To report on health-related quality of life (HRQOL) and depressive outcomes from an earlier trial using nurse counseling after intervention (NUCAI)

Nurses delivered as many as six 45–60 minutes sessions every two months. The sessions consisted of six components: completing a Hospital Anxiety and Depression Scale before each session to lead a discussion of current mental state, having a discussion of current physical problems, having a discussion of life functioning, providing the AFTER (Adjustment to Fear, Threat, or Expectation of Recurrence) intervention, providing general medical assistance, and referring patients to psychological care. The AFTER intervention had four components: expressing fear of recurrence, identifying beliefs about recurrence, evaluating self-examinations, reducing excessive checking behavior, and relaxation. Usual care was provided twice monthly in sessions about complications and monitoring for recurrence. Patients were referred for psychological aftercare if psychosocial problems were assessed.

• N = 179  
• MEAN AGE = 60.1 years (intervention), 60.7 years (control)
• MALES: 70%, FEMALES: 30%
• KEY DISEASE CHARACTERISTICS: Intervention type of cancer: 23% larynx, 47% oral cavity, 18% OP, and 13% hypopharynx; control type of cancer: 24% larynx, 19% oral cavity, 48% OP, and 8% hypopharynx; intervention tumor stage: I–II 58% and III–IV 42%; control tumor stage: I–II 59% and III–IV 40% 
• OTHER KEY SAMPLE CHARACTERISTICS: Working status intervention: employed 35%, unemployed 33%, retired 22%, and unknown 10%; working status control: employed 37%, unemployed 37%, retired 23%, and unknown 2%

• SITE: Single site    
• SETTING TYPE: Not specified    
• LOCATION: Utrecht, Netherlands

• PHASE OF CARE: Transition phase after active treatment

Single, blinded, randomized, controlled trial

• Questionnaires were completed at baseline before cancer treatment and at three, six, nine, 12, 18, and 24 months after treatment completion.
• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck (EORTC QLQ-C30 H&N 35)
• Center for Epidemiologic Studies Depression Scale (CES-D)
• Demographic and medical information collection

50% of patients were lost to follow-up, the majority of which were because of death or terminal disease. At 12 months, statistically significant differences in physical functioning, emotional functioning, pain, swallowing, social contact, opening the mouth, coughing, and depressive symptoms were present. At 18 months, statistically significant differences in global quality of life, role functioning, emotional functioning, pain, swallowing, opening mouth, and depressive symptoms were present. At 24 months, statistically significant differences in emotional functioning and fatigue were present. Appointments were difficult to complete at times because of the clinic environment.

The NUCAI showed significant improvements for patients with head and neck cancer 24 months after completing treatment.

• Risk of bias (no blinding)
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10% 
• Other limitations/explanation: High attrition rate because of disease state; several analyses of data; fatigue measured as one aspect of multicomponent quality of life

As a nurse-led intervention, this is a feasible option for patients with head and neck cancer desiring a problem-focused intervention for symptoms.

To investigate the effects of a psychosocial nurse counseling and after intervention (NUCAI) versus usual care on symptoms of depression and physical symptoms related to the head or neck cancer (HNC) of patients one year after the diagnosis of HNC.

The NUCAI consisted of six bimonthly 45-minute counseling sessions. NUCAI is a problem-focused method aimed at helping patients to manage the physical, psychological, and social consequences of HNC and its treatment. The intervention consisted of these components: evaluating current mental status, discussing current problems, systematically asking about physical problems and functioning, and providing the adjustment to the fear, threat or expectation of recurrence (AFTER) intervention. AFTER was nurse led. During one year, six sessions were provided with usual and regular medical follow-up visits. Usual care involved 10-minute appointments every two months, for examination and review. Patients were randomly assigned to the intervention or control group. Data were collected every three months for one year.

• The initial sample was composed of 205 participants with HNC. The final analysis included 150 participants.
• Mean patient age in the intervention group was 60.1 years; in the usual-care group, 60.7 years.
• The intervention group comprised 70.5% males and 29.5% females. The control (usual-care) group comprised 70.3% males and 29.7% females.
• The majority of patients in both groups were married. Cancer of the oral cavity was the most common cancer diagnosis among the patients.

• Single site
• Outpatient
• The Netherlands

Transition phase after active treatment

Randomized controlled trial

• Self-report questionnaires for age, gender, education level, and social status
• Medical records review for treatment, tumor type, and stage
• Center for Epidemiological Studies Depression Scale (CESD) (primary outcome)
• European Organization for Research and Treatment questionnaire for quality of life of cancer patients (EORTC QLC) for physical symptoms (secondary outcome)

• In the intervention group, 11.7% of patients did not attend sessions.
• Treatment fidelity is documented by using trained, experienced oncology nurses to conduct the intervention.
• One year after HNC treatment, levels of symptoms of depression were significantly lower in the intervention group than in the control group ( p < 0.05, –5.2 change with intervention). Overall physical symptoms decreased more in the intervention group than in the control group, with a significant decrease in pain and symptoms related to swallowing and opening the mouth.

Study findings showed significant reduction in depression; therefore, this intervention can be used in clinical settings to improve patient outcomes (e.g., reduction of depression and improvement of physical symptoms).

• The study had a risk of bias due to no appropriate attentional control condition.
• Protocol fidelity was questionable.
• Subject withdrawals ≥ 10%.
• At 12 months, 55 patients were lost to follow-up. In terms of age and education, findings showed a significant difference between patients who were lost to follow-up and patients who completed the study through 12 months. Patients who were lost to follow-up were older and more educated and had an advanced stage of tumor. Of all participants, 27% were lost to follow-up.
• Because all sessions occurred at clinic follow-up appointments, the potential for contamination or other relevant threats to validity is unknown.

This study utilized a nurse-led intervention for reduction of symptoms of depression in HNC patients. With proper training nurses can be equipped with the skill of providing psychological counseling to patients. Investigators noted  that, compared to the cost of counseling offered by a clinical psychologist or psychiatrist, the nurse-led intervention seems a cost-effective method.

To evaluate the efficacy of group mindfulness-based cognitive therapy (MBCT) in reducing fatigue in cancer survivors with mixed diagnoses.

Randomization and assignment to either the intervention condition or the wait-list condition was performed one week prior to the start of each group. Fatigue severity (Checklist Individual Strength [CIS]), functional impairment (Sickness Impact Profile [SIP]), and well-being (Health and Disease Inventory) were assessed before and after the nine-week intervention. The intervention group had a follow-up six months after the intervention.

Eighty-three patients (32% male, 68% female) were included. All cancer types were included; more than half of the patients had breast cancer. Three patients had a history of two types of cancer. 

Patients were included if 

• Completion of their last anticancer treatment (all cancer types accepted) was at least one year prior
• They were curatively treated
• They were 18 years or older
• They scored 35 or greater on the severity of fatigue subscale of the self-report CIS
• There was no other somatic disease or medicine use that could explain or influence fatigue. 

Patients were excluded if they were seen on intake by one of two therapists for assessment of psychiatric morbidity or if they were identified to be at risk for psychosis or severe depression.

• Single site   
• Helen Dowling Institute, Netherlands

• Patients were undergoing the long-term follow-up phase of care.
• The study has applicability for late effects and survivorship.

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

• CIS   
• SIP
• Health and Disease Inventory
• Sleep Quality Scale (SQS)
• Hospital Anxiety and Depression Scale (HADS)
   

Ninety-one percent of all participants attended at least seven sessions; the mean number of sessions attended was eight. One-third (30.6%) of all participants suffered from sleep disturbances at follow-up, and 39% in the intervention group showed clinically relevant improvement in fatigue severity. Fatigue severity postintervention was 35.7 in the intervention group compared to 43.4 in the control group (p = 0.00). The effect size for fatigue was 0.74 (d) (no confidence interval was provided for effect size). The mean well-being score at postmeasurement was significantly higher in the intervention group than in the wait-list group. Six months after the intervention, participants in both groups reported significantly less fatigue severity. There was no difference between groups in fatigue at six months.

MBCT was effective in the short term for chronic cancer-related fatigue (CCRF). Longer-term follow-up showed no differences with mindfulness-based stress reduction versus the controls.

• The study lacked an appropriate control group.
• The study had limited generalizability to other therapists, as the same two therapists led all groups.
• The protocol that the therapists used was not assessed for adherence.
• There were unequal numbers of participants in the two condition groups.
• Heterogenicity of the sample and the small sample size limited the control of confounding medical variables.
• Limited economic resources exist for program development in support of a standardized practice for therapist-led sessions at local cancer centers. 
• The study lacked an attentional control. 
• Timing of the first posttest measure was not stated, so it was not clear if any effects were lasting.

MBCT is an acceptable and potentially effective treatment for CCRF. Additional better randomized, controlled trials of the intervention should be conducted prior to routinely referring to MBCT therapists.

To assess the feasibility of a ​mindfulness-based stress reduction (MBSR) intervention for patients with lung cancer and their partners, and to determine whether MBSR decreases distress in the same population

Participants received eight weekly sessions (two and a half hours each) of an MBSR course with an additional psychoeducational component of coping with grief taught by health professionals and qualified mindfulness trainers. Assessments were made at baseline, postintervention, and three months later.

• N = 19 patients and 16 partners  
• MEAN AGE: Patients 61.7 years (range = 54–77 years), partners 60 years (range = 30–76 years)
• MALES: 53% (patients); 64% (partners), FEMALES: 47% (patients); 56% (partners)
• KEY DISEASE CHARACTERISTICS: Patients with lung cancer and their partners
• OTHER KEY SAMPLE CHARACTERISTICS: Dutch; 79% advanced stage lung cancer

• SITE: Single site    
• SETTING TYPE: Not specified    
• LOCATION: Holland

• PHASE OF CARE: Mutliple phases of care
• APPLICATIONS: Palliative care 

Pre- and post-test, single-arm feasibility study

• Hospital Anxiety and Depression Scale (HADS)
• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-LC14)
• Impact of Events Scale (IES)
• Penn State Worry Questionnaire (PSWQ)
• Mindful Attention and Awareness Scale (MAAS)
• The Self-Perceived Pressure Form Informal Care (SPPIC)
• The Care Derived Self Esteem of the Caregiver Reaction Assessment (CRA-SE)
• Semistructured interview

An MBSR intervention for patients with lung cancer and their partners was feasible. No statistically significant change in anxiety and depression or mindfulness and worry were observed in patients or partners. Caregiver burden decreased after the MBSR training post-treatment (p < 0.05), and at the three month follow-up (p < 0.01). Six patients and five partners were able to report on facilitators (participating with partner and in group) and barriers (physical function) to participating as well as themes of process of change (standing still, being aware, insight, letting go, and changing behavior and acceptance).

MBSR is feasible for patients with lung cancer and their partners.

• Small sample (< 30)
• Risk of bias (no control group)
• Findings not generalizable

MBSR may be an effective intervention for decreasing caregiver burden in the lung cancer population. Additional research is needed in larger randomized, controlled trials.

Five haptotherapy intervention sessions were given during the period of chemotherapy, according to the wishes of the patient. Outcomes were quality of life (QOL), mood, meaning in life, general functioning, physical and psychological symptoms, sleep quality, and body awareness.

• The intervention group included 31 patients with cancer aged 18 years or older treated with chemotherapy for the first time between April 2000 and November 2002.
• The control group included 26 patients with cancer who started first chemotherapy treatment between September 2002 and March 2003.

• Day clinic of the Diakonssenhuis Zeist (intervention group)
• Three hospitals in the Utrecht region (control group)

Patients were undergoing the active treatment phase of care.

This was a nonrandomized, exploratory study with a quasiexperimental design with an intervention and matched control group, which were both studied pre- and posttest.

• Questionnaire that measured a broad scale of physical, emotional, and psychological aspects of well-being
• European Organisation for Research and Treatment of Cancer (EORTC) (dimensions of QOL)
• Questionnaires taken from the Helen Dowling Institute
• Meaning of life
• General functioning
• Satisfaction with care
• QOL (visual analog scale [VAS])
• Symptoms (Rotterdam Symptom Check List [RSCL])
• Profile of Mood States (POMS)

Haptotherapy treatment improved the perceived general QOL and the perceived cognitive and social functioning of the patients. No improvement was found for mood, meaning in life, general functioning, physical symptoms, sleep quality, or body awareness.

• The study had a small sample size.
• No long-term follow-up was performed.
• The period between sessions varied because of patient wishes.
• The nonrandomized design may have contributed to selection bias.
• The amount of time between the first patient receiving the intervention and the control group being started was 2.5 years.
• Posttests were given to patients by the haptotherapist.
• The intervention group had a 38% drop-out rate.
• A haptotherapist is required for the intervention.

The intervention consisted of five 45-minute haptotherapy sessions given during the period of chemotherapy as the patient desired. The mean time between the first and last session was 11.5 weeks (range 3–36). Sessions were performed by two haptotherapists on days when patients received chemotherapy. The first session included an introduction to haptotherapy and a preliminary interview reviewing patient goals for treatment. After establishing the needs of the patient, the therapist sought to bring the patient in contact with his/her body and feelings through the means of touch. Through contact, patients opened up emotionally and began to speak more freely about their feelings. Conversation and physical contact both are part of the treatment and cannot be viewed separately. The treatment often involved the back, legs, feet, belly, neck, and shoulders.

• The sample included 57 patients with cancer undergoing chemotherapy.
• Patients were primarily women (80.6%) with breast cancer (41.9%).
• Mean age was 54 years for intervention and 52.7 years for the control group.
• The only significant difference between groups was that the intervention group had more children living at home compared to the control group.
• Patients in the intervention and control groups were matched with respect to sex, age, type of cancer, type of chemotherapy, evidence of metastasis, and prognosis.
• Patients in the control group were excluded if they used any form of complementary care during the period of chemotherapy.

Patients in the intervention group were recruited from the day clinic of the Diakonessenhuis Zeist. Patients from the control group were from three other hospitals in the Utrecht region.

Patients were undergoing the active treatment phase of care.

The study used a nonrandomized, pre-/posttest semiexperimental design, with 31 patients in the haptotherapy group and 26 in the control group.

• Visual analog scale (VAS)
• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
• Profile of Mood States (POMS)

The intervention group experienced decreased fatigue from pretest to posttest according to EORTC evaluation. Conversely, the control group experienced increased fatigue from pretest to posttest assessment. The observed differences did not reach statistical significance.

• The small sample size may have limited the ability to observe the true effects of the intervention.
• As sessions were provided on patients' request, a large variability of time existed between sessions.
• It is likely that the effects of haptotherapy do not last if too much time passes between sessions.
• The nonrandomized design may have contributed to selection bias.
• A drop-out analysis was performed due to a high drop-out rate in the intervention group.

To compare oral-based prophylactic antibiotics (quinolone-based prophylaxis or trimethoprim/sulfamethoxazole (TMP/SMZ)-based regimens) with placebo or no prophylaxis. Trials considering patients with cancer (both adults and children) undergoing chemotherapy in which oral prophylactic antibiotics were started before the expected onset of neutropenia were included.

DATABASES USED: MEDLINE from 1966–October 2002, EMBASE from 1988–October 2002, and the Cochrane Central Register of Controlled Trials, issue 2, 2002; the references were checked for additional articles. Authors of included papers were contacted.

• FINAL NUMBER STUDIES INCLUDED = 22 randomized trials
• KEY SAMPLE CHARACTERISTICS: Patients with cancer undergoing chemotherapy

Antibacterial prophylaxis (TMP/SMZ or quinolones) significantly reduced bacteremia by 57% and infection-related mortality. Quinolones significantly reduced the risk of gram-negative bacteremia, but TMP/SMZ did not. TMP/SMZ significantly reduced the risk of gram-positive bacteremia, but quinolones did not. No significant increase was reported in the risk of fungemia or fungal-related mortality with antibacterial prophylaxis. In subgroup analyses, a significant reduction was found in bacteremia in patients undergoing conventional chemotherapy and bone and marrow transplantation.

STUDY PURPOSE: To determine the efficacy of a low bacterial diet (LBD) versus a control diet in preventing infection and in decreasing infection-related mortality in adult and pediatric patients with cancer receiving chemotherapy that causes episodes of neutropenia

TYPE OF STUDY: Meta-analysis and systematic review

DATABASES USED: CENTRAL (2015, Issue 4), DARE (2015, Issue 4), PubMed (from 1946 to May 2015), EMBASE (from 1980 to May 2015), CINAHL (from 1981 to May 2015), reference lists of relevant articles and conference proceedings of the American Society of Hematology (ASH) (from 2000 to 2015), European Bone Marrow Transplantation (EBMT) (from 2000 to 2015), Oncology Nursing Society (ONS) (from 2000 to 2015), International Society for Paediatric Oncology (SIOP) (from 2000 to 2014), Multinational Association of Supportive Care in Cancer (MASCC) (from 2000 to 2015), ASCO (from 2000 to 2015), ICAAC (from 2000 to 2015), European Society for Clinical Nutrition and Metabolism (ESPEN) (from 2000 to 2015), American Society for Parenteral and Enteral Nutrition (ASPEN) (from 2000 to 2015), European Hematology Association (EHA) (from 2000 to 2015), National Institutes of Health Register via clinicaltrials.gov (May 2016), International Standard Randomized Controlled Trial Number (ISRCTN) Register

INCLUSION CRITERIA: Randomized, controlled trials (RCTs) comparing the use of an LBD versus a control diet in regard to infection rate

EXCLUSION CRITERIA: None stated

• FINAL NUMBER STUDIES INCLUDED = 3
• TOTAL PATIENTS INCLUDED IN REVIEW = 192 patients
• KEY SAMPLE CHARACTERISTICS: Adult and pediatric patients undergoing chemotherapy who experienced neutropenia

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics, elder care

No evidence suggests that a LBD decreases the incidence of infection in patients undergoing chemotherapy who experience neutropenia. However, the evidence was not robust enough for the authors to conclude that no benefit existed, so the possibility of benefit/no benefit was inconclusive.

• Limited search
• Mostly low quality/high risk of bias studies

A LBD is not recommended for patients undergoing chemotherapy who experience episodes of neutropenia. Further research is indicated to conclude that no benefit exists.

To compare multifraction radiation therapy schedules for the palliation of pain from bone metastases

The medical records of patients treated with either 20 Gy in five fractions or 30 Gy in 10 fractions of radiotherapy were used for data collection. Pain was assessed prior to and one month after treatment. Clinical response was graded as complete response (CR, pain resolution), partial response (PR, reductions of at least two points on a numeric scale), or no response (NR). The two groups' outcomes were compared according to radiotherapy schedule.

• N = 105
• MEDIAN AGE = 66.5 years (range = 32–86 years)
• MALES: 56%, FEMALES: 44%
• KEY DISEASE CHARACTERISTICS: Multiple tumor types were included, most commonly breast, lung, and prostate. In total, 140 painful lesions were included, and 29 patients had multiple lesions. The most common site was the spine.

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

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

Retrospective, descriptive study

• 11-point Numeric Rating Scale (NRS)
• Radiation Therapy Oncology Group (RTOG) criteria for adverse events

The overall response rate was 88.9%. In the 30 Gy group, the CR rate was 19% compared to 6.5% in the 20 Gy group (p = 0.019). The PR rate in the 30 Gy group was 68.3% compared to 83.1% in the 20 Gy group. There was no difference between groups in overall response rates. The mean decline in pain score was 3.2 in the 20 Gy group and 3.6 in the 30 Gy group. More patients in the 30 Gy group had multiple sites of bone metastases. The incidence of toxicity was higher in the 30 Gy arm (p = 0.0001). The most common toxicities were nausea, vomiting, and diarrhea. In the regression analysis, incorporating variables of age, radiation therapy site, gender, tumor type, and analgesic use did not reveal a statistic difference in outcomes between the groups.

Optimal doses and fractionation for the palliation of bone metastases-related pain were not defined. This study demonstrated similar pain relief with a more abbreviated course of treatment, suggesting that a shorter treatment course may be as effective as long-course treatment for pain palliation. This may result in less toxicity from radiation treatment.

• Risk of bias (no random assignment)
• Measurement validity/reliability questionable
• Other limitations/explanation: Type of pain measurement was unclear (i.e., was worst, current, or average pain measured). No information regarding the use of bone modifying agents or changes in pain medication during the study was provided.

The findings of this study suggested that short-term radiation treatment for pain from bone metastases may be as beneficial as longer term treatment, and it may have fewer adverse side effects. Additional research to develop evidence for the most beneficial radiation schedule is needed.

Recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF) mouthwash

400 mcg dissolved in 20 mL NS; control received 200 mL saline only
Mouthwashings 3 times a day for 30 min without swallowing, over a period of 5 days after inclusion in protocol. Avoid other oral intake for 1 hour.

Also standard protocol of mouth care – toothbrushing after each meal and rinsing oral cavity with 0.9% saline or in cases of inflammation, 0.12% chlorhexidine four times daily

Only MM patients received IV GCSF 5 mcg/kg from day +7 to neutrophil recovery.

The study was comprised of 41 patients (tx grp = 18, 23 placebo), with an age range of 16–69 years and a median age of 44.

All patients developed OM grade III-IV after auto- or allo-SCT.

Oct 1998 – Mar 2001

Prospective randomized, double-blind placebo-controlled study

WHO toxicity score grading mucositis from 0-4, EVA scale (visual analog) scoring swallowing induced pain from 0-10 3x a day, sleep quality evaluations as good, intermediate, and poor, and food intake, none, liquids, soft, regular

Also, infections, days with fever, fungal and viral oral infections, and need for broad spectrum antibiotics, TPN, and opioids were documented.


P < 0.05 = significant
 

No statistically significant differences in overall duration of mucositis or duration of maximum grade of OM. Mouth pain and sleep quality scores were similar.
More people in the rhGM-CSF group needed PCA morphine (50%, 8pts) versus the NS (10%, 2pts).
Also no significance in the use of TPN between the two groups.
 

Given cost, it appeared the results were not better than NS.

No benefit of GM-CSF mouthwash.
May actually show benefit of NS.

Schering-Plough supplied the rhGM-CSF.
Small diverse study group – long duration for study – other potential factors possibly change over time.
Study needs to be larger.
Only trialed with stem cell transplant recipients.
Patients were also rinsing with 0.9 NS and chlorhexidine as part of everyday mouth care (unable to determine number).

Study was from 1998-2001.

Study focused only on prevention after dev grade 3 – 4 OM.