Karen Schumacher

Randomized Clinical Trial of the Effectiveness of a Self-Care Intervention to Improve Cancer Pain Management

PURPOSE This randomized clinical trial tested the effectiveness of the PRO-SELF Pain Control Program compared with standard care in decreasing pain intensity scores, increasing appropriate analgesic prescriptions, and increasing analgesic intake in oncology outpatients with pain from bone metastasis. PATIENTS AND METHODS Patients were randomly assigned to the PRO-SELF intervention (n = 93) or standard care (n = 81). Patients in the standard care arm were seen by a research nurse three times and were called three times by phone between the home visits. PRO-SELF group patients were seen by specially trained intervention nurses and received a psychoeducational intervention, were taught how to use a pillbox, and were given written instructions on how to communicate with their physician about unrelieved pain and the need for changes in their analgesic prescriptions. Patients were coached during two follow-up home visits and three phone calls on how to improve their cancer pain management. RESULTS Pain intensity scores decreased significantly from baseline (all P <.0001) in the PRO-SELF group (ie, least pain, 28.4%; average pain, 32.5%; and worst pain, 27.0%) compared with the standard care group (ie, least increased by 14.6%, average increased by 1.9%, and worst decreased by 1.2%). The percentage of patients in the PRO-SELF group with the most appropriate type of analgesic prescription increased significantly from 28.3% to 37.0% (P =.008) compared with a change from 29.6% to 32.5% in the standard care group. CONCLUSION The use of a psychoeducational intervention that incorporates nurse coaching within the framework of self-care can improve the management of cancer pain.

Effects of caregiving demand, mutuality, and preparedness on family caregiver outcomes during cancer treatment.

PURPOSE/OBJECTIVES To test a model of family caregiving derived from the interactionist approach to role theory that hypothesized that three caregiving role implementation variables (caregiving demand, mutuality between caregivers and patients, and preparedness for caregiving) would predict multiple caregiving-specific and generic outcomes with different patterns of association across outcomes. DESIGN Descriptive, correlational. SETTING Surgical, radiation, and medical oncology settings. SAMPLE 87 family caregivers of adults receiving treatment for solid tumors or lymphoma. METHODS Caregivers completed the Demand and Difficulty subscales of the Caregiving Burden Scale; the Mutuality, Preparedness, and Global Strain scales of the Family Care Inventory; and the 30-item short form of the Profile of Mood States. Data were analyzed with simultaneous multiple regression. MAIN RESEARCH VARIABLES Caregiving demand, mutuality, preparedness, caregiving difficulty, global caregiver strain, tension, depression, anger, fatigue, vigor, confusion, and total mood disturbance. FINDINGS The model explained statistically significant proportions of variance in each outcome, with different patterns of association across outcomes. Demand was associated most strongly with caregiving difficulty and global strain. Mutuality was associated most strongly with caregiver anger. Unexpectedly, preparedness was associated more strongly with mood disturbance outcomes than with the caregiving-specific variables of difficulty and strain. CONCLUSIONS Further research should explore models that address implementation of the caregiving role to better elucidate how family caregivers learn and carry out the important role. IMPLICATIONS FOR NURSING Clinical assessment should include caregiving demand, the quality of the relationship between caregiver and patient, and preparedness for caregiving. Interventions could be tailored to meet caregiver needs in each area.

FAMILY CAREGIVERS: caring for older adults, working with their families.

As the U.S. population ages and health care costs soar, family and friends are called upon increasingly to provide care. While the typical caregiver is a 46-year-old woman with at least some college education, anyone in the infirm persons circle may be called upon to provide care. The kind of care provided varies greatly--from managing treatment and medication regimens to driving in from out of town to help with shopping--as does each caregivers reaction to providing such care. While some find caregiving terribly stressful, others find it rewarding. Nurses need to know how to identify the primary caregiver, discern the level of strain caused by caregiving, and create a partnership with the caregiver to help ease the burden. Accompanying text explores one caregivers experience.

The cancer family caregiving experience: An updated and expanded conceptual model

OBJECTIVE The decade from 2000 to 2010 was an era of tremendous growth in family caregiving research specific to the cancer population. This research has implications for how cancer family caregiving is conceptualized, yet the most recent comprehensive model of cancer family caregiving was published ten years ago. Our objective was to develop an updated and expanded comprehensive model of the cancer family caregiving experience, derived from concepts and variables used in research during the past ten years. METHODS A conceptual model was developed based on cancer family caregiving research published from 2000 to 2010. RESULTS Our updated and expanded model has three main elements: 1) the stress process, 2) contextual factors, and 3) the cancer trajectory. Emerging ways of conceptualizing the relationships between and within model elements are addressed, as well as an emerging focus on caregiver-patient dyads as the unit of analysis. CONCLUSIONS Cancer family caregiving research has grown dramatically since 2000 resulting in a greatly expanded conceptual landscape. This updated and expanded model of the cancer family caregiving experience synthesizes the conceptual implications of an international body of work and demonstrates tremendous progress in how cancer family caregiving research is conceptualized.

Putting cancer pain management regimens into practice at home

The purpose of this study was to describe the difficulties with pain management that patients and family caregivers bring to a nurses attention during a teaching and coaching intervention. Data were obtained from audiotaped and transcribed interactions between intervention nurses and patients (n = 52) and their family caregivers (n = 33) who were participating in a randomized clinical trial of a nursing intervention called the PRO-SELF Copyright Pain Control Program. Using qualitative content analysis, we found that patients had difficulty in seven areas when they attempted to put a pain management regimen into practice, namely: obtaining the prescribed medication(s), accessing information, tailoring prescribed regimens to meet individual needs, managing side effects, cognitively processing information, managing new or unusual pain, and managing multiple symptoms simultaneously. The findings from this study suggest that the provision of information about cancer pain management to patients and their family caregivers is not sufficient to improve pain control in the home care setting. Patients and their family caregivers require ongoing assistance with problem-solving to optimize their pain management regimen.

Mutuality and preparedness moderate the effects of caregiving demand on cancer family caregiver outcomes.

Background: Family caregiving researchers have explored the moderating or stress-buffering effects of variables such as coping and social support. However, the quality of the family caregiver-patient relationship and preparedness for caregiving have received little attention as potential moderators. Objective: To explore whether relationship quality and preparedness moderate the effects of caregiving demand on caregiver outcomes during cancer treatment. Methods: Eighty-seven family caregivers of patients receiving treatment for cancer completed the Demand and Difficulty subscales of the Caregiving Burden Scale, Mutuality and Preparedness Scales of the Family Care Inventory, and the short form of the Profile of Mood States. Using hierarchical multiple regression analyses, caregiving difficulty and total mood disturbance were regressed on two- and three-way interaction terms for demand, mutuality, and preparedness, controlling for caregiver age and gender, and the simple effect of each independent variable. Results: Negligible effects for two-way interactions were found. However, the three-way interaction between demand, mutuality, and preparedness explained statistically significant variance in both perceived difficulty of caregiving and total mood disturbance. High mutuality in combination with high preparedness protected caregivers from adverse outcomes when demand was high. When either mutuality or preparedness was low, caregivers were at greater risk for negative outcomes when demand was high, but not when demand was low. When both mutuality and preparedness were low, caregivers were at risk for mood disturbance even when demand was low. Discussion: Analysis of three-way interactions provided new theoretical insights into the protective effects of mutuality and preparedness and demonstrated conditions under which caregivers are at increased risk for negative outcomes.

Symptom Experience of Family Caregivers of Patients With Cancer

OBJECTIVES To review the literature on depression, anxiety,sleep disturbance, fatigue, and pain in family caregivers of patients with cancer in the context of the Symptom Management Model (SMM)developed at the University of California, San Francisco (UCSF). DATA SOURCES Published research studies and systematic reviews from 1990-2007. DATA SYNTHESIS Studies of depressive symptoms in caregivers of patients with cancer were the most numerous. A limited number of studies examined anxiety, fatigue, sleep disturbance, and pain. Most studies focused on the symptom experience dimension of the UCSF SMM. CONCLUSIONS Based on the small sample sizes, cross-sectional nature of the studies, and lack of comparison groups, little is known about the prevalence and effects of symptoms in caregivers of patients with cancer. IMPLICATIONS FOR NURSING Additional research is needed to determine the prevalence, severity, and effects of symptoms on caregivers. Better descriptive, correlational studies will lead to the development of interventions to improve symptom management for this group of caregivers.

The Use of a Responder Analysis to Identify Differences in Patient Outcomes Following a Self-Care Intervention to Improve Cancer Pain Management

Abstract Previously, we demonstrated, in a randomized clinical trial, the effectiveness of a psychoeducational intervention to decrease pain intensity scores and increase patients’ knowledge of cancer pain management with a sample of oncology patients with pain from bone metastasis. In the present study, we evaluated for changes in mood states (measured using the Profile of Mood States), quality of life (QOL; measured using the Medical Outcomes Study Short Form‐36 (SF‐36)), and pain’s level of interference with function (measured using the Brief Pain Inventory (BPI)) from baseline to the end of the intervention first between the intervention and the standard care groups and then within the intervention group based on the patients’ level of response to the intervention (i.e., patients were classified as non‐responders, partial responders, or responders). No differences were found in any of these outcome measures between patients in the standard care and intervention groups. However, when patients in the intervention group were categorized using a responder analysis approach, significant differences in the various outcome measures were found among the three respondent groups. Differences in the physical and mental component summary scores on the SF‐36 and the interference items on the BPI, among the three respondent groups, were not only statistically significant but also clinically significant. The use of responder analysis in analgesic trials may help to identify unique subgroups of patients and lead to the development of more effective psychoeducational interventions.

Pain management autobiographies and reluctance to use opioids for cancer pain management.

Although pain management education results in improved pain control for some patients, it does not work for all patients because some patients remain reluctant or unwilling to use prescribed analgesics to their optimal effect. In a randomized clinical trial that tested the effectiveness of the PRO-SELF© Pain Control Program, 11 patients declined to increase their analgesic use despite moderate to severe pain. These patients were selected for a qualitative analysis of their audiotaped discussions about pain management with their intervention nurses. This analysis revealed that these patients often spontaneously provided detailed explanations about why they were reluctant or unwilling to take analgesics in general or opioids in particular. We termed these explanatory accounts pain management autobiographies because of their narrative character and multilayered, richly detailed quality. Pain management autobiographies included stories about (1) previous experience with chronic pain management, including stigmatizing interactions with clinicians and family members; (2) bad experiences with cancer pain management, including severe constipation; and 3) strongly held conventions about medication use, including the belief that all medications are “toxins” that should be avoided. The study findings suggest that a small subset of patients with cancer pain may need interventions such as individual or family counseling or alternative pain management strategies to augment education about opioids.

Randomized controlled trial to assess reduction of cardiovascular disease risk in patients with bipolar disorder: the Self-Management Addressing Heart Risk Trial (SMAHRT).

OBJECTIVES Persons with bipolar disorder experience a disproportionate burden of medical conditions, notably cardiovascular disease (CVD), leading to impaired functioning and premature mortality. We hypothesized that the Life Goals Collaborative Care (LGCC) intervention, compared to enhanced usual care, would reduce CVD risk factors and improve physical and mental health outcomes in US Department of Veterans Affairs patients with bipolar disorder. METHOD Patients with an ICD-9 diagnosis of bipolar disorder and ≥ 1 CVD risk factor (N = 118) enrolled in the Self-Management Addressing Heart Risk Trial, conducted April 2008-May 2010, were randomized to LGCC (n = 58) or enhanced usual care (n = 60). Life Goals Collaborative Care included 4 weekly self-management sessions followed by tailored contacts combining health behavior change strategies, medical care management, registry tracking, and provider guideline support. Enhanced usual care included quarterly wellness newsletters sent during a 12-month period in addition to standard treatment. Primary outcome measures included systolic and diastolic blood pressure, nonfasting total cholesterol, and physical health-related quality of life. RESULTS Of the 180 eligible patients identified for study participation, 134 were enrolled (74%) and 118 completed outcomes assessments (mean age = 53 years, 17% female, 5% African American). Mixed effects analyses comparing changes in 24-month outcomes among patients in LGCC (n = 57) versus enhanced usual care (n = 59) groups revealed that patients receiving LGCC had reduced systolic (β = -3.1, P = .04) and diastolic blood pressure (β = -2.1, P = .04) as well as reduced manic symptoms (β = -23.9, P = .01). Life Goals Collaborative Care had no significant impact on other primary outcomes (total cholesterol and physical health-related quality of life). CONCLUSIONS Life Goals Collaborative Care, compared to enhanced usual care, may lead to reduced CVD risk factors, notably through decreased blood pressure, as well as reduced manic symptoms, in patients with bipolar disorder. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT00499096.