A randomized clinical trial of granulocyte macrophage colony stimulating factor mouthwash for oral mucositis in head and neck cancer.

PURPOSE: Oral mucositis (OM) is a significant problem for patients with head and neck cancer (HNC). The purpose of this double-blind, randomized clinical trial (RCT) was to evaluate the effectiveness of the granulocyte macrophage colony stimulating factor (GM-CSF) mouthwash compared to Salt and Soda mouthwash for both the prevention (prior to onset of OM) and treatment (beginning at the onset of OM to its healing) of radiation therapy (RT)-induced OM. METHODS: A total of 91 patients with HNC were randomized to receive: GM-CSF throughout both the prevention and treatment phases (GG group); Salt and Soda throughout both phases (SS group) or Salt and Soda during the prevention phase followed by GM-CSF at the onset of OM (SG group). Three groups were compared on the occurrence and grades of OM, functional status, pain, chewing, and swallowing during and after RT. RESULTS: No significant differences were found in the occurrence and grades of OM in the patients who used GM-CSF vs. Salt and Soda in the prevention phase. In addition, no differences were seen among the three groups in functional status, pain, chewing, and swallowing during and after RT. CONCLUSION: Given that GM-CSF was no more effective than Salt and Soda mouthwash for the prevention or treatment of OM, the readily available and cheaper mouthwash can be used at considerable cost savings.

Healthy Lifestyle Behaviors of Breast Cancer Survivors.

The purpose of this secondary analysis was to describe the extent to which women with breast cancer, who participated in a randomized control trial on exercise, adopted American Cancer Society (ACS) guidelines for healthy lifestyle behaviors. Women in the study exercised during cancer treatment and for 6 months after completion of treatment. The sample included 106 women, average age 50.7 years (SD = 9.6). Adherence to guidelines for 5 servings of fruits and vegetables ranged from 36% (n = 28) to 39% (n = 36). Adherence with alcohol consumption guidelines was 71% (n = 28) to 83% (n = 30). Adherence with meeting a healthy weight ranged from 52% (n = 33) to 61% (n = 31). Adherence with physical activity guidelines ranged from 13% (n = 30) to 31% (n = 35). Alcohol and healthy weight guidelines were followed by more than half of the participants, but physical activity and dietary guidelines were followed by far fewer women. Further prospective clinical studies are indicated to determine whether interventions are effective in producing a healthy lifestyle in cancer survivors.

Comparisons of exercise dose and symptom severity between exercisers and nonexercisers in women during and after cancer treatment.

CONTEXT: Although numerous studies of the efficacy of exercise are reported, few studies have evaluated changes in characteristics of exercise dose in women with cancer both during and after cancer treatment. OBJECTIVES: To describe the characteristics of exercise dose (i.e., frequency, duration, and intensity) and evaluate for differences in symptom severity (i.e., fatigue, sleep disturbance, depression, and pain) between women who did and did not exercise during and after cancer treatment. METHODS: In a sample of 119 women, two groups were classified: exercisers and nonexercisers. Exercisers were defined as women who met specific criteria for frequency (three times per week), duration (20 minutes/session), intensity (moderate), and mode (aerobic). Nonexercisers were defined as women who did not meet all these criteria. Evaluation of exercise dose was completed at baseline (T1: the week before chemotherapy cycle 2), at the end of cancer treatment (T2), and at the end of the study (T3: approximately one year after the T1 assessment) using self-report exercise questionnaires. RESULTS: Approximately 50% of the participants exercised during treatment and 70% exercised after treatment. At T1, exercisers had lower total fatigue, lower behavioral and sensory subscale fatigue scores, and lower depression scores (P = 0.038) than nonexercisers. No significant differences in sleep disturbance or pain were found between groups. At T2, exercisers had lower cognitive/mood subscale fatigue and depression scores than nonexercisers (P = 0.047). At T3, no significant differences were found between groups in any symptom severity scores. CONCLUSION: Both during and after cancer treatment, achieving or maintaining exercise guideline levels were met by most patients. Further study is needed to examine the link between exercise dose and symptom severity.

Identification of latent classes in patients who are receiving biotherapy based on symptom experience and its effect on functional status and quality of life.

PURPOSE/OBJECTIVES: to identify subgroups of patients receiving biotherapy with pain, fatigue, sleep disturbance, and depression and to determine functional status and quality of life differences between subgroups. DESIGN: a descriptive, prospective, cohort study design. SETTING: internet-based survey. SAMPLE: 187 patients with cancer receiving biotherapy. METHODS: pain intensity, Piper Fatigue Scale, General Sleep Disturbance Scale, Center for Epidemiological Studies-Depression, Karnofsky Performance Scale, and the Multidimensional Quality of Life Scale-Cancer were used at two time points one month apart (T1 and T2). Latent profile analysis identified subgroups. MAIN RESEARCH VARIABLES: biotherapy, symptoms, functional status, and quality of life. FINDINGS: At T1 (N = 187), five patient subgroups were identified, ranging from subgroup 1 (mild fatigue and sleep disturbance) to subgroup 5 (severe on all four symptoms). At T2 (N = 114), three patient subgroups were identified, ranging from subgroup 1 (mild pain, fatigue, and sleep disturbance without depression) to subgroup 3 (mild pain, moderate fatigue, and sleep disturbance with severe depression). At each time point, the patient subgroup with the most severe symptoms showed significantly lower functional status and quality of life. CONCLUSIONS: as with other cancer treatments, biotherapy can be divided into similar patient subgroups with four prevalent symptoms. Subgroups of patients differ in functional status and quality of life as a result of symptom severity. IMPLICATIONS FOR NURSING: clinicians should assess and identify patients with severe levels of the four prevalent symptoms and offer appropriate interventions. Future study is needed to investigate the factors that contribute to symptom severity and to examine the occurrence of symptom clusters that may place patients at increased risk for poorer outcomes.

Nutritional symptom and body composition outcomes of aerobic exercise in women with breast cancer.

The purpose of this secondary analysis was to examine the nutritional symptoms and body composition outcomes of aerobic exercise in women with breast cancer. A single-blind clinical trial, randomized to tailored Pro-Self(©) exercise during and after chemotherapy, after chemotherapy only, or no Pro-Self (usual care). One hundred women, average age 49.9 years (SD = 9.6), participated. Mild taste changes, nausea, constipation, and anorexia were experienced by 47% to 55% at baseline and end of treatment but diminished post treatment. No group differences were found in total nutritional symptoms or symptom severity. Intervention group participants maintained lean body mass; control group participants had nonsignificant lean body mass loss. Issues related to self-report, protocol adherence, and generalizability limit findings. Aerobic exercise is useful in achieving healthy weight and body composition, but the intensity and duration achieved during cancer treatment and recovery did not produce significant changes.

A randomized controlled trial of home-based exercise for cancer-related fatigue in women during and after chemotherapy with or without radiation therapy.

BACKGROUND: Few studies have evaluated an individualized home-based exercise prescription during and after cancer treatment. OBJECTIVE: The purpose of this study was to evaluate the effectiveness of a home-based exercise training intervention, the Pro-self Fatigue Control Program on the management of cancer-related fatigue. INTERVENTIONS/METHODS: Participants (N = 119) were randomized into 1 of 3 groups: group 1 received the exercise prescription throughout the study; group 2 received their exercise prescription after completing cancer treatment; and group 3 received usual care. Patients completed the Piper Fatigue Scale, General Sleep Disturbance Scale, Center for Epidemiological Studies-Depression Scale, and Worst Pain Intensity Scale. RESULTS: All groups reported mild fatigue levels, sleep disturbance, and mild pain, but not depression. Using multilevel regression analysis, significant linear and quadratic trends were found for change in fatigue and pain (ie, scores increased, then decreased over time). No group differences were found in the changing scores over time. A significant quadratic effect for the trajectory of sleep disturbance was found, but no group differences were detected over time. No significant time or group effects were found for depression. CONCLUSIONS: Our home-based exercise intervention had no effect on fatigue or related symptoms associated with cancer treatment. The optimal timing of exercise remains to be determined. IMPLICATIONS FOR PRACTICE: Clinicians need to be aware that some physical activity is better than none, and there is no harm in exercise as tolerated during cancer treatment. Further analysis is needed to examine the adherence to exercise. More frequent assessments of fatigue, sleep disturbance, depression, and pain may capture the effect of exercise.

The effect of symptom clusters on functional status and quality of life in women with breast cancer.

PURPOSE: The purposes of this study of women with breast cancer receiving chemotherapy with/without radiation therapy were to determine whether: (1) subgroups of oncology outpatients can be identified based on a specific symptom cluster (i.e., pain, fatigue, sleep disturbances, depression); (2) these subgroups differ on outcomes (i.e., functional status, quality of life); (3) subgroup membership changes over time. METHODS: A secondary data analysis using data collected from 112 women at initial chemotherapy. Symptom and outcome measures were completed at three time points: baseline (i.e., the week before cycle two - T1); end of cancer treatment (T2), end of the study (approximately one year after the start of chemotherapy - T3). Cluster analysis identified patient subgroups based on symptom severity scores. RESULTS: At T1 and T2, four patient subgroups were identified: ALL LOW (one or no symptom greater than the cut score), MILD (two symptoms), MODERATE (three or four symptoms), and ALL HIGH (four symptoms). At T3, three subgroups were identified: MILD, MODERATE and ALL HIGH. Subgroups with high severity levels of all four symptoms had poorer functional status and QOL at each time point than other subgroups (p<0.001). Group membership changed over time. CONCLUSIONS: Subgroups of patients with different symptom experiences were identified. For some patients severity of all four symptoms persisted months after cancer treatment. Initial and ongoing assessment to identify those patients in the ALL HIGH patient subgroup is important so that appropriate interventions to improve functional status and quality of life can be offered.

Self-reported sleep quality in family caregivers of gastric cancer patients who are receiving chemotherapy in Korea.

BACKGROUND: Shifting of cancer care from inpatient to outpatient in Korea can lead to negative outcomes for family caregivers. Little research has been performed on Korean family caregivers' sleep quality and its related symptoms: fatigue and depression. METHODS: We obtained data from a convenient sample of 103 family caregivers. Family caregivers completed sleep, depression, fatigue, and quality of life questionnaires. RESULTS: Of family caregivers, 80% had poor sleep quality. Positive correlation existed among symptoms, but symptoms were negatively correlated with quality of life. CONCLUSIONS: Health professionals need to include family caregivers in the overall patient care plan.