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A research protocol for a pilot, randomized controlled trial designed to examine the feasibility of a dyadic versus individual yoga program for family caregivers of glioma patients undergoing radiotherapy.

ABSTRACT: Background:Although the diagnosis and treatment of a primary brain tumor present unique challenges to patients and their family caregivers, evidence-based supportive care interventions are generally lacking. The primary aim of this research protocol is to determine the feasibility of implementing a dyadic yoga (DY) versus a caregiver yoga (CY) intervention or a wait-list control (WLC) group using a randomized controlled trial design. Methods:Seventy-five glioma patients undergoing radiotherapy and their family caregivers are randomized to the DY, CY, or a WLC group. Patient-caregiver dyads in the DY group and caregivers in the CY group receive 15 sessions (45?min each) over the course of patients' standard radiotherapy (6?weeks). Patients and caregivers in all groups complete baseline assessments of symptoms, quality of life (QOL), and health utilization outcomes prior to randomization. Follow-up assessments are performed 6?weeks and then again 3?months later. The primary outcome is feasibility (i.e., ??50% of eligible dyads consent, ??70% of enrolled dyads complete all assessments, and ??50% of all practice sessions are attended). We will also perform primarily descriptive analyses of the self-reported outcomes (e.g., fatigue, overall QOL) and explore potential intervention moderators (e.g., performance status) to inform a larger future trial. Conclusion:This trial will provide important information regarding the feasibility of a dyadic versus a caregiver yoga intervention regarding symptom, QOL, and health utilization outcomes in glioma patients and their caregivers. Trial registration:ClinicalTrials.gov NCT02481349.

SUBMITTER: Milbury K

PROVIDER: S-EPMC6657047 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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A research protocol for a pilot, randomized controlled trial designed to examine the feasibility of a dyadic versus individual yoga program for family caregivers of glioma patients undergoing radiotherapy.

Milbury Kathrin K Li Jing J Weathers Shiao-Pei SP Shih Tina T Malliaha Smitha S Li Yisheng Y Cohen Lorenzo L

Pilot and feasibility studies 20190725

<h4>Background</h4>Although the diagnosis and treatment of a primary brain tumor present unique challenges to patients and their family caregivers, evidence-based supportive care interventions are generally lacking. The primary aim of this research protocol is to determine the feasibility of implementing a dyadic yoga (DY) versus a caregiver yoga (CY) intervention or a wait-list control (WLC) group using a randomized controlled trial design.<h4>Methods</h4>Seventy-five glioma patients undergoing ...[more]

PMID: 31367462

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Project description:PurposeThis study aimed to refine a behavioral sleep intervention program targeting patients with Alzheimer's disease and their caregivers.MethodsIn this case series, key components of the sleep program were built upon previous intervention studies of patients with cognitive impairment/dementia. The intervention consisted of five weekly sessions covering sleep hygiene, sleep compression, stimulus control, daily walking/light exposure, relaxation/mindfulness, and caregiver training to manage patients' behavioral problems. The materials and structure were iteratively refined based on feedback from caregivers and sleep educators. Sleep diaries were used to evaluate sleep outcomes.ResultsFive out of six enrolled dyads completed the sessions. Several revisions were made during testing: the last session was changed from telephone to in-person; some components (e.g., sleep scheduling, mindfulness) were rearranged within or across sessions; sleep educator guidelines for sleep scheduling, light exposure, and walking were revised. After the fifth dyad, no additional issues were identified by the caregiver or the sleep educator. Four patients and three caregivers had improved sleep at the last session.ConclusionsThe iterative refinement process was successful in finalizing the intervention program, with evidence of sleep improvements. Formal pilot testing of the program will provide further information on feasibility and effectiveness.IMPLICATIONS FOR REHABILITATIONOur dyadic behavioral sleep program can be tailored to various types of sleep problems among patients with Alzheimer's disease and their family caregivers, with the goal of improving daytime function by reducing sleep disturbances at night.Caregiver training and participation of both members of the dyad in sleep management may benefit the patients' sleep and other health outcomes, reduce caregiver stress and burden, and ultimately delay or prevent institutionalization of Alzheimer's disease patients.

Project description:BACKGROUND:Cancer cachexia is a prevalent symptom of head and neck neoplasms. The reduction in skeletal muscle mass is one of the main characteristics which can lead to poor physical functioning. The purposes of this pilot randomized controlled trial were to determine the feasibility of progressive resistance training in cachectic head and neck cancer patients during radiotherapy and to explore possible risks and benefits. METHODS:Twenty cachectic participants with head and neck cancer receiving radiation were randomized to obtain either a machine supported progressive resistance training (n =?10) or usual care (n?=?10). The training took place 3 times weekly for 30 min. Intervention included 3 exercises for major muscle groups with 8-12 repetition maximum for 3 sets each. Bioelectrical impedance analysis, hand-held dynamometry, Six-Minute Walk Test and standardized questionnaires for fatigue and quality of life were used for evaluating outcomes at baseline before radiotherapy (t1), after 7 weeks of radiotherapy (t2) and 8 weeks after the end of radiotherapy (t3). RESULTS:All participants (n =?20) completed the trial. No serious adverse events occurred. At the initial assessment the cachectic patients had already lost 7.1?±?5.2% of their body weight. General fatigue (score 10.7?±?3.3) and reduced quality of life (score 71.3?±?20.6) were prevalent in cachectic head and neck cancer patients even before radiotherapy. An average improvement of weight loading for leg press (+?19.0%), chest press (+?29.8%) and latissimus pull-down (+?22.8%) was possible in the intervention group. Participants had at least 13 training sessions. The outcome measures showed nonsignificant changes at t2 and t3, but a trend for a better course of general fatigue and quality of life at t2 in the intervention group. CONCLUSIONS:Despite advanced tumor stage and burdensome treatment the intervention adherence is excellent. Progressive resistance training in cachectic head and neck cancer patients during radiotherapy seems to be safe and feasible and may have beneficial effects of general fatigue and quality of life. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03524755 . Registered 15 May 2018 - Retrospectively registered.

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A research protocol for a pilot, randomized controlled trial designed to examine the feasibility of a dyadic versus individual yoga program for family caregivers of glioma patients undergoing radiotherapy.

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A research protocol for a pilot, randomized controlled trial designed to examine the feasibility of a dyadic versus individual yoga program for family caregivers of glioma patients undergoing radiotherapy.

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