Lack of adherence with the analgesic regimen: a significant barrier to effective cancer pain management.

PURPOSE: To evaluate oncology outpatients' level of adherence to their analgesic regimen during a 5-week period. PATIENTS AND METHODS: A random sample of 65 adult oncology outpatients with a Karnofsky performance status score of >or= 50, an average pain intensity score of >or= 2.5, and radiographic evidence of bone metastasis were recruited for this longitudinal study from seven outpatient settings. On a daily basis, patients rated their level of pain intensity and recorded pain medication intake. Adherence rates for opioid analgesics prescribed on an around-the-clock (ATC) and on an as-needed (PRN) basis were calculated on a weekly basis. RESULTS: Overall adherence rates for ATC opioid analgesics ranged from 84.5% to 90.8% and, for PRN analgesics, from 22.2% to 26.6%. No significant differences over time were found in either of these adherence rates. CONCLUSION: One factor that seems to contribute to ineffective cancer pain management is poor adherence to the analgesic regimen.

A comparison of the affective state and quality of life of chemotherapy patients who do and do not develop chemotherapy-induced oral mucositis.

The purpose of this longitudinal study was to compare the quality of life and affective state of patients receiving chemotherapy who developed oral mucositis to patients who did not. Outpatients had their mouths assessed at the beginning of their chemotherapy, completed the Multidimensional Quality of Life scale, Cancer version (MQOLS-CA) and the Profile of Mood States (POMS). Patients again completed the MQOLS-CA and POMS if they developed mucositis during their three cycles (monthly), or if they did not and were exiting the study. Seventy-seven outpatients completed the study; 28 patients developed mucositis and 49 did not. The MQOLS-CA total scores for the entire sample decreased significantly over time (F(1,75) = 25.44, P < 0.001), but there was no group by time interaction, i.e., the change in MQOLS-CA total scores did not depend on mucositis status. While the POMS Total Mood Disturbance scores for the entire sample increased significantly over time (F(1,75) = 19.55, P < 0.001), there was a significant group by time interaction (F(1,75)= 4.85, P = 0.03). Patients who developed mucositis had a significant increase in mood disturbance compared to patients who did not. Further, the POMS subscales of depression and anger showed the same pattern of significant increases. In conclusion, the development of mucositis adversely affected the outpatients' affective states, but not their QOL.

Symptom clusters and their effect on the functional status of patients with cancer.

PURPOSE/OBJECTIVES: To determine the effect of the symptom cluster of pain, fatigue, and sleep insufficiency on functional status during three cycles of chemotherapy. DESIGN: Prospective, longitudinal. SETTING: 23 outpatient offices and clinics. SAMPLE: 93 patients with cancer. The typical participant was female (72%), married/partnered (65%), white (87%), and middle-aged (55.4 years), with an average of 14.8 years of education. METHODS: The Quality of Life-Cancer (QOL-CA) version instrument and the Karnofsky Performance Scale (KPS) were completed by 93 outpatients receiving chemotherapy at baseline (Time 1) and at the end of the third cycle (Time 2). Three items (pain, tires easily, sleeps enough to meet needs) from the QOL-CA questionnaire were used to measure the symptom cluster. MAIN RESEARCH VARIABLES: Symptom cluster, outcome, functional status, chemotherapy. FINDINGS: A hierarchical multiple regression model explained 48.4% of the variance in functional status. The KPS at Time 1 explained 30.8% of the variance in KPS at Time 2 (p < 0.001). After KPS at Time 1 was partialled out from KPS at Time 2, the four independent variables entered in the next step were considered predictors of the change in functional status between Time 1 and Time 2. Age explained 11.8% of the change (p = 0.001), pain explained 10.7% of the change (p = 0.002), and fatigue explained 7.3% of the change (p = 0.011). Sleep insufficiency statistically was not significant, only explaining 1% of the change (p = 0.344). CONCLUSION: This study provides beginning insights into the effect of a symptom cluster on patients' functional status. IMPLICATIONS FOR NURSING PRACTICE: Healthcare professionals need to be aware of the presence of symptom clusters and their possible synergistic adverse effect on patients' future morbidity.

The PRO-SELF Program: a self-care intervention program for patients receiving cancer treatment.

OBJECTIVES: To describe the development, testing, and refinement of the PRO-SELF Program as used in randomized clinical trials. DATA SOURCES: Research studies and articles. CONCLUSIONS: The PRO-SELF Program has made an important contribution in enhancing patients' self-care and reducing morbidity. It has the potential to contribute to self-care abilities of children and adolescents who have cancer. IMPLICATIONS FOR NURSING PRACTICE: It is imperative that patients and their families have the essential information, skills, and support to carry out effective self-care symptom management.

Randomized clinical trial of the effectiveness of 3 commonly used mouthwashes to treat chemotherapy-induced mucositis.

OBJECTIVE: To test the effectiveness of 3 mouthwashes used to treat chemotherapy-induced mucositis. The mouthwashes were as follows: salt and soda, chlorhexidine, and "magic" mouthwash (lidocaine, Benadryl, and Maalox). STUDY DESIGN: A randomized, double-blind clinical trial was implemented in 23 outpatient and office settings. Participants were monitored from the time they developed mucositis until cessation of the signs and symptoms of mucositis, or until they finished their 12-day supply of mouthwash. All participants followed a prescribed oral hygiene program and were randomly assigned a mouthwash. Nurses used the Oral Assessment Guide for initial assessment and taught patients how to assess their own mouths, then phoned the patients every other day to gather status reports. RESULTS: In 142 of 200 patients, there was a cessation of the signs and symptoms of mucositis within 12 days. No significant differences in time for the cessation of the signs and symptoms were observed among the 3 groups. CONCLUSIONS: Given the comparable effectiveness of the mouthwashes, the least costly was salt and soda mouthwash.

Family caregiving skill: development of the concept.

Families increasingly are expected to provide complex care at home to ill relatives. Such care requires a level of caregiving knowledge and skill unprecedented among lay persons, yet family caregiving skill has never been formally developed as a concept in nursing. The purpose of the study reported here was to develop the concept of family caregiving skill systematically through qualitative analysis of interviews with patients (n = 30) receiving chemotherapy for cancer and their primary family caregivers (n = 29). Open coding and constant comparison constituted the analytic methods. Sixty-three indicators of caregiving skill were identified for nine core caregiving processes. Family caregiving skill was defined as the ability to engage effectively and smoothly in these nine processes. Properties of family caregiving skill also were identified. Conceptualizing skill as a variable and identifying indicators of varying levels of skill provides a basis for measurement and will allow clinicians to more precisely assess family caregiving skill.

Factors influencing oral mucositis in patients receiving chemotherapy.

PURPOSE: Oral mucositis is a painful complication of chemotherapy and can greatly affect patients' morbidity and mortality. Findings from two previous studies suggested a decrease in the prevalence of chemotherapy-induced mucositis in patients with solid tumors. The purposes of this study were to follow a large cohort of outpatients to determine the prevalence of mucositis and to identify whether certain clinical factors were significant in the development of mucositis. DESCRIPTION OF STUDY: In this prospective study, a convenience sample of 199 outpatients was followed for three cycles or until mucositis developed. The clinical factors monitored included the following: pretreatment dental examination/repair; initial standard chemotherapy dosage; prophylactic use of colony-stimulating factors; and use of preventive mouthwashes or other prophylactic measures. RESULTS: Oral mucositis developed in 50 patients (25.1%). Prechemotherapy dental examination/repair and initial standard chemotherapy dosage were equivalent among both groups. Of the 48 patients in whom mucositis developed, 10 (20.8%) received prophylactic colony-stimulating factors. Of 134 patients in whom mucositis did not develop, 46 (34.3%) received prophylactic colony-stimulating factors. This difference was statistically nonsignificant. CLINICAL IMPLICATIONS: Differences in the clinical factors investigated could not explain the lower prevalence of oral mucositis among the current patient cohort. The reason for the diminishing prevalence of this side effect remains unclear, and additional parameters, particularly detailed oral hygiene practices, should be evaluated. In the meantime, oncology clinicians should consider the teaching of patients and urging them to use good oral hygiene practices as necessary and potentially preventive measures against chemotherapy-induced mucositis.

Risk factors for chemotherapy-induced oral mucositis: dental appliances, oral hygiene, previous oral lesions, and history of smoking.

Oral mucositis is one of the dose-limiting toxicities of several chemotherapy (CTX) agents. There are suggested risk factors that could influence the development of mucositis. The presence of dental appliances, history of oral lesions, or smoking have the potential to irritate the oral mucosa and produce breaks in the integrity of the mucosa. The purposes of this study were to determine if there were differences in the incidence, severity, and time to onset of CTX-induced mucositis in oncology outpatients who wore dental appliances, had a history of oral lesions, had varying oral hygiene/care practices, and had a history of smoking and those who did not. Patients who were initiated a course of CTX that included stomatotoxic agents were followed for three complete cycles of CTX. They were instructed on how to examine their mouths for mucositis, to contact, and then visit their outpatient settings if it occurred. Clinicians corroborated the presence of mucositis, and the Eiler's Oral Assessment Guide was used by clinicians to determine the severity. Of 332 outpatients, almost half (46%) wore some type of dental appliance, 32% had a history of oral lesions, 10% were currently smoking, and 63% had a history of smoking. Oral hygiene/care practices varied: 81% brushed their teeth two or more times a day, 29% flossed at least daily, 11% had visited their dentist within 2 months of beginning CTX, and 10% had their teeth professionally cleaned within two months of beginning CTX. There was a 31% (n = 104) incidence of CTX-induced mucositis. No significant differences were found in the incidence between patients who wore dental appliances, had a history of oral lesions, had a history of smoking, and practiced different hygiene/care and patients who did not. Of 104 patients who developed mucositis, the average severity rating was 13.05 +/- 2.88 (+/-SD) (a normal mouth is rated at 8) and the average time to onset was 22.3 +/- 21.46 days. There were no significant differences found in severity or time to onset of mucositis between patients who wore dental appliances, had a history of oral lesions, had a history of smoking, and practiced different dental hygiene/care and patients who did not. Although not significant, there were interesting differences in the time to onset across the suggested risk factors (e.g., patients who had visited a dentist or who had their teeth professionally cleaned within 2 months before beginning before CTX developed mucositis 7.4 and 10.6 days sooner, respectively, than patients who did not). These findings suggest that risk factors for the development of CTX-induced mucositis are not as simple and direct as clinicians may believe.

The PRO-SELF Mouth Aware program: an effective approach for reducing chemotherapy-induced mucositis.

Many oncology patients receive chemotherapy drugs that have the potential to induce oral mucositis. If mucositis is not prevented, patients will have to manage the problems associated with mucositis: pain, local infection, and decreased ability to take fluids or food. At the time of this writing, clinical approaches for mucositis management are variable and generally ineffective. The mouth care program, PRO-SELF: Mouth Aware (PSMA), presented in this article, was found to be a significant component of a self-care program that may have reduced the incidence of chemotherapy-induced mucositis. The PSMA program has three dimensions: (a) didactic information, (b) development of self-care exercises (skills), and (c) supportive interactions with a nurse in the setting where the patients are receiving their treatment. This program focuses on decreasing the direct (i.e., incidence and severity of mucositis) and indirect morbidities of oral mucositis (i.e., number of local infections, level of discomfort/pain, and disruption in fluid and/or food intake). It provides the critical dimensions (i.e., specific information, self-care exercises, and nurse support) to promote the prevention of mucositis. The PSMA program is designed to provide patients with a definitive self-care repertoire to manage chemotherapy-induced mucositis in the home without the direct supervision of a health care provider.

The revised Piper Fatigue Scale: psychometric evaluation in women with breast cancer.

PURPOSE/OBJECTIVES: To confirm the multidimensionality of the Piper Fatigue Scale (PFS) and to reduce the total number of PFS items without compromising reliability and validity estimates. DESIGN: Methodologic, part of a larger, cross-sectional, mailed survey design study. SETTING: Urban and suburban area in the northeast United States. SAMPLE: As part of the larger study, 2,250 surveys were distributed to women survivors of breast cancer who were on a mailing list for the educational organization Living Beyond Breast Cancer, 715 surveys (32%) were returned. Of these, 382 women met this methodologic study's criteria for having completed each of the 40 items on the PFS. The average respondent was 50 years old, postmenopausal, and treated with combination cancer therapy. METHODS: Principal axes factor analysis with oblique rotation. MAIN RESEARCH VARIABLES: Fatigue factors/subscales. FINDINGS: Five factors/subscales were identified initially. Because the fifth factor contained only two items (ability to bathe/wash and ability to dress), these items and the associated factor/subscale were dropped from the final solution. An additional nine items, not loading on any factor (> 0.40), also were dropped. The remaining items and factors/subscales were reviewed to ensure that the criteria were met: a pattern of inter-item correlations between 0.30-0.70; a minimum number of five or more items/subscale; standardized alpha for the subscales and total scale of at least 0.89; and absence of gender-specific items. CONCLUSIONS: The revised version of the PFS consists of 22 items and four subscales: behavioral/severity (6 items), affective meaning (5 items), sensory (5 items) and cognitive/mood (6 items). Standardized alpha for the entire scale (n = 22 items) is 0.97, indicating that some redundancy still may exist among the items. Additional revisions await further testing. IMPLICATIONS FOR NURSING PRACTICE: As fatigue is acknowledged to be the most frequent symptom experienced by patients with cancer, accurate measurement and assessment is essential to advance not only the science of fatigue but, most importantly, to evaluate the efficacy of intervention strategies on patient and family outcomes.

Gender differences in the dimensions of quality of life.

PURPOSE/OBJECTIVES: To explore gender differences and similarities in the dimensions of quality of life (QOL). DESIGN: Secondary analysis of the Multidimensional Quality of Life Scale--Cancer Version (MQOLS--CA) data from two different research studies. SETTINGS: Multiple outpatient oncology sites. SAMPLE: The typical female participant (n = 254) was 58 years old (SD +/- 11.3) with 14 years of education, married/partnered (64%), Caucasian (88%), and diagnosed with breast (47%) or colorectal (16%) cancer. The typical male participant (n = 222) was 60 years old (SD +/- 14) with 14.3 years of education, married/partnered (69%), Caucasian (85%), and diagnosed with colorectal (31%) or prostate (13%) cancer. METHODS: Factor analytic procedures and reliability testing. MAIN RESEARCH VARIABLES: QOL as measured by the MQOLS-CA, gender. FINDINGS: For women, two factors emerged from the analysis procedures-psychosocial well-being (7 items) and physical competence (6 items). For the men, two different factors emerged--vitality (8 items) and personal resources (4 items). None of the cancer-specific items from the MQOLS-CA loaded on any of the factors for either gender. CONCLUSIONS: Measurement of QOL requires gender-specific questions to accurately address the dimensions of the concept of QOL in females and males. IMPLICATIONS FOR NURSING PRACTICE: Additional research is warranted to replicate these findings. Gender-specific interventions could then be developed and tested to maximize the QOL of all patients.

A symptom-management program for patients undergoing cancer treatment: the Pro-Self Program.

OBJECTIVE: To describe the development, implementation, and refinement of the Pro-Self Program, a self-care intervention used in randomized clinical trials. The program is designed to provide adult patients undergoing cancer treatment with the information, skill, and support needed to engage effectively and consistently in prescribed self-care symptom management. The aim of the program is to enhance patients' self-care abilities to prevent symptoms or to reduce symptom severity and duration associated with disease and treatment. The program is based on work involving self-care during treatment for cancer. METHODS: Patients were provided the program at the initiation of chemotherapy or radiation therapy and followed to the completion of treatment. CONCLUSION: The program made an important contribution in teaching these patients self-care during the cancer treatment experience.

Helpseeking for self-discovered breast symptoms. Implications for early detection.

PURPOSE: Most breast cancer symptoms are discovered by women themselves, and at least one third of these women will be aware of their symptoms for 3 months or more before seeking an initial provider evaluation. The authors identify personal, social, and environmental influences on women's intention to seek an immediate provider evaluation (helpseek) versus to delay evaluation of a breast symptom that worried them. DESCRIPTION OF STUDY: Black women (N = 352) from the San Francisco Bay are women's organizations, community settings, and churches formed this convenience sample. Participants ranged across age, income, and educational levels. The survey contained 10 scales that measured health behavior variables, including new and existing scales augmented by items derived from prior interview and focus group investigations. RESULTS: Women of younger age and lower income were significantly less likely to intend to seek an evaluation for self-discovered breast symptoms. Single and partnered women were less likely to seek a provider evaluation than married or widowed women. Perceiving negative consequences of delaying, having previous habits of healthcare utilization, perceiving access to services, and feeling fearful were positively related to the intention to seek evaluation of breast symptoms. Holding fatalistic beliefs about getting breast cancer or dying and perceiving constraints to seeing a provider negatively influenced helpseeking intention. Racism in the healthcare delivery system was perceived, but was not a significant influence on helpseeking intention. A multiple linear regression model containing these variables explained 46% of the variance in helpseeking intention. CLINICAL IMPLICATIONS: This study shows that the intent to helpseek is not merely a matter of education and economics, but is dependent on a complex picture of personal, social, and economic factors. Gynecologic and primary care providers should consider this and the potential influences on helpseeking in the women for whom they provide cancer screening and early detection services. History taking should be expanded to assess women's ideas about the consequences of delaying evaluation of self-discovered breast symptoms, their sense of vulnerability to breast cancer, the constraints on cancer early detection they may be feeling related to role obligations, their economic or strategic limitations to accessing services, the pressures they may feel to hide a breast cancer symptom, or their own tendency to interpret the breast symptom as not threatening. Healthcare providers should not assume that helpseeking for breast symptoms is an automatic behavior for all women. Rather, providers should assess whether a women is the one in three who will delay the evaluation of a breast cancer symptom she discovers herself for months or years.

Patients' perspectives of fatigue while undergoing chemotherapy.

PURPOSE/OBJECTIVES: To explore the experience of fatigue from the perspective of patients undergoing chemotherapy. DESIGN: Qualitative research and secondary analysis of data from a larger study. SETTING: Participants were recruited from 18 sites, including large outpatient chemotherapy clinics and private medical oncologists' offices. SAMPLE: 127 adult patients who were beginning their first protocol of chemotherapy. METHODS: Data were collected through individual and open-ended interviews and a qualitative, thematic analysis of the participants' responses using grounded theory techniques. MAIN RESEARCH VARIABLE: The experience of fatigue as perceived by patients undergoing chemotherapy. FINDINGS: The analysis resulted in eight major thematic categories: (a) experiencing fatigue, (b) effects on well-being, (c) attribution of origin, (d) awareness and expectations, (e) emotional reactions, (f) activity, (g) the "biggest" concern, and (h) strategies and plans. CONCLUSIONS: This study demonstrates the variation, extent, duration, and temporality of fatigue among patients receiving chemotherapy and the dynamic, changing aspects of the experience. IMPLICATIONS FOR NURSING PRACTICE: Fatigue must be considered within the context of patients' daily lives and environments, disease processes, and treatment modalities. Nurses must listen carefully to patients' own descriptions of being tired. Further research examining patients' perspectives of and experiences related to fatigue is necessary to increase the theoretical understanding of fatigue and to improve therapeutic nursing interventions.

Comparison of methods to determine the prevalence and nature of oral mucositis.

PURPOSE: Chemotherapy-induced oral mucositis may cause considerable patient morbidity. Its prevalence has been reported as ranging from 30% to 39%, although a prevalence as high as 75% has been reported with 5-fluorouracil. This variation may be a function, in part, of the methods of measurement used across different studies. The first purpose of this study was to determine the prevalence of oral mucositis in a sample of 127 patients receiving specific chemotherapy. The second purpose was to compare different instruments and techniques for assessing oral mucositis. DESCRIPTION OF STUDY: A longitudinal design was used to collect data at four monthly chemotherapy cycles during drug nadir. The methods of measuring oral mucositis included interview (conducted monthly x 4); Eiler's Oral Assessment Guide (monthly x 4); Chemotherapy Knowledge Questionnaire and Behavior Checklist (both at the fourth month); Self-Care Behavior Log (ongoing over 4 months); and medical record review (collected at 4 months). RESULTS: The mucositis prevalence in this one sample ranged from 30% to 69% depending on the method of measurement. The use of multiple instruments and techniques captured a clinical picture of oral mucositis far more detailed than published reports--a picture not revealed with any one instrument or technique. The chart record severely underdocumented the prevalence of mucositis compared to the interview. This discrepancy could reflect under-reporting by the patients, inadequate history taking at provider visits, or perhaps the documentation of only the more severe mucositis or mouth problems in the medical record. CLINICAL IMPLICATIONS: Clinicians and researchers must choose their method of measurement carefully in relation to the purpose of assessment. For subjective tolerance of symptoms, the interview technique may be most useful. To test interventions, the use of a quantitative rating instrument is desirable. Intervention studies using multiple measures may require a combination of subjective and objective measures.

Randomized clinical trial of chlorhexidine versus placebo for prevention of oral mucositis in patients receiving chemotherapy.

PURPOSE/OBJECTIVES: To test the effectiveness of a nurse-initiated systematic oral hygiene teaching program-PRO-SELF: Mouth Aware (PSMA)-in conjunction with two mouthwashes (0.12% chlorhexidine or sterile water) in preventing chemotherapy-induced oral mucositis. DESIGN: Randomized, double-blind, placebo-controlled, clinical trial. SETTINGS: 23 outpatient clinics and office practices in California. SAMPLE: 222 patients who were starting a cycle of mucositis-inducing chemotherapy. METHOD: Participants were followed over three chemotherapy cycles. All patients were provided the PSMA program. Random assignment to a mouthwash occurred prior to the development of oral mucositis. Researchers used the Oral Assessment Guide to assess the patients oral cavities monthly (with the patients cycles of chemotherapy) and when patients reported any oral changes between cycles. MAIN RESEARCH VARIABLES: Type of mouthwash, incidence, days to onset, and severity of chemotherapy-induced oral mucositis. FINDINGS: No significant differences existed between the two mouthwashes in regard to incidence, days to onset, and severity of mucositis. CONCLUSIONS: Because chlorhexidine (S20 per pint) was no more effective than water, a substantial cost savings can be realized by rinsing with water. Interestingly, the PSMA program appeared to reduce the incidence of mucositis from on a prior estimate of 44% to less than 26%. IMPLICATIONS FOR NURSING PRACTICE: A nursing prescription of a systematic oral hygiene program using water as a mouth rinse is cost efficient and may be effective in preventing oral mucositis.

Differences in nausea, vomiting, and retching between younger and older outpatients receiving cancer chemotherapy.

The purpose of this study was to determine whether there were differences in the side effects of nausea, vomiting, and retching (N, V, and R) between younger ( < 65 years, n = 102) and older ( > or = 65 years, n = 25) persons receiving outpatient chemotherapy. A longitudinal 4-month study was used for the 127 participants recruited from 18 settings. Participants completed two questionnaires (Inventory of N, V, and R and Behavior Checklist) over the course of the study. The pattern between the younger and older patients' N, V, and R subscale scores was consistent in that the younger patients' scores were consistently (except on one occasion) higher than the older patients' scores, but this difference was statistically insignificant. This study furthers our understanding of N, V, and R and has several clinical implications.

MacDibbs Mouth Assessment. A new tool to evaluate mucositis in the radiation therapy patient.

PURPOSE: The purposes of this descriptive, longitudinal study were to evaluate the MacDibbs Mouth Assessment instrument for the assessment of mucositis in the radiation therapy patient being treated for head and neck cancer and to describe the course of radiation-induced mucositis in these patients. DESCRIPTION OF STUDY: This pilot study used self-report and provider assessment, as well as medical record review, to obtain data about ambulatory radiation therapy outpatients (n = 10). The participants were primarily male, white, middle-aged, married or partnered, unemployed, edentulous, currently smoking, and using alcohol. RESULTS: One or more mucositis ulcers were observed in all patients and occurred at an average of 2858.2 cGy. The corresponding Mouth Symptom Score was 5.9 (instrument range 0-21). Interrater reliability for 13 of the 14 items was 100%. The one difficulty encountered with the MacDibbs was in the measurement of ulcers longer than the periodontal probe used to measure them. CLINICAL IMPLICATIONS: The MacDibbs should prove useful for clinicians and researchers because it is efficient, easy to use, emphasizes accurate diagnosis of oral changes, has an easily discernible endpoint, and assesses signs and symptoms.

Informed consent: process and clinical issues.

PURPOSE/OBJECTIVES: To review the issues related to informed consent in a clinical cancer care setting and suggest strategies to improve the informed consent process. DATA SOURCES: Published books, journal articles, and clinical research experience. DATA SYNTHESIS: Clinicians and researchers are ethically obligated to maintain the informed consent process when treating participants in clinical cancer research. Nurse clinicians, clinical trial nurses, and nurse researchers often encounter dilemmas while ensuring proper informed consent. Nurses involved in pediatric cancer care must address specific consent issues relevant to children and youth. CONCLUSIONS: Informed consent does not end with a patient's signature on a form. Establishing and maintaining informed consent is a multidisciplinary effort in cancer clinical trials. Nurses can improve the informed consent process by ensuring adequate time for patient consideration and understanding and by reassessing consent during the study. IMPLICATIONS FOR NURSING PRACTICE: Clinical trial nurses and nurse investigators in both adult and pediatric oncology have a duty and obligation to maintain continued informed consent throughout a study and to be involved in all aspects of study planning and implementation.