To identify best practices for the management of constipation in patients with advanced progressive disease.

In this consensus-based guideline, the literature was reviewed and a multidisciplinary group met to develop the consensus statement. The guideline was revised and reviewed several times prior to publication.

Databases searched were PubMed and the Cochrane Library.

Search keywords were constipation, palliative care, advanced illness, laxatives, management, guidelines, and recommendations.

Inclusion and exclusion criteria were not provided.

• Patients were undergoing the end-of-life or palliative phase of care.
• The study has clinical applicability for palliative care.

This information was not provided. The consensus statement included only 20 references.

The consensus statement included information on the components of patient assessment, history, rectal and abdominal examination, management, goal development, and pharmacologic and nonpharmacologic interventions, as well as a best practice summary. Nonpharmacologic recommendations included maintaining adequate fluid and fiber intake, mobility, optimizing toileting with privacy, and positioning. Pharmacologic recommendations included selection of laxatives based on patient symptoms and preferences, as well as use of methylnaltrexone with opioid-induced constipation for patients who fail to respond to optimal laxative therapy. Osmotic laxatives, polyethylene glycol (PEG), and lactulose are supported by high-level evidence. Docusates and mineral oil should not be used.

• Patients with cancer were not identified as a specific target of the review.
• The number of articles reviewed to develop the consensus statement was not provided.

The consensus statement included a summary in outline format that reviewed the information provided in the body of the article. The summary is the most useful section of the document as the information is concise but contains adequate detail. No new information is provided. In addition, a decision tree was included that may be useful. Regular assessment is needed for the management of patients with constipation.

To evaluate the safety and effectiveness of magnetic resonance–guided focused ultrasound palliative treatment of bone metastases in patients with painful metastatic bone lesions for which other treatment was either not effective or not feasible

The procedure was done with patients in the magnetic resonance imaging (MRI) scanner under conscious sedation and analgesia with 5–10 mg midazolam and 2–40 mg IV morphine. The dosage was determined by the patients’ previous levels of opioid treatment. Pretreatment MRI and computed tomography (CT) scans were used to identify the treatment region. Each patient was positioned on a table over a water bath containing the ultrasound transducer so that the targeted lesions were positioned over the water bath. At the beginning of the procedure, low-power sonications were done to ensure targeting accuracy, and then treatment at therapeutic power levels was done. Proton resonance frequency shift in water temperature was used to monitor accuracy of the treatment location. At the end of the procedure, contrast-enhanced MRI was used to ensure that ablation was confined to the target tissue and that there was no significant damage to surrounding tissue. Patients had follow-up at three days, two weeks, one month, and three months after treatment. When possible, follow-up was also done at six months. The three-month visit included MR scan and CT imaging. Treatment response was categorized according to criteria of the International Bone Metastases Working Party guidelines on palliative radiotherapy endpoints (partial response was a two-point drop in visual analog scale score (VAS) with no increase in pain medication, or a drop of 25% in pain medication without increase in the pain score).

• The study reported on 31 patients.
• Mean patient age was 61 years (range = 40–85 years).
• The sample was 51.6% female and 48.4% male.
• Breast cancer was the most common tumor type, all patients had bone pain with bone metastases, and 67.7%  had prior radiation to the treatment site.

• Multisite
• Setting not specified
• Israel, Germany, and Canada

• Patients were receiving end-of-life and palliative care.
• The study has clinical applicability for late effects and survivorship.

The study was a prospective, uncontrolled trial.

VAS for pain level  

Thirty-six treatments were done, targeting 32 lesions. Average length of treatment was 66 minutes (range = 22–162 minutes). Average sonication energy was 1,135 joules (range = 440–1890 J). No device-related adverse events were reported. Twenty-five patients reached the three-month follow-up time point. In these evaluable patients, mean VAS score before treatment was 5.9; at three days after treatment, mean score was 3.8; and at three months, mean score was 1.8 (p < 0.003). At three months, 72% of patients had a significant reduction in pain (> 2 points), and 50% of patients had no pain. Overall, 36% had complete response and 36% had partial response as defined by the criteria used.

Findings demonstrated effective palliation of bone pain with MR-guided focused ultrasound treatment.

• The study had a small sample, with less than 100 participants.
• The study lacked a comparison or control group or blinding.
• The authors noted that, in some cases, pain assessment at very specific bone sites was not possible, and this may have contributed to the apparent rate of treatment failures. There were also difficulties in positioning the patient over the water bath, depending on the location of the bone lesion.

This procedure has promise for control of pain from bone metastases in patients who have not responded to other treatment, and, with further research, may have the potential for broader application. Further well-designed research comparing outcomes with this procedure versus that of other current approaches is warranted. Additional research to identify predictors of positive outcomes and those patients for whom this is most likely to be effective and practical according to lesion location would be useful.

To review the efficacy of complex decongestive physiotherapy (CDP) in patients with malignant lymphedema (LE) and to identify predictors for and characteristics of outcomes

• N = 29
• AVERAGE AGE = 49.2 years
• MALES: 6.9%, FEMALES: 93.1%
• KEY DISEASE CHARACTERISTICS: Malignant LE was defined as a percentage of excess volume greater than 5%. Patients had stage 4 cancer with a local regional recurrence. The acute onset or rapid progression of disease was present. Patients had combined skin ulcers, pain, paresthesia, or paralysis.
• OTHER KEY SAMPLE CHARACTERISTICS: Duration of LE, LE stage, pain rating scale, and range of motion of shoulder and knee

• SITE: Single site    
• SETTING TYPE: Outpatient    
• LOCATION: Changhua Christian Hospital Department of Physical Medicine and Rehabilitation in Taiwan

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

Retrospective

• Numeric Rating Scale (NRS) 0–10 for pain
• Circumferential volume measurements
• Percentage excess volume (PEV)
• Percentage reduction of excess volume (PREV)
• Descriptive statistics with categorical variables, nonparametric test, and mcNemar test

Excess circumference decreased, and CDP efficacy as defined by the PREV was 46.6%. Pain scores improved from 4.8 to 2.8. Shoulder range of motion improved from a mean of 151.7 to 159.7.

The authors demonstrated that intensive CDP improved lymphedema volume, pain, heaviness, tension, and range of motion in a small study of patients with malignant LE.

• Small sample (< 30)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results
• Other limitations/explanation: No quality of life measurement was used. Bandaging techniques were not clearly identified.

Previous thoughts or teachings may have suggested that cancer could be spread by manual lymphatic drainage. This study shows the importance of early treatment in patients with malignant LE with CDP, providing improvements in limb volume and range of motion. Patient tolerance and variations in bandaging were not clearly identified in this study, and these may require modifications to the patient’s comfort level.

To estimate the efficacy of and predictive factors for response to complete decongestive physical (CDP) therapy in women with breast cancer-related lymphedema

Retrospective review of records was done to describe results of a CDP program and analyze factors that might predict outcomes and CDP response. The CDP program consisted of 10–26 sessions of manual lymph drainage, compression therapy for 23 hours per day, remedial exercise, and skin and nail care instructions.

• The sample consisted of 107 female patients with breast cancer.
• Mean age of the sample was 52.8 years with a range of 26–74 years.
• Eighty-eight percent of the patients had modified radical mastectomy (all but one had axillary lymph node excision), and 64.5% had radiation therapy.
• Average duration of lymphedema was 22.4 months, and average baseline excess volume was 504. 

The study was conducted at a single-site, outpatient setting in Taiwan.

Patients were undergoing mutliple treatment phases of care.

 The study used a retrospective, observational design.

• Arm circumference measures were used to determine arm volume.
• Arm volume difference of at least 5% was defined as lymphedema.
   

• Post CDP, lymphedema volume decreased 226 ml (SD = 129 ml, range 790, -30).
• Baseline lymphedema severity and younger age were correlated with better response to CDP.
• Type of surgery and radiotherapy were not significantly correlated with lymphedema severity or CDP response.

 Findings suggest that baseline lymphedema and age are significantly related to longer-term response to CDP for lymphedema management.

• The study had no control group or binding and was not randomized.
• Other interventions that may have been used that could affect results were not described.
• The study was a retrospective design. 
• No information was given about compliance with compression bandaging.

This study provides little new information regarding efficacy of CDP in management of lymphedema in women with breast cancer. Findings show that initial severity of lymphedema may predict response to CDP, which suggests that early intervention for lymphedema can be important.

To evaluate the efficacy of an intensive complete decongestive physical (CDP) therapy program and identify predictive factors of response in lower-limb lymphedema

Women with unilateral LLL underwent a CDP program of 10–24 sessions that included 45 minutes of manual lymph drainage, compression therapy for 23 hours a day, and remedial exercise and instructions for skin and nail care.

• The sample was comprised of 44 female patients.
• Mean age of the sample was 62.2 years with a range of 38–83 years.
• All patients had cervical, endometrial, or ovarian cancers. 
• Lymphedema onset was an average of 64 months after treatment.
• Average excess volume in the affected limb was 1,764 ml with a range of 296 ml–4,112. 
• Forty-one percent of patients had radiotherapy.

The study was conducted at a single-site with multiple settings in Taiwan.

The study looked at mutliple phases of care.

The study used a retrospective review design.

Circumference measurements were used to calculate lymphedema volume.

• Post CDP lymphedema volume decreased an average of 755 ml and percentage of excess volume (PEV) comparison to the unaffected limb 18.8% (p < 0.001).
• PEV was found to be the only factor correlated with response to CDP (r = 0.57, p < 0.001).

Findings suggest that CDP is beneficial for management of lower-limb lymphedema. The lymphedema volume difference in the affected limb was directly correlated with response to CDP.

• The sample size was small with fewer than 100 patients.
• The study had no control group, binding, or randomized assignment. 
• No information was included regarding patient compliance with all aspects of the CDP program. 
• A retrospective design was used.

Findings suggest that CDP is beneficial for management of lower-limb lymphedema in patients treated for pelvic cancers. This is one of few studies for lower-limb lymphedema management. Nurses can educate and support patients in adhering to a CDP program to manage lymphedema. The authors noted that compliance with compression bandaging is a critical component of CDP, and nurses need to emphasize this with patients.

To test the hypothesis that women with suspected breast cancer who received a supportive care intervention during the diagnostic phase of care would have lower anxiety than those having usual care

The intervention was supportive care, emotional support, and educational information provided by nurses through three individual meetings and two telephone calls.

• The study reported on a sample of 114 participants.
• Mean participant age was 48.1 years.
• The sample was 100% female.
• All participants had a breast lump found through clinical examination or imaging that needed biopsy.
• Most women had no history, experience, or family history of breast disease.
• Most women had an education level of high school completion or beyond, were married or lived with partners, and had family or friends with whom to talk.

• Single site
• Outpatient setting
• Taiwan

Patients were undergoing the diagnostic phase of care.

A randomized controlled trial design was used.

State-Trait Anxiety Inventory (STAI)

Women in the intervention group had significantly lower state anxiety before biopsy and after learning the result compared to the control group (p = 0.008; p = 0.001).

Women with suspected breast cancer who received the supportive care program had lower anxiety than those receiving routine care.

• The study had no attentional control.
• Subjects in the experimental group received more time and attention than those in the control group, so the impact of the actual supportive program design versus the impact of just increased attention cannot be determined.
• Participants were not blinded to group assignment, which could have biased self-report results on the STAI.

Though resulting differences between groups were statistically significant, differences in scores between groups ranged from 1.14 to 2.12 on average, in a possible 80-point scale. The clinical relevance of this small difference is questionable, and the level of anxiety indicated by scores was still severe.

To investigate the effects of education and psychological support on anxiety, symptom distress, social support, and unmet supportive care needs of Taiwanese women newly diagnosed with breast cancer over three months following surgery

Education and psychological support was provided in the form of three individual face-to-face sessions and two telephone follow-up sessions. A standardized educational booklet was used. Sessions were done at the first postoperative visit, the first chemotherapy session, and three months after surgery. The telephone follow-up call was made seven days before chemotherapy and two months after surgery. Study measures were obtained at baseline, one month after surgery, and three months after surgery.

• N = 40 (experimental), 40 (control) 
• AVERAGE AGE = 50.7 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer, postsurgical intervention
• OTHER KEY SAMPLE CHARACTERISTICS: The majority of participants were married or living with a partner, had a higher educational level and family income, had a mastectomy versus a lumpectomy, and were undergoing chemotherapy.

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

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care, palliative care 

Two-group, nonrandomized, quasiexperimental study

All forms were in Chinese.

• State-Trait Anxiety Inventory (STAI) to measure anxiety
• Symptom Distress Scale (SDS) modified for breast cancer
• Modified Social Support Scale (SSS)
• Supportive Care Needs Survey–Short Form (SCNS-SF)

The experimental group experienced lower levels of overall unmet supportive care needs and had lower levels of unmet needs in other dimensions as well. Levels of state anxiety and symptom distress also were lower in this group. Primary concerns across groups were self-care and supportive care. Anxiety declined in both groups at similar levels by the first follow-up measure. By three months after surgery, there was a greater reduction in anxiety scores in the experimental group, which were significantly lower than those of the control group (p < .001).

The educational and psychological support components of the intervention improved the unmet supportive care needs of patients newly diagnosed with breast cancer three months after surgery.

• 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)
• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results 
• Key sample group differences that could influence results
• Other limitations/explanation: Patients were overwhelmingly married or had a partner, had a higher income, and had higher levels social support. The experimental group had significantly lower baseline state anxiety scores and significantly lower levels of unmet needs at baseline. No information was provided regarding the number of patients included in follow-up data collection; this is not reflected in the consort diagram. Usual care is not described. There is no discussion of any medication or other interventions that could have affected outcomes observed.

STUDY PURPOSE: To provide an evidence-based review to update treatment guidelines for depression in patients with cancer. Conducted analysis of pharmacologic and collaborative care interventions

TYPE OF STUDY: Meta-analysis and systematic review

• FINAL NUMBER STUDIES INCLUDED = 25 RCTs, 2 pharmacologic, 9 psychologic, 7 collaborative care
• TOTAL PATIENTS INCLUDED IN REVIEW = 3,502
• SAMPLE RANGE ACROSS STUDIES: 38–472
• KEY SAMPLE CHARACTERISTICS: Varied tumor types and multiple phases of care from active treatment to palliative care

PHASE OF CARE: Multiple phases of care
 
APPLICATIONS: Palliative care

All interventions examined had at least a short-term benefit for the treatment of depression. Pharmacologic interventions can be associated with adverse events, and psychological interventions had short-term efficacy but no long-term efficacy. Collaborative care interventions showed persistent benefit.

• Limited search
• Limited number of studies included
• High heterogeneity
• Relatively few studies for each type of intervention analyzed

Pharmacologic, psychological, and collaborative care interventions demonstrated at least a short-term benefit for the treatment of depression among patients with cancer at various treatment phases. Collaborative care interventions showed strong and sustained effectiveness, suggesting that the integration of depression treatment into oncology settings can improve patient outcomes.

To determine the impact of sertraline on executive function and quality of life in patients with advanced stage cancer and depression

At baseline, patients were evaluated for high levels of depressive symptoms. Patients with high levels were assigned to the intervention group. Patients in the intervention group were prescribed sertraline hydrochloride at 25–75 mg daily for 12 weeks. The dose of sertraline was evaluated two weeks after initiation and titrated to a therapeutic level as necessary. All patients were assessed at baseline prior to the initiation of sertraline in the intervention group and at 12 weeks. Participants were restricted from taking medications that might affect their cognitive functioning for greater than three days.

• N = 106
• MEAN AGE = 60.2 years (SD = 12.59 years)
• MALES: 53, FEMALES: 47
• KEY DISEASE CHARACTERISTICS: Stage 3 or 4 gastrointestinal, hematologic, or respiratory cancer; 86% received both chemotherapy and radiation therapy
• OTHER KEY SAMPLE CHARACTERISTICS: The mean educational level of the overall sample was 11.3 years (SD = 4.68 years). 

• SITE: Multi-site 
• SETTING TYPE: Multiple hospital settings
• LOCATION: First Affiliated Hospital of Zhejiang University, Zhejiang Hospital of Oncology, Shanxi Hospital of Oncology, China

Controlled trial with a pre- and post-trial design

• Wisconsin Card Sorting Test (WCST)
• Medical Outcomes Study Short Form survey (SF-36) 
• Hospital Anxiety and Depression Scale (HADS)
• Hamilton Anxiety Scale (HAM-A)
• Hamilton Depression Scale (HAM-D)

At baseline, patients with depressive symptoms had significantly higher scores indicating lower executive functioning than non-depressed patients on total errors, perseverative errors, nonperseverative errors, and categories achieved (p < 0.01), but not failure to maintain set as measured by the WCST. In addition, these patients had greater anxiety (p < 0.01) as measured by the HAM-A and poorer quality of life (p < 0.01) in all eight dimensions measured by the SF-36. At the 12-week follow-up, although patients in the intervention group had decreased HAM-D and HAM-A scores, scores were still significantly higher than in the control group (p < 0.05). In contrast, there were no longer any significant differences in executive functioning between groups. Similarly, because patients in the intervention group had improved scores on the SF-36 (p < 0.05), there were no longer any significant differences in quality of life between groups.

Sertraline may improve executive functioning and quality of life in patients with cancer. This improvement may be mediated by improvements in depressive symptoms.

• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (no appropriate attentional control condition)  
• Measurement/methods not well described
• Findings not generalizable
• Subject withdrawals ≥ 10% 
• Other limitations/explanation: Although participants were restricted from taking medications for greater than three days that might impact their cognitive functioning, it is unclear whether the patients might have been under the influence of those medications during their evaluation. The duration of the intervention effect is unknown because of the lack of long-term (i.e., greater than months) follow-up assessments.

Sertraline may improve executive function and quality of life in patients with advanced stage cancer and depression. However, more research with larger sample sizes, randomized group assignments, and longer follow-up is warranted to determine whether the intervention is effective and sustainable.

To evaluate the acceptability and feasibility of a couples-based coping intervention, Caring for Couples Coping with Cancer (4Cs), and to gather preliminary data on the efficacy of the intervention

A convenience sample of couples received the 4Cs intervention, a couples-based intervention delivered weekly for six weeks by a researcher or therapist to small groups of couples (three to eight). The couples received semistructured instruction using information via didactic instruction, group sharing and group interaction. Sessions were supplemented using the guidebook Live With Love: Hope for the Best, Prepare for the Worst. Assessments were made at baseline and upon completing the six-week intervention.

• N = 117 
• MEAN AGE = Caregivers; 56.8 years (range = 26–76 years), patients; 57.7 years (range = 26–79 years)
• MALES: Caregivers (33%); patients (76%), FEMALES: Caregivers (67%); patients (33%)
• KEY DISEASE CHARACTERISTICS: Gastrointestinal, lung, and urogenital cancers (55.6%, 29.9%, and 11.1%, respectively)
• OTHER KEY SAMPLE CHARACTERISTICS: Stage III and IV cancer; Chinese adult married couples

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

• PHASE OF CARE: Multiple phases of care

Nonrandomized, pre- and postintervention study

• Cancer Behavior Inventory (CBI-B)
• Dyadic Coping Inventory (DCI)
• Cancer-Related Communication Problems (CRCP-SF12)
• Hospital Anxiety and Depression Scale (HADS) 
• Benefit Finding Scale (BFS)
• Revised Dyadic Adjustment Scale (RDAS)

The 4Cs cancer program for couples was easy to recruit for, had relatively low drop-out rate, and was well-tolerated by the participants. The couples showed significant increases in self-efficacy (p < 0.01), the DCI (p < 0.05), the PCS of SF12 (p < 0.05), and positive emotions on benefit finding (p < 0.05). Participants also experienced a significant decrease in overall CRCP (p < 0.05) and anxiety (p < 0.01).

The 4Cs program was feasible to administer to couples facing cancer and appeared to have preliminary data supporting its benefit for the emotional health and coping of couples dealing with cancer.

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

The 4Cs couples-based intervention shows promise for improving couple efficacy, coping, physical health, and positive emotions. Larger, multisite, randomized, controlled trials of this intervention are needed.