Management of Concurrent Symptoms

To identify and synthesize the evidence for mind-body interventions for which the evidence suggests benefit for at least two of the three cluster symptoms of pain, fatigue, and sleep disturbance.

Databases searched were CINAHL, MEDLINE, and PsycINFO through March 2009.

Search keywords were guided imagery, hypnosis, relaxation, biofeedback, cognitive behavioral therapy, coping skills training, meditation, virtual reality, music AND cancer AND fatigue, sleep disturbance, sleep difficulty, insomnia, and pain.

Studies were included in the review if they

• Were limited to research
• Included adults aged 18 years and older
• Included mind-body activities that involved primarily mental activity that could be performed by almost all patients
• Included pain, fatigue, or sleep among study dependent variables.

Studies were excluded if they

• Involved the use of yoga
• Involved patients in whom a diagnosis of cancer was not yet established
• Had a sample that included people without cancer.

A total of 47 studies were identified. In four of those, all testing virtual reality, only the symptom of fatigue was measured, so these were eliminated.

The final sample included 43 studies. Study sample sizes and total patients involved across studies were not reported.

Relaxation

Six studies examined relaxation interventions in hospitalized patients, outpatients with chronic pain, and women with early-stage breast cancer.

• Significantly greater pain relief was obtained with progressive muscle relaxation compared to massage, usual treatment, mood manipulation, distraction, and controls.
• One study found no difference in pain between a daily relaxation exercise and distraction.
• Training in muscle relaxation did not improve fatigue in one study compared to provision of information.
• In one study, muscle relaxation improved sleep compared to usual treatment controls.

Imagery and Hypnosis

Six studies examined imagery and hypnosis.

• In four studies, imagery was used in hospitalized patients with cancer pain, and beneficial effects were reported.
• One study found no differences in pain or fatigue between patients with an imagery intervention and those receiving standard care.
• Four studies used imagery in comparison to cognitive-behavioral therapy (CBT) and combined imagery with relaxation. Of those, one study reported no significant effect, two reported significant pain reduction, and one reported significant reduction in fatigue and sleep disturbance.

Cognitive Behavioral Therapy (CBT)/Coping Skills Training (CST)

Twenty-one studies tested CBT/CST.

• In three studies, fatigue was the primary focus. Significantly more improvement in fatigue was reported with a six- to 12-week CBT/CST intervention compared to usual treatment and controls.
• Three studies evaluated CST effects on the combination of pain and fatigue. In all of these, a one-session CST intervention resulted in no difference in symptoms compared to controls.
• Seven studies evaluated the effects of CBT/CST on fatigue and sleep disturbance. One study reported a decreased incidence of fatigue and sleep disturbance using an audio recording for coping skills training prior to chemotherapy. Two studies reported improvement in sleep with a four- to eight-week CBT intervention, but only one of these also reported improvement in fatigue. One study reported improvement in sleep and fatigue with a five-session CBT intervention, two other studies showed improvement in sleep but no change in fatigue, and one study reported no improvement in either of these two symptoms.
• Four studies reported effects of CBT/CST on all three symptoms concurrently. One showed improvement in fatigue and sleep but no impact on pain. One study reported less sleep disturbance but no difference in pain or fatigue. One reported lower ratings of worst pain immediately after the CBT program and greater reduction in pain and fatigue six months after the intervention compared to controls. One study found no differences in any of the three symptoms with a CST intervention.

Meditation

Four studies were included.

• Three of these studies used mindfulness-based interventions. One study reported significant improvements in both fatigue and sleep among outpatients who participated in an eight-week intervention.

Music

• Four studies looked at the effect of music on pain. Two studies found significant improvements in a pre-/posttest design using 30 minutes of preferred music among hospitalized patients. Two other studies found no difference in pain with listening to music compared to control groups.
• Two studies tested a music intervention on fatigue. One found a significant effect, and one found no difference in fatigue between intervention and control groups.

Findings of this review were equivocal.

• Although the authors stated a criterion for inclusion of examination of at least two of the three symptoms of interest, the review appeared to include studies in which only one of these symptoms was reported.
• Few investigators used multisymptom interventions and evaluations.
• Measures of symptom clusters were not been well identified.
• Some instruments were stated to potentially be more sensitive; however, the scales and individual items that were most useful to measure this symptom cluster were not determined.
• Timing, dosage, and frequency of interventions varied among studies, making it difficult to draw systematic conclusions. Most music interventions were very brief.
• This review did not provide study details, such as clear sample descriptions, sample sizes, or actual statistical results, and no effect sizes were calculated, although some studies used the same outcome measures.

Although the findings did not clearly demonstrate the effects of these interventions across studies, the authors concluded that these interventions hold promise. Although such interventions carry minimal risk to patients, some interventions would require substantial time and resource commitment to provide.

To test the effectiveness of a brief intervention using a cognitive and behaviorally oriented approach on symptoms of fatigue.

Patients were randomly assigned to the intervention or usual care control group. The intervention included three individual face-to-face, sixty-minute sessions that coincided with chemotherapy treatment schedules. These were aimed at clarifying meanings, setting goals, educating patients about cancer-related fatigue, developing and discussing coping strategies, and cognitive restructuring. Sessions were audiotaped to ensure treatment fidelity. Study assessments were performed at baseline (cycle three of chemotherapy), the end of treatment, four weeks after the end of treatment, and nine months after study entry.

• In total, 50 patients (40% male, 60% female) were included.  
• Mean age was 59.1 years (standard deviation = 11.5 years).
• Colorectal cancers were the most common. Multiple other tumor types were included
• Of the patients, 80% had stage III or IV disease, and 76% had at least one other comorbid condition.

• Single site 
• Outpatient 
• United Kingdom

Patients were undergoing the active antitumor treatment phase of care.

The study was a randomized, controlled trial.

• 100-mm visual analog scale (VAS) for global fatigue
• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
• Fatigue outcome measure designed for the study
• Multidimensional Fatigue Inventory (MFI)
• Hospital Anxiety and Depression Scale (HADS)

VAS fatigue scores were significantly lower in the experimental group at Time 2, end of treatment (p = 0.03), but not at any other time point. EORTC physical functioning scores were higher in the experimental group at the end of treatment (p = 0.001) and at four weeks after treatment ended (p = 0.02). There was an overall trend over time favoring the experimental group; however, the trend was not significant and was smaller when data were controlled for medical conditions and HADS scores. No data for the nine-month time after treatment were provided.

Findings suggest that a cognitive-behavioral approach intervention can be beneficial in reducing fatigue during the short term after cancer treatment.

• The study had a small sample size, with less than 100 participants.
• The study had risks of bias due to no blinding and no appropriate attentional control condition.
• Subject withdrawals were 10% or greater. 

Findings suggest that cognitive-behavioral approach interventions to restructure thinking, set goals and coping strategies, and improve self-efficacy may be helpful in reducing fatigue immediately after chemotherapy treatment. This evidence is not strong, given the study limitations here, but the findings are potentially promising.

To evaluate the effectiveness of a combined biobehavioral intervention (CBI) and cognitive behavior therapy (CBT) for depressed patients coping with the stresses of cancer

12–20 individual 75-minute CBI and CBT sessions

Topics: Stress, coping, communication, seeking information

• N = 36
• MEAN AGE: 49 years
• MALES: 0%, FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast and gynecologic

• SITE: Single site   
• SETTING TYPE: Outpatient   
• LOCATION: Cancer Center in Northeast United States

PHASE OF CARE: Late effects and survivorship

Single group pre-post design

• Hamilton Rating Scale for Depression (HRSD)
• Beck Depression Inventory (BDI)
• Fatigue Symptom Inventory (FSI)
• Brief Pain Questionnaire
• Quality of Life

Depressive symptoms, fatigue, and mental health significantly improved following intervention.

CBI and CBT showed significant improvement in depression, fatigue, and quality of life and reduced cancer stress.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no random assignment)
• Subject withdrawals ≥ 10%

Cancer survivors who display depressive symptoms may benefit from CBI and CBT.

Participants received standard cognitive-based therapy, profile-tailored cognitive-based therapy, or usual care. Those in both therapy groups received 5- to 50-minute sessions. Standard cognitive-based therapy includes comprehensive cognitive and behavioral therapy that evaluates thoughts, feelings, and behaviors. It uses six to eight treatment strategies to teach patients to understand the relationship between pain, suffering, and emotions; to use symptom coping skills, problem-solving, relaxation, and self control; and to modify cognitive distortions associated with emotional distress. Profile-tailored cognitive-behavioral therapy (CBT) matched patient scores on the Biobehavioral Pain Profile (BPP) to specific CBT modules:  environmental influences, loss of control, health care avoidance, past and current experience, physiological responsitivity, and thoughts of disease progression.

• In total, 131 participants were included.
• Mean age was 52 years.
• Of the participants, 72% were female, 63% were Caucasian, and 35% were African American.
• Participants were experiencing cancer-related chronic pain for longer than 6 weeks, which was associated with disease progression, adjuvant therapy, or surgical exploration.
• Participants had at least one elevated score on the BPP.
• Most common diagnoses were breast, colon, and lung cancer and lymphoma.

One inpatient and three outpatient cancer centers in the Southeastern United States

Participants were undergoing the active treatment phase of care.

The study was a randomized trial.

Profile of Mood States (POMS) Symptom Distress Scale

No significant effects on fatigue were found.

• The study had poor retention. Only 28 patients completed the study; the end sample was very small.
• No intention-to-treat analysis was performed.
• Registered nurses received a two-day training course to deliver the intervention.
• Space to provide the intervention.

To investigate whether nurse monitoring and protocol management of physical symptoms alleviates fatigue

Patients were randomized to receive either usual care or nurse management patient-tailored treatment using treatment management protocols. In the experimental group, nurse specialists recorded interventions for multiple physical symptoms. During outpatient meetings with the nurse, symptom severity was monitored. When any symptoms were rated ≥ 4 on an 11-point scale, the nurse referred the patient to the oncologist for further assessment and initiation of treatment according to palliative care guidelines, such as medication adjustment, other referrals, or other interventions. Nurses managed as many symptoms independently as possible. Highly specific interventions for pain, nausea, vomiting, constipation, diarrhea, anorexia, dyspnea, cough, and dry mouth were used. No specific interventions aimed at fatigue were identified. Patients met with the nurse at 1, 2–4, 5–7, and 8–10 weeks. Study assessments were done via mail at baseline and one, two, and three months.

• The study reported on a sample of 137 patients.
• Mean patient age was 58 years.
• The sample was 59% female and 41% male.
• Multiple solid tumor types were represented, with breast, gastrointestinal, and urogenital being the most common.
• Seventy-eight percent of patients were married or living with a partner, with more intervention group patients in this group.
• All patients were Caucasian.
• Average time since cancer diagnosis was 57 months.
• Patients were not eligible if they had a level of anxiety or depression requiring referral for psychiatric care or cognitive impairment.

• Single site
• Outpatient setting
• The Netherlands

A randomized controlled trial design was used.

• Numeric rating scale (NRS) to assess symptoms on 0–10 scale
• Multidimensional Fatigue Inventory (MFI)
• EORTC Quality of Life Questionnaire (QLC-30)
• Brief Fatigue Inventory (BFI)
• Hospital Anxiety and Depression Scale (HADS)

Patients reported that the most troublesome symptoms were pain, dyspnea, and anorexia. Patients had a median of two symptoms with NRS scores of at least 4 at baseline. MFI scores for general fatigue declined significantly over time in the intervention group compared to controls, with effect size ranging from 0.26 to 0.35 (p = 0.01). NRS fatigue scores also demonstrated decline compared to usual care controls (p < 0.001). BFI scores were not reported. Overall symptom burden was reported to decrease over time in the intervention group, while there was no change in controls (maximal effect size = 0.64, p = 0.002). Anxiety decreased in the intervention group compared to controls (maximal effect size = 0.32, p < 0.001).

Findings suggest that comprehensive management and monitoring for symptom control by nurse specialists was effective in reducing anxiety and fatigue in patients with cancer.

• The study had baseline sample/group differences of import.
• The study had risk of bias due to no blinding and no appropriate attentional control condition.
• Unintended interventions or applicable interventions were not described that would influence results.
• The study used selective outcomes reporting.
• Measurement/methods were not well described.
• Participant withdrawals were ≥ 10%.
• At baseline, fewer control patients were married or partnered, and there was no analysis of significance of baseline differences. This support difference could have influenced results.
• BFI measures were not reported, causing one to question if findings were not consistent for changes in fatigue.
• Calculation of “total symptom burden” was not described.
• Patients who withdrew were more anxious and depressed than those who remained in the study.

Findings suggest that continued symptom management and monitoring with a protocol approach can be effective for reducing symptoms overall, and reducing fatigue and anxiety. There were no specific intervention approaches identified that were used for fatigue, so the suggestion is that reducing other symptoms can have a positive impact on fatigue. There were also no specific interventions identified for anxiety, but anxiety also declined over time. These results suggest that ongoing monitoring and attention to patients alone may positively impact these symptoms.

Intervention treatments were individualized based on patient scores on specific questionnaires that measured the six modules (perpetuating factors) of postcancer fatigue. These included:

1. Insufficient coping with the experience of cancer
2. Fear of disease recurrence
3. Dysfunctional cognitions concerning fatigue
4. Dysregulation of sleep
5. Dysregulation of activity
6. Low social support and negative social interactions.

If a patient had a score on a questionnaire that indicated problems in a specific module, the accessory module became part of the treatment. Therapy only varied in the number of modules, but within each module, the therapy was standardized. The intervention was delivered by three therapists with previous experience with patients with chronic fatigue. Therapy sessions ranged between five and 26 sessions (mean = 12.5 sessions [standard deviation = 4.7 sessions]), with a duration of one hour during a six-month period. Cognitive and behavioral techniques used in therapy addressed the six modules of postcancer fatigue. Patient outcomes were assessed at baseline and six months after enrollment.

• In total, 98 patients with cancer were included.
• The ratio of males:females was almost equal.
• There were multiple diagnoses, the most common being breast cancer (about 30% in both groups).
• Patients in the waiting list condition underwent chemotherapy more often and had less psychological distress compared with patients in the intervention group.
• Participants were excluded if they were receiving current psychological/psychiatric treatment, were younger than 18 years, or were older than 65 years.

• Outpatient clinics of medical oncology, urology, surgery, orthopedic, hematology, and gynecology 
• The rationale for the intervention was based on the model of precipitating and perpetuating factors.

Patients were undergoing the active treatment phase of care.

The study was a randomized, controlled trial with a

1. Cognitive-behavioral therapy (CBT) intervention (n = 50)
2. Waiting list condition (patients were told that they could start the intervention after the second assessment) (n = 48).

Checklist Individual Strength (CIS)

Patients in the CBT intervention group experienced a statistically significant decline in fatigue severity (difference, 13.3; 95% confidence interval [CI] [8.6, 18.1]), as well as functional impairment (difference, 21.6; 95% CI [12.7, 30.4]) compared with patients in the waiting list condition (p < 0.001). The proportion of patients with significant improvements in fatigue severity and functional impairment was significantly higher than the intervention condition compared with the waiting list condition, indicating clinical significance (p < 0.001).

• The study was limited to patients younger than 65 years; however, 50% of cancer is diagnosed after this age.
• Controlled follow-up was not possible because patients in the waiting list group were offered CBT after the six-month assessment.
• There was no attention placebo control goup; therefore, the possibility cannot be ruled out that attention played a role in the improvements observed in the intervention group.

The primary aim was to demonstrate the efficacy of a brief nursing intervention (BNI) and cognitive-behavioral therapy (CBT) compared to usual care (UC). The secondary aim was to determine the role of physical activity in reducing fatigue during cancer treatment.

In total, 220 patients were randomly assigned to one of three groups:  BNI, CBT, or UC.

• The study was comprised of 220 patients (139 females and 81 males), and two patients dropped out.
• Age ranged from 18 to 75 years.
• Diagnoses included breast cancer (48%), prostate cancer (23%), other tumors (29%).
• The marital statuses of the patients were married/cohabiting (81%) and other (19%).
• Patients were excluded if they had head and neck and lung cancers.

• Setting Type 1:  Multisite
• Radboud University Nijmegen Medical Centre and six regional hospitals in The Netherlands

The study was a multicenter, randomized, controlled trial.

• Fatigue severity was assessed using the fatigue subscale of the Checklist Individual Strength (CIS-fat).
• Functioning was assessed using the Dutch language version of the Short Form-36 (SF-36) Health Survey.
• Symptom Checklist-90 (SCL-90) measured psychological distress.
• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
• Physical activity was measured by an actometer and the Daily Observed Activity score, and the Questionnaire Physical Activity (QPA) measured whether patients complied with advice concerning physical activity.

The CBT group was significantly less fatigued than the UC group. Between the BNI and the UC groups, no significant difference in fatigue was found. Physical activity was found not to mediate the effect of CBT on fatigue.

CBT during curative cancer treatment resulted in less fatigue compared to the BNI and UC groups. The mediation hypothesis was rejected.

• The majority of patients were from the university hospital.
• Contamination could have occurred.
• The BNI intervention by the nurses consisted only of two one-hour sessions and a booklet, whereas the CBT intervention consisted of up to ten one-hour sessions over six months with trained therapists given a protocol and supervision every two weeks with case discussions, with the nurses being less experienced than the therapists.
• Actometer and self-report data were not obtained for all patients.

Further study is warranted to determine the effects of specific nursing interventions on the experience of fatigue in patients with cancer.

To test the effects of a psychoeducational intervention on pain, fatigue, and sleep disturbance.

Patients were randomly assigned to the intervention group or the wait-list control group. The intervention consisted of a single one-on-one training session with a research nurse, which was followed by recorded guidance that provided imagery, relaxation exercises, and nature sounds. Most exercises lasted 20 minutes and were delivered via an mp3 player. The study lasted two weeks.

• The sample was comprised of 78 patients (41% male, 59% female).
• Mean age was 60.29 years (standard deviation = 11.09 years).
• Patients had lung, prostate, colorectal, or gynecologic cancer.
• Patients were receiving chemotherapy or radiation therapy and had multiple concurrent symptoms at baseline.
• At study entry, all patients had to have fatigue, sleep disturbance, and pain scores of at least 3 on an 11-point numeric scale.
• Of the patients, 71% were taking steroids, 59% were taking opioids, and 86% were taking antiemetics.
   

• Multisite
• Outpatient
• Midwestern United States

Patients were undergoing the active antitumor treatment phase of care.

The study used a randomized, controlled trial, pre- and postintervention design.

• Selected items from various instruments, including the Brief Fatigue Inventory (BFI), Brief Pain Inventory (BPI), and Pittsburgh Sleep Quality Index (PSQI)
• Eleven-point numeric scales, to measure symptoms
• Patient diaries, which recorded use of cognitive-behavioral therapy (CBT) exercises
• Symptom cluster score, calculated by averaging the pain, fatigue, and sleep disturbance scores
• Symptom interference subscale of the MD Anderson Symptom Inventory (MDASI)

• Comparison of pre- and postintervention symptom severity scores showed a significant reduction in the severity of pain, fatigue, and sleep disturbance and symptom interference (p = 0.000).
• Symptom cluster scores and individual symptom scores declined in both the intervention and control groups.
• The reductions in symptom cluster severity (p < 0.05), pain (p < 0.01), and fatigue (p < 0.05) were significantly greater in the intervention group than in the control group; however, the effect sizes (calculated as partial eta) were extremely small (range 0.041–0.093).

The intervention demonstrated a small statistically significant effect on the symptoms of pain and fatigue and the overall symptom cluster of pain, fatigue, and sleep disturbance.

• The study had a small sample size, with less than 100 patients.   
• The study had risks of bias due to no blinding and no appropriate attentional control condition.
• The sample included baseline and group differences of import.
  • The control group had higher depression scores at baseline than did the intervention group.
  • A greater number of those in the intervention group dropped out of the study, suggesting that the intervention was not well accepted. Intention-to-treat analysis used the last value carried forward. If symptoms worsened, this would produce biased results.
• Although the intervention was called a CBT intervention, whether cognitive reframing or problem solving was a part of the intervention was unclear. The intervention appeared to have been a relaxation or imagery therapy.
• Measurement validity and reliability were questionable.
  • Authors used Z-scores to compare sleep disturbance severity, rather than actual scores; the reason for this was unclear. The actual change in Z-scores for this symptom was larger than the score changes associated with other symptoms, but the Z-score change was not statistically significant.
  • Whether average individual symptom scores were more meaningful than the total score for the cluster was unclear.  
• The intervention may be too expensive or impractical, in terms of training needs, to be feasible.

The intervention was a relaxation or imagery therapy rather than a true CBT. The intervention was associated with short-term statistically significant benefits, but the actual size of the effect was small. Findings suggested that approaches using relaxation and imagery may result in some small benefit for patients, but the effect was weak.

To examine the effects of nurse-led cognitive-behavior therapy (CBT) on fatigue and quality of life (QOL) experienced by patients with breast cancer who were currently undergoing radiotherapy.

An oncology nurse-led six-week intervention program that included cognitive restructuring, education about breast cancer and medical treatment, relaxation therapy, and rehabilitation exercise was offered to women receiving radiation therapy at a university hospital in Korea. Nurses who led the course attended the beginner’s course of CBT for 36 hours.

• In total, 71 patients (71% female) were included.           
• Age ranged from 25 to 60 years.
• Patients had breast cancer.
• Of the patients, more than half had a partial mastectomy, 93% had no family history of breast cancer, and nearly half had received chemotherapy.

Single site

Patients were undergoing the active antitumor treatment phase of care. 

The study used a quasiexperimental pre-/posttest design with a nonequivalent control group.

• Korean version of the Revised Piper Fatigue Scale (PFS)
• QOL Scale for Korean Patients With Cancer

Levels of fatigue increased in both groups at the posttests. Increases in the levels of fatigue were greater in the control group than in the experimental group. Levels of QOL increased in the experimental group and decreased in the control group.

Nurse-led CBT did not show a significant effect in reducing the levels of cancer-related fatigue, although the increments of fatigue were significantly lower than the control group. Nurse-led CBT was effective in increasing QOL.

• The study had a small sample size, with less than 100 patients.
• The study had a risk of bias due to no blinding.
• Findings were not generalizable
• Intervention expensive, impractical, or training needs.
• Authors mentioned seasonal influence – fatigue is exacerbated in the winter and alleviated in the summer.

There is a role for oncology nurses to lead a structured cognitive-based intervention program to help alleviate cancer-related fatigue in women with breast cancer receiving radiotherapy.

To test the effectiveness of a psychological intervention combining cognitive-behavioral therapy (CBT) and hypnosis (CBTH) to treat radiotherapy-related fatigue.

Forty-five patients were randomized to two groups:  CBTH and standard medical care. Weekly and daily fatigue were measured with two covariates:  neuroticism and history of chemotherapy. In the CBTH group, the patients participated in a 15-minute hypnosis session with guided imagery and suggestions for reduced fatigue and a sense of relaxation and energy. Patients were given a CD of the hypnosis intervention to listen to at home. The therapist provided a 30-minute CBT skills session, including how to recognize negative beliefs, consequences of those beliefs, how to change these, and how to practice behavioral strategies and exercise to manage treatment-related fatigue. The therapist reviewed information and progress with each patient twice weekly for a total of 12 sessions in 5- to 15-minute sessions.

• The sample was comprised of 42 patients (100% female). 
• Patients were older than 18 years.
• Mean age was 53.45 years (standard deviation [SD] = 10.43 years) for the CBTH group and 52.78 (SD = 11.65 years) for the control group.
• Patients had breast cancer stage 3 or lower.
• Karnofsky Performance Status (KPS) was 98.75 (SD = 3.19) in the CBTH group and 96.57 (SD = 7.45) in the control group.

• Type1
• Single site
• Urban radiation oncology clinic

The study was a randomized, clinical trial using a repeated measures design.

• Weekly fatigue was measured using the Functional Assessment of Chronic Illness Therapy (FACIT)–Fatigue Subscale (FS)
• Daily levels of fatigue were measured using a 100-mm visual analog scale (VAS). 
• Possible covariates were neuroticism, measured using the NEO-Five Factor Inventory Neuroticism Subscale (NEO-N) shortened form self-report questionnaire; the second covariate was history of chemotherapy, assessed via medical record review and scored as yes or no.

Among the control group, weekly FSs increased over time at a rate of 1.57 points/week (p < 0.001). Over the course of radiotherapy, individuals in the intervention group had little increase in FS fatigue (0.6 points/week) (p = 0.01).

An intervention combining CBT and hypnosis was effective for controlling fatigue in patients with breast cancer undergoing radiotherapy, independent of neuroticism or past chemotherapy.

• The study had a small sample size, with less than 100 patients.
• The study lacked a sufficient attentional control.

Replication of the intervention effects should be studied in a larger population with appropriate attentional control procedures.

To determine the effectiveness of integrating a depression management program into the care of patients with cancer and major depressive disorder (MDD).

Patients were randomized into the treatment group or the usual care group. The treatment group received up to 10 individual one-to-one 45-minute sessions over a three-month period; some occurred via telephone or in the patients' homes, as needed. The intervention consisted of education about depression and its treatment, problem-solving and coping strategies, and collaboration with each patient’s oncologist and primary care provider. Two repeat sessions were offered to persons whose Patient Health Questionnaire-9 (PHQ-9) scores were increasing. No further intervention occurred after six months, but a progress-monitoring interview was conducted at 12 months.

• The sample was comprised of 200 patients.
• Mean patient age in each group was 56.6 years.
• The usual care group included 71 women and 28 men, and the intervention group included 70 women and 31 men.
• Patients had breast, colorectal, gynecologic, genitourinary, hematologic, lung, and mixed cancers.
• Patients were eligible based on the presence of MDD antidepressant therapy (any dose or therapeutic dose). Symptoms (depression, anxiety, pain, fatigue, and physical functioning) were also identified.

• Home visit or telephone visit, if patients were unable to attend the single site
• Regional cancer treatment center in Scotland, United Kingdom

Patients were undergoing the active treatment and transitional phases of care.

The study was a randomized trial with a control (usual care) group.

• Hospital Anxiety and Depression Scale (HADS)
• Structured Clinical Interview for DSM-IV (SCID-IV), to determine if patients met the criteria for MDD
• PHQ-9, to assess the severity of depression
• Hopkins Symptom Checklist (SCL-20) depression scale, to measure changes in depression
• A 10-item subscale of the Symptom Checklist-90 (SCL-90) questionnaire, to measure anxiety
• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
• EuroQol EQ-5D questionnaire, to measure quality of life for economic analysis

Measurements revealed no statistically significant differences in the two groups at baseline, including differences in the use of antidepressant medication. However, at three and six months, more patients in the intervention group than in the control group were using a therapeutic level of antidepressants. Depression scores on the SCL-20 decreased between baseline and three months in both groups, but the scores decreased more in the intervention group. More patients in the intervention group had a depression score that decreased by at least 50% from baseline to the three-month follow-up (p = 0.0008). In addition, several patients in the intervention group no longer met the criteria for MDD at three months and had reduced anxiety and fatigue. The study showed no significant changes in pain or physical functioning at three or six months. In addition, at six and 12 months, the study showed a significant improvement in quality of life for patients in the intervention group.

Supplementation of usual care with a nurse-delivered intervention for the management of depression reduced the symptoms of depression, anxiety, and fatigue more than usual care alone. There were no significant improvements in pain or physical functioning. The authors noted the close relationship of anxiety and fatigue to depression as a possible rationale for the cluster of improvements.

• The study had risk of bias due to no attentional control.
• Patient bias may have affected the outcome assessments:  the Hawthorne effect may have applied because patients knew that management of depression was taught.

A cost-effective, patient-acceptable, nurse-delivered intervention can support the management of depression, anxiety, and fatigue in patients with cancer and MDD. At 12 months, the evidence showed a sustained effect of the three-month intervention.