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Randomized Pilot Trial of a Telephone Symptom Management Intervention for Symptomatic Lung Cancer Patients and Their Family Caregivers.

ABSTRACT: Lung cancer is one of the most common cancers affecting both men and women and is associated with high symptom burden and psychological distress. Lung cancer patients' family caregivers also show high rates of distress. However, few interventions have been tested to alleviate significant problems of this population.This study examined the preliminary efficacy of telephone-based symptom management (TSM) for symptomatic lung cancer patients and their family caregivers.Symptomatic lung cancer patients and caregivers (n = 106 dyads) were randomly assigned to four sessions of TSM consisting of cognitive-behavioral and emotion-focused therapy or an education/support condition. Patients completed measures of physical and psychological symptoms, self-efficacy for managing symptoms, and perceived social constraints from the caregiver; caregivers completed measures of psychological symptoms, self-efficacy for helping the patient manage symptoms and managing their own emotions, perceived social constraints from the patient, and caregiving burden.No significant group differences were found for all patient outcomes and caregiver self-efficacy for helping the patient manage symptoms and caregiving burden at two- and six-weeks post-intervention. Small effects in favor of TSM were found regarding caregiver self-efficacy for managing their own emotions and perceived social constraints from the patient. Study outcomes did not significantly change over time in either group.Findings suggest that our brief telephone-based psychosocial intervention is not efficacious for symptomatic lung cancer patients and their family caregivers. Next steps include examining specific intervention components in relation to study outcomes, mechanisms of change, and differing intervention doses and modalities.

SUBMITTER: Mosher CE

PROVIDER: S-EPMC5075493 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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Randomized Pilot Trial of a Telephone Symptom Management Intervention for Symptomatic Lung Cancer Patients and Their Family Caregivers.

Mosher Catherine E CE Winger Joseph G JG Hanna Nasser N Jalal Shadia I SI Einhorn Lawrence H LH Birdas Thomas J TJ Ceppa DuyKhanh P DP Kesler Kenneth A KA Schmitt Jordan J Kashy Deborah A DA Champion Victoria L VL

Journal of pain and symptom management 20160709 4

<h4>Context</h4>Lung cancer is one of the most common cancers affecting both men and women and is associated with high symptom burden and psychological distress. Lung cancer patients' family caregivers also show high rates of distress. However, few interventions have been tested to alleviate significant problems of this population.<h4>Objectives</h4>This study examined the preliminary efficacy of telephone-based symptom management (TSM) for symptomatic lung cancer patients and their family careg ...[more]

PMID: 27401514

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Project description:CONTEXT:Little research has explored coping skills practice in relation to symptom outcomes in psychosocial interventions for cancer patients and their family caregivers. OBJECTIVES:To examine associations of coping skills practice to symptom change in a telephone symptom management (TSM) intervention delivered concurrently to lung cancer patients and their caregivers. METHODS:This study was a secondary analysis of a randomized pilot trial. Data were examined from patient-caregiver dyads (n = 51 dyads) that were randomized to the TSM intervention. Guided by social cognitive theory, TSM involved four weekly sessions where dyads were taught coping skills including a mindfulness exercise, guided imagery, pursed lips breathing, cognitive restructuring, problem solving, emotion-focused coping, and assertive communication. Symptoms were assessed, including patients' and caregivers' psychological distress and patients' pain interference, fatigue interference, and distress related to breathlessness. Multiple regression analyses examined associations of coping skills practice during the intervention to symptoms at six weeks after the intervention. RESULTS:For patients, greater practice of assertive communication was associated with less pain interference (β = -0.45, P = 0.02) and psychological distress (β = -0.36, P = 0.047); for caregivers, greater practice of guided imagery was associated with less psychological distress (β = -0.30, P = 0.01). Unexpectedly, for patients, greater practice of a mindfulness exercise was associated with higher pain (β = 0.47, P = 0.07) and fatigue interference (β = 0.49, P = 0.04); greater practice of problem solving was associated with higher distress related to breathlessness (β = 0.56, P = 0.01) and psychological distress (β = 0.36, P = 0.08). CONCLUSION:Findings suggest that the effectiveness of TSM may have been reduced by competing effects of certain coping skills. Future interventions should consider focusing on assertive communication training for patients and guided imagery for caregivers.

Project description:BackgroundStress management interventions combining technology with human involvement have the potential to improve the cost-effectiveness of solely human-delivered interventions, but few randomized controlled trials exist for assessing the cost-effectiveness of technology-assisted human interventions.ObjectiveThe aim of this study was to investigate whether a technology-assisted telephone intervention for stress management is feasible for increasing mental well-being or decreasing the time use of coaches (as an approximation of intervention cost) while maintaining participants' adherence and satisfaction compared with traditional telephone coaching.MethodsA 2-arm, pilot randomized controlled trial of 9 months for stress management (4-month intensive and 5-month maintenance phases) was conducted. Participants were recruited on the web through a regional occupational health care provider and randomized equally to a research (technology-assisted telephone intervention) and a control (traditional telephone intervention) group. The coaching methodology was based on habit formation, motivational interviewing, and the transtheoretical model. For the research group, technology supported both coaches and participants in identifying behavior change targets, setting the initial coaching plan, monitoring progress, and communication. The pilot outcome was intervention feasibility, measured primarily by self-assessed mental well-being (WorkOptimum index) and self-reported time use of coaches and secondarily by participants' adherence and satisfaction.ResultsA total of 49 eligible participants were randomized to the research (n=24) and control (n=25) groups. Most participants were middle-aged (mean 46.26, SD 9.74 years) and female (47/49, 96%). Mental well-being improved significantly in both groups (WorkOptimum from "at risk" to "good" Â>0.85; P<.001), and no between-group differences were observed in the end (Â=0.56, 95% CI 0.37-0.74; P=.56). The total time use of coaches did not differ significantly between the groups (366.0 vs 343.0 minutes, Â=0.60, 95% CI 0.33-0.85; P=.48). Regarding adherence, the dropout rate was 13% (3/24) and 24% (6/25), and the mean adherence rate to coaching calls was 92% and 86% for the research and control groups, respectively; the frequency of performing coaching tasks was similar for both groups after both phases; and the diligence in performing the tasks during the intensive phase was better for the research group (5.0 vs 4.0, Â=0.58, 95% CI 0.51-0.65; P=.03), but no difference was observed during the maintenance phase. Satisfaction was higher in the research group during the intensive phase (5.0 vs 4.0, Â=0.66, 95% CI 0.58-0.73; P<.001) but not during the maintenance phase.ConclusionsThe technology-assisted telephone intervention is feasible with some modifications, as it had similar preliminary effectiveness as the traditional telephone intervention, and the participants had better satisfaction with and similar or better adherence to the intervention, but it did not reduce the time use of coaches. The technology should be improved to provide more digested information for action planning and templates for messaging.Trial registrationClinicalTrials.gov NCT02445950; https://www.clinicaltrials.gov/ct2/show/study/NCT02445950.

Project description:BackgroundCaregiving can be stressful, potentially creating physical and psychological strain. Substantial evidence has shown that family caregivers suffer from significant health problems arising from the demands of caregiving. Although there are programs supporting caregivers, there is little evidence regarding their effectiveness. Acupressure is an ancient Chinese healing method designed to restore the flow of Qi (vital energy) by applying external pressure to acupoints. A randomized, wait-list controlled trial was developed to evaluate the effectiveness of a self-administered acupressure intervention on caregiver stress (primary objective) and stress-related symptoms of fatigue, insomnia, depression, and health-related quality of life (secondary objectives) in Chinese caregivers of older family members.MethodsTwo hundred Chinese participants, aged ≥ 21 years, who are the primary caregivers of an older family member and screen positive for caregiver stress and symptoms of fatigue/insomnia/depression will be recruited from a community setting in Hong Kong. Subjects will be randomized to receive either an immediate treatment condition (self-administered acupressure intervention) or a wait-list control condition. The self-administered acupressure intervention will include (i) an individual learning and practice session twice a week for 2 weeks, (ii) a home follow-up visit once a week for 2 weeks, and (iii) 15-min self-practice twice a day for 6 weeks. The wait-list control group will receive the same acupressure training after the intervention group has completed the intervention. We hypothesize that Chinese family caregivers in the intervention group will have lower levels of caregiver stress, fatigue, insomnia, depression, and higher health-related quality of life after completion of the intervention than participants in the wait-list control group.DiscussionThis study will provide evidence for the effectiveness of self-administered acupressure in reducing stress and improving symptoms of fatigue, insomnia, depression, and health-related quality of life in Chinese family caregivers. The findings will inform the design of interventions to relieve negative health effects of caregiving. Furthermore, the results can raise community awareness and serve as a basis for policymaking, planning, and allocation of resources regarding empowerment of family caregivers for self-care.Trial registrationCurrent Controlled Trials NCT02526446 . Registered August 10, 2015.

Project description:BackgroundCaring for people with dementia at home requires considerable time, organization and commitment. Therefore, informal caregivers of people with dementia are often overburdened. This study examined the effects of the telephone-based Talking Time intervention, which is an approach used to strengthen the psychological health-related quality of life (HRQoL) and social support of informal caregivers of people with dementia living at home.MethodsThis study was a Medical Research Council framework phase two randomized controlled trial. The intervention consisted of a preliminary talk, information booklet, six structured telephone-based support group meetings and a structured written self-evaluation of each support group meeting. The control participants performed their usual individual self-organized care. After completing the data collection, the control group received the Talking Time intervention for fidelity reasons. The primary outcome was the self-rated psychological HRQoL of the informal caregivers, which was measured with the mental component summary of the General Health Survey Questionnaire Short Form 12 (SF-12).ResultsThirty-eight informal caregivers and their relatives were included and allocated to the intervention or control groups (n = 19 each). After 3 months, the Talking Time intervention group demonstrated an increase in the self-rated psychological HRQoL scores, whereas the scores decreased in the control group. However, the standardized effect size of 1.65 (95% Confidence Interval, - 0.44 - 3.75) was not significant. Additionally, the secondary outcomes demonstrated no significant results. The differences between the groups in most outcomes were in the expected direction. No adverse effects were identified due to the intervention.ConclusionsThe Talking Time intervention is feasible and shows nonsignificant promising results with regard to the self-rated psychological HRQoL. After further adjustment, the intervention needs to be evaluated in a full trial.Trial registrationClinical Trials: NCT02806583 , June 9, 2016 (retrospectively registered).

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Randomized Pilot Trial of a Telephone Symptom Management Intervention for Symptomatic Lung Cancer Patients and Their Family Caregivers.

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Randomized Pilot Trial of a Telephone Symptom Management Intervention for Symptomatic Lung Cancer Patients and Their Family Caregivers.

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