Objective: To determine through a random controlled trial how, after adjusting for pain and fatigue status at intake, a 10 contact 20 week nursing intervention compared with conventional care effects the number of symptoms reported by patients, their levels of social and physical function and their emotional distress at 20 weeks? This research addresses an important issue in supportive cancer care interventions: Are these trials equally effective for patients at all levels of severity at intake into the trial? If not, do the risk factors (pain and fatigue) either alone or in interaction with other covariates explain variations at outcomes?
Design: A multi-site randomized clinical trial was implemented in oncology treatment settings.
Population: Patients with a diagnosis of a solid tumor and undergoing a first course of chemotherapy, who had a family caregiver, who could speak and read English, and without hearing deficits that limited telephone conversation were eligible.
Sample: Recruiters approached all consecutive patients meeting criteria, explained the study, and provided them a brochure about their study roles. Patients and family caregivers who consented were interviewed at baseline and randomized to the experimental or control group. At entry into the study 56 and 50 patients in the experimental and control groups respectively reported pain and fatigue; 43 or 49 reported either pain or fatigue or neither symptom respectively. In each group three quarters of the patients were female with a mean age of 55 years, 90% were Caucasian, and two-thirds had at least some college education. Attrition from the study was 38% across all waves for all reasons and equal between groups.
Variables: To assess symptoms, patients were asked if they had experienced any of 12 symptoms. If yes, then they were asked to define days present and the severity and the limitations the symptoms imposed. Physical role impact and social role functioning were measured using the subscales of the SF-36 and depression was assessed using the CES-D. All measures had reliability coefficients that exceeded .79 at all observations.
Methods: All patients and caregivers were interviewed a baseline, 10, 20 and 32 weeks. Patients and caregivers in the experimental arm received the 10 contact, 20-week intervention. The first intervention was in person for the patient and caregiver. Subsequent interventions alternated between in person and telephone contacts. The 10-week interview was conducted after the 4th intervention, the 20-week at the end of the intervention and the 32-week contact 12 weeks later. To address the research questions multi-variate analyses of variance were used.
Experimental Intervention: Nurse interveners assessed each patient and caregiver at each contact. Assessments focused on 12 symptoms, physical function, and emotional distress. Patients scored dimensions in terms of severity, and impact upon limitations. All scores that reached a five or higher on a ten point scale of severity or 3 or higher on a five point scale of impact were considered to reach threshold and became a problem in the intervention. Intervention strategies were drawn from evidence-based lists on communication, symptom management, support, and teaching/information. Each problem was evaluated at subsequent contacts and interventions were continued, changed or deleted as appropriate. Caregiver problems were addressed along with the tasks of caring, role strain and emotional distress and managed through similar intervention strategies.
Findings: There was a main effect for the intervention on mean count of patient symptoms (excluding pain and fatigue) at 20 weeks with a non-significant trend favoring the experimental group at 32 weeks). Similar findings existed for physical role impact and social functioning. There was a gender by group effect on emotional distress at 20 but not 32 weeks. When pain and fatigue or either symptom only was entered into the model the intervention there was a significant (p<.05) for symptoms, social and physical role function. Emotional distress was lower for those with either symptom and females with either symptom reported a significant improvement (p<.02) compared to their counterparts in the control group.
Conclusions: Evidence-based interventions must be adjusted to address patients at differing levels of severity. These findings suggest that a 10 contact, 20-week intervention has a positive effect on the control of the number of other symptoms reported. However the intervention was less successful for those with both pain and fatigue than those reporting only one of the two symptoms at intake.
Implications: This suggests that future nursing intervention trials be tested at varying levels of severity for key outcomes such as symptoms and social and physical role functioning.
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