To compare outcomes between women receiving the tolerable upper limit intake of vitamin D3 to those receiving recommended dietary allowances.

Patients were randomized to receive either usual recommended dose or 4,000 IU vitamin D3 and 1,000 mg calcium carbonate. Participants had a four-week run-in period with 600 IU to normalize serum levels, and then received treatment according to random assignment. Treatment was given for six months. Adherence was determined by pill counts at study visits and symptoms were monitored through weekly diaries.

• N = 113   
• AGE: Mean = 60.9 years (SD = 8.8)
• FEMALES: 100%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: Breast cancer receiving aromatase inhibitors and experiencing AIMSS
• OTHER KEY SAMPLE CHARACTERISTICS: Patients had been on AI treatment an average of 19.9 months, and 54% had prior chemotherapy.

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

PHASE OF CARE: Late effects and survivorship

Double-blind RCT

• Australian/Canadian osteoarthritis hand index
• Western Ontario and McMaster osteoarthritis index (WOMAC)
• Breast cancer trial symptom scale-musculoskeletal subscale (BCPT-MS)
• Handgrip strength
• Serum hormone and 25(OH)D levels
• Use of analgesics

In the intervention group, serum total and free 25(OH)D levels increased (p < 0.0001).  After six months, there were no differences in outcome measurement scores between groups.

High-dose vitamin D3 did not results in improvement in AI-related musculoskeletal symptoms.

No information on use of analgesics is provided

This study did not show an effect of high-dose vitamin D3 for musculoskeletal side effects associated with AI treatment.

To directly compare fentanyl sublingual tablets (FST) and subcutaneous morphine (SCM) in the first 30 minutes of a severe breakthrough pain episode.

Patients were randomly assigned to receive FST or SCM. Placebo was saline solution or a sublingual tablet reproducing the fentanyl preparation. Re-medication was available after 30 minutes for patients who did not achieve at least a 2-point reduction in pain. Average pain scores were obtained at baseline, 10, 20, 30, and 60 minutes. SCM was given at a 5 mg dose, and the dose for FST was 100 mcg. A non-inferiority margin of 1 point on the pain scale was used.

• N = 113   
• AGE: Mean = 60 years (range = 23-88)
• MALES: 48.7%  
• FEMALES: 51.3%
• KEY DISEASE CHARACTERISTICS: Multiple tumor types; GI and urogenital were most common
• OTHER KEY SAMPLE CHARACTERISTICS: Current pain of 6 or greater on a 1 to 10 numeric pain scale. Well-controlled background pain for previous 24 hours. Median pain intensity was 7.5 in both groups.

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

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

Double-blind, double dummy, noninferiority RCT

Numeric rating scale

Overall there was no significant difference in change of pain intensity between groups; however, non-inferiority of FST was not shown because the difference between groups was less than the margin established for testing. Patients tended to prefer the tablet rather than subcutaneous injection.

Subcutaneous morphine showed slightly better efficacy than the fentanyl tablet for reducing breakthrough pain intensity. Both approaches were effective.

Risk of bias (no blinding)

This study showed that both fentanyl sublingual tablets and subcutaneous morphine were effective in reducing the intensity of breakthrough pain. Findings here showed slightly better efficacy of the subcutaneous morphine, though patients preferred the tablet.

STUDY PURPOSE: To evaluate different oral or transmucosal fentanyl formulations for breatkthrough pain

TYPE OF STUDY: Systematic review

DATABASES USED: MEDLINE, EMBASE, Cochrane Collaboration through June 2012

INCLUSION CRITERIA: Not specified

EXCLUSION CRITERIA: Not specified

TOTAL REFERENCES RETRIEVED: 414

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Risk of bias assessment based on Cochrane, approach GRADE system classification. Lack of detail in some studies did not allow for risk of bias determination.

FINAL NUMBER STUDIES INCLUDED: 11

TOTAL PATIENTS INCLUDED IN REVIEW: 1,121

SAMPLE RANGE ACROSS STUDIES: 25 to 139

PHASE OF CARE: Late effects and survivorship

Fentanyl buccal tablets: 2 studies
Oral transmucosal fentanyl citrate: 5 studies
Sublingual fentanyl citrate tablets: 2 studies
Fentanyl buccal soluble film: 1 study
Intranasal fentanyl spray: 2 studies
Fentanyl pectin nasal spray: 4 studies
All oral and intranasal formulations seem to be effective treatment for breakthrough episodes and it is not possible to conclude that any formulation is superior to others. There is limited information regarding long-term safety. Transmucosal opioids appear to be superior to immediate-release morphine.

Transmucosal opioids are effective for managing breakthrough pain and appear to be superior to immediate-release opioid.

• Limited number of studies included
• Studies are rather old and many additional studies have been published since the end date of this search

Transmucosal opioids are effective for management of breakthrough pain. Nurses can advocate for use of these formulations which appear to be superior to immediate-release morphine. Transmucosal opioids have more rapid onset, which is important for breakthrough pain. There are varied methods for establishing dosages to be used and further work to identify most effective methods for dose determination would be helpful.

To investigate the effectiveness of wound analgesia for pain in patients undergoing lung cancer resection

Patients were randomly allocated to receive either continuous surgical wound site infusion of bupivacaine or normal saline as a placebo control. All patients use PCA postoperatively. All patients received a standardized anesthetic management. After surgery, all had IV PCA of 5 mg bolus morphine followed by 1.2 mg per hour with a 5-10 minutes lockout for the first 48 hours postoperatively. Additional morphine or ketorolac was given if needed due to a pain score greater than 4, at 15 mg, every 6 to 8 hours. No oral pain medications were used. Cytokine levels were measured before surgery and at 6, 12, 24, 48, and 72 hours postoperatively.

• N = 55   
• AGE: Mean = 63 years
• MALES: 58%  
• FEMALES: 42%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: Non-small cell lung cancer; 96% had lobectomy

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

PHASE OF CARE: Active anti-tumor treatment

Double-blind, placebo-controlled RCT

• VAS for pain
• Pulmonary function tests FVC% and FEV1%
• Analgesic requirement
• Blood samples for cytokine levels

Cytokines IL6, IL10, and TNF alpha were significantly lower in the wound analgesia group (p < 0.001). Pain scores were consistently lower in the wound analgesia group at all time points in the study at rest (p < 0.001) and after coughing (p = 0.01). Those in the wound analgesia group required less additional morphine (p = 0.03) or ketorolac (p = 0.01) compared to the placebo group. The wound analgesia group had faster recovery of FEV1 (p = 0.01) and FVC (p = 0.02). There were no adverse events associated with the analgesia.

Wound analgesia infusion was effective for postoperative pain control, reduction in cytokine levels, and faster recovery of pulmonary function after lung resection.

Small sample (< 100)

This study adds to a growing body of evidence showing effectiveness of wound analgesia for management of postoperative pain. Nurses can advocate for consideration of this type of approach for postoperative pain management in their patients.

To assess the feasibility of conducting a trial of a psycho-educational intervention involving the provision of tailored information and coaching to improve management of a cancer-related symptom cluster (fatigue, pain, and sleep disturbance) and reduce symptom cluster effects on patient health outcomes in the Vietnamese context, and to undertake a preliminary evaluation of the intervention.

A parallel-group, single-blind, pilot, quasiexperimental trial with pre-/post-test follow up was conducted in a cancer department of a general public hospital in Hanoi, Vietnam. Participants in the control group received standard treatment. Patient assigned to the intervention group received the psycho-educational program which consisted of three individualized psychoeducational sessions of up to one hour, tailored to meet patient’s major symptom concerns. Strategies such as energy conservation and restorative activities for fatigue management, sleep hygiene for sleep disturbance, and adherence to prescribed therapy for pain management were explored. A patient self-management booklet was provided at the first session to facilitate education and support.

• N: 102 
• MEAN AGE: 55.86 years
• MALES: 40%  
• FEMALES: 60%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Gastrointestinal, breast, lung, hepatic, and hematologic malignancies

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: Hanoi, Vietnam

• PHASE OF CARE: Active anti-tumor treatment
• APPLICATIONS: Elder care, palliative care

Single-blind, pilot, quasi-experimental trial with pre-/post-test follow up.

• Numerical Analogue Scales (NAS)
• Brief Fatigue Inventory (BFI)
• Brief Pain Inventory (BPI)
• Hospital Anxiety and Depression Scale
• EuroQol-5D-5L
• Intervention Rating Profile-15
• Symptom self-management diary

The intervention group demonstrated a significant reduction in symptom cluster severity (p < 0.0001), fatigue severity, fatigue interference (p = 0.03), sleep disturbance (p < 0.0001), depression, and anxiety when compared to the control group. For fatigue severity, while the intervention group witnessed no change in fatigue severity (p = 0.4), the control group observed a significant increase (p = 0.01). Depression (p = 0.004) and anxiety (p < 0.0001) decreased significantly in the intervention group, there was significant increase in depression (p = 0.04) and no change in anxiety (p = 0.08) in the control group. There were no significant differences in pain severity, pain interference, functional status, or health-related quality of life.

Psychoeducational interventions may help to achieve improvement in some symptoms such as fatigue and sleep disturbances, but future RCTs are needed to test the effectiveness of a symptom cluster intervention in Vietnam.

• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Findings not generalizable
• Other limitations/explanation: Non-strict patient randomization, potential for placebo or social desirability effects.

Study provides preliminary evidence to support potential efficacy of a psycho-education intervention in improving symptom cluster severity, fatigue burden, sleep disturbance, and psychological distress.

To determine if an educational and support intervention could reduce pain during mammography

The day before mammography, women were randomized to a usual care control group or the experimental group. The experimental group received a standardized nursing intervention consisting of 10 minutes of face-to-face education about the procedure and accompanying the women during the procedure to provide support and answer questions. Pain was assessed in all women immediately after the test and 10 minutes later. Anxiety was measured prior to the procedure.

• N = 436   
• AGE: 54.3% were younger than age 60 years
• FEMALES: 100%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: All were undergoing breast cancer screening
• OTHER KEY SAMPLE CHARACTERISTICS: 72% had no or only primary school education. 96% had previous mammographies.

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

PHASE OF CARE: Diagnostic

RCT

• Visual analog scale for pain
• Speilberger State Trait Anxiety Inventory

State anxiety prior to the mammography was higher in the control group (p = 0.03). In the control group, 26.3% experienced pain, compared to 19% of the experimental group (OR = 0.44, 95% CI [0.24, 0.81]). The intervention was only shown to be effective in women who did not expect pain and did not fear outcomes of the screening.

The education and support intervention provided appeared to reduce pain associated with mammography, particularly for women who had an expectation of pain or feared screening outcomes.

• Baseline sample/group differences of import
• Risk of bias (no blinding)

A psychoeducational intervention by nurses was helpful to reduce post-mammography pain among women undergoing screening mammography.

To evaluate the efficacy of dexmedetomidine in combination with bupivacaine for analgesia with paravertebral block

Women undergoing breast cancer surgery receiving a paravertebral block were randomized to receive only bupivacaine, the combination of bupivacaine and dexmetedomidine in the block, or a sham block. All had the same general anesthesia and received IV PCA with morphine for postoperative pain management. All were premedicated with oral diazepam two hours prior to surgery. Vital signs, pain scores, and sedation scores were recorded every 30 minutes for the first two hours, and then at 4, 8, and 24 hours after surgery. Morphine 1.5 mg was given every five minutes until pain level was 3 or less, when pain score was 3 or greater.

• N: 45   
• AGE: Mean = 47.27 years
• FEMALES: 100%
• CURRENT TREATMENT:  Other
• KEY DISEASE CHARACTERISTICS: Breast cancer undergoing unilateral breast surgery

Double-blind, sham, controlled RCT

• Numeric pain rating scale
• Richmond Agitation Sedation Score 
• Time to first analgesic request: NRS of 3 or greater
• Cumulative morphine consumption
• Time to mobilization

There were no significant differences across groups in duration of surgery or duration of anesthesia. Total morphine consumption was significantly lower in the group who received the combination of dexmetedomidine and bupivacaine compared to the other groups (p < 0.001). Pain intensity scores were significantly lower in this group compared to the others at all time points both at rest and on movement (p < 0.001).

Paravertebral block with the cominbation of dexedetomidine and bupivacaine was associated with better postoperative pain control in this group of patients.

Small sample (< 100)

Use of dexmedetomidine as an adjunct to bupivacaine in paravertebral block was effective for reduction in postoperative pain and overall opioid consumption in this study. This study was limited by its small sample size. Additional research in this approach is warranted.

To examine the effect of music on patients undergoing HCT with the purpose of reducing social confinement in this group of patients

Patients were assigned to music and control groups by a throw of dice. Live music sessions with a therapist were done in the patient’s room twice weekly for 30 minutes each. Study assessments were done at the end of music therapy sessions.

• N = 100   
• AGE: Mean = 33.35 years
• MALES: 55%  
• FEMALES: 45%
• CURRENT TREATMENT: Combination radiation and chemotherapy
• KEY DISEASE CHARACTERISTICS: All were undergoing HCT; most were allogeneic

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

PHASE OF CARE: Active anti-tumor treatment

RCT

Visual analog scale (VAS) for pain and anxiety

Anxiety was lower in the music group after the first (p < 0.001) and last sessions (p = 0.002). Pain was lower after the first music session in the music group but, at study completion, there was no difference between groups in pain.

Music may help to alleviate anxiety associated with social isolation in patients undergoing HCT.

• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Measurement validity/reliability questionable
• Other limitations/explanation: Only post-measurement of symptoms, so no data regarding if symptom levels changed with music. The duration of the study was not described, so timeframe of final measurement for both groups is unclear. VAS measurement for anxiety not validated. No way to tell if baseline anxiety was clinically relevant or not, there were no baseline measures

This study showed that music therapy may be helpful for patients undergoing HCT in terms of anxiety. This study has multiple design limitations. Music therapy is a low-risk intervention; however, it does require staff time of a music therapist. Further research regarding benefit of live music therapy versus listening to music would be helpful.

STUDY PURPOSE: To assess the evidence of efficacy of massage in treating pain and function and quality-of-life issues in cancer populations

TYPE OF STUDY: Meta analysis and systematic review

DATABASES USED: PubMed CINAHL, Embase, PsycINFO

INCLUSION CRITERIA: Patients with pain, massage therapy, if provided as part of multimodal interventions, effects could be separately evaluated, RCT, 

EXCLUSION CRITERIA: Interventions provided by tools, such as chair massage

TOTAL REFERENCES RETRIEVED: 4,099

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Scottish Intercollegiate Guidelines Network checklist for study quality, and the External Validity Assessment Tool to measure generalizability of results. Standards for reporting interventions for clinical trials of acupuncture (STRICTA) were adapted for application to studies using massage, and applied for study evaluation. Most studies were determined to be acceptable–four were deemed low quality. Only 18.8% of studies described the amount of time massaging a location.

FINAL NUMBER STUDIES INCLUDED: 16, with 12 in meta analysis

PHASE OF CARE: Not specified or not applicable     

APPLICATIONS: Palliative care

Massage versus no treatment: three studies (167 patients) compared massage to no treatment for pain severity, Although the SMD overall was significant, heterogeneity was high. No recommendation could be made regarding massage versus no treatment.

Massage versus active comparator: 10 studies (708 patients) compared massage to various attention control comparisons or usual care. Six of these were pooled for analysis, and showed reduction in pain intensity, but this was not statistically significant.

Massage versus active comparators for fatigue: six studies (539 patients) yielded an SMD of -1.06, but this was not statistically significant, and there was high heterogeneity.

This analysis showed favorable effects of massage for fatigue and pain intensity; however, overall results were not statistically significant.

• Limited number of studies included
• High heterogeneity
• Method of measurement used for fatigue is not discussed.

Massage is a low-risk intervention that might be helpful for some people in dealing with pain and fatigue. This analysis provided only weak evidence in favor of this intervention

To compare the effects of local infiltration of bupivacaine with nerve block for pain control with mastectomy

Electronic health records of all patients who had mastectomy with immediate tissue expander reconstruction were used for data collection. Pain scores from the recovery room and surgical units were obtained and average pain scores for postoperative days 1-2 were used in analysis. All opioids used intraoperatively and postoperatively were converted to oral morphine equivalents.

• N = 97   
• FEMALES: 100%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: All had breast cancer 
• OTHER KEY SAMPLE CHARACTERISTICS: The majority had unilateral mastectomy with no ALND.  There was no difference between groups in intraoperative time or recovery room time.

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Mayo Clinic, Rochester

PHASE OF CARE: Active anti-tumor treatment

Retrospective cohort analysis

• Pain score on numeric scale 
• Time to first opioid postoperatively
• Antiemetic use on day 1

Opioid use in the recovery room was significantly lower in those who had local bupavacaine injection (p < 0.001). Day of surgery pain scores were lower with bupavacain (p = 0.008). Fewer patient in the bupavaine group required antiemetics (p = 0.03) and waited longer for the first dose of opioid after surgery (p = 0.006). Daily average pain was lower with bupivacaine (p = 0.05), and total opioid consumption was slightly lower.

Local infusion of bupivacaine appeared to be more effective that paravertebral block for postoperative pain control in this group of patients.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)

Nurses can advocate for consideration of local anesthetic infiltration for pain control in patients undergoing mastectomy.