To determine the feasibility and effects of providing therapeutic massage at home for patients with metastatic cancer

• N = 39 (final sample); 20 received massage intervention, 10 received no-touch control, 9 received usual-care control
• MEAN  AGE = 55.1 (SD = 11)
• MALES: 18%, FEMALES: 82%
• KEY DISEASE CHARACTERISTICS: Metastatic cancer
• OTHER KEY SAMPLE CHARACTERISTICS: 56% had breast cancer.

• SITE: Single site  
• SETTING TYPE: Home    
• LOCATION: Boston, MA; oncology clinics at a large urban academic medical center

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Palliative care 

• Pilot randomized, controlled trial
  • No blinding

• State-Trait Anxiety Inventory (STAI)
• Brief Pain Inventory-Short Form
• Global measure of perceived stress

The study shows that therapeutic massage at home is a feasible intervention. However, its effects on anxiety or pain were not conclusive. The small and uneven sample sizes across groups are a major weakness of the study. Although two measures were used for anxiety, the authors did not state which measures were used for the main analysis. Validity of measurements (i.e., alertness, and quality-of-life measure) is also problematic.

• Small sample (< 30)
• Risk of bias (no control group)
• Measurement of validity/reliability questionable

The role of nurses for this intervention is not clear. The massage therapy given in the present study was a professional intervention.

An experienced oncology social worker with a master’s degree in social work led six individual, one-hour counseling sessions. All participants attended at least four sessions. The sessions included three components: support, problem solving, and coping skills.

• The sample (N = 78) was comprised of caregivers of patients who had received a cancer diagnosis at least three months prior.
• Patients scored a 1–3 on the Eastern Cooperative Oncology Group Global Performance Scale.

Regional medical oncology center

The study was a properly designed randomized controlled trial: intervention (n = 38) versus standard available care (n = 40).

• Zarit Burden Inventory
• Caregiving Mastery and Caregiving Satisfaction subscales of the Lawton Caregiving Appraisal Composite Scale
• Montgomery and Borgatta Burden Scale
• Center for Epidemiologic Studies–Depression Scale
• State-Trait Anxiety Inventory
• Dyadic Adjustment Scale (used to measure marital satisfaction)
• Social Functioning Subscale of the Health and Daily Living Form (adapted; used to measure social support)
• Medical Outcomes Study Short Form–20
• Help Seeking Coping Index
• Index of Coping Responses

For caregivers who reported high levels of burden, the intervention led to a significant improvement in their ability to cope with pressing problems. No main effects of the intervention were found on any outcome variable. For caregivers who reported low marital satisfaction, the intervention led to improvement in physical, role, and social functioning.

• The study had a small sample, with only 27% of those eligible agreeing to participate.
• The sample was primarily Caucasian.
• Contamination of the control group was reported.

To examine the effectiveness and safety of the antidepressant sertraline (selective serotonin reuptake inhibitor) in treating somatic and emotional symptoms of depression in patients with cancer

To evaluate the effect of sertraline treatment on quality of life (QOL)

The intervention was a 12-week trial with a flexible dose regimen of sertraline. Patients started at a dosage of 25 mg/day, with a possible increase to 100 mg/day. The treatment response was assessed at baseline (T0), week 4 (T1), and week 12 (T2).

• The study reported on a sample of 35 patients with cancer.
• Mean patient age was 51.97 years, with a range of 23–72 years (SD = 13.26).
• The sample was 86% female and 14% male.
• Cancer type was diverse, but the majority (54%) had breast cancer. Cancer stage was diverse, with relatively even distribution.
• All patients were undergoing chemotherapy during the study, and all were diagnosed with mood disorder at baseline.

• Single site
• Outpatient setting

Patients were undergoing the active treatment phase of care.

An open-label, noncomparative, prospective pilot study design was used.

• Hospital Anxiety and Depression Scale (HADS): To measure depression and anxiety
• Montgomery-Åsberg Depression Rating Scale (MADRS): To measure depression
• Mini-Mental Adjustment to Cancer (Mini-MAC) Scale: To measure psychological response to the diagnosis of cancer
• Clinical Global Impression (CGI): To measure severity of psychological illness
• Dosage Record and Treatment Emergent Symptom (DOTES) Scale: To measure adverse effects of the clinical treatments and their possible relation with the drug used
• Quality of Life Index: To measure QOL

Mean daily dose of sertraline was 57.50 (+_18.74) mg at T1 and 57.41 (+_18.10) mg at T2. Both mean depression scores, analyzed by HADS and MADRS scales, and HADS anxiety scores significantly decreased during the 12 weeks of study (all p values < 0.05). Mean Mini-MAC scores showed that hopelessness and anxious preoccupation decreased significantly at T2 compared with T0 (p < 0.05). QOL improved over time (p < 0.05). CGI was improved over the treatment period; however, no statistical tests were involved. No severe adverse effects were observed. Six patients reported varying degrees of side effects (nausea, agitation, insomnia, and dizziness).

Sertraline may be effective for the treatment of depressed outpatients with cancer. However, stronger evidence is needed.

• The study had a small sample, with less than 100 patients.
• Internal validity is limited due to the lack of control group, the lack of control over the time lapse since cancer therapy, and the small sample size.
• External validity is limited due to the nature of the sample (i.e., small size and single setting).
• Lack of information regarding measurements for validity and reliability is a minor flaw.

Nurses can inform patients of a possible option to decrease depressive symptoms during chemotherapy.

To examine the effectiveness and safety of sertraline on somatic and emotional symptoms of depression and on the quality of life of cancer patients

The intervention was a 12-week trial with a flexible-dose regimen of sertraline (a selective serotonin reuptake inhibitor). Patients started the regimen with a dose of 25 mg/day, with a possible increase to 100 mg/day. The treatment response was assessed at baseline (T0), at week 4 (T1), and at week 12 (T2).

• N = 35.
• Mean age = 51.97 (SD = 13.26; 23–72 years).
• 30 female, 5 male.
• Cancer type and stage: diverse. Majority: breast cancer (54%).
• All patients underwent chemotherapy during the study and were diagnosed with mood disorder at baseline.

Single site (outpatient)

Active treatment

Open-label noncomparative prospective pilot study

• Hospital Anxiety and Depression Scale (HADS) for depression and anxiety
• Montgomery-Asberg Depression Rating Scale (MADRS) for depression
• Mini-Mental Adjustment to Cancer (mini-MAC) scale for psychological response to the diagnosis of cancer
• Clinical Global Impression (CGI) for severity of psychological illness
• Dosage Record and Treatment Emergent Symptom (DOTES) scale for the adverse effects of the clinical treatments and their possible relation to the drug used
• Quality of Life (QL) index for quality of life

Mean daily dose of sertraline was 57.50 (±18.74) mg at T1 and 57.41 (±18.10) mg at T2. Both mean depression scores, HADS and MADRS, and HADS anxiety scores significantly decreased during the 12 weeks of the study (all p's < 0.05). Mean mini-MAC scores show that hopelessness and anxious preoccupation decreased significantly at T2, compared with scores at T0 (p < 0.05). Quality of life improved over time (p < 0.05). CGI improved over the treatment period; however, no statistical tests were involved. No severe adverse effects were observed. 6 patients reported varying degrees of side effects (e.g., nausea, agitation, insomnia, dizziness).

Sertraline may be effective; a more definitive conclusion requires stronger evidence.

• Small sample: < 100.
• Internal validity is limited because of the lack of a control group, the lack of control over the lapse of time since the beginning of cancer therapy, and the small sample size.
• External validity is limited because the sample size was small and testing occurred in one setting only.
• Minor flaws include lack of information regarding measurements of validity and reliability.

Nurses can tell patients that sertraline may be an option in the treatment of symptoms of depression during chemotherapy.

Sertraline was started at a dosage of 25 mg/day in a single daily dose, with a possible dosage increase based on individual response and tolerability until 100 mg/day. A minimum dosage of 50 mg/day had to be reached. Patient outcomes were assessed at baseline (T0), week 4 (T1), and week 12 (T2).

• The study was comprised of 35 adult patients with cancer undergoing chemotherapy treatment with mood depression (scoring greater than five on the SCID-PO scale-depression subscale).
• The majority of patients were female (85.7%) and were diagnosed with colorectal cancer (20%), breast cancer (54.3%), lung cancer (8.6%), and onco-hematologic pathology (17.1%).

Psychooncology Unit, St. Giovanni Battista Hospital, University of Turin, Italy

Patients were undergoing the active treatment phase of care.

The study used a pilot, open-label, noncomparative, prospective design.

Montgomery-Åsberg Depression Rating Scale (MADRS)

For lassitude (fatigue), a subitem on the MADRS, there was a significant difference between baseline and week 12. Between baseline and week 4, an improvement was evident but not significant. Fatigue was not a major outcome.

• The study had a small sample size.
• The study had an open-label design without a control group.
• There was heterogeneity in terms of cancer stage and diagnosis.

To investigate the efficacy and tolerability of duloxetine in patients with cancer with mood disorder

Consecutive patients with diagnosed mood disorder started a regimen of duloxetine. They received an initial dose of 30 mg/day for one week, then 60 mg daily. If response was poor after one month, the dose was increased to 120 mg. Benzodiazepines were allowed as needed during the first two weeks. Study assessments were done at baseline, week 4, and week 12. Analysis compared results pertaining to those who had cancer and to those who did not.

• The study reported on a sample of 37 patients, 23 with cancer.
• Mean patient age was 63.6 years (SD = 10.9 years).
• The sample was 44.7% male and 45.3% female.
• Cancer types were not reported.

• Single site
• Outpatient setting
• Italy

Prospective observational design

• Hospital Anxiety and Depression Scale (HADS)
• State-Trait Anxiety Inventory
• EORTC questionnaire

Overall, 20% of patients dropped out of the study. Of the patients with cancer, 15% dropped out due to agitation, insomnia, or tachycardia. Analysis showed similar response over time of those with and without cancer diagnoses. Depression and anxiety by all measures declined at all follow-up times (p < 0.001).

Duloxetine was effective in reducing anxiety and depression in patients with and without cancer. The majority of patients tolerated the medication well.

• The study had small sample sizes, with samples of fewer than 30 and fewer than 100, respectively.
• The study had risks of bias due to no control group, no blinding, and no random assignment.
• Participant withdrawals were ≥ 10%.

Findings suggest that antidepressant use by patients with cancer who also have clinically relevant mood disorders can improve symptoms of anxiety and depression. Note: Most antidepressant studies that show a positive impact involve use by patients who have clinically relevant mood disorders at baseline.

To determine effectiveness of an early physiotherapy program in reducing the risk of secondary lymphedema in women after surgery for breast cancer

Early therapy included manual lymph drainage, stretching exercises for key muscle groups, progressive active and assisted shoulder exercises, proprioceptive facilitation exercises without resistance along with education consisting of instruction with printed materials. All patients were followed up 4 weeks after surgery and at 3, 6 and 12 months. Follow-up time points were somewhat flexible by design; however, actual differences in follow-up are not described. If secondary lymphedema occurred, complex decongestive therapy was carried out.

• The study sample (N = 116)  was comprised of female patients with breast cancer postoperatively.
• Mean age was 52.9 years.
• Patients were excluded if they were receiving adjuvant therapies.

The study took place in an outpatient setting in Spain.

The study used a randomized, single-blinded, controlled trial design.

• Arm circumference was measured at 5 cm intervals on both arms.
• Demographic data was collected.
• Computed volume ratio was compared between arms.

Incidence of secondary lymphedema was 25% in the control group compared to 7% in the intervention group (p = 0.01). In both groups the volume of the affected arm increased over time. In the control group, the volume was an average of 5.1% greater in the affected arm compared to 1.6% greater in the intervention group (p = 0.0065). Survival analysis showed that secondary lymphedema developed more rapidly in the control group and the protective effect of early physiotherapy remained for a longer time.

Early physiotherapy can be an effective intervention for prevention or mitigation of secondary lymphedema after surgery for breast cancer within one year after surgery.

• Actual exercise done by the control group is not known.
• Adherence of any patients to educational guidance is not discussed.
• Methods state that complex decongestion would be done in any case of lymphedema; however, these findings or differences between groups are not mentioned.
• One-year follow-up does not make it clear if early physiotherapy remains effective over the longer term.

Early physiotherapy and related exercises are helpful in preventing or mitigating lymphedema in the short term for patients who have had surgery for breast cancer involving axillary lymph node dissection. Ongoing research in this area is needed to determine effective strategies in the longer term for this chronic problem.

To investigate the safety and efficacy of single-dose palliative chest reirradiation for pain control

Patients who had been treated with three-dimensional conformal radiation therapy (RT) and concurrent cisplatin-based therapy were given reirradiation to the chest area previously included in the > 90% prescribed dose region. Pain management was evaluated according to the World Health Organization step ladder.

• N = 78  
• MEDIAN AGE = 67.3 years (range = 37–88 years)
• MALES: 70.5%, FEMALES: 29.5%
• KEY DISEASE CHARACTERISTICS: 76% of participants had local tumor recurrence.

• SITE: Single site  
• SETTING TYPE: Outpatient    
• LOCATION: Turkey

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

Retrospective, descriptive study

• 10-point Visual Analog Scale (VAS) for pain
• National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0
• Response evaluation criteria in solid tumors

There were no radiation-associated toxicities greater than grade 2. The median VAS score before reirradiation was 7 (range = 4–9), and the median score after reirradiation was 3 (range = 0–8, p < 0.001). Thoracic disease was stabilized in 33.3% of patients and partially regressed in 21.1%. No factors predicting better pain responses were identified.

Reirradiation to the chest area was effective for most patients in reducing pain associated with non-small cell lung cancer. It was not associated with severe adverse effects. Two patients developed esophagitis, and three developed pneumonitis. The median time to the lowest pain score was 27 days, and the mean duration of relief was 6.1 months.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Unintended interventions or applicable interventions not described that would influence results
• Measurement/methods not well described
• Findings not generalizable
• Subject withdrawals ≥ 10% 
• Other limitations/explanation: This study had a retrospective design. The timing of VAS measurements was not mentioned. No information about other interventions for pain relief or medication alterations within the duration of study observations was recorded.

Locoregional failures at the margins of previous RT fields can be associated with severe pain in patients with lung cancer. This study suggested that single-dose reirradiation may reduce pain.

• Patients received 150 mcg octreotide subcutaneously three times daily once they were unresponsive to oral loperamide administration (4 mg three times per day for 48 hours).
• All patients received hydration and were advised to consume a low-fiber, low-lactose diet.

• The study reported on 42 patients with rectal carcinoma who experienced grade 2-3 diarrhea associated with at least one course of 5-fluorouracil (5-FU) administration refractory to loperamide during whole pelvic radiation therapy (RT).
• The maximum number of days of octreotide treatment was five. If patients had progressive improvement of chemoradiotherapy-induced diarrhea (CRTID) during the five days of treatment but not a complete response (CR), chemoradiotherapy (CRT) was discontinued and octreotide was extended for three days.

This study was prospectively designed.

The primary goal was complete resolution of CRTID. The secondary goal was prevention of treatment delays attributed to diarrhea.

• The median duration of diarrhea prior to first dose of octreotide was 78 hours.
• Most cases of diarrhea were diagnosed in the first four weeks.
• The median time-to-first dose of octreotide acetate was 19 days.
• All patients tolerated octreotide well.
• Complete resolution of diarrhea was achieved in 34 of 42 patients during the planned treatment period (five days).
• Average time to CR was 2.7 days.
• No treatment delays were reported in 34 patients who responded to subcutaneous octreotide administration.
• CRT was delayed an average of 7.7 days in the eight unresponsive patients.
• Those with CR were able to be treated as outpatients; nonresponders required hospitalization.

• The sample size was small.
• The study looked at rectal carcinoma only so generalizing to other disease sites is difficult.
• No statistical significance was reported.
• Only descriptive results were provided.

In the original protocol, infliximab was given as an intravenous infusion at 5 mg/kg over a two-hour period, followed by a two-hour observation period, at baseline and two, four, and every four weeks after that if improvement was demonstrated. After a patient suffered a serious infection following the week 2 infusion, the dosing regimen was amended to 5 mg/kg at week 0 and every four weeks after if improvement was observed. The first five patients were treated under the original protocol, and the next 12 were treated according to the amended protocol. Patient outcomes were evaluated at every time point.

• The sample was comprised of 17 patients with end-stage cancer.
• Mean age was 63.5 years.
• The majority of the patients were male (76.5%) and had multiple cancer diagnoses, with the most common being renal cell carcinoma (23.5%) and nonsmall cell lung carcinoma (NSCLC) (23.5%).
• Patients were excluded if they had a reversible cause of fatigue (i.e., anemia, hypercalcemia, hyponatremia, or hypothyroidism) or had major surgery, chemotherapy, or radiotherapy within four weeks of study enrollment, which were medical contraindications for infliximab treatment.

Outpatient, daytime therapy clinics for specialist palliative care at the Marie Curie Hospice, United Kingdom

Patients were undergoing the palliative phase of care.

This was an open-label, pilot study.

Fatigue Severity Scale (FSS)

The infliximab intervention did not show an overall improvement of fatigue in patients. However, a small cohort of six patients showed an improvement in FSS scores over time with repeated infliximab infusions, although this difference did not reach statistical significance. The six patients shared a similar profile of NSCLC that was progressive through chemotherapy and received the amended protocol treatment.

• The study had a small sample size.
• The stuck lacked a neutral comparison group.