To determine the effect of oral proteolytic enzymes for prevention of acute side effects in patients with head and neck cancer.

Patients were randomly assigned to the control or experimental group.

The enzymes taken were a combination of papain 100 mg, trypsin 40 mg, and chymotrypsin 40 mg (MUCOS Pharma). Patients took three tablets, three times per day, three days prior to start of radiation therapy (RT), and up to five days after completion.

Mucositis, skin reaction, and dysphagia were graded at each visit during and after RT. Scoring was done at baseline, weekly, and five to six months following treatment.

• The sample was comprised of 98 men.
• Age ranged from 18 to 65 years.
• Patients had T3/T4 cancers of the head and neck region with squamous cell.
• Patients received Cobalt 60 gamma radiation at a standard daily dose of 2 Gy in 25 to 35 fractions over six to seven weeks. 
• Thirty-three patients were hospitalized to ensure compliance.

• Multisite
• Indore and Cuttack, India

The study was a prospective, randomized, open-label trial.

• Radiation Therapy Oncology Group (RTOG) criteria
• Compliance was monitored by counting pills.
• Grading was performed by the same person every time.
• Wilcoxon summed was used to test for differences.

• The average skin reaction score was lower in those treated with enzymes (p < 0.0001).
• The maximal extent of acute toxicity was lower in those who took enzymes.
• Two patients in the experimental group were dropped due to the most severe acute reactions.

Oral proteolytic enzymes may be helpful in reducing the severity of radiodermatitis.

• Slightly more than one-third of the patients had to be hospitalized to ensure compliance with treatment, which suggests the impracticality for clinical use in this population.
• Multiple patients had treatment delays, most of which were associated with social issues.
• Skin reactions per RT dose levels were not compared.

To determine the effectiveness of an assistive mobile flexion bar during exercise to reduce arm volume in patients diagnosed with lymphedema related to breast cancer treatment

Participants were randomly selected, and all participants received the intervention. Participants received a single one hour of active exercising split into 12-minute sections with 3 minutes of flexion bar use between each section. The flexion bar is a T-shaped apparatus, the vertical bar remains fixed (10 cm away from the patient on a tabletop), and the horizontal bar rotates (30 cm above the tabletop) to allow extension and flexion of arm muscles. All of the participants wore a compression sleeve on the affected limb. The participants independently performed the exercise routine, and the sole purpose of the interventionist was to control the time of exercise intervals and to help participants maintain proper posture and spinal alignment.

• The study sample (N = 21) was comprised of female patients with breast cancer who were diagnosed with arm lymphedema.
• All patients had radiotherapy postoperatively and were 2–12 years postoperative.

The study took place at a rehabilitation facility in Brazil.

Patients were undergoing active lymphedema treatment.

The study used a prospective trial design.

• Water displacement measured limb volume before and after the flexion bar intervention.
• Participants' arm volume was measured before and after each exercise session.

The participants initial mean volume was 2,089.9 ml. After the exercise session, the mean final volume decreased to 2,023.0 ml. The study used a paired t-test with an alpha error of 5% as acceptable. The results concluded in a mean loss of 66.9 ml (p < 0.001). There was a significant reduction in limb volume, using active exercises with a facilitating device (mobile flexion bar).

The trial suggests that the use of an apparatus mobile flexion bar may improve the efficacy of lymphedema reduction by myolymphokinetic exercises. Active exercises are beneficial to patients with lymphedema because it promotes muscle contraction and lymphatic drainage. The study has its risks for bias based on the small sample size and the lack of a control group.

• The sample size was small, with less than 30 participants.
• The time in years from surgery is a large range.
• The study has a risk of bias because of no control group, blinding, or random assignment.

Because of the statistical significance of the findings of the study, it is important for nurse researchers to repeat the study using a more rigorous study design. If the experiment were repeated as a randomized controlled trial with a larger sample size, the results would be more generalizable. It would also be interesting to compare the use of a mobile flexion bar to active exercise without the use of a facilitating device to determine the necessity.

STUDY PURPOSE: To investigate the efficacy of antidepressants and anticonvulsants in combination therapy for neuropathic pain in patients with cancer

TYPE OF STUDY: Meta-analysis and systematic review

• FINAL NUMBER STUDIES INCLUDED = 8
• TOTAL PATIENTS INCLUDED IN REVIEW: 1,359
• SAMPLE RANGE ACROSS STUDIES: Unavailable
• KEY SAMPLE CHARACTERISTICS: Five studies involved chemotherapy-induced neuropathic pain, and one involved postmastectomy pain. One study included only breast cancer. Four studies included varied tumor types.

PHASE OF CARE: Multiple phases of care
 
APPLICATIONS: Palliative care

When both types of interventions were considered, use of these adjuvant medications in combination pharmacotherapy was superior to control regimens (p < 0.010, MD = -0.41). However, in subgroup analysis, anticonvulsants (MD = -0.12, 95% CI [-0.64, 0.39]) did not show a significant effect. Antidepressants showed some efficacy (MD = -0.54, 95% CI [-0.94, -0.12]) based on only two studies. Anticonvulsants showed better efficacy among studies including only chemotherapy-induced neuropathic pain. Withdrawals in experimental groups was two times higher than in control groups. Study duration ranged from 10 days to 6 weeks.

Use of adjuvant antidepressants and anticonvulsants had a significant but small effect on neuropathic pain, and anticonvulsants considered alone showed no overall significant effectiveness. Evidence was too limited to formulate a recommendation for use.

• Limited number of studies were included.
• Few studies existed for each type of medication.
• Three studies were of very short duration.
• Overall analysis included a study with topical application and one that included opioid use in the experimental group—these inclusions could have skewed overall findings.

There is limited evidence to demonstrate effectiveness of anticonvulsants or antidepressants as adjuvant medications for neuropathic pain management, and high withdrawal rates in studies within groups receiving these drugs may point to their potential side effects. Nurses need to be aware of and monitor the adverse side effects of these medications.

To examine the effect of colony-stimulating factors (CSFs) used as primary and secondary prophylaxis on incidence of febrile neutropenia, infection, and survival in older adults.

The study used data from the Surveillance, Epidemiology, and End Results (SEER) Medicare database. ICD-9 codes were used to define inclusion diagnoses and definition of febrile neutropenia. 

Use of CSF, the type of chemotherapy administered, and the use of antibiotics were defined in terms of CPT codes. Regression analysis was used to analyze effects of primary and secondary CSF prophylaxis on outcomes of interest. Primary prophylaxis was defined as CSF during chemotherapy before occurrence of fever, infection, or neutropenia. Secondary prophylaxis was CSF administration that occurred after these events. Study used data from 1992–2002.

• Total cases numbered 13,203, with 5,266 receiving any CSF.
• Mean age was 74.9 years, with a range of 65–102.
• Women made up 53% of the sample; men made up 47%.
• All patients had non-Hodgkin lymphoma (NHL). 
• 62% had low comorbidity burden, as defined by ICD-9 coding.
• 44% had large B-cell lymphoma.
• 18% had follicular lymphoma. 
• 89.2% were Caucasian. 
• All socioeconomic groups were essentially equally represented.
   

Multi-site (SEER data)

There were mutliple phases of care

Application is for elder care

Retrospective cohort study

• Chemotherapy administration defined as ICD-9 code 9925; CPT codes 96400-96549, J9000-9999, and Q0083-0085; revenue codes 0331, 0332, and 0335; and ICD-9 V codes, k V58.1, V66.2, and V67.2.
• Use of CSF was identified by CPT codes J1440, J1441, and J2820.
• Febrile neutropenia was defined as the combination of neutropenia (ICD-9 288.0) and fever present (780.6).

Sixty percent of cases did not receive any CSF. Those who had 5–9 CSF administrations for primary prophylaxis has a 42% lower risk of febrile neutropenia (OR = 0.58, 95% confidence interval [CI] [0.41, 0.83]) and those with 10 or more administrations had a 48% lower risk after data were adjusted for age, marital status, stage, and other characteristics. Those with 5–9 administrations had a 27% lower incidence of infection, and those with 10 or more administrations had a 52% lower risk (OR = 0.48, 95% CI [0.35, 0.66]). Primary prophylactic CSF was not associated with longer overall survival. Secondary prophylaxis was associated with improved overall survival, with a strong dose-response effect. A range of 11–23 administrations was associated with a 23% lower risk of mortality (HR = 0.77, 95% CI [0.71, 0.84]), and those with more than 23 administrations had a 13% lower risk of mortality than others. Protective effects of primary prophylaxis was highest in those receiving the largest number of chemotherapy administrations and in those with large B-cell lymphoma.

Primary prophylaxis with CSF in older adults is effective in preventing febrile neutropenia and infection, but was not associated with improved survival. Secondary prophylaxis was associated with longer overall survival.

• Risk of bias (sample characteristics)
• Measurement validity/reliability questionable
• Findings not generalizable
• Measurement validity/reliability questionable
• The sample was limited to patients with NHL from 1992–2002, and findings would not necessarily be applicable to patients with other types of disease and those receiving newer and other treatment regimens. 
• Although data were stratified for classes of chemotherapeutic drugs there was no specific subgroup analysis based on different types of chemotherapy or other treatments.
• Reliability of medical records coding is across organizations is known to be questionable, so findings should be considered with this in mind.
• Definition of neutropenia by code, which depends upon physician documentation and does not specify actual lab results as criteria can be questionable.
• A higher proportion of patients who got primary prophylaxis had higher stage disease—it is not stated as to whether there were statistically significant differences in this factor or not and those who received CSF were more likely to have received radiation therapy as well.   
• Although data were said to be stratified for age, it is not clear if the factor of combined therapy was considered in analysis.

Findings support the use of primary prophylactic CSF for prevention of infection and febrile neutropenia, and secondary prophylaxis in improving survival in this group of patients. Limitation of retrospective statistical analysis using medical records code data only need to be considered in interpretation and application of these results.

To provide advice for patient care in daily practice regarding the management of side effects of sunitinib.

Information was compiled and clinical experts were asked to identify the degree to which they agreed or disagreed with the information. Those measures agreed on by 70% of respondents were included in this summary. Clinicians had to have cared for at least 30 patients receiving sunitinib. Twelve German clinical experts provided analysis.

Databases searched were PubMed, Embase, Current Contents, and recommendations of oncology societies.

Key topics were sunitinib and tyrosine kinase inhibitor therapy management recommendations.

Arterial Hypertension:

• Mandatory blood pressure monitoring is recommended as often as daily. No clear recommendations exist for monitoring or optimal treatment with antihypertensives. The exact mechanism of effect is unclear, and hypertension may resolve during regular two-week pauses in treatment and reappear with continuation of therapy.
• Agreement was reached on routine exercise, weight control, a sodium-restricted diet, and decreased alcohol consumption.

Fatigue:

• Maintain normal social and physical activity.
• Balance work and sleep schedules.
• Get moderate exercise.
• Measure body weight routinely.
• Use distraction (e.g., reading).
• Offer medical treatment for secondary causes such as hypothyroidism, depression, anemia, or pain.
• Consider reduction of sunitinib in cases with reduced quality of life.

Mucositis/Oral Disorders:

• Avoid irritating food or drinks, such as spicy, acidic, very hot or cold, and dry or hard foods.
• Use lip protection.
• Oral hygiene is important.
• Use of dexpanthenol lozenges and ointment is appropriate for mucosal protection.  
• Oral symptoms should be treated with topical anesthetics, steroids, or anti-infectives.
• In case of pronounced symptoms, consider interruptions of sunitinib.

Diarrhea:

• Advise patients to split food and drinks into small amounts.
• Avoid spicy or fried food and large amounts of fruits and vegetables.
• Maintain sufficient fluid intake.
• Avoid use of laxatives.
• In cases of severe diarrhea, provide IV fluid and electrolytes.  
• Early treatment with agents such as loperamide is advised.
• Interruption or dose reduction of sunitinib was considered appropriate for grade 3 or 4 diarrhea only.

Nausea and Vomiting:

• Eat a bland diet with small servings.
• Use antiemetic drugs such as dopamine agonists and proton-pump inhibitors.
• Sunitinib dosage may be reduced 12.5 mg in cases of grade 3 or 4 symptoms, or if symptom interventions are not successful.

Skin Reactions

Hand-Foot Syndrome:

• Protect the hands and feet from heat and hot water.
• Use cold packs for pain relief.
• Apply moisturizers daily.
• Use systemic anti-inflammatory medication in some cases.
• Use topical antifungals for localized superinfection.
• Use oral ibuprofen or paracetamol for pain control.
• For grade 2 symptoms, consider break-in sunitinib.
• For grade 3 symptoms, interrupt treatment temporarily and use lower doses after symptoms have resolved to lower than grade 1.

Erythema, Dry Skin, and Dermatitis:

• Prevent sun exposure and use ultraviolet (UV) protective lotions with 15 to 30 sun protective factor (SPF).
• Avoid irritating care products.
• Use fatty creams or ointments after showering daily.
• Limit sunitinib dose alterations as much as possible. Only 66% agreement was reached that a treatment break should be considered with grade 2 to 4 skin toxicity.

• Experts were from a single setting, and one author was employed by Pfizer.
• Recommendations were based on the opinion of a few experts, who had limited patient experience with sunitinib. The association with varied levels of evidence to support these recommendations is not evident.
• Advice for patients and physicians was built mainly from the opinions of experts, rather than supporting data from controlled trials.

A significant need exists for more scientific evidence on the prevention and management of side effects caused by these agents for cancer treatment.

To evaluate the effectiveness of a single dose of fosaprepitant in combination with dexamethasone and 5-HT₃ for chemotherapy-induced nausea and vomiting (CINV)

• Patients who were to receive cisplatin were randomly assigned to the experimental group or the control group. The experimental group received a single, 150-mg dose of IV fosaprepitant administered with a 5-HT₃ receptor antagonist and a corticosteroid prior to cisplatin-based chemotherapy. The control group received matched placebos for the experimental regimen and the currently recommended three-day oral regimen of aprepitant for five days after treatment.
• Ondansetron and dexamethasone were administered at current dosing recommendations.
• Patients kept diaries of episodes of vomiting, daily nausea assessment, and use of rescue mediation.
• Adverse effects were assessed at each clinic visit.

• The study consisted of 2,322 participants.
• The median age was 56 years in the experimental group and 57 years old in the control group.
• The study group was 36.7% female and 63.3% male.
• The most frequent diagnosis was lung cancer. Other cancers were GI, reproductive or genitourinary, renal and urinary tract, and breast cancer.
• The study group was 56% white and 29% Asian.
• All patients were scheduled to receive their first course of cisplatin ≥ 70 mg/m².

The study was conducted at multiple outpatient settings in 27 different countries.

All patients were in active treatment.

The study was a double-blind, randomized-controlled, parallel group.

The following measurement tools were used.

• Visual analogue scale (VAS) 100 mm for assessment of nausea
• Daily diary to record vomiting or retching episodes
• Use of rescue therapy (Common Terminology for Adverse Events [CTAE v3.0])

• No significant differences were found between groups for the primary endpoint of no vomiting or retching episodes with no use of rescue medication or episodes during the delayed phase.
• No significant differences were found between groups for the proportion of subjects who reported no significant nausea (defined as < 25 on the VAS).
• Overall, in both groups, slightly more than 74% reported no episodes of vomiting or use of rescue therapy in the delayed phase for nausea.
• Overall, the adverse events seen with the fosaprepitant regimen was similar to that seen with the three-day aprepitant regimen.

• The fosaprepitant regimen as used was as effective for the prevention of acute and delayed nausea associated with cisplatin-based chemotherapy as the currently recommended oral aprepitant regimen.
• A single dose of 150 mg of fosaprepitant was sufficient to suppress delayed CINV for 2–5 days after therapy.

• Findings demonstrated that a single, IV-dose regimen with this agent is an effective alternative to oral neurokinin 1 (NK1) receptor antagonists used as currently recommended for prevention of delayed onset CINV.
• Nurses should be aware of potential infusion-site reactions.
• About one-fourth of patients were refractory to this regimen, indicating the continued need to explore individualized alternatives for maximum symptom control.
• The most effective timing of these treatments for prevention of delayed onset CINV is not yet fully clear.

To evaluate the safety and efficacy of aprepitant, dexamethasone, and palonosetron as an antiemetic regimen for prevention of acute and delayed nausea and vomiting

Patients received one oral dose of 285 mg aprepitant and 20 mg dexamethasone one hour prior to cyclophosphamide and/or doxorubicin chemotherapy and 25 mg IV palonosetron 30 minutes prior to chemotherapy. Patients completed study diaries prior to the start of the single-day chemotherapy and then daily for five days.

• The sample consisted of 41 participants.
• Median age was 51, with a range of 33–74 years.
• Forty of the patients were female (97.5%), and one was male (2.5%). 
• Patients were diagnosed with solid tumors (no other information provided). The majority (n = 41) had performance statuses of 0 or 1.
• All patients received cyclophosphamide; 90% received doxorubicin and cyclophosphamide combination therapy.
• Patients could not receive corticosteroids or antiemetic agents other than the study drug doses immediately before or during the study period.

The study was conducted at multiple outpatient settings in Vermont and Maine.

All patients were in active treatment.

The study was a prospective trial.

• Patients recorded frequency and intensity of nausea and vomiting in study diaries.
• Nausea and vomiting was also measured based on the use of rescue antiemetic medication.

• Overall
  • 51% had a complete response (no vomiting and no rescue therapy)
  • 95% had no emesis
  • 32% had no nausea
• Acute phase (0–24 hours post chemotherapy)
  • 76% had complete response
  • 100% had no emesis
  • 59% had no nausea
• Delayed phase (24–100 hours post chemotherapy)
  • 66% had complete response
  • 95% had no emesis
  • 41% had no nausea
• Only 27% of patients had more than 1 day of significant nausea.
• No major adverse effects from medications were noted.

The single-day, three-drug (aprepitant, dexamethasone, palonosetron) antiemetic regimen is a safe and effective antiemetic regimen for patients receiving mildly or minimally emetogenic chemotherapy.

• No control group or comparison was provided.
• Only patients with low potential for nausea and vomiting were included in the study.
• Potential for bias exists, as patients may have underestimated their symptoms or rescue medications because they were a part of a study.

Identifying effective single-day antiemetic regimens may improve adherence to supportive care guidelines and reduce nausea and vomiting symptoms in patients receiving chemotherapy.

To investigate the effect of a single low dose (600 mg) of preoperative oral gabapentin on morphine consumption after total mastectomy and axillary dissection; to determine if the specified administration of gabapentin is safe 

Before total mastectomy and axillary dissection, patients received 600 mg gabapentin or placebo. Pain, sedation, nausea, vomiting, and side effects were monitored every 30 minutes for 2 hours and then every 2 hours until 12 hours after surgery.

• The sample was composed of 46 patients.
• The age range of patients was 18–75 years. In the placebo group, mean patient age was 44.9 years. In the gabapentin group, mean patient age was 46.6 years. 
• All patients were female. All patients were undergoing total mastectomy with axillary dissection ASA I or II.

• Single setting
• Inpatient
• Postanesthesia care unit

Randomized double-blind placebo-controlled trial

• 100-point pain rating scale
• Observer’s assessment of alertness or sedation
• Reports of nausea and number of episodes of vomiting

• Postoperative morphine consumption was 48% lower in the gabapentin group than in the placebo group (P < 0.001). 
• Compared to patients who received gabapentin, patients who received placebo had significantly higher postoperative pain scores and shorter times to rescue dose (P < 0.001).
• Authors noted no difference between groups in regard to sedation, incidence of nausea, and other side effects.

Pre-emptive administration of a single oral dose of gabapentin, 600 mg, led to a decrease in the use of postoperative analgesic.

• The study had a small sample size, with fewer than 100 patients.
• The study involved only one dose of gabapentin at a single time.
• The study followed patients for only 12 hours after surgery.

The use of preoperative gabapentin was associated with improved pain control and quality of life, without excessive side effects.

The purpose of the study was to determine whether calcium and magnesium infusions would prevent or ameliorate neurotoxity associated with oxaliplatin, enable a larger cumulative oxaliplatin dose delivered, ameliorate acute neuropathy associated with oxaliplatin, and whether any adverse events occurred.

Patients were randomly assigned to receive either IV calcium gluconate plus magnesium sulfate, 1 g each in 100 ml D5W for 30 minutes immediately before and after each dose of oxaliplatin, or an identical-looking placebo. Patients underwent a physical examination at study entry and before each two-week chemotherapy cycle, including an assessment for adverse events and toxicity as well as laboratory testing. Patients completed daily questionnaires before each dose of FOLFOX and for five days after completion of each cycle.

• The total sample consisted of 102 participants with a majority being men (53%) and older than age 65 (64%).
• All participants had stage II or III adenocarcinoma of the colon and were scheduled to receive six months of oxaliplatin-based FOLFOX chemotherapy.
• Exclusion criteria included a preexisting peripheral neuropathy of any grade, hypercalcemia, and having received prior neurotoxic chemotherapy.

The study was conducted in multiple outpatient settings throughout the United States.

• Active treatment
• Late effects

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

• The National Cancer Institute's Common Terminology Criteria for Adverse Events, verion 3.0
• A patient questionnaire using a 0–10 scale for sensitivity, discomfort swallowing, and muscle cramps.
• The North Central Cancer Treatment Group patient-reported outcome questionnaire to detect onset of neurotoxicity symptoms.

The study accrual was stopped before the original goal because of a data monitoring committee report regarding a similar trial in patients receiving palliative FOLFOX treatment in which interim analysis showed lower response rates in patients receiving calcium and magnesium. However, subsequent independent analysis of the data showed that initial interpretations were incorrect and that antitumor response was lower in that study's placebo group.

Results of the current study showed that the incidence of grade 2 or higher sensory neurotoxicity was significantly lower in the calcium and magnesium group on two different measurement scales (p < 0.04). In addition, onset of grade 2 or higher was significantly delayed in patients who received calcium and magnesium (p = 0.03). Patient report of numbness also was lower in the calcium and magnesium group (p = 0.021). The study intervention did not appear to have an effect of oxaliplatin-specific symptoms such as muscle cramps, throat discomfort, and cold sensitivity toxicities. No patients developed hypercalcemia.

The findings provide some support for the hypothesis that calcium and magnesium infusions can decrease oxaliplatin-related cumulative sensory neurotoxicity. The results suggest that some types of neurotoxic effects may be reduced, while no obvious effect on other symptoms is apparent.

• The study may have been underpowered because of premature closure to subject accrual.
• No information is provided regarding whether or not there were any FOLFOX dose reductions or discontinuations that also may have affected study findings.
• The authors stated that this was because of early study closure; however, why this would prevent providing any such data is unclear.

Calcium and magnesium infusion may reduce neurotoxicity associated with chemotherapy agents. Additional research in this area is needed to determine if both elements are required and what is the most effective dosages, timing, and efficacy with agents other than oxaliplatin. Research would further clarify the role of this intervention with specific neuropathic symptoms and whether this intervention is effective with various chemotherapeutic agents.

To compare effects of a mindfulness-based intervention to those of a psychoeducational telephone consultation on quality of life, depression, fatigue, and anxiety.

The study was begun as a randomized, controlled trial and patients were allocated at random to either the mindfulness-based or psychoeducational groups. Because of patient complaints about group assignment, in the second half of the study, patients were allocated to the group of their choice. The mindfulness intervention was based on mindfulness-based stress reduction concepts and activities and was provided in 2.5-hour group sessions weekly for eight weeks. They also had homework assignments, two 2.5-hour booster sessions at the end of 1 and 2 months during a three-month follow-up phase, and an all-day retreat. At baseline, individuals were interviewed to establish individual goals and, at the end of the program, were interviewed regarding goal attainment, maintenance of acquired skills, and evaluation of personal experience. The comparison group received 15-30 minutes of psychoeducational consultations by telephone twice a month for eight weeks. During the follow-up period, they had additional phone calls at the end of months 1 and 2. Study measures were obtained two weeks before and after the initial intervention and three months postintervention. Consultation with intervention teachers was used to evaluate treatment fidelity.

• N = 62, with 53 completers
• MEAN AGE = 52.1 (SD = 14.1)
• MALES: 50%, FEMALES: 50%
• KEY DISEASE CHARACTERISTICS: Patients were at least six months after completion of HCT and in complete remission at the time of enrollment. The mean time since transplantation was 7.5 years. All had hemotologic disease

• SITE: Not stated/unknown  
• SETTING TYPE: Not specified  
• LOCATION: Switzerland

• PHASE OF CARE: Late effects and survivorship

• Quasi-experimental phase and RCT phase

• Profile of Health Related Quality of Life in Chronic Disorders
• FACT scale
• CESD scale
• Fatigue questionnaire
• FACIT fatigue scale
• Spielberger State Trait Anxiety scale
• Goal Attainment assess on 11-point scale from -5 (completely unmet) to 5 (beyond expectation)

Quality of life and depression improved immediately after the intervention (p < 0.02)  At the three-month follow-up, significant differences were noted between groups, with improved quality of life in the mindfulness group (p = 0.04)  and lower depressive symptoms  and anxiety in the psychoed group (p = 0.04). There was no significant effect of either intervention on fatigue. There were no differences in outcomes based on whether the patient was randomly assigned or chose the preferred intervention.

Findings suggest that a mindfulness-based intervention may have positive benefits for overall quality of life and depressive symptoms in the short term, but this study did not show a long-term impact on depression or anxiety. No effect was seen for fatigue.

• Small sample (less than 100)
• Subject withdrawals of 10% or greater 
• Other limitations/explanation: 14.5% attrition in the mindfulness group and 7% in the comparison group. Booster sessions were only attended 50% of the time.

Findings suggest that a group mindfulness-based program for HCT survivors is feasible, although the overall attrition and poor attendance at follow-up sessions suggests it is difficult to maintain involvement in the longer term. Additional study incorporating Web-based and telephonic follow-up boosters might be more practical for patients to attend. Although there were some immediate effects for depressive symptoms, these were not long lasting. Additional research is needed to explore long-term benefits and most effective methods for delivery of this type of intervention.