To assess the long-term efficacy of a video-based behavioral therapy for insomnia (VCBT-I) as compared to a professionally administered intervention (PCBT-I) and to a no treatment group (CTL).

Participants were randomized to receive one of two types of CBT for insomnia or a control arm with no intervention. The PCBT-I arm received six weekly individual treatment sessions (50 minutes each) with a companion booklet at each session. This was administered by a psychologist or PhD student with CBT experience. The VCBT-I group received a 60-minute video, and they were instructed to watch 5–20 minutes each week and to read a companion booklet each week. They had telephone access to a licensed psychologist if they had questions. All received pre- and postintervention evaluations, as well as long-term follow-up evaluation at 3, 6, and 12 months.

• N = 242  
• AGE = 54.4 years (SD = 8.8 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Study participants had breast cancer within 18 months of completing radiation with insomnia symptoms or using hypnotic medications.  
• OTHER KEY SAMPLE CHARACTERISTICS: 63.9% were married and 92.8% were peri- or postmenopausal.

• SITE: Single site    
• SETTING TYPE: Outpatient  
• LOCATION: Quebec University Hospital, Canada

• PHASE OF CARE: Transition phase after active treatment

• Three-arm randomized, controlled trial

• Insomnia Severity Index (ISI)
• Daily sleep diary: sleep onset latency (SOL), wakefulness after sleep onset (WASO), early morning awakenings (EMA), total wake time (TWT), total sleep time (TST), sleep efficiency (SE) ratio of total sleep time: time spent in bed, and usage of hypnotic medications
• Multidimensional Fatigue Inventory (MFI)
• EORTC Cancer Quality of Life Core 30 (EORTC-QLQ-C30) global quality of life score, item #13
• Dysfunctional Beliefs and Attitudes about Sleep (DBAS)

Post-treatment to follow-up in PCBT-I arm showed significant increase in EMA and TST. The VCBT-I group showed a significant increase in WASA. The control arm showed a significant increase in all sleep variables. There was a reduction, albeit nonsignificant, in the use of hypnotics in the PCBT-I arm, a significant reduction in the VCBT-I arm, and an increase in the control arm. Insomnia remission rates were significantly higher for the PCBT-I group at three and six months when compared to the VCBT-I group. No difference existed at 12 months.

The PCBT-I and VCBT-I groups showed immediate and sustained improvement in several sleep outcomes at three- and six-month follow-ups. When compared, the face-to-face intervention was superior to the video-delivered intervention. The remission rate remained highest in the PCBT-I group. With that said, results should be interpreted with caution because of secondary to selection bias, attrition with significant differences in those who dropped out, and differences in study groups.

• Risk of bias (sample characteristics)
• Selective outcomes reporting
• Findings not generalizable
• Subject withdrawals at 10% or greater
• Not controlling for hypnotic use could affect outcomes/breast cancer only.
• Only 20% of eligible participants agreed to participate, suggesting selection bias.

Further study is needed to document alternative ways to deliver CBT interventions for improving sleep outcomes. Personalized 1:1 CBT appears to be the most effective, although when resources are limited, a video-based intervention can be substituted and does show efficacy.

To determine feasibility and assess patient satisfaction with a self-administered format of cognitive-behavioral therapy (CBT) for insomnia comorbid with cancer.

To provide initial information on the effect of self-administered CBT on subjective measures of sleep and other symptoms.

Patients were given a battery of self-report scales to complete for baseline evaluation and were then contacted by an interviewer. They underwent a 75-minute interview followed by instructions to complete a sleep diary for two weeks. Then, patients were given the self-help CBT module for insomnia. It was comprised of six modules, each with a video segment and booklet covering the following topics on sleep and insomnia:  (1) insomnia facts, (2) stimulus control therapy and sleep restriction strategies, (3) cognitive restructuring strategies, (4) revision of maladaptive sleep cognitions, (5) sleep hygiene, and (6) relapse prevention strategies. They were instructed to read one module per week for six weeks. At posttreatment and follow-up, they completed the same battery of self-report scales and sleep diaries.

• The sample was comprised of 11 female patients; seven participated in three-month follow up.
• Mean age was 51.5 years (range 37–74).
• Patients had received radiation therapy for breast cancer; 7 of 11 were undergoing active treatment versus 4 of 11 who had completed therapy 10 to 60 months before the study.
• Patients had insomnia symptoms (score of ≥8 on the Insomnia Severity Index [ISI]) or used psychotropic medications for sleep at least three nights per week.
• Patients were excluded if they had metastatic disease, cognitive impairment, or major mental or psychiatric illness.

• Single site  
• Outpatient
• Quebec radiation oncology clinic

Patients were undergoing the transition phase after initial treatment.

The study used a single-group, nonrandomized pre-/post design.

• Treatment Perception Questionnaire (TPQ)  
• Treatment Satisfaction Interview
• Insomnia Severity Index (ISI)
• Morin Sleep Diary
• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
• Dysfunctional Beliefs and Attitudes about Sleep (DBAS)
• Hospital Anxiety and Depression Scale (HADS)
• Multidimensional Fatigue Inventory (MFI)

All patients adhered to the treatment, and all found the format to be excellent and interesting. All patients reported subjective improvement in their sleep quality and motivation to continue the strategies in the future. Sleep measures showed effect sizes of large magnitude in total ISI score, wake after sleep onset, sleep onset latency, sleep efficiency, and total DBAS score. There were moderate effect sizes of HADS–Depression (HADS-D) and QOL scores, with small effect sizes for total sleep time, hypnotics usage, HADS–Anxiety (HADS-A), and MFI scores. These results were sustained at three months.

A self-help CBT strategy for insomnia in patients with breast cancer is feasible. It appears to improve sleep outcomes and dysfunctional beliefs and may improve QOL and depression.

• The study had a small sample size, with less than 30 patients.
• The study had a high drop-out rate; only 7 of 11 patients completed all evaluations at all timepoints.
• The study lacked a control group, and the study was underpowered.

Self-administered CBT for insomnia may be a good first line strategy to treat insomnia in patients with cancer. It allows for treatment at a time that is convenient to the patient and for improved access to care because it can be performed without a sleep expert present.

To test the short-term efficacy of a video-based delivery of cognitive behavioral therapy for insomnia compared to a professionally administered method and a no-treatment group

Patients with breast cancer postradiation therapy who were 18 months post-treatment with insomnia were randomized into one of three groups: a video-based cognitive behavioral therapy intervention (VB-CBTI) (60 minute video with six booklets), a professionally delivered CBTI (six weekly, 50-minute, in-person sessions), or a no-treatment group.

• N = 242
• MEAN AGE = 54.4 years (SD = 8.8 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer; 18 months postradiation therapy for nonmetastatic cancer; poor sleep defined by Insomnia Severity Index scores; sleep medication use
• OTHER KEY SAMPLE CHARACTERISTICS: Able to read French; no cognitive impairments; no psychiatric disorders; no prior diagnoses of sleep disorders other than insomnia; no nightshift work; no psychotherapy for insomnia; no language, hearing, or visual deficits; 25.6% taking antidepressants; 31% taking anxiolytics; 73% receiving hormone therapy

• SITE: Single-site
• SETTING TYPE: Outpatient    
• LOCATION: Canadian oncology and radiology department (academic)

• PHASE OF CARE: Transition phase after active treatment

Randomized, controlled, three-arm intervention study

• Mini Mental State Exam (MMSE)
• Structured Clinical Interview for DSM Disorders (SCID)
• Insomnia Severity Index (ISI) (pretreatment)
• Sleep diary
• Multidimensional Fatigue Inventory (MFI)
• Hospital Anxiety and Depression Scale (HADS)
• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (​EORTC-QLQ C30)
• Dysfunctional Beliefs and Attitudes Scale (DBAS)
• Actigraphy secondary outcomes

Group-by-time interactions were significant for sleep variables with video-based CBTI being associated with greater sleep improvements compared to the control group for sleep variables other than early-morning awakening and total sleep time (p < 0.001). There were no significant differences between in-person and video-based CBTI for sleep onset latency, wake after sleep onset, total wake time, and sleep efficiency. In-person treatment was associated with a greater reduction in ISI scores, early morning awakening, and total wake time compared to video-based CBTI. The magnitude of change over time was greater with in-person CBTI compared to video CBTI. Both interventions demonstrated a greater improvement in sleep outcomes than the control group. Actigraphy showed a significant reduction (pre/post) in the in-person group only. Secondary outcomes among the in-person group included a significant reduction in depression (p < 0.001), fatigue (p < 0.001), and dysfunctional beliefs about sleep (p < 0.001).

Both CBTIs were effective in improving sleep compared to usual care. The video format seems to be an effective treatment option, but in-person therapy continues to show better efficacy. CBTI also was associated with improvements in fatigue and depression scores.

• Subject withdrawals ≥ 10%
• Other limitations/explanation: There always is a risk for treatment contamination with randomized, controlled trials. This study was limited to patients who received radiation treatment and those willing to participate in CBTIs, which limits generalizability. There were significant baseline differences in the numbers of participants taking anxiolytics on a regular basis with the highest proportion concentrated in the control group; this could have led to an underestimation of the results of the intervention alone.

CBTIs can be challenging to implement because access to care for patients with cancer is varied. Although in-person therapy was most effective, the video-based intervention also was effective in improving sleep, fatigue, and depression outcomes. Providing options to rural populations without access to in-person care is essential for increasing efficacy in a wider population with insomnia. The findings of this study regarding the efficacy of a video-based CBTI provide nurses with another option that warrants its use as a treatment with longer effects.

The study included eight (60- to 90-minute) weekly sessions of cognitive therapy (CT), followed by three booster sessions given at three-week intervals. The focus of therapy was aimed at developing an optimistic but realistic attitude toward their situation as opposed to a negative or overly positive attitude. 

Patients were randomly assigned either to the (1) CT group or the (2) waiting list control (WLC) condition.

Outcomes were depression, anxiety, insomnia, fatigue, quality of life (QOL), and immunological measures.

The sample was comprised of 45 Caucasian women with metastatic breast disease (stage IV) with depressive symptoms determined by Hospital Anxiety and Depression Scale–Depression (HADS-D) scores.

The study was conducted at three Canadian cancer clinics.

Patients were undergoing the active treatment phase of care.

The study was a two-group clinical trial with a WLC.

• Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
• Scale for Suicide Ideation (SSI)
• HADS
• Beck Depression Inventory (BDI)
• Hamilton Depression Rating Scale (HDRS)
• Insomnia Severity Index (ISI)
• Multidimensional Fatigue Inventory (MFI)
• European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTC QLQ-C33)
• EORTC Breast Cancer Specific QOL Questionnaire Module (EORTC QLQ-BR23)
• Health Behavior Questionnaire (HBQ)
• List of Life Events (LLE)
• Immunologic Measures included lymphocyte subpopulations, natural killer cell activity, and cytokine secretion.
   

Although the group comparison was statistically significant on the HDRS measure only, comparison of means of other measures (BDI and HADS-D) revealed a reduction in depression scores in the treatment group versus the control group. In pooled group analysis, these gains were sustained. Also, when using the pooled data set only, the authors found decreased anxiety, fatigue, and insomnia symptoms. No treatment effect was found on the immune variables.

The study supports the efficacy of using CT for treating depressive symptoms in women with metastatic breast cancer.
 

• The study had a small homogenous sample.
• Patients were not severely depressed, which left less room for improvement.
• A licensed psychologist trained in CT is required to deliver treatment.

The study included eight weekly 90-minute group sessions of combined behavioral (stimulus control and sleep restriction), cognitive (cognitive restructuring), and educational (sleep hygiene, fatigue, and stress management) strategies.

Outcomes were sleep, medication use, psychological distress, and quality of life (QOL).

Patients were recruited from the community by advertisement.

The sample was comprised of 57 women who had completed radiation and chemotherapy for stage I to III breast cancer and met Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria for a chronic insomnia syndrome.

Canada

Patients were undergoing the long-term follow-up phase of care.

The study was a two-group clinical trial with a wait-list control.

• Insomnia Interview Schedule (IIS)
• Structured Clinical Interview for DSM-IV
• Sleep diary
• Polysomnography
• Insomnia Severity Index (ISI)

Treated patients showed a significantly greater improvement in sleep posttreatment as assessed by self-reported instruments. However, data from polysomnography were not significantly more improved. Treated patients reduced use of sleep medication.

• The sample was homogeneous (i.e., all white), with most being highly educated, and included a self-selected study group.
• The study used a wait-list control.
• A Master’s-level psychologist who has experience in the administration of this treatment protocol must be included.

The cognitive-behavioral therapy (CBT) intervention for insomnia consisted of eight weekly sessions of approximately 90 minutes, offered in groups of four to six patients, and delivered by a clinical psychologist. The treatment protocol was multimodal and combined behavioral (e.g., stimulus control therapy, sleep restriction), cognitive (i.e., cognitive restructuring), and educational (i.e., sleep hygiene, fatigue and stress management) strategies that were described in a treatment manual given to all participants. A booster session was offered to participants one month after the end of treatment. Missed treatment sessions were rescheduled; therefore, all patients received the entire treatment program. Outcomes were evaluated at the conclusion of the intervention, as well as at three, six, and 12 months after the end of treatment.

Fifty-seven women with stage I to III breast cancer who met the diagnostic criteria for a chronic insomnia syndrome (CBT group, n=27; comparison group, n=30) were included.

Diagnostic criteria included

• Difficulty initiating and/or maintaining sleep, whereby sleep-onset latency and/or wake after sleep onset is greater than 30 minutes
• Sleep efficiency (ratio of total sleep time to total time spent in bed) was lower than 85%
• Difficulties occurring for at least six months
• Difficulties causing marked distress or significant impairment in daytime functioning (e.g., fatigue, disturbed mood, performance deficits).

Only patients whose insomnia was judged to be secondary to cancer were included in the study (i.e., those whose sleep difficulties were caused or aggravated by the cancer diagnosis or treatment).  Most of the sample had received prior adjuvant treatment with radiation therapy (85.2%), chemotherapy (37%), or hormone therapy (59.3%).  Slightly more than one-third of the sample was currently receiving hormone therapy (37%).

Exclusion criteria included severe major depression or other serious psychiatric disorder; presence of a sleep disorder other than insomnia (e.g., sleep apnea), presence of another illness affecting the immune system (e.g., human immunodeficiency virus [HIV] infection), and regular use of a psychotropic medication other than hypnotics (e.g., antidepressants) unless the dosage used was stable in the last month and did not increase during the study; and current involvement in psychotherapy.

• Outpatient
• Large academic medical center
• Participants were recruited through flyers and pamphlets, ads placed in local newspapers, and physician referrals.

Patients were undergoing the active treatment phase of care.

This was a randomized, controlled trial, with patients randomly assigned to CBT for insomnia or a wait-list control group.

Multidimensional Fatigue Inventory (MFI)

Analysis of pooled data revealed a statistically significant improvement in fatigue from pre- to posttreatment, with maintenance of this improvement during the 12-month follow-up period.

• The fact that the study sample was primarily Caucasian and well educated and all patients were survivors of breast cancer may limit the generalization of the findings.
• The use of a wait-list control condition did not allow for the control of nonspecific therapeutic elements in the intervention, such as therapist empathy, group support, etc.
• A modest amount of continuing education, as well as access to some instructional materials for patients, are needed to prepare health care professionals to deliver CBT interventions for insomnia.

Patients received multimodal cognitive-behavioral therapy (CBT) that combined cognitive, behavioral, and educational strategies. Treatment consisted of eight weekly sessions administered in a group of four to six participants and was combined with use of stimulus control, sleep restriction, cognitive therapy, sleep hygiene, and fatigue and stress management. The treatment protocol was based on clinical procedures developed by Morin (1993) and was adapted by the investigators for the cancer population.

Fifty-seven breast cancer survivors were randomly assigned to a CBT (n=27) or waiting list condition (n=30).

Patients were included in the study if they

• Had completed radiotherapy of chemotherapy for a stage I to III breast cancer at least one month prior to enrollment
• Met the Diagnostic and Statistical Manual of Mental Disorders-Fourth Editoin (DSM-IV) diagnostic criteria for a chronic insomnia syndrome.

Patients who regularly used psychotropic medications other than hypnotics (e.g., antidepressants) were excluded unless the dosage use was stable in the last month and did not increase during the study. Individuals currently receiving psychotherapy were also excluded.

• Cancer research facility
• Participants were recruited via fliers and pamphlets, advertisements placed in local newspapers, and physician referrals.

Patients were undergoing the long-term follow-up phase of care.

This was a randomized, controlled trial with a waiting list control group and a 12-month follow-up period to assess the short- and long-term effects of the intervention.

Multidimensional Fatigue Inventory (MFI)-French Canadian version to measure fatigue

Pooled analyses within an intent-to-treat framework revealed significant differences between pre- and posttreatment on fatigue (p < 0.001). No significant difference was detected between posttreatment and the three-, six-, and 12-month evaluations of fatigue, suggesting that the clinical improvement relative to the outcome of fatigue was durable.

• Participants were primarily Caucasian and well educated.
• Of the patients, 36% who were interested in the study and had responded to the advertisement screened out or declined to participate once they heard more about the study. This may limit the generalization of the findings.
• Reasons for exclusion included severe psychiatric disorder, not meeting the DSM-IV diagnostic criteria for chronic insomnia, or having insomnia that was not judged to be secondary to cancer (some participants were also screened out due to ongoing cancer treatment).
• Approximately 20% of the individuals judged the study to be too burdensome when they learned the treatment details and declined to be enrolled.
• Use of the waiting list control condition did not allow for the control of nonspecific therapeutic ingredients.
• Trained personnel were needed to administer the CBT intervention.
• Group treatment had costs.

It is not possible to determine whether the improvements in fatigue observed in this study are attributable to the CBT strategies or to other ingredients common to all psychotherapeutic approaches (e.g., therapist empathy, group support). Sustained improvements in fatigue may also be a result of a maturation effect wherein fatigue declined as might be expected, with greater distance from treatment.

STUDY PURPOSE: To develop clinical practice guidelines on the use of antimicrobials, mucosal coating agents, anesthetics, and analgesics for the prevention and management of oral mucositis

TYPE OF STUDY: Systematic review

DATABASES USED: Ovid, MEDLINE

KEYWORDS: Acyclovir, amitriptyline, adhesive, amphotericin B, analgesic, analgesia, antacid, antibiotic, anti-infective, alfentanil, aqua oral, benzocaine, coating agent, clarithromycin, diclosan, doxepin, fentanyl, film, fluconazole, gabapentin, IB-367, hydromorphone, iseganan, kaopectate, ketamine, kefir, lidocaine, local anesthetic, “magic” or “miracle” mouthwash, mouth rinse or mouthwash, mucoadhesive, methadone, morphine, nystatin, patient controlled, polymyxin, povidone-iodine, polyvinylpyrrolidone, protegrin, sucralfate, tetracaine, tetracycline, tobramycin, topical, zilactin, xylocaine. In addition, the brand names of commercial products in these categories also were searched, including Gelclair^®, MuGard^®, and UlcerEase.

INCLUSION CRITERIA: Studies that focused on the use of antimicrobials, coating agents, anesthetics, and analgesics; English studies; published in MEDLINE on or before December 31, 2010; all age groups; and published in a peer-reviewed journal

EXCLUSION CRITERIA: Articles that did not report on effects of an intervention on mucositis, animal or in vitro studies, literature reviews, non-English papers

TOTAL REFERENCES RETRIEVED: 1,384

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Only articles that reported on the effects of an antimicrobial, mucosal coating agent, anesthetic, or analgesic on oral mucositis that met the inclusion criteria described were included in the review. Also, articles did not have any major or minor flaws per Hadorn and levels of evidence were based on the Somerfield criteria. The results were sorted into three classifications: recommendation, suggestion, and no guidelines possible.

FINAL NUMBER STUDIES INCLUDED = 62

SAMPLE RANGE ACROSS STUDIES, TOTAL PATIENTS INCLUDED IN REVIEW: Not discussed in the review

KEY SAMPLE CHARACTERISTICS: Included patients actively being treated for head and neck cancers, hematologic cancers, and solid tumors with radiotherapy, chemotherapy, chemoradiotherapy, and high-dose total body irradiation for hematopoietic stem cell transplant

PHASE OF CARE: Active treatment

Recommendations were made against the use of topical antimicrobial agents for the prevention of mucositis, including recommendations against the use of iseganan for mucositis prevention in hematopoietic stem cell transplantation (HSCT) and head and neck radiation therapy (RT) and antimicrobial lozenges for mucositis prevention in head and neck RT. Recommendations were made against the use of sucralfate for the prevention and treatment of oral mucositis due to chemotherapy or RT. Recommendations were made for the use of patient-controlled analgesia with morphine in HSCT, transdermal fentanyl in HSCT and standard-dose chemotherapy treatment, and morphine and doxepin mouth rinse in patients with head and neck cancer undergoing RT. No guidelines were recommended for any of the other agents reviewed due to insufficient or conflicting evidence.

Additional well-designed RCT studies are needed on the prevention and management of oral mucositis. Studies that look at systemic dosing and absorption may be helpful.

Lack of high-level of evidence prevented the development of guidelines in many of the agents reviewed, such as topical anesthetics, antimicrobial agents, and mucosal coating agents.

The recommendations for use in clinical practice were made for the use of patient-controlled analgesia with morphine in patients undergoing HSCT and for transdermal fentanyl in HSCT and standard-dose chemotherapy treatment, and morphine and doxepin mouth rinse in patients with head and neck cancer undergoing RT. Any use of the other agents in this study were not recommended for use in the prevention or treatment of oral mucositis and should be used with caution.

To determine the effectiveness and safety of adding olanzapine to triple antiemetic therapy with aprepitant, palonosetron, and dexamethasone as highly emetic anthracycline-containing adjuvant chemotherapy for patients with primary breast cancer

Forty-five patients with breast cancer who experienced greater than grade 1 nausea or any vomiting after the first cycle of chemotherapy using both epirubicin and cyclophosphamide were included. Low-dose olanzapine (2.5 mg per day) was administered orally from the first day of chemotherapy for four days, and the number of episodes of vomiting, scale of nausea, dietary intake, and somnolence were compared with the symptoms after the first cycle.

• N = 45   
• MEAN AGE = 49.7 (SD = 13 years)
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Patients with breast cancer receiving 5-flourouracil, epirubicin, and cyclophosfamide (FEC) or epirubicin and cyclophosphamide (EC) therapy in an adjuvant or neoadjuvant setting

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Iwate Medical University Hospital

• PHASE OF CARE: Active antitumor treatment

• Nonrandomized, prospective, phase-II trial without placebo control

• Common Terminology Criteria for Adverse Events
• Clopper-Pearson method
• Excel statistics
• Cochran-Armitage test
• Paired t-test or Dunnett t-test

The nausea was significantly improved by adding olanzapine (p < 0.05). The mean nausea scale and dietary intake were improved by adding olanzapine.

Adding low-dose olanzapine for patients with insufficient nausea relief with triplet antiemetic therapy consisting of palonosetron, a steroid, and aprepitant can be effective and is tolerable.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Key sample group differences that could influence results

Patients with breast cancer with highly emetogenic regimens containing both cyclophosphamide and anthracycline treated with triple therapy for resistant nausea could benefit from the addition of low-dose olanzapine.

To determine the benefit of an educational program on arm and shoulder function for patients with breast cancer given prior to surgery and axillary lymph node dissection three months postoperatively

• N = 149  
• AGE ≥ 20 years
• FEMALES: 100%
• OTHER KEY SAMPLE CHARACTERISTICS: Patients with breast cancer were divided into two groups, those receiving axillary lymph node dissections (ALNDs) and those receiving sentinel lymph node dissections (SLNDs). Within these two groups, patients selected to be either in the intervention or the control group. Exclusion criteria included bilateral breast cancer or recurrence.

• SITE: Single site    
• SETTING TYPE: Other    
• LOCATION: Miyagi, Japan

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Assessment of postoperative arm function

This was a longitudinal controlled trial that was not randomized. There was a control group and an intervention group.

• All measurements were taken at hospital admission, one week postoperatively when the drains were removed, one month postoperatively, and at the close of the study three months postoperatively. 
• Arm girth measurements included two points, forearm girth and upper arm girth, and comparison to the unaffected side.
• For grip strength, a standard dynamometer was used, and differences between dominant and nondominant were determined.
• Shoulder range of motion included three planes, flexion, abduction, and horizontal extension. Differences were calculated.
• Subjective Perception of Post-Operative Functional Impairment of the Arm (SPOFIA) given preoperatively
• Disabilities of the Arm, Shoulder, and Hand (DASH)

Patients with training prior to breast cancer surgery and ALND developed grip strength and perceived improved arm function compared to those who did not receive training and education. No lymphedema was assessed after two months postoperatively. The exercises and the type of intervention were not described. The outcomes of the program require additional randomized studies.

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

Patients with breast cancer usually fail to discuss many symptoms in the DASH or SPOFIA assessment tools. If patients are taught to report these symptoms and not to consider them normal or anticipated, particularly right after surgery, nurses might refer rehabilitation earlier.