To evaluate the relationship between patient expectations of postchemotherapy nausea and subsequent reports of nausea

Databases searched were MEDLINE, PsycINFO, and CINAHL.

Search keywords were expectancy, expectations, placebo effects or placebo responses with chemotherapy and nausea or emesis.

Studies were included if they

• Measured patient expectation for post-chemotherapy nausea.
• Reported occurrence, severity, or frequency of post-chemotherapy nausea.

Studies were excluded if they focused only on anticipatory nausea.

The authors independently coded the sample characteristics, the independent and dependent variables, and whether the study met the inclusion criteria for each study. Differences were discussed, and a final assessment negotiated for each study. A global effect size was calculated for each study. No formal scoring was used to assign a quality score to each study. Publication bias was addressed using the Egger test and calculations of failsafe.

• The review consisted of 17 studies.
• The average study sample size was 141 participants, ranging from 29–67, and totaling 1,497 patients.
• Patients with breast cancer were most frequently studied.
• Ten studies involved highly emetogenic chemotherapy (HEC), and four involved therapy with low emetogenic potential.

• Patients who expected to experience nausea were almost twice as likely to experience postchemotherapy nausea (pooled effect size, Cohen’s d = 0.35, OR = 2.07, p < 0.0001).
• No significant relationship was found among nausea frequency, severity, duration, or peak nausea level.
• Findings differed based on the timing of measurement in the study. Larger effect sizes were seen in studies in which post-treatment nausea was assessed after multiple infusions compared to those in which nausea was assessed after the first infusion.
• A slightly higher effect size was seen in studies that controlled for nausea history.

This meta-analysis confirmed that nausea expectations and experience of post-chemotherapy nausea are positively correlated. The discussion also identified research methods, such as incorporating expectancy-based manipulations that consider the source of the patient’s expectations, actively investigating the possible moderators of the association between expectancy and post-chemotherapy nausea (e.g., age, anxiety), and measuring the expectancies before the first chemotherapy administration.

• Methods and timing of nausea measurement varied among studies, which influenced effect sizes seen here.
• No subgroup analysis was provided based on the level of emetogenic potential of the chemotherapy, which would be expected to influence actual symptom occurrence.
• Forms for abstraction of data (no documented protocol) were not used and, therefore, not available for replication or expansion of the meta-analysis.

Prechemotherapy assessment needs to include patient expectations regarding the experience of postchemotherapy nausea. If a patient expects that he or she will experience nausea, additional evidence-based interventions to minimize nausea should be used prior to and during chemotherapy administration.

The Tibetan yoga (TY) intervention involved seven weekly sessions with a yoga instructor who used imagery and exercise and included four aspects:  controlled breathing and visualization, mindfulness, two types of posture, and daily practice. Outcomes were psychological adjustment, sleep, and fatigue.

• The sample comprised 39 (final N = 38) patients with lymphoma.
• Mean age was 51 years in both groups.

• Community outpatient setting affiliated with a comprehensive cancer center
• Southern United States

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

The study used a prospective, quasiexperimental design with two groups, including a wait-list control.

Pittsburgh Sleep Quality Index (PSQI)

The TY group reported significantly lower sleep disturbances scores (total PSQI) at follow-up (5.8 for TY versus 8.1 for the wait-list control). At follow-up, the TY group reported better subjective sleep quality, shorter latency, longer duration, and use of fewer sleep medications.

• The study had a small sample size.
• The study did not control for time since diagnosis.
• Methods of yoga taught may vary with instructor.
• Training in yoga is required.
• Costs are incurred for a space for the class and an instructor.

To compare the effectiveness of a cognitive-behavioral therapy (CBT) group intervention versus a relaxation and guided imagery (RGI) group training intervention.

The intervention groups received nine 90-minute weekly sessions, and the control group received standard care. The outcomes measured were psychological distress, sleep, fatigue, and health locus of control.

• The study was comprised of 170 patients with stage I or II breast cancer.
• Patients were between two and 12 months since surgery and were receiving treatment (chemotherapy or radiotherapy).

Oncology center in northern Israel

Patients were undergoing the active treatment phase of care.

This was a randomized, controlled trial.

• Brief Symptom Inventory (BSI)
• Fatigue Symptom Inventory (FSI)
• Perceived Stress Scale-10-item (PSS-10)
• Mini Sleep Questionnaire (MSQ)
• Multidimensional Health Locus of Control (MHLC)
• Global Severity Index (GSI)
• Adherence questionnaire with a Likert scale
   

GSI and perceived stress decreased in both intervention groups but not in the control group. Means of fatigue symptoms and sleep difficulties decreased in both intervention groups but only significantly in the RGI group. External health locus of control decreased more in the CBT group. No differences were observed among groups in internal locus of control. Participants in the RGI group reported significantly higher self-practice adherence at home than did those in the CBT group.

 

• Fifty-six of the 170 patients were excluded from the analysis due to missing more than two meetings or not completing questionnaires.
• The study required a therapist trained in CBT and RGI.
• The method of recruiting participants may have affected the generalizability of the results.
• The follow-up should have been for longer periods and with more assessment points.
   

A study design with four groups—CBT, RGI, combined CBT and RGI, and control—could shed light on whether combining CBT and RGI is more advantageous than delivering either intervention individually.

There were two groups:

1. Yoga intervention group (n = 20) 
2. Wait-list control group (n = 19). 

Randomization was performed using minimization.

Yoga sessions consisted of exercises in controlled breathing, visualization, and mindfulness with Tsa lung and Trul khor poses. Patients attended seven weekly sessions with a Tibetan yoga instructor. Written materials were provided.

• The sample was comprised of eight patients with lymphoma receiving CHOP or similar chemotherapy within 12 months posttreatment.
• Patients were predominantly female and posttreatment.
• Mean age was 51 years.
• Race and ethnicity were not reported.
• Patients were excluded if they had a psychotic illness.

• Outpatient
• Large specialized cancer center
• Classes were conducted at a Wellness Center.

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

The study was a randomized, clinical trial.

• Brief Fatigue Inventory (BFI)
• Distress:  Impact of Events Scale (IES)
• Anxiety:  State-Trait Anxiety Inventory (STAI) 
• Depression:  Center for Epidemiologic Studies Depression scale (CESD)
• Sleep disturbances:  Pittsburgh Sleep Quality Index (PSQI) 
• Measures were taken at baseline and follow-up:  posttest and one week, one month, and three months later.

No significant differences were found in fatigue.

• The study had a small sample size.
• There was a possible floor effect because the scores were low.
• The adherence rate was variable.
• Timing of the measure may be a significant confounding factor because the study included patients both on and off treatment.
• A trained Tibetan Yoga instructor was required for the delivery of the intervention.

Patients attended 90-minute weekly sessions for a total of nine weeks. The cognitive-behavior (CB) component of the intervention emphasized learning to identify negative thinking patterns and restructure them into more adaptive, stress-reducing patterns. Mental distraction, problem-solving, and decision-making strategies were also covered. The behavioral component emphasized activity scheduling, graded task assignment, behavioral distraction, and behavioral experiment techniques. Homework exercises were assigned, and written material was provided for the application of CB strategies. Relaxation and guided imagery (RGI) participants practiced deep breathing and autogenic relaxation. Each relaxation experience lasted 20 to 30 minutes, and after sessions, participants discussed their sensations, feelings, and experiences to identify and work on problems identified in the relaxation process. Strategies to overcome sleep problems were also discussed and practiced. Participants were given RGI audio cassettes for further use at home. Group size consisted of six to eight participants. Questionnaires were completed at preintervention, postintervention, and at a four-month follow-up.

The study included 114 women with early stage breast cancer (stages I and II) who were 2 to 12 months postsurgery and were receiving chemotherapy or radiotherapy.

CB Group

• Mean age was 55.9 years (range 28–74).
• Mean education was 13.5 years (range 9–20).
• Of the patients, 76.3% were married, 52.6% were unemployed, 57.9% were secular, and 60.5% received chemotherapy treatment.

RGI Group

• Mean age was 51.8 years (range 27–74).
• Mean education was 13.2 years (range 8–19).
• Of the patients, 64.1% were married, 61.5% were unemployed, 61.5% were secular, and 64.1% received chemotherapy treatment.

Control Group

• Mean age was 52.9 years (range 27–70).
• Of the patients, 81.1% were married, 64.9% were unemployed, 56.8% were secular, and 56.8% received chemotherapy treatment.

The study was conducted at a large oncology department in northern Israel.

Patients were undergoing the active treatment phase of care.

The study was a randomized, controlled trial with three groups:
•    CB (n = 38)
•    Relaxation and guided imagery (n = 39)
•    Control (n = 37).

Fatigue Symptom Inventory (FSI)

Means of the fatigue symptoms declined in both intervention groups between pre- and posttest time points, but only the decline in the RGI group was statistically significant. Similar results were observed at the four-month follow-up, and fatigue means remained significantly lower in the RGI group compared to the CB and control groups.

Study participants may have been more motivated or suffered from less psychological distress than those who did not agree to participate; therefore, the generalizability of the results is questionable. Four-month follow-up may have been too short. The authors did not measure the compliance of patients in the intervention protocols (i.e., using audiotapes on their own time).

To compare the effectiveness of a cognitive behavioral (CB) group intervention for relatives of patient with cancer with a control group
 

The cognitive behavioral (CB) intervention consisted of nine structured, 90-minute group sessions. Individual groups had five to seven participants and were conducted by a senior social worker with psycho-oncology experience as well as training in group therapy and CB therapy. Participants were provided written materials at every session and audiocassettes or compact discs for home practice of relaxation with guided imagery. The CB intervention had a cognitive and a behavioral component. Cognitive techniques were taught to identify and challenge negative and automatic thinking patterns and beliefs. Participants were taught to restructure thoughts into more adaptive patterns, reframe, problem-solve, and find alternative strategies to use with recurrent and stressful situations. Behavioral techniques taught were relaxation, guided imagery, and deep breathing.

• The sample was comprised of 104 participants assigned to a CB intervention group (n = 52) or a control group (n = 52).
• Mean age of participants was 53 years (range = 24 to 72 years).
• The sample was 66% female and 34% male.
• Caregivers did not have a present or past cancer diagnosis.
• Participant relatives were mainly spouses (49%), children (20%), parents (16%), or others (14%).
• Participant relatives’ diagnoses of cancer were breast (41%), colon (25%), prostate (9%), gynecologic (16%), and other (12%).

• Single site  
• Outpatient setting
• Haifa, Israel

Active antitumor treatment

A repeated measures, controlled trial design was used.

• Global Severity Index (GSI) was calculated as the mean of all item scores on the Brief Symptom Inventory (BSI) to assess psychological distress. Internal consistency was good, ranging from 0.87 to 0.91.
• Psychological Adjustment to Illness Scale–Self Rating (PAIS-SR): Internal consistency was good, ranging from 0.84 to 0.87.
• Mini Sleep Questionnaire was used to measure problems with falling asleep, restless sleep, and early awakening in the morning. Internal consistency was good, ranging from 0.87 to 0.89.
• Multidimensional Scale of Perceived Social Support was used to measure social support from significant others, family, and friends. Internal consistency was good, ranging from 0.92 to 0.95.
• Compliance with home practice was assessed with two questions.
   

There were significant group X time interactions for all of the psychosocial variables in the CB group but not in the control group. Significant main group effects were for psychological distress, psychosocial adjustment, and sleep problems but not for perceived support in the CB group but not the control group. Significant main time effect was for sleep difficulties and psychosocial adjustment. The between group effect size difference was 0.11–0.18.

There were significant improvements in perceived support from time 1 to time 3 (p < 0.0001) for the CB group but not for the control group.

Reliable Change Index (RCI) is a measure of clinical significance. RCI (6.5) showed clinically significant improvement in psychological distress from preintervention to follow-up in 30.8% (n = 16) of the participants in the CB  group as compared to  3.9% (n = 2) of the participants in the control group. Psychological adjustment, sleep problems, and perceived support levels for the CB group were also clinically significant (for PAIS, RCI = 2.2; for sleep difficulties, RCI = 14.8; for perceived support, RCI = 3.2).

On average, the amount of  thought monitoring was performed 2.7 (SD = 2.5) times per week at time 2 and 1.9 (SD = 1.7) times per week at time 3. Relaxation with guided imagery  was performed 3.4 (SD = 3.8) (time 2)  to 2.3 (SD = 2.9) times per week (time 3).

The results from this study indicate that the CB group intervention was effective in reducing psychological distress and sleep problems, and improving psychological adjustment for relatives of patients with cancer who participated. The CB intervention had a long-term effect that was maintained over the four-month follow-up.

Greater preintervention distress and a greater amount of  home-practice thought monitoring and relaxation/guided imagery compliance were significant predictors of the total change in participants’ level of distress.

The CB intervention was administered by a social worker who was highly experienced and familiar with psycho-oncology, group therapy, and CB therapy. Consequently, the study social worker was highly prepared to administer this CB group intervention. This indicates that the individual administering the CB intervention should be highly trained to replicate the successes of this research.
 

• The study has risk of bias due to no blinding, no randomization, and no appropriate attentional control condition. 
• Subject withdrawals were 10% or greater.
• The study had self-selection of control group participants in that they initially agreed to participate in the group intervention but could not attend due to other obligations.
• The study had a high refusal rate and losses to follow up.

The CB group intervention can be effective for improving psychological distress, psychological adjustment to illness, and sleep difficulties of relative caregivers of patients with cancer. This intervention can have both short-term and long-term psychosocial effects. Nurses can provide referrals for a CB intervention for highly distressed caregivers or those who are having sleeping problems and issues with adjustment to their relatives’ illness.

Further research is needed to replicate this study using a randomized controlled design. Additionally, an abbreviated CB intervention for relatives of patients with cancer needs to be developed for caregivers who have time constraints.
 

Yoga intervention was a seven-week Tibetan yoga (TY) program provided to patients with lymphoma who were undergoing active treatment or who had concluded treatments within the past 12 months. The TY intervention consisted of stress-reduction techniques, including:

• Regulated breathing
• Visual imagery
• Meditation and mindfulness techniques
• Various low-impact postures.

TY classes were conducted by an experienced TY instructor. After each class, participants were given an audiotape that walked them through all of the techniques. They were encouraged to practice the techniques at least once per day.

Patient characteristics used for group assignment were the type of cancer (Hodgkin or non-Hodgkin lymphoma), the status of treatment (active treatment or completed), gender, age, and baseline state anxiety scores. The allocation process was concealed from investigators. Patients were randomized and notified of their group assignment by telephone. Three separate cohorts of patients were assigned to either the TY group (n = 20) or the wait group (n = 19). The wait group was offered the program three months after the last follow-up assessment was completed. (One participant dropped out of study before attending any classes; therefore, 19 were evaluated.)

Measures were taken at baseline, one week, one month, and three months after the last session.

The study reported on 39 patients with lymphoma.

A randomized controlled trial design was used.

• Impact of Event Scale (IES)
• State-Trait Anxiety Inventor (STAI)
• Center for Epidemiologic Studies Depression Scale (CESD)
• Brief Fatigue Inventory (BFI)
• Pittsburgh Sleep Quality Index (PSQI)

There were no statistical differences between groups on the measures of psychological adjustment (intrusion or avoidance, state anxiety and depression) and fatigue. However, the TY program reduced patients’ sleep disturbances (p < 0.004).

• The study had a small sample size.
• The study used a mixed sample of patients with cancer undergoing active treatment as well as cancer survivors 12 months after treatment.
• The study had special costs associated with training (TY instructor and audiotapes).

To provide preliminary data on the diffusion of psychosocial benefit (anxiety, depressed mood, and marital quality) for women diagnosed with breast cancer when only their partners received a psychoeducational intervention focused on the breast cancer experience

Five group sessions focusing on stress-reduction and interpersonal communication were delivered to the patient’s partner. The program focused on enhancing partner adjustment to the breast cancer experience and skill training to enhance the diagnosed woman’s perceived support. Sessions focused on stress-reduction strategies, enhancing listening skills, and resisting a tendency to fix or reassure prematurely, along with nonverbal strategies to enhance their interpersonal connection.

• The study reported on a sample of nine patients and their partners.
• Mean patient age was 52.7 years (range = 32–69 years); mean partner age was 56.2 years (range = 37–68 years).
• The sample was 100% female.
• Patients had local or regional (stages 0–III) breast cancer. Time since breast cancer diagnosis was an average of 4.5 months.
• All participants were Caucasian and had a total household income of more than $80,000 per year.
• Average total years in the relationship was 26.7 (range = 5–44).

• Single site
• Outpatient clinic
• Pacific Northwest region of the United States

Patients were undergoing the diagnosis phase of care.

A pre/post-test design was used.

• Spielberger State-Trait Anxiety Inventory (STAI) Form Y – state anxiety subscale
• Center for Epidemiologic Studies – Depression scale (CES-D)
• Dyadic Adjustment Scale – 32-item test to measure marital quality
• Mutuality and Interpersonal Sensitivity Scale – 32-item cancer-specific measure of marital quality

Average patient state anxiety score improved from 44.1 preintervention to 31 postintervention (p = 0.01).

There is preliminary support for a diffusion of benefit to the diagnosed woman when a psychoeducational intervention is delivered to her partner in terms of depression and anxiety.

• The study had a small sample size.
• The sample was homogenous, with high education and income levels.
• The study had a high attrition rate (33%).

Findings may not be applicable to other socioeconomic or education level groups.

The study intended to evaluate the efficacy of homeopathy in managing menopausal symptoms.

Six homeopathic medications were  “most prescribed”: Amyl nitrosum, Calcium carbonate, Lachesis, Natrum mur, Pulsitilla, and Sepia.

Thirty-one (31) participants completed the initial consultation and one follow-up visit. Three groups of subjects were included:

1. Menopausal symptoms/no cancer history (n = 11)
2. Menopausal symptoms/breast cancer/no recent tamoxifen (n = 7)
3. Menopausal symptoms/breast cancer/taking tamoxifen (n = 13)

• Inclusion criteria: All women seen in an outpatient homeopathic clinic in Glasgow, Scotland.
• Exclusion criteria: None

The study was an uncontrolled, pilot outcome study of homeopathic treatment of hot flashes, stratified for breast cancer (yes versus no) and tamoxifen use (yes versus no).

Questionnaires assessing frequency and severity of hot flushes and changes in conventional medications that might influence hot flushes were completed at initial consultation and at follow-up visits.

The number of participants that reported improvement in hot flush frequency and severity were as follows: Group 1: 8 (73%), 8 (73%) Group 2: 6 (86%), 6 (86%) Group 3: 10 (77%), 10 (77%). There was a “clinical impression of useful benefit.\"

Study limitations included small sample size (31 participants), failure to indicate age of participants or cause of menopausal symptoms, use of unvalidated questionnaire,i nconsistent  follow-up, no descriptions of  homeopathic medications.

To document the prescription and administration of antiemetic therapy with a secondary objective of collecting data on the effectiveness of the antiemetic medications being used when possible

After each admission, pediatric patients were interviewed to assess the degree of nausea and vomiting experienced until discharge. The antiemetic medications and chemotherapy they received were documented each day. On the day following discharge, phone calls were made to assess nausea and vomiting and to record antiemetic medications used at home.

• N = 25  
• AGE RANGE = 4–16 years
• MALES: 60%, FEMALES: 40%
• KEY DISEASE CHARACTERISTICS: Variety of cancer diagnoses; aged more than four years

• SITE: Single site    
• SETTING TYPE: Inpatient  
• LOCATION: Our Lady's Children Hospital in Dublin, Ireland

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics

Prospective audit

Nausea and vomiting were assessed by the Pediatric Nausea Assessment Tool (PeNAT) and the MASCC Antiemesis Tool (MAT).

Most patients received a combination of a 5HT3 antagonist and metoclopramide. One took dexamethasone. There was no apparent association between the antiemetic prescribed and emetogenic potential of the chemotherapy taken. Vomiting increased a little from days one to five of chemotherapy administration in spite of medication, but children mainly reported no or only a little nausea (PeNAT 1 or 2). Three reported more or a lot of nausea (PeNAT 3 or 4). Anticipatory vomiting occurred in two episodes, acute vomiting in 17, and delayed vomiting in 24. Of the 20 children who did not take any antiemetics after discharge, 11 were not prescribed any. Dexamethasone was prescribed for only one patient despite evidence indicating that it should be an essential part of almost all antiemetic regimens.

The discrepancies in prescriptions to manage chemotherapy-induced nausea and vomiting were obvious. The PeNAT scale was easy to manage, but it may not have been efficient for detecting previous experience with younger children. The MAT was easy to comprehend and follow.

• Small sample (< 30)
• Baseline sample/group differences of import
• Measurement validity/reliability questionable
• Findings not generalizable
• Other limitations/explanation: In addition to the limitations of a clinical audit, children aged less than eight years old could not provide retrospective decisions on their nausea in the previous 24 hours, and nausea was difficult.
• It was difficult to assess when the child was discharged from the hospital despite the use of the PeNAT scale at home. Data related to dietary intake and degree of nausea were not obtained in this study. The emetogenic potential of the chemotherapy administered was not taken into consideration.

The timely assessment and prescription of appropriate antiemetics for children is extremely important. Educational support for families regarding the assessment of delayed chemotherapy-induced nausea and vomiting is crucial for the control of symptoms.