genetic counseling
  • OTHER KEY SAMPLE CHARACTERISTICS: No advanced cancer; within five years of knowing genetic status; older than age 18 years

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Outpatient    
  • LOCATION: Australia

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care

Study Design

  • Single blind randomized, controlled trial

Measurement Instruments/Methods

Baseline questionnaires for socioeconomic information, cancer history and treatment, family history of cancer, age when notified of mutation status, BRCA1/2 mutation status of female relatives, risk-reducing surgeries, screening behaviors, and supportive care services used. At time 2, peer satisfaction was asked; Impact of Event Scale (IES) measuring distress; a single item question for anxiety; 16-item scale to measure unmet needs. 10-item cognitive appraisals about genetic testing scale.

Results

There was little change in the mean scores on most outcome measures during the three time points. Unmet needs was the only outcome measure that decreased consistently over time. Breast cancer distress (IES) showed a significantly lower level of stress in the IG (p < 0.01). Anxiousness and stress were  lower in the IG at the first two time points (p < 0.03), but there was no difference after that. Telephone based intervention reduced distress and unmet information needs for this group. Percent of patients contacted continued to decline over time, and by the sixth phone call less than 25% had any contact.

Conclusions

Peer support programs may be effective at reducing distress and anxiety in those who are BRCA1/2 carriers.

Limitations

  • Risk of bias (no appropriate attentional control condition)
  • Measurement validity/reliability questionable
  • Intervention expensive, impractical, or training needs
  • Subject withdrawals of 10% or greater 
  • Other limitations/explanation: Usual care is not well defined; family members in the IG were not assigned to the same peer. A high percentage of the intervention group did not have actual contact after the third call, suggesting that the duration of the intervention was not practical or accepted. Those who dropped out had higher baseline stress scores. A single-item scale was used for measurement of anxiety.

Nursing Implications

Peer support among women with genetic mutations may prove to reduce distress. This type of support may be beneficial for other patient populations. Findings from this study suggest that the greatest needs and efficacy may be in the short term, since many patients did not have contact after the third phone call. As anxiety tends to decline over time, it is unclear from this study what the actual efficacy was for anxiety.

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White, V.M., Macvean, M.L., Grogan, S., D'Este, C., Akkerman, D., Ieropoli, S., . . . Sanson-Fisher, R. (2012). Can a tailored telephone intervention delivered by volunteers reduce the supportive care needs, anxiety and depression of people with colorectal cancer? A randomised controlled trial. Psycho-Oncology, 21, 1053–1062.

Study Purpose

To assess the effectiveness of a volunteer-delivered, tailored telephone-based intervention in reducing unmet supportive care needs and elevated levels of anxiety and depression among people with colorectal cancer

Intervention Characteristics/Basic Study Process

The intervention utilized a checklist of unmet needs that patients with colorectal cancer completed. Specially trained volunteers then followed up with patients, by means of telephone consultation, to review needs and devise an action plan.

Sample Characteristics

  • The study reported on a sample of 653 patients with colorectal cancer.
  • Mean patient age was 64.57 years (SD = 9.2 years).
  • The sample was 40.5% female and 59.5% male.
  • Of sample patients, 78% were married; 49% had undergone chemotherapy, 89% had undergone surgery, and 10% had undergone radiotherapy; and almost 90% had at least a high school education.

Setting

  • Outpatient setting
  • Australia

Phase of Care and Clinical Applications

Transition phase of care

Study Design

Randomized controlled trial

Measurement Instruments/Methods

  • Supportive Care Need Survey (SCNS)
  • Hospital Anxiety and Depression Scale (HADS)
  • Nine-item colorectal cancer symptom checklist (developed for study)
  • Eleven-item questionnaire on the use of supportive care services (developed for study)
  • Medical Outcome Study Social Support Survey (MOS-SSS)

Results

  • The prevalence of elevated anxiety decreased over time in the intervention group (p < 0.01).
  • Compared to the control group, the intervention group reported a greater use of services (p < 0.01).

Conclusions

This study suggests that a volunteer-delivered, telephone-based intervention is plausible and acceptable to patients with cancer and that the intervention was effective in getting patients to use available services. This approach was associated with reduced anxiety over time, but did not have an impact on depression or prevalence of unmet needs as identified by the patients.

Limitations

  • The study design lacked an attentional control.
  • The study did not include discussion regarding supportive services utilized and whether they met patients’ unmet needs.
  • The intervention was delivered to patients three to four months postdiagnosis, and the highest period of unmet needs may actually be sooner in the treatment trajectory.

Nursing Implications

Tailoring support and interventions to only those patients with unmet needs might be a better allocation of resources while producing significant results.

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Wheat, J., Currie, G., & Coulter, K. (2007). Management of acute radiation skin toxicity with wheatgrass extract in breast radiation therapy: pilot study. Australian Journal of Medical Herbalism, 19, 77–80.

Study Purpose

To examine the potential benefits of wheatgrass extract in reducing severity and delaying the onset of acute radiation skin toxicity in breast irradiation.

Intervention Characteristics/Basic Study Process

  • Agents:  wheatgrass extract (experimental) and sorbolene cream (control). Dosage, onset of application, frequency of application, and duration of application were not identified.
  • Time Periods:  four weeks and six months after completion of radiation therapy (RT). The authors did not specify whether the first time point was the fourth week during treatment or four weeks after the completion of RT.
  • Quality of life (QOL) was measured using the Spitzer Quality of Life Index (SQLI). The timing and frequency of SQLI administration was not identified. 
  • RT:  The type and dose of RT was not identified.

Sample Characteristics

  • The sample was comprised of 20 women (10 in each treatment arm).
  • Mean age was 55.3 years in the control group and 55.0 years in the experimental group.
  • Patients had breast cancer and were treated with lumpectomy.

Setting

  • Single site
  • Australia

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

The study was a prospective, pilot, single-blind (patients), randomized, controlled clinical trial with two arms:  wheatgrass extract (experimental) and sorbolene cream (control).

Measurement Instruments/Methods

  • ONS Radiation Dermatitis scale/NCI Common Toxicity Criteria v.2     
  • SQLI:  lower scores = better performance

Results

No statistically significant difference existed between the wheatgrass group and the sorbolene group with regard to onset and peak radiodermatitis development. There was a significant difference in QOL between the wheatgrass (M = 9.5) and sorbolene (M = 9.8; p = 0.014) groups when all time periods were measured, with better QOL in the wheatgrass group.

Conclusions

The study design and results were not strong enough to include as evidence for or against wheatgrass as a deterrent to the development of radiodermatitis. 

Limitations

  • The study had a small sample size, with less than 30 patients.
  • The study groups were unequal with regard to breast and body size.
     

Nursing Implications

This potential intervention needs further study in a larger group. The findings are not valid for use as evidence at this stage of investigation.

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Weze, C., Leathard, H. L., Grange, J., Tiplady, P., & Stevens, G. (2004). Evaluation of healing by gentle touch in 35 clients with cancer. European Journal of Oncology Nursing, 8, 40–49.

Intervention Characteristics/Basic Study Process

The healing touch method was a noninvasive, noncondition-specific method in which hands were placed on various parts of the body for about 40 minutes; particular attention was given to areas of pain or discomfort. Four one-hour sessions were conducted over four to six weeks (or withdrawn).

Sample Characteristics

  • The sample was comprised of 35 patients (11 men and 23 women reported).
  • Mean age was 57 years (range 24–80).
  • About half of the sample had cancer for less than a year, and about half had cancer for one to five years.
  • Cancer types were mixed, but 40% of patients had advanced disease.

Setting

  • Outpatient center for complementary care
  • Eskdale, Cumbria

Phase of Care and Clinical Applications

Patients were undergoing the active treatment and long-term follow-up phases of care.

Study Design

The study used a one-group, pre- and posttest feasibility design.

Measurement Instruments/Methods

  • EuroQol EQ-5D
  • Visual analog scales:  Sleep disturbance was scored from 0 to 3 (sleeping too much), 4 to 7 (sleeping well), and 8 to 10 (sleeping poorly).

Results

A statistically significant improvement was found from pre- to posttest for sleep disturbance.

Limitations

  • The study had a small sample size.
  • Healthcare providers must be trained in healing touch.
  • Participants’ baseline scores served as their own controls.
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