The study assessed the effects of tibolone versus placebo in postmenopausal women receiving tamoxifen, measuring effects on hot flashes, endometrium, and serum lipid and lipoproteins.

Women were randomized to receive 20 mg/day tamoxifen plus 2.5 mg/day tibolone or placebo.

Seventy (70) post-menopausal women less than or equal to 75 years of age (mean age: 58. I years) with Stage IIB or less started on tamoxifen postoperatively. Sixty-seven (67) patients completed the study. I

• Inclusion criteria:
  • Post-menopausal women less than or equal to 75 years of age with newly diagnosed Stage Ilb or lower breast cancer
  • Surgical treatment with conservative therapy or modified radical mastectomy
  • Receiving tamoxifen therapy
  • Last menstrual period one year or more before the diagnosis of breast cancer
  • Serum estradiol concentration of less than or equal to 30 pg/mL
• Exclusion criteria:
  • Other malignancies; prior hysterectomy or bilateral oophorectomy; endometrial hyperplasia/adenocarcinoma; cervical smear result showing moderate dysplasia or worse
  • Cardiovascular, cerebrovascular, or thromboembolic disorders
  • Uterine bleeding of unknown cause; severe liver disorders 
  • Drug or alcohol abuse in the previous 12 months
  • Requirement for cancer therapy (other than tamoxifen therapy and radiotherapy)
  • Nedication that may affect the metabolism of tibolone
  • Use of steroids or tamoxifen in the six weeks prior to the study
  • Hormonal implants at any time

This was an outpatient, multicenter trial.

The trial was a double-blind, randomized, placebo-controlled, multicenter, pilot study.

The trial's primary end point was frequency and severity of hot flashes at three months. Daily hot flash diaries were used to assess frequency and severity of hot flashes. The Landgren scale assessed intensity of hot flashes and sweats. Patients completed a questionnaire to assess interference of hot flashes and sweats with everyday life. Endometrial biopsies were taken at 6 and 12 months. Monthly diaries assessed the incidence of bleeding or spotting throughout the study. Serum lipid profiles were assessed.

Daily diaries showed no change in the daily number of hot flashes with either tibolone or placebo (p = 0.219) after three months. There was a significant reduction in the severity of hot flashes with tibolone verses placebo (-0.4 versus 0.2, p = 0.031). The Landgren scale showed a mean change in the number of hot flashes of –0.6 with tibolone and +1.1 with placebo after 12 months (p = 0.022). Endometrial biopsies were normal and vaginal bleeding similar in both groups. Significant decrease in triglycerides ( 23% versus 1.4%) and HDL (12% versus 19%) with tibolone versus placebo after 12 months were noted.

The study was limited by its small sample size with less than 100 participants.

The effect of tibolone on recurrence of breast cancer is unknown.

To investigate the short- and long-term effects of classical massage therapy on cytokine responses and the Th1/Th2 ratio, depression, mood, and perceived stress in patients with primary breast cancer; to evaluate the relevance of classical massage therapy in the context of oncologic care  

Authors randomized 34 women into two groups. The massage group received a 30-minute classical massage twice per week for five weeks. The control group received standard medical care only. Time points in the study were before intervention, at the end of the five-week intervention period, and at six weeks after the intervention. At these time points, participants completed several measurement instruments, and investigators took blood samples to determine cytokine concentrations and the Th1/Th2 ratio.

• The sample was composed of 29 participants.
• Mean age of patients in the massage group was 59.5 years; in the control group, 59.9 years.
• Because participants were patients with breast cancer, the assumption is that 100% of participants were female.
• The tumor size of all participants was less than or equal to T2; nodal state, less than or equal to N2. The time since disease onset was less than four years before the study. Participants had completed surgery, chemotherapy, and/or radiation therapy at least three months prior to the beginning of the study.
   

Unspecified

• Phase of care: long-term follow-up
• Clinical applications: late effects and survivorship

Randomized controlled trial

• Perceived Stress Questionnaire (PSQ), to assess the subjective experience of stressful situations on the cognitive and emotional level. Authors used a 20-item German version of the PSQ, a version consisting of four subscales: worries, tension, demands, and joy. These are rated with a four-point Likert scale and subscale values are transformed into scores 0–100. High scores correspond to high levels of stress.    
• Patient Health Questionnaire (PHQ), to screen, diagnose, and evaluate the severity of different psychiatric diseases. Depression score is derived from nine items, and the sum of the scores varies 0–27. The higher the score, the more severe the depression.    
• Berlin Mood Questionnaire, or Berliner Stimmungsfragebogen (BSF), a self-report of mood developed on the basis of the Profile of Mood States (POMS). The 30-item BSF measures six mood states and rates each on a five-point scale. Authors used BSF scales of anxious depression and elevated mood.
• BD Cytometric Bead Array (CBA) kit to measure cytokine concentrations.
   

• Authors noted no significant sociodemographic or clinical differences between participants in the massage group and those in the control group.
• At five weeks, immediately after massage, depression and anxious depression decreased significantly, compared to depression and anxious depression in the control group (p = 0.005, effect size (ES) = 1.39 in PHQ scores).
• Stress and elevated mood did not change significantly after massage therapy.
• Changes of cytokine concentrations and Th1/Th2 ratio were insignificant, although authors noted a slight shift toward Th1 in the massage group over time.

Massage therapy is an efficient treatment for reducing depression in breast cancer patients. Insignificant results concerning immunologic parameters, stress, and mood indicate that further research is needed to determine psychological and immunologic changes associated with massage therapy.

• The study had a small sample size, with fewer than 30 participants.
• The study had a risk of bias due to no attentional control condition.
• Improvement of psychometric parameters may differ with massage therapist.
• Cytokine levels may fluctuate or increase coincident with immunologic processes, such as infections or chronic diseases.
• Authors do not make clear whether, at the five-week time point, measures were taken immediately after the massage. Timing could influence results.
• Authors stated that effect size for depression was 1.39 on a 100-point scale, but they did not state how effect size was calculated.

Massage therapy may be an effective intervention to offer to patients who struggle with depression. Additional studies should evaluate the effectivenss of this intervention as well as its effect on immunologic parameters, stress, and mood.

To determine whether centralized telephone-based care management cued by automated symptom monitoring can improve depression and pain in patients with cancer

In this study, called the Indiana Cancer Pain and Depression Trial, centralized telecare management was conducted by a nurse-physician specialist team that worked in concert with automated home-based symptom monitoring. The means of monitoring was interactive voice recording or Internet. A nurse care manager assessed symptom response and medication adherence, provided pain- and depression-specific education, and made treatment adjustments according to evidence-based guidelines. Intervention patients received scheduled calls (at baseline, at 1 week, and at 4 and 12 weeks) and received calls when automated monitoring indicated problems in symptom management. Control group received usual care. Data were collected at baseline and at months 1, 3, 6, and 12.

• The sample was composed of 405 patients, 202 in the intervention group and 203 in the control group.
• Mean patient age in the intervention group was 58.7 years (SD = 11 years); in the control group, 59 years (SD = 10.6 years).
• In the intervention group, 63% of patients were female and 37% were male. In the control group, 72% were female and 28% were male.
• The sample included diverse cancer types (more than 20% of patients had breast cancer) and various disease stages. Patients had to have depression, pain, or both to be eligible. Depression was defined by a score equal or greater than 10 on the Patient Health Questionnaire-9; cancer pain, by a worst-pain score equal or greater than 6 on the Brief Pain Inventory (BPI). Baseline demographic and clinical characteristics between groups were balanced.

• Multisite
• Outpatient
• Sixteen community-based urban and rural oncology practices in Indiana

Randomized controlled trial

• Twenty-item Hopkins Symptom Checklist (HSCL-20), to measure depression severity
• BPI, to measure pain severity 
• Single-item scale, 0–10, to measure overall quality of life
• SF-12 Health Survey, to measure physical and mental components
• Generalized Anxiety Disorder questionnaire, to measure anxiety
• Somatic Symptom Scale, to measure physical-symptom burden

• Over the 12 months of the trial, of the 274 patients with pain, the 137 patients in the intervention group had greater decreases in pain severity (≥ 30% decrease), as measured by the BPI (as a continuous severity score or as a categorical pain responder), than did the 137 patients in the usual care group (p < 0.001 for both groups).
• Over the 12 months of the trial, of the 309 patients with depression, the 154 patients in the intervention group had greater decreases in depression (≥ 50% decrease), as measured by the HSCL-20 (as a continuous severity score or as a categorical depression responder), than did the 155 patients in the usual care group (p < 0.001).
• The standardized effect size for between-group differences at 3 and 12 months was 0.67 (95% CI 0.33–1.02) and 0.39 (95% CI 0.01–0.77) for pain and 0.42 (95% CI 0.16–0.69) and 0.41 (95% CI 0.08–0.72) for depression.
• The intervention group had better outcomes in several health-related quality-of-life domains: mental health, vitality, anxiety, and physical-symptom burden.

This study showed that centralized telecare management with automated symptom monitoring may be a feasible approach for geographically dispersed urban and rural oncology practices. This approach may be effective in improving the pain and depression of cancer patients.

Lack of control of the type of cancer treatment and of the time lapse since treatment might have affected study findings.

Cost will be involved in training the care manager and in the hiring of trained personnel. The cost-effectiveness of the collaborative care model needs to be further examined. Findings suggest that telecare management used with automatic systems cued by patient problems can be an effective approach.

To determine whether centralized telephone-based care management and automated symptom monitoring can reduce depression and pain in patients with cancer

Participants in the intervention group received centralized telecare management, conducted by a nurse-physician specialist team, and automated home-based symptom monitoring by means of interactive voice recording or Internet. The control group received usual care. Data were collected at baseline and at months 1, 3, 6, and 12.

• The sample was composed of 405 participants, 202 in the intervention group and 203 in the control group.
• In the intervention group, mean patient age was 58.7 years (SD = 11.0). In the control group, mean patient age was 59 years (SD = 10.6 years).
• Most participants, more than 60%, were female.
• The sample included cancers of diverse types and stages.
• To be eligible, patients had to have depression, pain, or both as defined by a score of at least 10 on the Patient Health Questionnaire-9 (PQ-9) or a score of at least 6 on the Brief Pain Inventory (BPI).

• Multisite
• Outpatient
• Indiana, United States

Random controlled trial with double blinding, with stratified randomization by symptom type (pain only, depression only, or both pain and depression)

• Twenty-item Hopkins Symptom Checklist (HSCL-20), to measure severity of depression
• Brief Pain Inventory (BPI), to measure severity of pain
• A single-item 0–10 scale, to measure overall quality of life
• SF-12, to provide physical-component and mental-component summary scores
• Generalized Anxiety Disorder Scale, to measure anxiety
• Somatic Symptom Scale, to measure physical-symptom burden

• The number of patients with pain was 274. Over the 12 months of the trial, the 137 patients in the intervention group had greater improvements in pain severity, as measured by BPI scores, than did the 137 patients in the usual-care group (p < 0.001).
• The number of patients with depression was 309. Over the 12 months of the trial, the 154 patients in the intervention group had greater improvements in HSCL-20 scores than did the 155 patients in the usual-care group (p < 0.001). The HSCL-20 scores of the intervention group decreased at least 50%.
• The standardized effect size for between-group differences, at 3 and 12 months, was 0.67 and 0.39, repectively, for pain and 0.42 and 0.41, respectively, for depression.
• Compared to the usual-care group, the intervention group had better outcomes in several health-related quality-of-life domains.

The intervention may be effective at reducing pain and depression. The intervention proved to be a feasible care approach for geographically dispersed urban and rural oncology practices.

Lack of control over type of cancer treatment and over the time lapse since treatment might have affected study findings.

Cost will be involved in training the care manager and in hiring trained personnel. The cost-effectiveness of the collaborative care model needs to be further examined. Studies show mixed results regarding effect of by-telephone patient management; further work in this area is warranted. Use of technology may be a viable approach to ongoing patient support.

The intervention was a self-administered stress management training (SSMT) program for patients treated with radiation therapy. The usual care only (UCO) intervention included the usual psychosocial care typically provided at the institution where patients were receiving treatment. Participants in the SSMT program met individually with a nurse for approximately five minutes to receive instructional materials and explanations. The instructional materials consisted of a 15-minute prerecorded videotape, a 12-page booklet, and a 35-minute prerecorded audiotape titled “Active Relaxation,” which taught paced breathing, active relaxation, and positive thinking with guided imagery instructions. Data were collected at baseline and weeks 1, 2, and 3.

• The study reported on a sample of 310 patients prior to starting treatment with radiation.
• The UCO group had 156 patients, and the SSMT group had 154 patients.

Multiple centers in South Florida

A randomized controlled trial design was used.

• Mental Component Summary score of the Medical Outcomes Study–short form (SF-36)
• Center for Epidemiologic Studies–Depression Scale (CES-D)
• State-Trait Anxiety Inventory (STAI)–state anxiety
• Statistical analyses repeated measures using SAS PROC MIXED based on unstructured covariance matrix model assumption
• The models used for analysis included the baseline measures as covariates: the effects of treatment alone, time alone, the interaction of treatment with time, the quadratic effect of time, and the quadratic effect of treatment and time.

SSMT is effective only in those patients receiving radiotherapy with initially higher levels of psychological distress at baseline.

Special training needs include the creation of the SSMT tool (instructional materials, video tables, and audiotapes).

Intervention requires screening for psychological distress.

To update the 1999 American Society of Clinical Oncology (ASCO) guideline for antiemetics in oncology 

The update committee reviewed studies identified through a literature search.

Databases searched were MEDLINE, the National Library of Medicine, and the Cochrane Collaboration Library (1998-Feb. 2006).

Studies were included if they were phase II and III randomized, controlled trials.

The search identified the following studies.

• Systematic reviews and meta-analysis on neurokinin 1 (NK1) receptor antagonists in the prevention of chemotherapy-induced nausea and vomiting (CINV) related to high-dose chemotherapy
• A meta-analysis of randomized trials assessing the efficacy of dexamethasone in controlling CINV
• Three systematic reviews and meta-analyses of 5-hydroxytryptamine 3 (5-HT₃) receptor antagonists

Additional materials provided to the committee were

• Two additional systematic reviews available prepublication from the Cancer Care Ontario Program in Evidence-Based Care
• Consensus statements and guidelines from Multinational Association of Supportive Care in Cancer (MASCC).

• The combination of 5-HT₃ receptor antagonist, dexamethasone, and aprepitant is recommended before highly emetogenic chemotherapy (HEC). This combination is recommended for patients receiving an anthracycline and cychlophosphamide. At equivalent doses for the prevention of acute emesis, 5-HT₃ receptor antagonists have equivalent safety and efficacy. 
• For patients receiving HEC, antiemetic agents of lower therapeutic index are not an appropriate first choice. Agents with lower therapeutic index should be used in patients who are unable to take to a 5-HT₃ receptor antagonist, dexamethasone, and aprepitant because of allergy or side effects or for whom these agents have been ineffective.
• For patients receiving moderately emetogenic chemotherapy (MEC), a combination of a 5-HT₃ receptor antagonist and dexamethasone is recommended.
• In patients receiving cisplatin and all other agents of high emetic risk, the combination of aprepitant and dexamethasone is recommended for the prevention of delayed emesis.
• The combination of a 5-HT₃ receptor antagonist and dexamethasone is no longer a recommendation for the prevention of delayed emesis after HEC.
• The recommendation to lower the dose of dexamethasone when administered as an antiemetic with aprepitant does not apply to corticosteroids for anticancer therapy.

To compare, in clinical practice, the effect and safety of a new matrix fentanyl patch (Fentanyl Improved Transdermal [FIT]) patch) to oral and other transdermal opioid treatment

Patients were randomly assigned to either FIT patch or standard opioid treatment via oral or transdermal route. Morphine was the only rescue medication allowed. Patients could receive radiotherapy and chemotherapy as well as nonpharmacologic and pharmacologic pain management therapies. Patients randomized to FIT therapy switched from existing regimens to FIT therapy by means of standard conversion ratios. Patients had an initial screening visit and four additional visits. Each evening each patient assessed his or her pain and recorded the pain rating in a diary. Adverse events were monitored in follow-up visits through the 30-day trial period and for one week longer. Patients assessed adverse events on a four-point scale and recorded the rating.

• The sample of patients who completed the trial was composed of 170 patients.
• In the FIT group, mean patient age was 63.1 years (SD = 11.04 years). In the control arm, mean patient age was 61.3 years (SD = 11.66 years).
• Of all patients, 40% were female and 60% were male.
• Overall, 11% of patients randomized were opioid naive.
• Authors did not report cancer diagnoses. All patients had a baseline Karnofsky performance score of 50 or higher.

• Multisite
• Outpatient
• Seven European countries

Randomized open-label parallel-group design

• Numeric rating scale (0–10), to measure pain intensity
• Four-point scale to rate adverse events, including constipation, nausea, sleep disturbance, and daytime drowsiness

• There was no significant difference between groups regarding pain intensity ratings.
• Subgroup analysis revealed no differences based on concomitant chemotherapy or radiotherapy or on subgroup analysis based on nocioceptive versus neuropathic pain.
• Between groups, there were no significant differences in the prevalence or severity of adverse effects.
• Authors observed no new or unexpected adverse drug reactions.

Results showed no differences, in terms of pain management or adverse effects, between the new transdermal patch and standard transdermal or oral opioid treatment. Findings suggest that the new type of patch is safe and, in terms of efficacy, similar to standard treatments.

• The study has a risk of bias due to no appropriate control group.
• Authors provided no analysis of other medications or approaches used for pain management. (These were not controlled in the study.) Authors did not report analysis of morphine use for breakthrough pain.
• Patients' diaries were the source of adverse events and pain intensity scores. Note, however, that authors stated that patients' records regarding rescue medication, for example, could not have been accurate. If patients' records were inaccurate, the study should have provided objective or observer scoring.

Transdermal fentanyl, delivered by means of conventional patch or FIT patch, is an effective means of controlling cancer pain.

To assess the efficacy and long-term tolerability of infranasal fentanyl spray (INFS)

In an initial titration phase, the effective dose of INFS was determined for each patient. An effective dose was defined as one that was successful in treating three of four episodes of breakthrough pain. If pain relief was insufficient, an additional dose was administered in the alternate nostril. Titration was repeated if the patients’ background opioid dosage was adjusted during the trial. During the efficacy phase patients received, in randomized double-blind sequence, the titrated effective dose of INFS or placebo for administration at home. Patients were randomized to treatment sequences for eight episodes of breakthrough pain. Patients used a diary to record pain intensity at 0, 10, 20, 40, and 60 minutes after administration. Pain ratings were according to a numeric rating scale. Patients were monitored during the 10-month open-label extension phase. Patients received 30-day supplies of INFS, in appropriate doses, during monthly clinic visits. Weekly telephone contact provided data about adverse events, concurrent medications, and INFS efficacy.

• In all,120 patients were enrolled and achieved an effective dose; 113 were randomized and 111 were included in the intent-to-treat analysis.
• Mean patient age was 60.6 years. Age range was 35–79 years.
• Of all patients, 49.5% were female and 50.5% were male.
• The study included patients with multiple cancer sites. Most frequent diagnoses were breast, lung, colon-rectal, and female genital cancer. All patients in whom race was reported were white. Of all patients, 54% received fentanyl for background pain and 43% received morphine sulfate. The other subjects received other opioids.

• Multisite
• Outpatient
• Anesthesiology departments, palliative care units, and oncology clinics in Austria, Denmark, France, Germany, and Poland

Double-blind randomized, double-dummy two-way crossover study

• 11-point numeric rating scale (0–10) of pain intensity
• Five-point scale (0 = poor, 5 = excellent) that provided patient's general impression of treatment efficacy
   

• INFS was associated with pain intensity decreases that were significantly greater than those associated with placebo (p < 0.001).
• Compared with placebo, INFS pain reduction improved with increases in dose related to time after administration (p < 0.0001). Rating of general impression of efficacy at 60 minutes after use was significantly higher (p < 0.001) with INFS than with placebo.
• During the efficacy phase, 22 patients experienced adverse events. Most common effects were nausea and vertigo.

INFS titrated to an effective dose demonstrated some effectiveness in relieving breakthrough pain in this group of patients. Long-term tolerability could not be clearly determined because of the small number of patients who completed the extension phase of the study. Most patients appeared to tolerate IFNS well.

• Approximately one-third of patients who entered the extension phase of the trial withdrew consent. Reasons for withdrawal were not cited, and findings did not include withdrawals as adverse events. Lacking details about withdrawals, the actual prevalence and types of adverse events associated with long-term INFS use are unknown.
• Authors considered a small numeric reduction in pain scores—from baseline to 10 minutes, a difference of 0.5 or a change greater than 2—to mean that the treatment was clinically effective. Whether a patient would consider such levels of change indicative of effective treatment is unknown.

Findings suggest that INFS may be a useful adjunctive approach to deal with the breakthrough pain of patients with cancer who have chronic opioid-managed pain. INFS may be more useful as a short-term, rather than a long-term approach; the matter of long-term efficacy and tolerability requires further study.

To determine whether tapentadol prolonged-release (PR) is effective and tolerable for managing moderate to severe tumor-related pain

Patients whose pain was rated 5 or above on an 11-point scale were randomized (2:1) and titrated to an optimal dose of tapentadol PR (100–250 mg BID) or morphine sulfate CR (40–100 mg BID) over two weeks. Immediate-release morphine sulfate was allowed as needed as a breakthrough medication. During the last three days of titration, patients who achieved an average pain intensity of less than 5 and took less than 20 mg per day of rescue pain medication entered a four-week maintenance period. Patients who received tapentadol were rerandomized (1:1) to either tapentadol BID or a placebo for the maintenance period. Response at the end of titration and response at the end of the maintenance were assessed. Tolerability and side effects were evaluated.

• N = 327
• AGE = 68% < 65 years, 32% ≥ 65 years
• MALES: 53%, FEMALES: 47%
• KEY DISEASE CHARACTERISTICS: The most common neoplasms included were breast and nipple cancers and non-small cell neoplasms of the respiratory tract. Metastases were present in greater than 75% of all patients.   

• SITE: Multi-site    
• SETTING TYPE: Not specified    
• LOCATION: 71 sites in 16 countries

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

Randomized-withdrawal, parallel-group, active- and placebo-controlled, double-blinded study

During the study, pain levels were evaluated with an 11-point Numeric Rating Scale (NRS) twice daily. The proportion of patients classified as responders (patients who completed 28 or more days, had a mean pain intensity score < 5, and had a mean total daily dose of ≤ 20 mg rescue medication during the maintenance period) was evaluated as a primary endpoint during the titration and maintenance periods. Mean pain intensity at the start of the maintenance period was calculated as the mean daily pain intensity scores during the last three days of the titration period. Mean weekly pain intensity during the maintenance period was calculated from the mean daily pain intensity scores during each week of the maintenance period. Adverse events were coded using the Medical Dictionary for Regulatory Activities v15.0. The treatments for emergent adverse events in all groups were collected and compared as were specific gastrointestinal and nervous system effects and general disorders or administration site effects.

Patients receiving tapentadol were twice as likely to respond than the patients who received a placebo. Tapentadol PR was noninferior to morphine CR (p < 0.001). Mean pain intensity scores improved in both the tapentadol PR and morphine CR groups during titration. These reductions were sustained throughout the maintenance period. There were no statistically significant differences between the tapentadol and placebo groups in changes in pain intensity from the start of maintenance to weeks 1–4 (p ≥ 0.0152). A higher percentage of patients in the placebo group (72.1%) took ≥ 20 mg per day of rescue morphine immediate-release compared to the tapentadol (71.4%) or morphine CR (61.5%) groups. During titration, 50% of patients in the tapentadol group and 63.9% of patients in the morphine group reported one or more treatment-emergent adverse effects (TEAEs). A smaller percentage of patients receiving tapentadol PR had any TEAEs (p = 0.0039) than those receiving morphine CR.

Tapentadol PR 100–250 mg BID was effective in the treating tumor-related pain. The analgesic effect of tapentadol PR was not inferior to morphine CR and had better overall and gastrointestinal tolerability than morphine CR. However, more tapentadol users required rescue pain medication than those taking morphine CR.

• Findings not generalizable
• Subject withdrawals ≥ 10%  
• Other limitations/explanation: The comparison of tapentadol PR and morphine CR was limited to two weeks because of the study design.

Tapentadol, one of a new class of centrally acting analgesics, was effective in treating tumor pain and was generally better tolerated than morphine CR. Nurses should be familiar with the common side effects associated with this medication including nausea, vomiting, constipation, dizziness, sleepiness, and fatigue to safely care for patients receiving this drug.

To evaluate the effects of a stepped psychotherapeutic intervention on patients with baseline anxiety

Patients who had completed curative therapy, were referred for follow-up, found to have relevant levels of distress, and consented to participation had a telephone interview at baseline. After the interview, they were randomized to usual care or the stepped program, which included watchful waiting, guided self-help via the Internet or a booklet, face-to-face problem-solving therapy, and psychological interventions and/or medications. Time frames for data collection varied depending upon the duration of the stepped program. General measures were obtained at 3, 6, 9, and 12 months after study entry. Usual care consisted of no psychosocial care in 64% of the group.

• N = 156, 106 at 12-month follow-up   
• MEAN AGE = 62 years (SD = 9.4 years)
• MALES: 60.9%, FEMALES: 39.1%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Patients with head and neck or lung cancer in various stages
• OTHER KEY SAMPLE CHARACTERISTICS: Of the patients, 77.6% had anxiety or a depressive disorder.

• SITE: Single site   
• SETTING TYPE: Multiple settings    
• LOCATION: Netherlands

PHASE OF CARE: Transition phase after active treatment

Single-blind, randomized, controlled trial

• Hospital Anxiety and Depression Scale (HADS)
• European Organization for Research and Treatment of Cancer Core Quality of Life (EORTC QLC-C30)
• EORTC IN-PATSAT32 for inpatient satisfaction with care 
• Composite International Diagnostic Interview (CIDI) for the presence of depression or an anxiety disorder

The course of anxiety (p = 0.046) and depression (p = 0.007) was better for the intervention group than for the controls. When corrected for baseline anxiety and depression, depression was better for the intervention group over time (p < 0.001), but anxiety was not significantly different (p = 0.061). The stepped program had more influence over the course of symptoms among patients with a depression or anxiety disorder compared to those without a psychiatric disorder (p = 0.001). Among those without a psychiatric disorder, no differences in anxiety or depression scores were observed after a six-month measurement.

The stepped psychological intervention approach was shown to be effective to reduce anxiety and depression in the short-term, and had particular effectiveness for individuals with psychiatric disorders.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Subject withdrawals ≥ 10% 
• About 40% were lost to follow-up at six months.
• Patients were not blinded.  
• No information was provided regarding medication use, etc.
• More patients in the intervention group used alcohol.
• Although all patients had clinically relevant anxiety at study entry, the majority of patients in the usual care group had no interventions.
• Patients had completed initial treatment at highly varied time points prior to the study.

Psychiatric and stepped psychological interventions resulted in relatively short-term improvement in anxiety and depression among patients with cancer and anxiety. Interventions were most helpful for individuals with anxiety or depressive disorders over a longer period of time as well.