Browsing by Author "Ghosh, Sunita"
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Item Open Access A mixed-method evaluation of a volunteer navigation intervention for older persons living with chronic illness (Nav-CARE): findings from a knowledge translation study(2020-10-15) Pesut, Barbara; Duggleby, Wendy; Warner, Grace; Bruce, Paxton; Ghosh, Sunita; Holroyd-Leduc, Jayna; Nekolaichuk, Cheryl; Parmar, JasneetAbstract Background Volunteer navigation is an innovative way to help older persons get connected to resources in their community that they may not know about or have difficulty accessing. Nav-CARE is an intervention in which volunteers, who are trained in navigation, provide services for older persons living at home with chronic illness to improve their quality of life. The goal of this study was to evaluate the impact of Nav-CARE on volunteers, older persons, and family participating across eight Canadian sites. Methods Nav-CARE was implemented using a knowledge translation approach in eight sites using a 12- or 18-month intervention period. A mixed method evaluation was used to understand the outcomes upon older person engagement; volunteer self-efficacy; and older person, family, and volunteer quality of life and satisfaction with the intervention. Results Older persons and family were highly satisfied with the intervention, citing benefits of social connection and support, help with negotiating the social aspects of healthcare, access to cost-effective resources, and family respite. They were less satisfied with the practical help available for transportation and errands. Older persons self-reported knowledge of the services available to them and confidence in making decisions about their healthcare showed statistically significant improvements (P < .05) over 12–18 months. Volunteers reported satisfaction with their role, particularly as it related to building relationships over time, and good self-efficacy. Volunteer attrition was a result of not recruiting older persons in a timely manner. There was no statistically significant improvement in quality of life for older persons, family or volunteers from baseline to study completion. Conclusions Findings from this study support a developing body of evidence showing the contributions volunteers make to enhanced older person and family well-being in the context of chronic illness. Statistically significant improvements were documented in aspects of client engagement. However, there were no statistically significant improvements in quality of life scores even though qualitative data illustrated very specific positive outcomes of the intervention. Similar findings in other volunteer-led intervention studies raise the question of whether there is a need for targeted volunteer-sensitive outcome measures.Item Open Access A phase III, multicenter, randomized controlled trial of preoperative versus postoperative stereotactic radiosurgery for patients with surgically resectable brain metastases(2022-12-30) Das, Subhadip; Faruqi, Salman; Nordal, Robert; Starreveld, Yves; Kelly, John; Bowden, Gregory; Amanie, John; Fairchild, Alysa; Lim, Gerald; Loewen, Shaun; Rowe, Lindsay; Wallace, Carla; Ghosh, Sunita; Patel, SamirAbstract Background Postoperative stereotactic radiosurgery (SRS) is a standard management option for patients with resected brain metastases. Preoperative SRS may have certain advantages compared to postoperative SRS, including less uncertainty in delineation of the intact tumor compared to the postoperative resection cavity, reduced rate of leptomeningeal dissemination postoperatively, and a lower risk of radiation necrosis. The recently published ASCO-SNO-ASTRO consensus statement provides no recommendation for the preferred sequencing of radiotherapy and surgery for patients receiving both treatments for their brain metastases. Methods This multicenter, randomized controlled trial aims to recruit 88 patients with resectable brain metastases over an estimated three-year period. Patients with ten or fewer brain metastases with at least one resectable, fulfilling inclusion criteria will be randomized to postoperative SRS (standard arm) or preoperative SRS (investigational arm) in a 1:1 ratio. Randomization will be stratified by age (< 60 versus ≥60 years), histology (melanoma/renal cell carcinoma/sarcoma versus other), and number of metastases (one versus 2–10). In the standard arm, postoperative SRS will be delivered within 3 weeks of surgery, and all unresected metastases will receive primary SRS. In the investigational arm, enrolled patients will receive SRS of all brain metastases followed by surgery of resectable metastases within one week of SRS. In either arm, single fraction or hypofractionated SRS in three or five fractions is permitted. The primary endpoint is to assess local control at 12 months in both arms. Secondary endpoints include local control at other time points, regional/distant brain recurrence rates, leptomeningeal recurrence rates, overall survival, neurocognitive outcomes, and adverse radiation events including radiation necrosis rates in both arms. Discussion This trial addresses the unanswered question of the optimal sequencing of surgery and SRS in the management of patients with resectable brain metastases. No randomized data comparing preoperative and postoperative SRS for patients with brain metastases has been published to date. Trial registration Clinicaltrials.gov , NCT04474925; registered on July 17, 2020. Protocol version 1.0 (January 31, 2020). Sponsor: Alberta Health Services, Edmonton, Canada (Samir Patel, MD).Item Open Access Building a new life: a qualitative study of how family carers deal with significant changes(2022-07-01) Duggleby, Wendy; O’Rourke, Hannah M.; Baxter, Pamela; Nekolaichuk, Cheryl; Thompson, Genevieve; Peacock, Shelley; Ghosh, Sunita; Holroyd-Leduc, Jayna; McAiney, Carrie; Dubé, Véronique; Swindle, Jennifer; Pagnucco-Renaud, Madeleine; Sana, SaminaAbstract Background Family carers of persons living with dementia who are residing in long term care (LTC), often experience significant changes in their roles and relationships which affects mental and physical health. Research has focused on describing the carers’ experience, but not on how they deal with these changes or their perceptions of support needs. The purpose of this study was to explore how family carers of persons living with dementia residing in LTC deal with significant changes and to understand how best to support these carers. Methods Eight face-to-face audio-recorded focus group interviews were conducted with 45 participants from September 2019 to January 2020, as part of a larger study aimed at guiding the adaptation of an online toolkit to support family carers of persons living with dementia residing in LTC. Applied thematic analysis was used to analyze the focus group data. Findings/results Carers dealt with the significant changes they experienced through the process of “building a new life” consisting of two sub-processes: a) building new relationships (with their family member, LTC staff and others outside of LTC), and b) finding space for themselves (sharing of care and finding balance). Understanding dementia, support from others (staff, family and friends), connecting with resources, and being included in care decisions helped carers build a new life. Conclusion The process of building a new life describes the ways that family carers deal with the life-altering changes they experienced when a family member is admitted to LTC. Carers may be supported in building their new life, by providing them with information about dementia and how to relate to staff and their family member living with dementia. The quality of care being provided and the LTC environment may also play an important role in how carers deal with the significant changes they experience.Item Open Access Content of Serious Illness Care conversation documentation is associated with goals of care orders—a quantitative evaluation in hospital(2022-06-29) King, Seema; Douglas, Maureen; Javed, Sidra; Semenchuk, Jocelyn; Ghosh, Sunita; Dunne, Fiona; Moledina, Aliza; Fassbender, Konrad; Simon, JessicaAbstract Background The Serious Illness Care Program (SICP) increases quality of documentation about patients’ values and priorities, but it is not known whether patient characteristics and goals of care are associated with the elements documented. The purpose of this study was to explore for associations between the quantity and type of elements documented after SICP conversations with patient characteristics and goals of care order. Methods Documentation of SICP conversations by internal medicine physicians with hospitalized patients was evaluated in a retrospective chart review between March 2018 to December 2019. The conversations occurred after SICP implementation in a Tertiary Hospital, Medical teaching unit which uses “Goals of Care Designation” (GCD) medical orders to communicate a patient’s general intent, specific interventions, and preferred locations of care. A validated SICP codebook was used to determine the frequency of conversation elements documented for (1) Goals and Values; (2) Prognosis/illness understanding; (3) End-of-life care planning and (4) GCD/Life-sustaining treatment preferences. Univariate and multivariate generalized linear models were used to analyze associations between quantity of elements documented and patient characteristics (age, gender, frailty, language spoken and GCD). Results Of 175 SICP conversations documented, in the univariate analysis more goals and values were documented for patients who understand/speak English (0.89; 95% CI: 0.14 - 1.63) and more content was recorded for patients with a non-resuscitative GCD focus (“Medical”: 2.42; 95% CI: 1.51 – 3.33; “Comfort”: 1.06; 95% CI: 0.24 – 1.88) although not in all domains. In the multivariate analysis, controlling for age, gender, language and frailty, the association between content scores and GCD remained highly significant. Patients with a non-resuscitative GCD had higher total domain scores than those with a resuscitative GCD (“Medical”: 1.27 95% CI: 0.42–2.13; “Comfort”: 2.67, 95% CI:1.71–3.62). Conclusion The type of content documented by physicians after a SICP conversation is associated with the patient’s goals of care.Item Open Access Examining the effects of a high-protein total diet replacement on energy metabolism, metabolic blood markers, and appetite sensations in healthy adults: protocol for two complementary, randomized, controlled, crossover trials(2019-12-27) Oliveira, Camila L P; Boulé, Normand G; Sharma, Arya M; Elliott, Sarah; Siervo, Mario; Ghosh, Sunita; Berg, Aloys; Prado, Carla MAbstract Background High-protein diets and total diet replacements are becoming increasingly popular for weight regulation; however, further research is needed to elucidate their impact on the physiology of body weight regulation. The aim of this inpatient metabolic balance study is to compare the impact of a high-protein total diet replacement versus a control diet (North American) on energy expenditure, macronutrient oxidation rates and balances, metabolic blood markers and appetite sensations in healthy adults. Methods Two randomized, controlled, cross-over clinical trials conducted separately in men and women will be conducted. In each trial, participants will be allocated to two isocaloric arms: a) Control diet: 55% carbohydrate, 15% protein, and 30% fat; b) High-protein total diet replacement: 35% of carbohydrate, 40% protein, and 25% fat. They will receive the prescribed diets for 32 h while inside the whole-body calorimetry unit. Diets will be designed to ensure participants are in energy balance. The following physiological changes will be compared between groups: energy expenditure, macronutrient oxidation rates and balances, metabolic blood markers, and appetite sensations. Body composition will be assessed at baseline using dual-energy X-ray absorptiometry. Discussion This will be the first inpatient metabolic balance study examining the impact of a high-protein total diet replacement on energy metabolism, metabolic blood markers and appetite sensations in healthy young adults (of both sexes) using a whole-body calorimetry unit. Results of this clinical trial can ultimately be used to develop strategies to optimize high-protein diet interventions and weight management. Trial registration ClinicalTrials.gov Identifiers: NCT02811276 (registered on 16 June 2016) and NCT03565510 (registered on 11 June 2018). Protocol version NCT02811276: version 10 (2 March 2018); NCT03565510: version 3 (28 September 2018).Item Open Access Gastrointestinal and genitourinary toxicity profiles of metformin versus placebo in men with prostate cancer receiving prostate radiotherapy: interim toxicity results of a double-blinded, multicenter, phase II randomized controlled trial(2021-11-04) Kim, Julian O.; McDonald, Megan O.; Ong, Aldrich; Koul, Rashmi; Dubey, Arbind; Hunter, William; Ahmed, Shahida; Quon, Harvey; Yee, Don; Parliament, Matthew; Sivananthan, Gokulan; Danielson, Brita; Rowe, Lindsay; Ghosh, Sunita; Usmani, NawaidAbstract Androgen deprivation therapy (ADT) used for prostate cancer (PCa) management is associated with metabolic and anthropometric toxicity. Metformin given concurrent to ADT is hypothesized to counteract these changes. This planned interim analysis reports the gastrointestinal and genitourinary toxicity profiles of PCa patients receiving ADT and prostate/pelvic radiotherapy plus metformin versus placebo as part of a phase 2 randomized controlled trial. Men with intermediate or high-risk PCa were randomized 1:1 to metformin versus placebo. Both groups were given ADT for 18–36 months with minimum 2-month neoadjuvant phase prior to radiotherapy. Acute gastrointestinal and genitourinary toxicities were quantified using CTCAE v4.0. Differences in ≥ grade 2 toxicities by treatment were assessed by chi-squared test. 83 patients were enrolled with 44 patients randomized to placebo and 39 randomized to metformin. There were no significant differences at any time point in ≥ grade 2 gastrointestinal toxicities or overall gastrointestinal toxicity. Overall ≥ grade 2 gastrointestinal toxicity was low prior to radiotherapy (7.9% (placebo) vs. 3.1% (metformin), p = 0.39) and at the end of radiotherapy (2.8% (placebo) vs 3.1% (metformin), p = 0.64). There were no differences in overall ≥ grade 2 genitourinary toxicity between treatment arms (19.0% (placebo) vs. 9.4% (metformin), p = 0.30). Metformin added to radiotherapy and ADT did not increase rates of ≥ grade 2 gastrointestinal or genitourinary toxicity and is generally safe and well-tolerated.Item Open Access Indirect costs associated with out-of-country referral for proton therapy: a survey of adult and pediatric patients in Alberta, Canada(2021-07-11) Middleton, Jacqueline; Black, Karina; Ghosh, Sunita; Eisenstat, David D.; Patel, SamirAbstract Background Patients in Alberta, Canada are referred to the United States (US) for proton treatment. The Alberta Ministry of Health pays for the proton treatment and the cost of flights to and from the United States. This study aimed to determine the out-of-pocket expenses incurred by patients or patients’ families. Methods An electronic survey was sent to 59 patients treated with proton therapy between January 2008 and September 2019. Survey questions asked about expenses related to travel to the US and those incurred while staying in the US, reimbursement of expenses, and whether any time away from work was paid or unpaid leave. Results Seventeen respondents (response rate, 29%) reported expenses of flights for family members (mean, CAD 1886; range CAD 0–5627), passports/visas and other travel costs (mean, CAD 124; range CAD 0–546), accommodation during travel to the US (mean, CAD 50; range CAD 0–563), food during travel to the US (mean, CAD 89; range CAD 0–338), accommodation in the US (rented home/apartment mean, CAD 7394; range CAD 3075-13,305; hotel mean, CAD 4730; range CAD 3564-5895; other accommodation mean CAD 2660; range CAD 0–13,842), transportation in the US (car mean, CAD 2760; range CAD 0–7649; bus/subway mean, CAD 413; range CAD 246–580), and food in the US (mean, CAD 2443; range 0–6921). Expenses were partially reimbursed or covered by not-for-profit organizations or government agencies for some patients (35%). Patients missed a mean of 59 days of work; accompanying family members missed an average of 34 days. For 29% this time away from work was paid, but unpaid for 71% of respondents. Conclusions Multiple factors contributed to the expenses incurred including age of the patient, number of accompanying individuals, available accommodation, mode of transportation within the US, and whether the patient qualified for financial support. Added to this burden is the potential loss of wages for time away from work. The study showed a large variation in indirect costs for each family and supports actively seeking more opportunities for financial support for families with children with cancer.Item Open Access Mixed-methods single-arm repeated measures study evaluating the feasibility of a web-based intervention to support family carers of persons with dementia in long-term care facilities(2018-10-31) Duggleby, Wendy; Jovel Ruiz, Kathya; Ploeg, Jenny; McAiney, Carrie; Peacock, Shelley; Nekolaichuk, Cheryl; Holroyd-Leduc, Jayna; Ghosh, Sunita; Brazil, Kevin; Swindle, Jennifer; Forbes, Dorothy; Woodhead Lyons, Sandra; Parmar, Jasneet; Kaasalainen, Sharon; Cottrell, Laura; Paragg, JillianAbstract Background Following institutionalization of a relative with Alzheimer disease and related dementias (ADRD), family carers continue to provide care. They must learn to negotiate with staff and navigate the system all of which can affect their mental health. A web-based intervention, My Tools 4 Care-In Care (MT4C-In Care) was developed by the research team to aid carers through the transitions experienced when their relative/friend with ADRD resides in a long-term care (LTC) facility. The purpose of this study was to evaluate MT4C-In Care for feasibility, acceptability, ease of use, and satisfaction, along with its potential to help decrease carer’s feelings of grief and improve their hope, general self-efficacy, and health-related quality of life. Methods The study was a mixed-methods single-arm repeated measures feasibility study. Participants accessed MT4C-In Care over a 2-month period. Data were collected at baseline and 1 and 2 months. Using a checklist, participants evaluated MT4C-In Care for ease of use, feasibility, acceptability, and satisfaction. Measures were also used to assess the effectiveness of the MT4C-In Care in improving hope (Herth Hope Index), general self-efficacy (GSES), loss and grief (NDRGEI), and health-related quality of life (SF12v2) of participants. Qualitative data were collected at 2 months and informed quantitative findings. Results The majority of the 37 participants were female (65%; 24/37), married (73%; 27/37), and had a mean age of 63.24 years (SD = 11.68). Participants reported that MT4C-In Care was easy to use, feasible, and acceptable. Repeated measures ANOVA identified a statistically significant increase over time in participants hope scores (p = 0.03) and a significant decrease in grief (< 0.001). Although significant differences in mental health were not detected, hope (r = 0.43, p = 0.03) and grief (r = − 0.66, p < 0.001) were significantly related to mental health quality of life. Conclusion MT4C-In Care is feasible, acceptable, and easy to use and shows promise to help carers of family members with ADRD residing in LTC increase their hope and decrease their grief. This study provides the foundation for a future pragmatic trial to determine the efficacy of MT4C-In Care. Trial registration ClinicalTrials.gov NCT03571165. June 30, 2018 (retrospectively registered).Item Open Access Study protocol: pragmatic randomized control trial of my tools 4 care- in care (MT4C-in care) a web-based tool for family Carers of persons with dementia residing in long term care(2020-08-10) Duggleby, Wendy; O’Rourke, Hannah; Swindle, Jennifer; Peacock, Shelley; McAiney, Carrie; Baxter, Pamela; Thompson, Genevieve; Dubé, Véronique; Nekolaichuk, Cheryl; Ghosh, Sunita; Holroyd-Leduc, JaynaAbstract Background When a family member resides in long term care facility (LTC), family carers continue caregiving and have been found to have decreases in mental health. The aim of My Tools 4 Care – In Care (an online intervention) is to support carers of persons living with dementia residing in LTC through transitions and increase their self-efficacy, hope, social support and mental health. This article comprises the protocol for a study to evaluate My Tools 4 Care-In Care (MT4C-In Care) by asking the following research questions: 1) Is there a 2 month (immediately post-intervention) and 4 month (2 months post-intervention) increase in mental health, general self-efficacy, social support and hope, and decrease in grief and loneliness, in carers of a person living with dementia residing in LTC using MT4C-In CARE compared to an educational control group? 2) Do carers of persons living with dementia residing in LTC perceive My Tools 4 Care- In Care helps them with the transitions they experience? Methods This study is a single blinded pragmatic mixed methods randomized controlled trial. Approximately 280 family carers of older persons (65 years of age and older) with dementia residing in LTC will be recruited for this study. Data will be collected at three time points: baseline, 2 month, and 4 months. Based on the feasibility study, we hypothesize that participants using MT4C-In Care will report significant increases in hope, general self-efficacy, social support and mental health quality of life, and significant decreases in grief and loneliness from baseline, as compared to an educational control group. To determine differences between groups and over time, generalized estimating equations analysis will be used. Qualitative descriptive analysis will be used to further evaluate MT4C-In Care and if it supports carers through transitions. Discussion Data collection will begin in four Canadian provinces (Alberta, Manitoba, Ontario and Saskatchewan) in February 2020 and is expected to be completed in June 2021. The results will inform policy and practice as MT4C-In Care can be revised for local contexts and posted on websites such as those hosted by the Alzheimer Society of Canada. Trial registration NCT04226872 ClinicalTrials.gov Registered 09 January 2020 Protocol Version #2 Feb 19, 2020.