To evaluate the efficacy of turmeric in preventing radiation-induced mucositis. Secondary endpoints included the efficacy of turmeric rinses on treatment breaks and weight loss.

The trial held the same recommended oral care for the treatment and comparison groups. Participants also were asked to swish after oral intake and wait 30 minutes to eat after swishing with the prescribed solution. The treatment group (turmeric rinses) was instructed to have a caregiver dissolve the contents of one 400 mg capsule of turmeric in 80 ml of boiled and cooled water. The patient was then instructed to swish 10 ml of the solution one hour prior to radiation; one, two, four, and six hours after radiation; and at HS. The comparison group was instructed to mix a povidone-iodine solution at 1 ml Betadine^® to 100 ml water and swish 10 ml twice per day for six weeks.

• N = 80   
• AGE: Older than or equal to 18 years
• MEAN AGE: Treatment group: 56.8 years, comparison group: 55.08 years
• MALES: 80%, FEMALES: 20%
• KEY DISEASE CHARACTERISTICS: Patients with head and neck cancer undergoing 70 Gy radiation or radiation plus chemotherapy
• OTHER KEY SAMPLE CHARACTERISTICS: No oral surgery six weeks prior to study; no previous treatment to head or neck; no high doses of non-steroidal anti-inflammatory drugs; no poorly controlled DM; no hypertension, schizophrenia, bipolar disease, or severe depression

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: Mangalore Institute of Oncology, Mangalore, India

• PHASE OF CARE: Active antitumor treatment

• Single-center, investigator-blinded, randomized controlled trial

• Radiation Therapy Oncology Group oral mucositis grading system

There was a significantly (p < 0.0001) lower rate of intolerable mucositis (grades 3 and 4) in the turmeric group. There was no significant change in treatment days lost between groups. Weight loss in the turmeric group was less (p < 0.001).

Turmeric rinses are beneficial in reducing grade 3 and 4 mucositis in patients with head and neck cancer undergoing chemotherapy or chemotherapy and carboplatin, compared with twice-daily povidone-iodine rinses.

• Small sample (< 100)
• Risk of bias (no blinding)
• Findings not generalizable
• Other limitations/explanation: Comparison of povidone-iodine twice-daily rinses might not be a fair comparison, as there is not good evidence thus far that povidone-iodine rinses are a good treatment for preventing oral mucositis. Additionally, the patients clearly were not blinded. Lastly, twice-a-day rinsing versus six-times-a-day rinsing does not seem to be an appropriate comparison.

Turmeric rinses may provide some protection against oral mucositis for patients with head and neck cancer undergoing radiation and radiation plus chemotherapy; however, more research is needed. The treatment was reported as well tolerated, and there was no mention of adverse side effects.

To evaluate the effects of a yoga program versus supportive care on symptoms of depression among women with breast cancer during treatment

Patients were randomized to the yoga program or a control supportive therapy program. Yoga included education, breathing exercises, meditation, and relaxation techniques with imagery. Subjects were provided with audiotapes of the practices for use at home. Home practice was monitored via telephone calls, weekly home visits, and a daily patient log. Subjects were to practice at home for at least one hour three times per week. The comparison group used supportive, expressive therapy and education provided by therapists in an unstructured approach aimed at addressing fears and concerns and improving support from others among other issues. The intervention took place over a 24-week period including the time of surgery and following adjuvant chemotherapy or radiotherapy. There were four to six study assessments, depending on the treatment, that were scheduled pre- and postsurgery and mid- and postradiation or chemotherapy. Interventions were done on an individual basis.

• N = 69
• AGE: Not provided
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: 87% of participants had grade 3 breast cancer.

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

• PHASE OF CARE: Active antitumor treatment

Single, blinded, randomized, controlled trial

• Beck Depression Inventory (BDI)
• Symptom checklist

Both groups reported decreased depression over time. An analysis of covariance showed a larger decrease in depression at all time points measured in the yoga group (p < 0.01). The study sample was appropriate according to the authors' power analysis. Depression scores were directly and strongly correlated (ranged from 0.49–0.77, p < 0.001) with symptom distress scores.

Yoga was shown to be beneficial in reducing symptoms of depression among women with breast cancer during the trajectory of active treatment. Depression was strongly related to symptom scores.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Questionable protocol fidelity
• Subject withdrawals ≥ 10% 
• Other limitations/explanation: There was an initial drop-out rate of about 30% that was fairly evenly spread across both study groups. Patients were not blinded. This study had a repeated measures design with a potential testing effect. There was no information regarding the patients' actual adherence to the prescribed frequency of yoga practice. Control patients had only one session in the perioperative phase and one follow-up session compared to the weekly visits for the intervention group. Baseline depression scores were higher in the control group. No information was provided regarding symptom management.

The findings of this study suggest that yoga is beneficial to women with breast cancer during active treatment to manage depressive symptoms. They also show that adverse symptoms were strongly related to depression, and depression was higher with more severe adverse symptoms. This points to the importance of effective symptom management as part of the overall reduction of depression.

To evaluate the effectiveness of complete decongestive therapy (CDT) in Indian patients

Patients had clinical evidence of lymphedema (with a difference in arm volumes of at least 200 ml) and were being treated with CDT. They also were at least four months since surgery or radiation therapy. CDT consisted of intensive therapy using manual lymph drainage for 45 minutes four times a week followed by multilayer compression bandaging. Patients were educated on skin and nail care, use of isotonic exercises with bandages on, and re-application of bandages. After the intensive phase, patients were to massage themselves twice daily, perform isotonic limb exercises, and care for skin and nails three times a day. They also applied low-stretch compression bandages and elevated the limb at night. Assessments were performed before and after the intensive phase and monthly for three months.

• Mean age of the sample (N = 32) was 52 with a range of 30–76.
• All patients were females who had surgery for breast cancer with level II axillary dissection.
• Patients with recurrent disease were excluded.
• Twenty-four percent of patients had puckered scars, indicative of severe infection or radiodermatitis. 
• Ninety-two percent had adjuvant chemotherapy and post-operative radiotherapy. 
• Most patients had lymphedema of the right arm and were right handed

• Single site
• Outpatient
• India

The phase of care was the transition phase after active treatment.

 The study used a prospective trial design.

• Water displacement was used to measure volume.
• Circumferential arm measurements were taken.
• Skin and subcutaneous thickness was measured using high-frequency ultrasound probes.
   

After intensive therapy, the mean reduction in absolute limb volume was 485 ml by volumetry and 2,274 ml by measurement (p < 0.001).  In the maintenance phase, there was a non-significant increase in limb volume of 20.3 ml.  Reductions in skin and subcutaneous thickness showed the same pattern as the volume reduction. Three patients developed skin irritation and blistering following bandage application, and one patient who developed recurrent cellulitis following bandaging in the maintenance phase was excluded from the study.

The study demonstrates effectiveness of intensive CDT for management of lymphedema.

• The study had a small sample size (N < 100).
• There was no control group, binding, random assignment, or appropriate attention control condition.
• Subjects who developed skin problems with bandaging were removed from the study with no intent-to-treat analysis.
• Information about degree of adherence to maintenance therapy is not provided.
• The follow-up period for maintenance evaluation was relatively short. 

Findings demonstrated effectiveness of intensive CDT for lymphedema management and effectiveness of maintenance therapy for several months. Findings also showed the need for patients and caregivers to closely monitor skin condition with use of compression bandaging as well as have knowledge of related self care. It appears that self massage and bandaging can be used effectively for maintenance. It is important for patients to know how to perform self care and mointor side effects and be able to adhere to self-care regimens. 

PHASE OF CARE: Transition phase after active treatment
 
APPLICATIONS: Elder care, palliative care

Venlafaxine is superior compared to placebo or other nonhormonal therapies in the management of hot flashes. Clonidine also demonstrated benefits.

Dose of 75 mg venlafaxine is efficacious for hot flashes in women with breast cancer and should be considered as a first-line treatment. Venlafaxine or clonidine is safe and not associated with breast cancer mortality or CYP2D6 activity.

There was a high heterogeneity among trials. None was analyzed as intention to treat (ITT) analysis. Concealment of allocation was unclear among three of six. Blinding was not feasible in the study with acupuncture. In five of six studies, blinding of outcome assessment was unclear or absent. Incomplete data or missing was not equal in groups in all studies.

This is important for cancer survivors without clear guidelines on symptom management after cancer treatment. North American population, mostly tool validation; expected differences in other populations. An apparent benefit exists in reducing hot flashes, but it needs a multicentered trial to confirm. Nurses should advise further research in standardizing hot flash scoring and need a standardized scoring approach.

Authors recruited for the study were patients with stable metastatic breast cancer or prostate cancer who had at least a six-month life expectancy. Patients were randomized into an immediate treatment group and a wait-list control. All participants had follow-up at 6, 12, and 18 weeks. The intervention consisted of keeping a well-being diary, using a CD with a 10-minute recording to complete a mindfulness body scan, and planning a pleasurable activity.

• The sample was composed of 27 participants with metastatic breast or prostate cancer.
• Mean age of women was 60.8 years; mean age of men was 72.4 years.
• Of female participants, 13 were in the analysis phase; of males, 14 were in the analysis phase.
• A stable life expectancy greater than 6 months was a condition of inclusion. Patients with a psychiatric diagnosis were included if the condition was diagnosed as stable.

• Single site
• Outpatient
• Cambridge, Cambridgeshire, England

Active treatment and transition

Randomized controlled trial

• World Health Organization Quality of Life Instrument-BREF (WHOQOL-BREF)
• Hospital Anxiety and Depression Scale (HADS)
• Social and Occupational Functioning Assessment Scale (SOFAS)
• Life Orientation Test, Revised (LOT-R)
• Ten Item Personality Inventory (TIPI)

Positive qualitative feedback reflected a statistically significant (p = 0.046) improvement in quality of life. Although HADS scores improved after the intervention, the change was not significant, and SOFAS scores did not change significantly. Adherence to the intervention was 67% for CD listening, 71% for writing in the diary, and 46% for activity planning.

The intervention was associated with some improvement in quality-of life-measures, but there was no effect on depression or anxiety.

• The study had a small sample size, with fewer than 30 participants and a high attrition rate.
• The study had risk of bias due to no blinding.
• Measures of internal consistency reliability for the instruments were not reported.
• Follow-up occurred by different methods: in the clinic, at home, via telephone, or by means of a mailed survey.
• Patients complained of repetitiveness in the diary-writing aspect of the intervention. They study did not include analysis of patient adherence to or actual use of the approach.

Findings do not indicate that mindfulness-based intervention, as used in this study, had an impact on well-being.

To test the feasibility of a brief self-administered psychological intervention to improve well-being in patients with cancer

The intervention consisted of patient diary and CD meditation for home use with brief telephone support. Patients were requested to record three positive experiences each day in the diary and to plan one enjoyable activity each week and record in the diary. A recorded mindfulness “body scan” (meditation approach) 10 minutes in length was provided to each patient, and he or she was instructed to use this twice a day. Brief telephone contact was made in weeks 1, 2, and 4 to answer questions and encourage continued home practice.

• The study reported on a sample of 46 patients.
• Mean patient age was 60.8 years for women and 72.4 years for men.
• The sample was 47.8% female and 52.2% male.
• Female patients were diagnosed with breast cancer, and male patients were diagnosed with prostate cancer.

• Outpatient setting
• United Kingdom

Patients were undergoing the transition phase of care after initial treatment.

A randomized controlled trial design was used.

• World Health Organization Quality of Life Scale (WHO-QOL-BREF)
• Hospital Anxiety and Depression Scale (HADS)
• Social and Occupational Functional Assessment Scale (SOFAS): Interviewer-rated measure of overall level of functioning
• Life Orientation Test–revised (LOTR): 10-item scale to measure optimism/pessimism
• Ten-Item Personality Inventory (TIPI)

The drop-out rate was almost 50% at the six-week point. Quality of life showed significant improvement at the six-week point (p = 0.046). No other significant differences were identified.

Compliance rates of patients remaining in the study suggest that the approaches used here were easy enough to use and acceptable to them; however, the extremely high drop-out rate suggests that the actual feasibility of this approach for any length of time is questionable.

• The study had a small sample size.
• The study has questionable feasibility due to the high drop-out rate.
• The final sample was too small to detect any significant differences.

This study involved multiple follow-up periods and several self-report questionnaires. The burden of this activity may have contributed to the high drop-out rate.

Determine the effectiveness of group psycho-education on well-being and depression among breast cancer survivors in Malaysia

In this cluster, non-randomized trial conducted over a one-month period, 34 adult women with non-metastatic breast cancer participated in a group psycho-education class on well-being status and depression. The class was designed to inform and discuss cancer and treatment. They were evaluated with a pre/post-test questionnaire, as well as a pretest socio-demographic questionnaire.

• N = 34    
• AGE = Older than 18 years; 47% older than 50 years; 26.5% for both 30–49 years and younger than 30 years
• MALES: 0%, FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Non-metastatic breast cancer on appropriate medications
• OTHER KEY SAMPLE CHARACTERISTICS: 70.6% were married; 47% completed secondary level of education, 32.3% completed primary level of education, and 20.6% completed college level of education; 29.4% were employed; comorbid conditions: 55.6% had hypertension, 44.4% had diabetes, and 22.2% had both

• SITE: Single site 
• SETTING TYPE: Outpatient 
• LOCATION: Melaka, Malaysia

PHASE OF CARE: Active antitumor treatment

Cluster, non-randomized trial

• Pre-test questionnaire for socio-demographic profile
• World Health Organization (Five) Well-being Index (WHO-5 Well-being Index)

The study showed that psycho-education decreased depression and increased the state of well-being among participants. Post-test results significantly improved for three of the five items on the WHO-5 Well-being Index.

Psycho-education may be one way to improve the overall well-being of patients diagnosed with breast cancer. More research is needed with larger numbers and a multi-site setting to validate improved well-being.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (no appropriate attentional control condition)  
• Risk of bias(sample characteristics)
• Measurement/methods not well described
• Measurement validity/reliability questionable
• Findings not generalizable
• Only women included; findings not generalizable because of small size
• Measurement of well-being not clearly reflective of anxiety or depression

Psycho-education may be one way to improve the overall well-being of patients diagnosed with breast cancer, but as nursing professionals, taking a holistic approach to patient care and recognizing and addressing other contributing factors, such as biological and social factors, are important.

To determine whether the effect of ketamine on postoperative pain can be enhanced and prolonged if ketamine is administered IM in repeated and escalating subanesthetic doses before surgery; to determine if administration of ketamine as specified can reduce consumption of analgesia

Patients were randomized to receive a placebo (saline) or ketamine.

• The first 40 patients (consecutive) received one injection 3–4 hours before surgery. Group K1 received one ketamine injection.
• The next 40 patients received two injections, one injection 11–20 hours before surgery and another 3–4 hours before surgery. Group K2 received two ketamine injections.
• The last 40 patients received three injections, one injection 17–18 hours before surgery, one at 11–12 hours before surgery, and another 3–4 hours before surgery. Group K3 group received three ketamine injections.

Postoperatively, for two days, all patients received IV morphine, by means of patient-controlled analgesia (PCA), to control pain for as long as requested. PCA was initiated in the postanesthesia care unit. The PCA consisted of a bolus of 1.5 mg morphine. After a morphine dose, a patient could not access another dose for seven minutes.

• The sample was composed of 120 patients.
• Mean patient age was 43–47 years. Mean age varied by injection group.
• The sample included 69 males and 51 females.
• The sample included 42 cases of abdominal tumor, 25 cases of bowel tumor, and 53 cases of bone or muscle tumor.

• Single site
• Inpatient
• Israel
   

• Phase of care: end-of-life care
• Clinical applications: end-of-life and palliative care

Double-blind, placebo-controlled randomized controlled trial

• Numeric Rating Scale (NRS), a 0–10 scale of pain intensity, which patients completed every 15 minutes during the first postoperative hour and every 30 minutes until discharge from the PACU    
• Overall satisfaction, measured by means of a subjective response, before the patient's discharge, from the surgeon
• Adverse-event questionnaire
   

Group K2's mean 48-hour score (P = 0.0004) and group K3's mean 48-hour score (P = 0.046) were lower than the corresponding scores of the placebo groups. Compared to the placebo groups, patients in K2 and K3 used less morphine. PCA use was approximately 50% less than PSA use in placebo-group counterparts (P < 0.05). Ketamine at 25 mg caused dizziness for two minutes.

Two or three injections of ketamine before surgery for cancer attenuated postoperative pain and decreased opioid requirements for 48 hours after surgery.

• The study was conducted at one site only.
• The study assessed patients for 48 hours only.
• Patients were randomized for ketamine use but not for the number of doses received.
• Different types of surgery can be expected to yield different levels of postoperative pain.

Ketamine injections before cancer surgery may attenuate postoperative pain. Ketamine can be associated with dizziness and other side effects.

To determine the effectiveness and safety of a disseminated community-based exercise program for cancer survivors who completed cancer treatment.

Twice weekly over a period of 12 weeks, YMCA personal trainers supervised groups of seven to 14 study participants during 90-minute exercise sessions at 13 YMCA sites. Study measures were administered at baseline and after the 12-week exercise program. The standardized protocol included aerobic warm-up (10 minutes), resistance training (50 minutes), and community building time (e.g., sharing personal experiences, didactic and experiential training in breathing, relaxation, stress management, and nutrition). Precautions or contraindicated movements were noted for each participant, and resistance training was individualized. YMCA personal trainers had at least one year of personal training experience and received a specialized 16-hour group training by a cancer rehabilitation physical therapist. Additional training to address emotional issues for participants and trainers was provided by a licensed clinical psychologist with expertise in cancer survivorship. Participants and immediate family received access to YMCA facility branches and were encouraged to exercise outside of the sessions.

• In total, 187 patients (17.6% male, 82.4% female) with both pre- and postintervention data were included. 
• Mean age was 57.7 years (standard deviation [SD] = 10.3)
• Patients had mixed cancers (55.5% breast cancer, 7.5% lymphoma, and 5% leukemia and prostate cancers).
• Mean time since diagnosis was 5.6 months (SD = 6.9 months).
• Eligibility included being off cancer treatment for longer than 90 days, with no evidence of active disease. Medical clearance was required to participate in the exercise program.  
• Of the patients, 97.3% were Caucasian and non-Hispanic/non-Latino, 63.6% had completed four-year college or graduate school education, and 49.7% reported working full- or part-time for pay.

• Multisite (13 YMCA sites as part of LIVESTRONG Exercise and Thrive [E & T] Program)
• Community
• Western Washington State

Patients were undergoing long-term follow-up postcancer treatment.

This was a prospective pre/post (nonrandomized) study design.

Validated patient-reported outcomes measures included

• Health-related quality of life: Short Form 36 Health Survey (SF-36), version 2
• Fatigue: Fatigue Symptom Inventory (FSI)
• Insomnia: Three items were developed for this study, rated from rarely or never (0) to nearly every day (4) for: “Does it take you more than half an hour to fall asleep at night?” “Do you wake during sleep and have difficulty falling back to sleep?” and “Do you wake earlier than you want in the morning and are you unable to get back to sleep?”
• Physical activity level: SF-36, version 2, physical component summary
• Physiologic measures:  six-minute walk test, resting heart rate, blood pressure, one repetition maximum test (upper and lower body strength), and sit and reach test (flexibility)
• Muscle and joint problems: Muscle and Joint Measure with subscales assessed (1) muscle aches or stiffness (myalgias); (2) joint pain; (3) stiffness or swelling (arthralgias) and muscle cramps; and (4) muscle weakness
• Social support:  brief seven-item measure used in the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) study (study testing a psychosocial intervention on patients with postacute myocardial infarction)
• Injuries and/or lymphedema during classes:  Assessment was developed for the study using yes/no response items, including: “During your participation in E & T did you have any injuries?” and “As far as you know did you have any swelling or lymphedema that developed during E & T?” For those participants responding positive to the lymphedema question, subsequent questions were asked to determine if the lymphedema symptoms developed before or during the E & T program and (if lymphedema developed during the program) if the symptoms were a flare-up of existing lymphedema or a new site of lymphedema.
• Program evaluation: Five items were developed for the study, including: “How satisfied are you with your participation in the program overall?,” “Were the staff leading the program competent and knowledgeable?,” and “How easy or difficult was it for you to participate in the program?.”

The study indicated that the community-based exercise program has important beneficial effects on physiologic, symptom, and quality of life health outcomes for cancer survivors and is safe to implement. Findings suggested that the program is helpful for improving fatigue, insomnia, physical function, overall musculoskeletal symptoms, mental health, social support, and physical activity in cancer survivors. Average baseline insomnia ratings of 1.63 (SD = 0.93) differed significantly from postintervention ratings of 1.43 (SD = 0.85) (p < 0.001).  Additionally, the exercise program indicated notable improvements in physiologic measures (blood pressure, upper and lower body strength, walking endurance, and flexibility).

Community-based exercise groups for cancer survivors of mixed diagnoses and ages, who have completed active treatment, have physiologic and psychosocial benefits and appear to be safe. Because the participants self-selected to be part of the study and were screened for their ability to participate, findings cannot be generalized to the larger cancer survivor population.

• The study had a risk of bias due to no control group, no blinding, no random assignment, no appropriate attentional control condition, and the sample characteristics*.
• Participant withdrawals were 10% or greater.
• * Measurement validity/reliability was questionable. Findings were not generalizable. The intervention was expensive, impractical, and/or training needs. Participants were 82.4% female and non-Hispanic (Caucasian); the ethnic and racial homogeneity of the sample limited the generalizability of the findings. More than half of the participants had a breast cancer diagnosis. Self-referral and convenience sampling provided a population of participants who were motivated to self-initiate participation in an exercise program. Several measures were developed for the study, including the measure of insomnia; thus, there was a lack of previous established reliability and validity. Although access to the YMCA was provided to participants, the intervention was expensive in terms of participant time and effort, and personal trainers required special cancer-related training and one year of personal training experience. Having the intervention delivered to groups offsets the cost to a certain degree. Thirty-four of of 221 participants were excluded from the analysis because data were only available at one time point; there was a 15% withdrawal rate.

Survivors may benefit from participating in a community-based exercise program tailored to meet their individual needs as a survivor; however, exercise programs should be preceded by consultation with health care providers. Additional nursing research is needed to determine the effect of resistance training and other exercise protocols in more diverse cancer survivor populations.

Databases searched were MEDLINE and Index Medicus, EMBASE, CINAHL, CancerLIT, Allied and Complementary Medicine Database (AHMED), PsycINFO, CISCOM, Cochrane Database, and Database of Abstracts and Reviews of Effects (DARE).

The search yielded 27 studies from 1974–2003, only one of which was a randomized controlled trial (RCT). Authors analyzed only the RCT.

Results of one RCT documented effectiveness of hypnotherapy in treating symptoms in terminally ill adult cancer patients.

The lack of well-designed studies to be analyzed calls for further research, involving effectively designed studies, to establish the effectiveness of hypnotherapy.