Evaluating the Impact of Culturally-Specific Patient-Centric Behavioral Intervention Package versus Usual care for Tobacco Cessation among Patients attending Non- Communicable Disease Clinics in North India: A Single-Blind Trial Pilot Study Protocol (Preprint)

2020 ◽  
Author(s):  
GARIMA BHATT ◽  
SONU GOEL ◽  
RAKESH GUPTA ◽  
SANDEEP GROVER ◽  
BIKASH MEDHI

BACKGROUND In a low & middle-income country (LMIC) like India, non – communicable diseases (NCDs) contribute a major proportion (61.8%) of all causes of death. Out of this 48% of cardiovascular diseases (CVDs), 23% of Chronic Respiratory Diseases (CRDs), 10% of Cancer deaths are attributable to tobacco use. Tobacco use is a major risk factor for NCDs and thus, the tobacco cessation approach is a high priority intervention to combat complications and death among NCD patients. While there are several interventions available for tobacco cessation, in resource constraint country like India, the effectiveness of low cost, culturally specific patient-centric tobacco cessation behavioral intervention holds a potential which needs to be evaluated. OBJECTIVE In this study, a newly devised evidence-based tobacco cessation intervention package including a behavioral approach will be compared with the existing/usual care provided under the National Programme for Prevention and Control of Cancers, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) at NCD clinics. METHODS Design: Two arm, parallel-group randomized controlled trial. Participants: Patients aged ≥ 30 years suffering from any NCD, currently using tobacco and attending NCD clinics in two districts of Punjab, India. Sample size: A total of 200 participants meeting the selection criteria will be recruited. They will be allocated either to the intervention arm or control (usual care) arm (100 each) using block randomization. Intervention: For the participants, there will be four face-to-face disease-specific cessation counseling sessions, disease-specific pamphlets, short text messages in vernacular language i.e, Punjabi. Follow-ups will be done at the 3rd, 6th, 9th, and 12th months. Primary outcome: Seven-day abstinence, biochemically verified by plasma cotinine levels. Secondary outcome: Quit attempts, number of sticks/number of times of SLT usage in a day, and stage of behavior change in tobacco user. RESULTS This multi-component culturally specific- patient-centric behavioral intervention package for tobacco cessation at NCD clinic settings with a focus on the individual, family, and social environment could increase the outreach of cessation services using existing resources thereby strengthening health systems and improving the quality of life of NCD patients. CONCLUSIONS This multi-component culturally specific- patient-centric behavioral intervention package for tobacco cessation at NCD clinic settings with a focus on the individual, family, and social environment could increase the outreach of cessation services using existing resources thereby strengthening health systems and improving the quality of life of NCD patients. CLINICALTRIAL The study protocol is registered with Clinical Trials Registry, India. The registration number is CTRI/2018/01/011643.

2021 ◽  
Vol 14 ◽  
pp. 1179173X2110566
Author(s):  
Garima Bhatt ◽  
Sonu Goel ◽  
Rakesh Gupta ◽  
Sandeep Grover ◽  
Bikash Medhi

Background In a low and middle-income country (LMIC) like India, non—communicable diseases (NCDs) contribute a major proportion (61.8%) of all causes of death. Out of this, 48% of cardiovascular diseases , 23% of Chronic Respiratory Diseases , and 10% of Cancer deaths are attributable to tobacco use. Tobacco use is a major risk factor for NCDs and thus, the tobacco cessation approach is a high priority intervention to combat complications and death among NCD patients. While several interventions are available for tobacco cessation, in resource constraint countries like India, the effectiveness of low-cost, culturally specific patient-centric tobacco cessation behavioral intervention holds a potential that needs to be evaluated. A newly developed evidence-based tobacco cessation intervention package will be compared with the existing/usual care provided under the National Programme for Prevention and Control of Cancers, Diabetes, Cardiovascular Diseases, and Stroke (NPCDCS) at NCD clinics. Methods and design 2 arm, parallel-group randomized controlled trial. Participants Patients aged ≥30 years suffering from NCD, currently using tobacco, and attending NCD clinics in 2 districts of Punjab, India. Sample size A total of 200 participants meeting the selection criteria will be recruited. They will be allocated either to the intervention arm or control (usual care) arm (100 each) using block randomization. Intervention For the participants, there will be 4 face-to-face disease-specific cessation counseling sessions, disease-specific pamphlets, short text messages in vernacular language, that is, Punjabi. Follow-ups will be done at the third, sixth, ninth, and 12th months. Primary outcome Seven-day abstinence, biochemically verified by plasma cotinine levels. Secondary outcome Quit attempts, number of sticks/number of times of smokeless tobacco usage in a day, and stage of behavior change in tobacco users. Discussion This multicomponent culturally specific-patient-centric behavioral intervention package for tobacco cessation at NCD clinic settings focusing on the individual, family, and social environment could increase the outreach of cessation services using existing resources, thereby strengthening health systems and enhancing the quality of life of NCD patients. Trial registration The protocol for the study has been registered with the Clinical Trials Registry in India under the registration number CTRI/2018/01/011643.


2014 ◽  
Vol 13 (4) ◽  
pp. 981-990 ◽  
Author(s):  
Pierre Gagnon ◽  
Lise Fillion ◽  
Marie-Anik Robitaille ◽  
Michèle Girard ◽  
François Tardif ◽  
...  

AbstractObjective:We developed a specific cognitive–existential intervention to improve existential distress in nonmetastatic cancer patients. The present study reports the feasibility of implementing and evaluating this intervention, which involved 12 weekly sessions in both individual and group formats, and explores the efficacy of the intervention on existential and global quality of life (QoL) measures.Method:Some 33 nonmetastatic cancer patients were randomized between the group intervention, the individual intervention, and the usual condition of care. Evaluation of the intervention on the existential and global QoL of patients was performed using the existential well-being subscale and the global scale of the McGill Quality of Life (MQoL) Questionnaire.Results:All participants agreed that their participation in the program helped them deal with their illness and their personal life. Some 88.9% of participants agreed that this program should be proposed for all cancer patients, and 94.5% agreed that this intervention helped them to reflect on the meaning of their life. At post-intervention, both existential and psychological QoL improved in the group intervention versus usual care (p = 0.086 and 0.077, respectively). At the three-month follow-up, global and psychological QoL improved in the individual intervention versus usual care (p = 0.056 and 0.047, respectively).Significance of results:This pilot study confirms the relevance of the intervention and the feasibility of the recruitment and randomization processes. The data strongly suggest a potential efficacy of the intervention for existential and global quality of life, which will have to be confirmed in a larger study.


2020 ◽  
Author(s):  
Roganie Govender ◽  
Christina H Smith ◽  
Helen Barratt ◽  
Benjamin Gardner ◽  
Stuart Taylor

Abstract Background: Dysphagia or difficulty in swallowing affects quality of life for most patients with head and neck cancer. SIP SMART – [Swallowing Intervention Package: Self-Monitoring, Assessment, Rehabilitation Training] aims to improve post-treatment swallowing outcomes through a targeted and tailored pre-treatment intervention. This feasibility study assessed 1) recruitment and retention, 2) patient acceptability of randomisation and participation, 3) patient adherence, and 4) sought to identify a suitable primary outcome for a definitive trial, including sample size estimation. Methods: This two-arm parallel group non-blinded randomised feasibility trial took place within a head and neck centre at a teaching hospital in London, UK. Patients newly diagnosed with stage III/IV head and neck cancer were recruited and underwent 6-month follow-up. Patients were randomised to SIP-SMART or usual care via an online web-based system. SIP SMART comprised two 45-minute consultations including a baseline clinical and instrumental swallowing assessment, relevant educational information, targeted swallowing exercises, and specific behaviour change strategies to increase exercise adherence. Usual care comprised a single session including a baseline clinical assessment and generic information about the likely impact of treatment on swallowing. Results: A total of 106 patients were identified at pre-screening, 70 were assessed for eligibility. Twenty-six patients did not meet eligibility criteria [0.37, 95% CI 0.27 to 0.49]. Five of 44 [0.11, 95% CI 0.05 to 0.24] eligible patients were not approached by researchers during clinic. Seven [0.18, 95% CI 0.08 to 0.33] of the 39 approached declined participation. Target recruitment (32 consented patients) was achieved within the timeframe. At 6-months 29/32 [0.91, 95% CI 0.76 to 0.97] patients remained in the trial. Acceptability of randomisation and participation in the intervention was favourable, and adherence to the exercises exceeded the pre-defined 35% minimum criterion. The MD Anderson Dysphagia Inventory swallow related quality of life measure was selected as the most suitable primary outcome for sample size estimation. No adverse effects arose from the intervention, or study participation. Conclusions: A definitive trial of the SIP SMART intervention compared to usual care is feasible and can be undertaken with patients with head and neck cancer treated within the NHS. Trial Registration: ISRCTN40215425


2020 ◽  
Author(s):  
Roganie Govender ◽  
Christina H Smith ◽  
Helen Barratt ◽  
Benjamin Gardner ◽  
Stuart Taylor

Abstract Background: Dysphagia or difficulty in swallowing affects quality of life for most patients with head and neck cancer. SIP SMART – [Swallowing Intervention Package: Self-Monitoring, Assessment, Rehabilitation Training] aims to improve post-treatment swallowing outcomes through a targeted and tailored pre-treatment intervention. This feasibility study assessed 1) recruitment and retention, 2) patient acceptability of randomisation and participation, 3) patient adherence, and 4) sought to identify a suitable primary outcome for a definitive trial, including sample size estimation. Methods: This two-arm parallel group non-blinded randomised feasibility trial took place within a head and neck centre at a teaching hospital in London, UK. Patients newly diagnosed with stage III/IV head and neck cancer were recruited and underwent 6-month follow-up. Patients were randomised to SIP-SMART or usual care via an online web-based system. SIP SMART comprised two 45-minute consultations including a baseline clinical and instrumental swallowing assessment, relevant educational information, targeted swallowing exercises, and specific behaviour change strategies to increase exercise adherence. Usual care comprised a single session including a baseline clinical assessment and generic information about the likely impact of treatment on swallowing. Results: A total of 106 patients were identified at pre-screening, 70 were assessed for eligibility. Twenty-six patients did not meet eligibility criteria [0.37, 95% CI 0.27 to 0.49]. Five of 44 [0.11, 95% CI 0.05 to 0.24] eligible patients were not approached by researchers during clinic. Seven [0.18, 95% CI 0.08 to 0.33] of the 39 approached declined participation. Target recruitment (32 consented patients) was achieved within the timeframe. At 6-months 29/32 [0.91, 95% CI 0.76 to 0.97] patients remained in the trial. Acceptability of randomisation and participation in the intervention was favourable, and adherence to the exercises exceeded the pre-defined 35% minimum criterion. The MD Anderson Dysphagia Inventory swallow related quality of life measure was selected as the most suitable primary outcome for sample size estimation. No adverse effects arose from the intervention, or study participation. Conclusions: A definitive trial of the SIP SMART intervention compared to usual care is feasible and can be undertaken with patients with head and neck cancer treated within the NHS.Trial Registration: ISRCTN40215425, registered retrospectively http://www.isrctn.com/ISRCTN40215425


2011 ◽  
Vol 31 (7) ◽  
pp. 1084-1106 ◽  
Author(s):  
TONI C. ANTONUCCI ◽  
KIRA S. BIRDITT ◽  
CAREY W. SHERMAN ◽  
SARAH TRINH

ABSTRACTThere have been fundamental changes in the intergenerational family, and yet families continue to be an important part of people's lives. We use the convoy model to describe the factors that influence supportive relations within intergenerational families, beginning with a description of the changing structure of the intergenerational family. We next outline support exchanges, detailing how personal characteristics, especially gender, race, age and socio-economic status, and situational characteristics, in particular family structure and intergenerational context, influence support exchanges. Instrumental and emotional family exchanges are described, with special attention to the unique circumstances of care-giving in intergenerational families. We also examine the importance of recognising differences in the quality of intergenerational relations, again noting the influence of personal and situational characteristics. Variations in support quality, e.g. positive, negative and ambivalent, and its influence on wellbeing are discussed. As families and individuals change, differences emerge at the individual, family and societal levels. We consider the implications of changes and stability in intergenerational relations and make recommendations about how best to envisage and plan future intergenerational family support. Societies with fewer resources as well as individuals and families with diverse individual histories must be innovative and creative in meeting the needs of older people as well as those of all family members.


2019 ◽  
Author(s):  
Roganie Govender ◽  
Christina H Smith ◽  
Helen Barratt ◽  
Benjamin Gardner ◽  
Stuart Taylor

Abstract Background: Dysphagia or difficulty in swallowing affects quality of life for most patients with head and neck cancer. SIP SMART – [Swallowing Intervention Package: Self-Monitoring, Assessment, Rehabilitation Training] aims to improve post-treatment swallowing outcomes through a targeted and tailored pre-treatment intervention. This feasibility study assessed 1) recruitment and retention, 2) patient acceptability of randomisation and participation, 3) patient adherence, and 4) sought to identify a suitable primary outcome for a definitive trial, including sample size estimation. Methods: This two-arm parallel group non-blinded randomised feasibility trial took place within a head and neck centre at a teaching hospital in London, UK. Patients newly diagnosed with stage III/IV head and neck cancer were recruited and underwent 6-month follow-up. Patients were randomised to SIP-SMART or usual care via an online web-based system. SIP SMART comprised two 45-minute consultations including a baseline clinical and instrumental swallowing assessment, relevant educational information, targeted swallowing exercises, and specific behaviour change strategies to increase exercise adherence. Usual care comprised a single session including a baseline clinical assessment and generic information about the likely impact of treatment on swallowing. Results: A total of 106 patients were identified at pre-screening, 70 were assessed for eligibility. Twenty-six patients did not meet eligibility criteria [0.37, 95% CI 0.27 to 0.49]. Five of 44 [0.11, 95% CI 0.05 to 0.24] eligible patients were not approached by researchers during clinic. Seven [0.18, 95% CI 0.08 to 0.33] of the 39 approached declined participation. Target recruitment (32 consented patients) was achieved within the timeframe. At 6-months 29/32 [0.91, 95% CI 0.76 to 0.97] patients remained in the trial. Acceptability of randomisation and participation in the intervention was favourable, and adherence to the exercises exceeded the pre-defined 35% minimum criterion. The MD Anderson Dysphagia Inventory swallow related quality of life measure was selected as the most suitable primary outcome for sample size estimation. No adverse effects arose from the intervention, or study participation. Conclusions: A definitive trial of the SIP SMART intervention compared to usual care is feasible and can be undertaken with patients with head and neck cancer treated within the NHS. Trial Registration: ISRCTN40215425


2019 ◽  
Author(s):  
Roganie Govender ◽  
Christina H Smith ◽  
Helen Barratt ◽  
Benjamin Gardner ◽  
Stuart Taylor

Abstract Background: Dysphagia or difficulty in swallowing affects quality of life for most patients with head and neck cancer. SIP SMART – [Swallowing Intervention Package: Self-Monitoring, Assessment, Rehabilitation Training] aims to improve post-treatment swallowing outcomes through a targeted and tailored pre-treatment intervention. This feasibility study assessed 1) recruitment and retention, 2) patient acceptability of randomisation and participation, 3) patient adherence, and 4) sought to identify a suitable primary outcome for a definitive trial, including sample size estimation. Methods: This two-arm parallel group non-blinded randomised feasibility trial took place within a head and neck centre at a teaching hospital in London, UK. Patients newly diagnosed with stage III/IV head and neck cancer were recruited and underwent 6-month follow-up. Patients were randomised to SIP-SMART or usual care via an online web-based system. SIP SMART comprised two 45-minute consultations including a baseline clinical and instrumental swallowing assessment, relevant educational information, targeted swallowing exercises, and specific behaviour change strategies to increase exercise adherence. Usual care comprised a single session including a baseline clinical assessment and generic information about the likely impact of treatment on swallowing. Results: A total of 106 patients were identified at pre-screening, 70 were assessed for eligibility. Twenty-six patients did not meet eligibility criteria [0.37, 95% CI 0.27 to 0.49]. Five of 44 [0.11, 95% CI 0.05 to 0.24] eligible patients were not approached by researchers during clinic. Seven [0.18, 95% CI 0.08 to 0.33] of the 39 approached declined participation. Target recruitment (32 consented patients) was achieved within the timeframe. At 6-months 29/32 [0.91, 95% CI 0.76 to 0.97] patients remained in the trial. Acceptability of randomisation and participation in the intervention was favourable, and adherence to the exercises exceeded the pre-defined 35% minimum criterion. The MD Anderson Dysphagia Inventory swallow related quality of life measure was selected as the most suitable primary outcome for sample size estimation. No adverse effects arose from the intervention, or study participation. Conclusions: A definitive trial of the SIP SMART intervention compared to usual care is feasible and can be undertaken with patients with head and neck cancer treated within the NHS. Trial Registration: ISRCTN40215425


Author(s):  
B. Carragher ◽  
M. Whittaker

Techniques for three-dimensional reconstruction of macromolecular complexes from electron micrographs have been successfully used for many years. These include methods which take advantage of the natural symmetry properties of the structure (for example helical or icosahedral) as well as those that use single axis or other tilting geometries to reconstruct from a set of projection images. These techniques have traditionally relied on a very experienced operator to manually perform the often numerous and time consuming steps required to obtain the final reconstruction. While the guidance and oversight of an experienced and critical operator will always be an essential component of these techniques, recent advances in computer technology, microprocessor controlled microscopes and the availability of high quality CCD cameras have provided the means to automate many of the individual steps.During the acquisition of data automation provides benefits not only in terms of convenience and time saving but also in circumstances where manual procedures limit the quality of the final reconstruction.


2010 ◽  
Vol 39 (2) ◽  
pp. 34-36
Author(s):  
Vaia Touna

This paper argues that the rise of what is commonly termed "personal religion" during the Classic-Hellenistic period is not the result of an inner need or even quality of the self, as often argued by those who see in ancient Greece foreshadowing of Christianity, but rather was the result of social, economic, and political conditions that made it possible for Hellenistic Greeks to redefine the perception of the individual and its relationship to others.


2017 ◽  
Vol 3 (1) ◽  
pp. 112-126 ◽  
Author(s):  
Ilaria Cristofaro

From a phenomenological perspective, the reflective quality of water has a visually dramatic impact, especially when combined with the light of celestial phenomena. However, the possible presence of water as a means for reflecting the sky is often undervalued when interpreting archaeoastronomical sites. From artificial water spaces, such as ditches, huacas and wells to natural ones such as rivers, lakes and puddles, water spaces add a layer of interacting reflections to landscapes. In the cosmological understanding of skyscapes and waterscapes, a cross-cultural metaphorical association between water spaces and the underworld is often revealed. In this research, water-skyscapes are explored through the practice of auto-ethnography and reflexive phenomenology. The mirroring of the sky in water opens up themes such as the continuity, delimitation and manipulation of sky phenomena on land: water spaces act as a continuation of the sky on earth; depending on water spaces’ spatial extension, selected celestial phenomena can be periodically reflected within architectures, so as to make the heavenly dimension easily accessible and a possible object of manipulation. Water-skyscapes appear as specular worlds, where water spaces are assumed to be doorways to the inner reality of the unconscious. The fluid properties of water have the visual effect of dissipating borders, of merging shapes, and, therefore, of dissolving identities; in the inner landscape, this process may represent symbolic death experiences and rituals of initiation, where the annihilation of the individual allows the creative process of a new life cycle. These contextually generalisable results aim to inspire new perspectives on sky-and-water related case studies and give value to the practice of reflexive phenomenology as crucial method of research.


Sign in / Sign up

Export Citation Format

Share Document