To review the use of corticosteroids and infliximab in the treatment of patients with immune-mediated colitis secondary to anti-CTLA-4 antibody treatment

Five patients in a phase III trial for malignant melanoma treatment who developed diarrhea after receiving anti-CTLA-4 antibody treatment were evaluated. Four patients received tremelimumab, and one received ipilimumab. All five patients presented with acute diarrhea within a median of 35 days (range 10–53) after the last anti-CTLA-4 dose. Diarrhea was defined as loose or watery, nonbloody, and occurring four to eight times daily. Laboratory results were benign, and infection diarrhea was ruled out. Each patient underwent flexible sigmoidoscopy that revealed edema, erythema, ulcerations, and fibrinopurulent exudates. All five patients were treated with high-dose corticosteroids (prednisone 40–60 mg by mouth daily) for one week. Patients with continued, relapsed, or partial response beyond one week of treatment were treated with infliximab 5 mg/kg.

• N = 5   
• AGE = 50–78 years
• MALES: 2, FEMALES: 3
• CURRENT TREATMENT: Immunotherapy
• KEY DISEASE CHARACTERISTICS: Malignant melanoma
• OTHER KEY SAMPLE CHARACTERISTICS: No previous history of unexplained diarrhea or inflammatory bowel disease, acute diarrhea after receiving anti-CTLA-4

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: Miami, FL

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

Prospective, observational trial

Case series report

Treatment with infliximab resulted in a resolution of symptoms within two to three days in all patients. Resolution was defined as a return to baseline bowel habits of one to two solid bowel movements per day. One patient had recurrence of symptoms within three weeks and was given a second treatment with infliximab with success. All patients had a four- to six-week follow-up to ensure resolution. None had a repeat sigmoidoscopy. The authors concluded that, to their knowledge, no untoward side effects to inflixamab have occurred, including infection. The discussion refers to this regimen as based on one article (Beck et al.). The discussion also raises concerning issues about the affect of infliximab on tumor response. The current authors further state that the drug could affect other immune suppressant properties, predisposing patients to serious infection and cancer progression.

Infliximab was effective in resolving immunotherapy-related diarrhea in this small group of patients.

• Small sample (< 30)
• Baseline sample/group differences of import
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Selective outcomes reporting
• Measurement/methods not well described
• Findings not generalizable

Anti-CTLA-4 antibody treatment can cause immune-mediated colitis. Nurses must be knowledgeable about advances in the treatment of immune-related adverse reactions, such as colitis.

PHASE OF CARE: Multiple phases of care

CBT-I resulted in a significant improvement on sleep efficiency relative to control from pre- to postintervention (p < 0.01), with a medium effect size pooled across studies (0.53, 95% CI [0.39; 0.68]); and improvement at six-month follow-up (p < 0.01), with effect size (0.33,  95% CI [0.11, 0.54]). There were significant improvement on sleep onset latency relative to control from pre- to postintervention (p < 0.01), with a small to medium effect size pooled across studies (0.43, 95% CI [0.27, 0.58]); and it persisted at six months (p < 0.01), with effect size pooled across studies (0.27, 95% CI [0.11, 0.44]). And, finally, there were significant improvements on wake after sleep onset from pre- to post-intervention (p < 0.01), with a small to medium effect size pooled across studies (0.41, 95% CI [0.24, 0.59]) persisting at six months (p < 0.01), with effect size pooled across studies (0.27, 95% CI [0.11, 0.44]). Overall, there were statistically significant improvements in insomnia severity following CBT-I relative to control from pre- to postintervention (p < 0.01), with a large effect size pooled across studies (0.77, 95% CI [0.6, 0.93]). Four RCTs reported data on insomnia severity at six months (p < 0.01), with effect size pooled across studies (0.54, 95% CI [0.37, 0.73]).

The results of the meta-analysis indicate that survivors of cancer treated with CBT-I showed improvements in sleep efficiency, sleep onset latency, and wake after sleep onset as measured by sleep diaries, and insomnia symptom severity as measured by the ISI when compared to the usual care, waitlist control, or active comparator conditions. In addition, the observed effects persisted at six-month follow-up, suggesting that CBT-I provides significant, lasting improvements in sleep. Future research should examine the mechanisms by which CBT-I improves sleep in the cancer population. And specifically, the relative impact of behavioral versus cognitive change is unclear.

It was not possible to directly compare the efficacy of CBT-I as delivered either individually, in a group, online, or via video. Majority of included trials were conducted in women with stage I-III breast cancer, and it is unclear how well the observed results will generalize across the cancer continuum.

Individuals diagnosed with cancer are particularly vulnerable to insomnia with a prevalence rate almost twice that of the general population (50%–60% versus 12%–25%). CBT-I was effective across diverse treatment modalities, intervention lengths, and cancer diagnoses or stages in improving sleep diary outcomes that were durable at six months.

To investigate the effectiveness of integrative medicine therapies on pain and anxiety among patients with cancer

The integrative medicine (IM) therapies included in this study were in three different categories, (a) bodywork, which included craniosacral therapy, medical massage, and reflexology, (b) mind-body and energy (MBE) therapies, which were further divided into separate categories, and (c) traditional Chinese medicine, which included acupressure, acupuncture, and Korean hand therapy. Patients could receive therapy from one category or from more than one in combination therapy.

• N = 1,833  
• MEDIAN AGE = 59 years (range = 44–74 years)
• MALES: 35.8%, FEMALES: 64.2%
• KEY DISEASE CHARACTERISTICS: Primary malignancy sites included female breast, bronchus, lung, trachea, colorectal area, hematopoietic or lymph area, and prostate. Patients with all other primary malignancies who were not included in any of these categories were grouped together into an “other” cancer site designation.

• SITE: Single site
• SETTING TYPE: Inpatient hospital
• LOCATION: Midwest United States

• PHASE OF CARE: Acute, chronic, and palliative  
• APPLICATIONS: Elder care and palliative care 

This retrospective, observational study collected data from electronic medical records.

• Pain and anxiety scores were taken by practitioners directly before and after each session using an 11-point scale on which 0 indicated no pain and 10 the worst pain imaginable.

The results of this study indicated that IM therapies need more extensive research to validate findings, suggesting a correlation between improved self-reported pain and anxiety scores and use of these therapies alone or in combination.

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

Nurses in the oncology inpatient and outpatient settings are instrumental in research evaluating pain management techniques such as IM therapies. Nurses conduct, lead, and participate in every aspect of these studies evaluating patient outcomes from pain management interventions for patients with cancer. Observational studies and qualitative research will be instrumental in developing future evidence-based guidelines.

To evaluate the effect of methylphenidate on fatigue in women with recurrent gynecologic cancer.

Women with recurrent gynecologic cancer currently receiving chemotherapy and reporting fatigue at baseline were prescribed methylphenidate. The dose started at 5 mg taken at 8 am and noon and was titrated up to 10 mg at two weeks if the patient reported a limited response. Data were obtained at baseline and two, four, and eight weeks.

• In total, 13 women were included. 
• Average age was 59 years (range 23–87).
• All patients had recurrent gynecologic cancer:  ovary (n = 25), endometrial (n = 1), cervical (n = 1), vaginal (n = 1), sex cord endometrial (n = 1), ovary and endometrial (n = 1), and unknown histology (n = 2).
• Patients were Caucasian (n = 29), Native American (n = 1), African American  (n = 1), and unknown (n = 1); no other demographic was information available.

• Single site   
• Outpatient   
• Comprehensive cancer center in the United States; University of Oklahoma

Patients were undergoing the active treatment on chemotherapy phase of care.

The study was a prospective trial.

• Fatigue Symptom Inventory (FSI) 
• Functional Assessment of Cancer Treatment–General (FACT-G)
• Brief Symptom Inventory (BSI)

Thirty-two women were initially enrolled; only 13 completed the eight-week follow-up. Scores on the FSI decreased statistically significantly from baseline at all measurement points (week 2, p = 0.0088; week 3, p = 0.0007; week 3, p = 0.0001). BSI scores also decreased, with scores at weeks 4 and 8 significantly lower than baseline (p = 0.015 and 0.0015, respectively). There was an overall change in FACT-G scores over time (p = 0.0351), with significant change in physical well-being (p = 0.0235) and emotional well-being (p = 0.0099). There was no change in family/social and functional well-being.

Methylphenidate may be beneficial to women with recurrent gynecologic cancer experiencing treatment-related fatigue.

• The study had a small sample size, with less than 100 patients.
• The study lacked a control group.
• There was significant attrition.
• The group was very select (recurrent gynecologic cancer).
• There was one treatment site in one country.
• The study lacked racial/ethnic diversity.

Findings suggest that methylphenidate may be beneficial in this small select type of patients. No adverse drug information was formally collected (the authors reported several patients withdrew from the study due to blurred vision, confusion, and dizziness but did not address whether these might be drug- or disease-related); thus, nurses would need to monitor patients closely who receive these drugs.

To assess the effectiveness, after two months, of celiac plexus block (CPB) versus thoracoscopic splanchnicectomy (TS) in patients receiving appropriate medical management (MM) for the pain of pancreatic and other abdominal malignancies

Patients were randomized to one of three treatment groups (MM, MM+CPB, or MM+TS) in blocks of three, stratified by treatment center, tumor type, and current opioid status (opioid naive, not taking strong opioids or started strong opioids within three days before recruitment, or taking strong opioids for more than three days prior to recruitment). Clinical assessments and data collection occurred at randomization, at weeks 2 and 4, and then monthly. Local researchers were not blinded to procedure. Patients completed a daily diary for two months and completed questionnaires at follow-up visits. Oral modified-release morphine was prescribed according to standard practice in each setting and increased 30%–50% as needed for pain control. Rescue medication for breakthrough pain was immediate-release oral morphine. Adjuvant analgesic agents—including amitriptyline, valproate, or gabapentin—were also used as needed for neuropathic pain. NSAIDs or dexamethasone was used for liver capsule pain. Opioid switching occurred as needed to avoid side effects or because of a patient's inability to take oral medications. Opioid rotation was not used. Patients maintained a daily diary of pain assessment.

• Of the 65 patients recruited, 47 completed the study. Authors analyzed data based on intention to treat. In the MM group were 24 patients; in the MM+CPB, 20 patients; in the MM+TS, 21 patients.
• Mean patient age in the MM group was 65.5 years; in the MM+CPB group, 60.5 years; in the MM+TS group, 60.2 years. The age range in all groups was 46–81 years.
• Of all patients, 50.8% were female and 49.2% were male.
• Patients had a confirmed unresectable malignancy of the pancreas or upper abdominal viscera and required opioid analgesia or they had pancreatic or gastric cancer before they had pain. Of the 65 patients recruited, 57 had pancreatic cancer, three had gallbladder cancer, one had bile duct cancer, one had duodenal cancer, and three had unknown malignancies.
• Patients were excluded from the study if they had had previous thoracic surgery or a history of tuberculosis or another intrathoracic inflammatory condition likely to cause extensive adhesions, if they were unfit for general anesthesia, or if they had a life expectancy of less than one month.

• Multisite
• Outpatient
• United Kingdom

Open randomized comparison

• Reduced version of the short form Brief Pain Inventory (BPI)
• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Core Module
• Adverse-event assessment by clinicians
• Opioid consumption
• Four-point Likert scale for pain assessment (assessments recorded in daily diary)

Pain relief was achieved in one third of patients at two weeks and in just under half of all patients at two months. Researchers observed no differences between groups in pain scores or total opioid consumption at any time point. Two months after randomization, 73% of subjects were taking opioids. Four serious adverse events occurred in three patients: One patient in the MM group was hospitalized for confusion eventually thought to be unrelated to the study medication, one patient was hospitalized for wound infection after TS, and one patient in the TS group had intraoperative bleeding that was resolved with sutures. Of all participants, 53% took opioids regularly during the study and 11.8% took adjuvant analgesics. Worst pain and average pain declined somewhat in all groups.

Authors reported no significant intergroup differences in pain scores or opioid consumption and no correlation between continued use of opioids and effective pain relief. The absence of any benefit from interventions led researchers to question the value of the interventions.

• The study had a small sample size, with fewer than 100 participants.
• Due to slow recruitment and poor pain responses, researchers elected to discontinue the study. Even in the MM group, one fourth of patients had stopped taking opioids at the two-month interval but reported no significant difference in pain control.
• This study did not assess the psychological and social effects of pain. This may have had an impact on pain reporting.
• Authors expressed concern about the possibility of the open design of the study influencing patients' perceptions of pain and patients' expectations regarding the treatment arm to which they were randomized.
• Authors did not report actual statistical results.
• The study was underpowered to detect differences.
• Authors did not report actual opioid doses or data regarding use of rescue medications.

The study presents insufficient evidence to support the efficacy of one treatment over the others.

To compare the efficacy of a tetrahydrocannabinol:cannabidiol (THC:CBD) extract, a nonopioid analgesic endocannabinoid system modulator, and a THC extract to the efficacy of placebo in relieving the pain of patients with advanced cancer; to compare the safety and tolerability of the treatments with those of placebo

Patients with cancer pain, who experienced inadequate analgesia despite chronic opioid dosing, were randomized to THC:CBD extract (n = 60 patients), THC extract (n = 58), or placebo (n = 59) for a two-week, multicenter randomized double-blind, placebo-controlled trial.

• The sample was composed of 177 patients.
• Mean patient age was 60.2 years.
• Of all patients, 82 were female and 95 were male.
• In the sample, the primary cancer sites were breast (29), prostate (24), and lung (20). In the sample, pain classifications included mixed pain (89), bone pain (65), neuropathic (39), visceral (37), and somatic/incident (18). Baseline morphine equivalents median was 120 mg.

• Multisite
• Hospice, hospital, and university settings
• The United Kingdom, Belgium, and Romania

Randomized, double-blind, placebo-controlled, parallel-group study

• Numeric Rating Scale (NRS), 0–10
• Brief Pain Inventory (Short Form) (BPI-SF)
• European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30) Version 3.0
• Patient-generated diary
• Analysis of covariance (ANCOVA)

• Compared to the placebo and THC groups, approximately twice as many patients in the THC:CBD group had an NRS reduction from baseline of at least 30% (THC:CBD = 23 patients [43%], THC = 12 patients [23%], placebo = 12 patients [21%]).
• The THC groups showed a nonsignificant change, similar to the change in the placebo group.
• In median dose of opioid background medication and in mean number of doses of breakthrough medication across treatment groups, authors observed no change from baseline.
• Authors noted no significant group differences in sleep quality or nausea scores or in pain control assessment. However, the EORTC QLQ-C30 showed, compared to placebo, worsening of nausea and vomiting in the THC:CBD group. The EORTC QLQ-C30 showed no worsening of nausea and vomiting in the THC group.

THC:CBD may be of benefit as an adjunct to opioid when pain is not fully controlled despite chronic opioid therapy. However, this conclusion warrants further investigation; the EORTC questionnaire showed a worsening of nausea and vomiting in the THC:CBD group, compared to the placebo group. In addition, patients in this study reported a consistent impairment of cognitive function. In addition, though authors reported at least a 30% reduction in NRS from baseline in the THC:CBD group, from baseline no change occurred, across treatment groups, in median dose of opioid background medication or mean number of doses of breakthrough medication.

• Treatment models may have varied, country to country.
• The study was very short, with a duration of only two weeks.

THC:CBD extract—a nonopioid analgesic, endocannabinoid system modulator—may be a useful adjunct in managing the pain of patients who have inadequate analgesia from chronic opioids. However, one must consider the potential side effects (i.e. nausea, vomiting, impaired cognitive functions) that may occur as a result of adding this medication.

To test whether three breathing training sessions are better than one in patients with intrathoracic malignancy experiencing breathlessness

Participants were randomized to receive either one or three hour sessions of training in four techniques (breathing control, pacing/prioritizing, relaxation, and anxiety management). Those randomized to three sessions had the sessions at intervals spaced one week apart. All participants received written and DVD/video reinforcement material and a telephone call from their therapist a week after the final session. The training was provided by the professional who would normally be responsible for completing such training at the given clinical site and included physiotherapists, occupational therapists, and a lung cancer clinical nurse specialists. At two sites, the professionals were described as being a part of a specialist palliative care breathlessness intervention service. Outcomes were measured at week 4 and compared to baseline.

• N = 156   
• MEAN AGE = 69 years
• AGE RANGE = 38–92 years
• MALES: 60%, FEMALES: 40%
• CURRENT TREATMENT: Immunotherapy
• KEY DISEASE CHARACTERISTICS: Patients had intrathoracic cancers (primary or secondary), refractory breathlessness with a self-reported intensity of less than or equal to 3 of 10 on a numerical rating scale (NRS), an expected prognosis of less than three months (clinician estimated), and no prior experience with breathing training.  
• OTHER KEY SAMPLE CHARACTERISTICS: Of note, only 3% of the participants had a non-lung cancer diagnosis (categorized in the study as “other”), 8% had mesothelioma, and 89% had primary lung cancer.

• SITE: Multi-site   
• SETTING TYPE: Multiple settings    
• LOCATION: England, Scotland, and Wales. Settings varied from hospitals, various outpatient oncology/lung/palliative/care outpatient clinics, to hospice units and patients’ homes.

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

• Randomized, controlled trial

• Patient reported worst breathlessness over last 24 hours as reports on a 1–10 NRS (primary outcome)
• Average intensity of breathlessness, distress due to breathlessness, coping with breathlessness, and satisfaction of breathlessness care as self-reported on a 0–10 NRS
• Injustice and catastrophizing scale
• Chronic Respiratory Questionnaire–Self-Administered Survey (CRQ-SAS)
• Hospital Anxiety and Depression Scale (HADS) 
• Karnofsky Performance Status Score
• EQ-5D and EQ visual analog scale (EQ VAS) for health status
• Brief COPE
• Clinical Global Impression of Change and health service utilization

• Primary outcome: Worst breathlessness as self-reported at week 4 was reduced in both groups with no significant difference between groups.
• Secondary outcomes: The average intensity of breathlessness and coping with breathlessness were similar between arms; distress and sense of mastery over breathlessness were worse in the three-session arm.

No evidence exists that three sessions of breathing training for patients with intrathoracic malignancy with breathlessness were beneficial, and no increased distress and mastery over breathlessness occurred in those receiving three sessions over one. A single session of training is recommended if breathing training is used for breathlessness.

• Risk of bias (no control group)
• Findings not generalizable
• While the study included only those with a prognosis of less than or equal to three months, 30 participants died over the eight weeks they were followed (greater than 10% of participants). While they were not dropouts, this number suggests that the prognostic inclusion criteria was difficult to control for but also that follow-up is missing on a number of the patients. Also, most of the participants had lung cancer, so study results may not be generalizable to other populations.

This study does not assess the effectiveness of breathing training over the standard of care for patients with cancer. If breathing training is considered based on other factors and other evidence, the nurse should be aware that this study does not support use of more than one session.

To investigate the long-term safety and tolerability of 9-tetrahydrocannabinol (THC)/cannabidiol (CBD) spray and THC spray in relieving pain in patients with advanced cancer

Patients who had previously participated in a two-week parent RCT to investigate the efficacy, safety, and tolerability of THC/CBD spray and THC spray in patients with cancer-related pain were invited to take part in the long-term, open-label, follow-up study. This study took place at 22 study sites in the United Kingdom and Belgium. Visits occurred at the conclusion of the RCT study or at extension study screening, 7–10 days later, then every four weeks, and at study completion or withdrawal. Adverse events, vital signs, blood sample analyses, changes in medication dosing and in current medical conditions were monitored at each visit. A pump action oromucosal spray was used to deliver the study medication. Each 100 uL actuation of THC/CBD spray delivered 2.7 mg of THC and 2.5 mg of CBD to the oral mucosa. Each actuation of THC delivered 2.7 mg of THC, and each actuation of placebo (in the parent RCT) delivered the excipients plus colorants.

N = 43  

MEAN AGE = 57.5 years for the THC/CBD group, 58.6 years for the THC group

MALES: THC/CBD: 59%, THC: 25%; FEMALES: THC/CBD: 41%, THC: 75%

KEY DISEASE CHARACTERISTICS: Breast (21%), prostate (16%), rectum (16%), lung (7%), and bone cancers (5%)

OTHER KEY SAMPLE CHARACTERISTICS: Those who had participated in the original RCT in Romania were not included in this study. The most commonly reported pain type was mixed pain, affecting more than half of all the patients, followed by neuropathic pain (37%) and bone pain (28%). Exclusion criteria included those with a history of severe cardiovascular, renal, hepatic, convulsive, or psychiatric disorder (other than depression associated with pain), patients currently taking levodopa, those pregnant or lactating or those not using adequate contraception, and those with oral cavity cancers or those whose previous treatments had included radiotherapy to the floor of the mouth.

• SITE: 22 study sites 
• SETTING TYPE: Not stated   
• LOCATION: United Kingdom and Belgium

• PHASE OF CARE: Palliative
• APPLICATIONS: Elder care, palliative care

Patients self-titrated THC/CBD spray (n = 39) or THC spray (n = 4) to symptom relief or maximum dose and were assessed regularly for safety, tolerability, and evidence of clinical benefit.

• Vital signs
• Adverse events
• Blood sample analyses
• Pain assessment
• Changes in medical condition
• Current dose of study medication
• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
• Brief Pain Inventory-Short Form (BPI-SF)

The efficacy end point of change from baseline in mean BPI-SF scores for both “pain severity” and “worst pain” domains demonstrated an improvement at each visit in the THC/CBD spray patients. The EORTC QLQ-C30 scores demonstrated an improvement from baseline in the domains of insomnia, pain, and fatigue.

Long-term use of the THC/CBD spray was generally well tolerated. No evidence was seen of a loss of effect for the relief of cancer-related pain with long-term use. Patients who continued the medication did not seek to increase their dose of THC/CBD or other pain medication over time, suggesting a useful benefit of cannabinoids in cancer-related pain.

Small sample (less than 100)

Findings not generalizable

No comparable information with the study group, making drawing conclusions from the results difficult

Discrepancy between patient continuation within the study and the level of satisfaction of clinicians with level of pain relief

For patients with cancer-related pain, pain is a major issue. The adjuvant use of cannabinoids in patient with cancer-related pain could provide a great benefit. The proportion of patients reporting satisfactory analgesia was greater for the THC/CBD spray than placebo overall. The results of this study show that patients and investigators considered that maintenance or treatment with THC/CBD spray was justified by the clinical importance of pain management in patients with cancer-related pain.

Patients assigned to the dog visit group participated in 15-minute sessions three times per week for four weeks with one or two visitor dogs. Two female dogs (a long-haired dachshund and a whippet), accompanied by a dog handler, were used. During visiting sessions, the dogs sat on the sofa with the participant. Participants combed, petted, played, and talked with the dog. The handlers ensured the participant’s safety and recorded the dog’s behavior and nature of the interaction during these sessions. Patients assigned to the friendly human visit group met with the same adult for 15-minute sessions three times per week for four weeks. Visitors were volunteer nursing students, emeritus nursing faculty, hospital administrative staff, and community members. Visitors were instructed to engage the participant in a superficial “park bench” type of conversation, such as talk about the weather, movies, and local events. All were instructed that visits should contain no discussion of personal health or controversial matters. Patients assigned to the silent reading group read research-provided magazines for 15 minutes three times per week for four weeks. Magazines were selected based on lack of content related to health and fitness, cancer and treatments, self-help, counseling, and animal-assisted therapy. Example magazines included Newsweek, Car and Driver, and Smithsonian.

• The study included 30 adults undergoing nonpalliative radiation therapy.
• The majority of participants were Caucasian (n = 28) and female (n = 21).
• Mean ages were 61, 59, and 58 years for the dog visit group, human visit group, and silent reading group, respectively.
• Most participants had some college education and were married.
• Participants had cancer at multiple sites, but the most common site was breast.
• Patients were excluded if they were younger than 18 years, non-English speaking, had known pet allergies, were more than four weeks past initial diagnosis, or were receiving radiation therapy for metastases.

Outpatient radiation therapy units of two hospitals in a midsized city in the midwestern United States

Patients were undergoing the active treatment phase of care.

The study used a longitudinal, randomized pre-/posttest design with three groups:

1. Dog visit group (n = 10)
2. Friendly human visit group (n = 10)
3. Silent reading group (n = 10).

Profile of Mood States (POMS)

Animal-assisted therapy did not result in improved fatigue compared to other groups. All groups experienced a decrease in fatigue scores between pre- and posttest scores; however, that difference did not reach statistical significance. In addition, the decline difference score for the dog visit group was smaller than the difference for both the human visit and reading groups.

• Disease progression during the time of the intervention was not measured, and worsened cancer and the accompanying symptoms may have affected the participants’ responses.
• The study had a small sample size.
• The intervention time was short.
• No neutral comparison group was included.

To determine whether an at-home weight lifting program was feasible and effective in patients with breast cancer-related lymphedema

Prior to the start of the intervention, all participants wore compression garments according to their usual protocols (determined from the previous three months, day and night or day only) for two weeks. All garments had to be less than one month old and be of at least Compression Class (CCL) II. At the end of the control period, patients introduced resistance exercises over a four-week period, beginning with five repetitions and ending with 10 repetitions maximum. If lymphedema was not exacerbated, weights were increased by .5–1 kg every other session until the 10-repetition maximum was reached. After the four-week introduction period, patients were provided with flexible dumbbells ranging from .5–12 kg and were asked to exercise three times per week with at least one day between sessions. Patients performed four sets of the following exercises in this order, resting one to three minutes between each set: 1) shoulder flexion in a standing position, 2) shoulder adduction, 3) elbow extension in a supine position, and 4) elbow flexion in sitting position. Patients used 50% of the recommended weight for the first set and the full weight for the remaining three sets. Weight resistance levels were individually adjusted according to guidelines by the American College of Sports Medicine. Patients completed a minimum of eight repetitions per set when possible, and weight was increased by .5 kg when patients could complete more than 12 repetitions per set. Participants were not required to wear a compression garment during the exercises, but they were to put it on immediately following the exercises. Data were collected at baseline and at the end of the 12-week intervention.

• N = 23 (10 women participated in an additional study)
• AVERAGE AGE = 58 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Patients had to be less than 70 years old 

• SITE: Single-site    
• SETTING TYPE: Home    
• LOCATION: Sweden

• PHASE OF CARE: Late effects and survivorship

Pre/post pilot study

• Log book (i.e., wearing compression garment, completing exercises per protocol)
• Water displacement method
• Bioelectrical impedance spectroscopy 
• Magnetic resonance imaging (MRI)
• Body weight
• Isometric muscle strength device

All patients in the study followed the minimum criteria for the protocol (exercise at least two times per week). All patients who participated had lymphedema (mean lymphedema relative volume was 19.6%, SD = 11.7%, range = 5.1%–53.5%). No significant changes in arm volume were observed during the control period. At the completion of the intervention, there was a significant reduction in absolute volume from 448 ml to 427 ml (p < .03) and relative volume from 19.2% to 18% (p < .005). Multiple muscle groups showed an improvement in strength at the conclusion of the study period (shoulder flexors p = .001, shoulder adductors p = .001, elbow flexors p = .003, and elbow extensors p = .002). Ten additional participants took part in a study with an MRI. There was no significant reduction in arm volume for these participants after the intervention.

This home-based weight lifting program did not exacerbate or worsen lymphedema in this study. Participants saw some improvement in absolute arm volume and relative arm volume at the conclusion of the 12-week study period. Additional improvements were seen in the strength of multiple muscle groups. Overall, patients found the study to be feasible, and the majority of patients were at least minimally compliant with the exercise protocol.

• Small sample (< 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)  
• Other limitations/explanation: It is unclear how much the participants exercised prior to the intervention.

A home-based exercise program was acceptable for women with lymphedema following breast cancer treatment. Women were able to complete the minimum requirements of the protocol and exercise at least twice per week for 12 weeks. Nurses should assess women for readiness to participate in home-based exercise programs and provide appropriate recommendations for those who are motivated to participate in such a program. Home-based weight lifting is safe for patients with lymphedema and does not make lymphedema worse. In addition, weight lifting improves the strength of multiple muscle groups.