scholarly journals Partnering with general practitioners to optimize survivorship for patients with lymphoma: a phase II randomized controlled trial (the GOSPEL I trial)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Raymond Javan Chan ◽  
Stephanie Buhagiar ◽  
Laisa Teleni ◽  
Camilla Simonsen ◽  
Jane Turner ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Shared Care ◽  
Cancer Center ◽  
Patient Reported ◽  
Follow Up Care ◽  
Shared Care Model ◽  
Related Quality ◽  
Health Related

Abstract Background Survival rates for lymphoma are highest amongst hematological malignancies. In 2019, it was estimated that over 6400 Australians were diagnosed with lymphoma, a group of hematological malignancies with a high 5-year survival rate of ~ 76%. There is an increased focus on the promotion of wellness in survivorship and active approaches to reducing morbidity related to treatment; however, current models of follow-up care heavily rely on hospital-based specialist-led care. Maximizing the potential of general practitioners (GPs) in the ongoing management of cancer is consistent with the national health reform principles and the Cancer Council Australia’s Optimal Care Pathways. GPs are well positioned to provide guideline-based follow-up care and are more likely to address comorbidities and psychosocial issues and promote healthy lifestyle behaviors. This study aims to test the feasibility of the GOSPEL I intervention for implementing an integrated, shared care model in which cancer center specialists and community-based GPs collaborate to provide survivorship care for patients with lymphoma. Methods We describe a protocol for a phase II, randomized controlled trial with two parallel arms and a 1:1 allocation. Sixty patients with Hodgkin’s and non-Hodgkin’s lymphoma will be randomized to usual specialist-led follow-up care (as determined by the treating hematologists) or a shared follow-up care intervention (i.e., GOSPEL I). GOSPEL I is a nurse-enabled, pre-specified shared care pathway with follow-up responsibilities shared between cancer center specialists (i.e., hematologists and specialist cancer nurses) and GPs. Outcome measures assess feasibility as well as a range of patient-reported outcomes including health-related quality of life as measured by the Functional Assessment of Cancer Therapy—Lymphoma, patient experience of care, symptom distress, comorbidity burden, dietary intake, physical activity behaviors, financial distress/interference, and satisfaction of care. Safety indicators including hospital admission and unscheduled lymphoma clinic visits as well as process outcomes such as intervention fidelity and economic indicators will be analyzed. Discussion This trial is designed to explore the feasibility and acceptability of a new model of shared care for lymphoma survivors. Patient-reported outcomes as well as potential barriers to implementation will be analyzed to inform a larger definitive clinical trial testing the effects and implementation of a shared care model on health-related quality of life of lymphoma survivors. Trial registration Australia and New Zealand Clinical Trials Registry ACTRN12620000594921. Registered on 22 May 2020.

scholarly journals Partnering with General Practitioners to Optimize Survivorship for Patients with Lymphoma: A phase II Randomized Controlled Trial (The GOSPEL 1 Trial)

2020 ◽  
Author(s):  
Raymond Chan ◽  
Stephanie Buhagiar ◽  
Laisa Teleni ◽  
Camilla Simonsen ◽  
Jane Turner ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Shared Care ◽  
Cancer Center ◽  
Patient Reported ◽  
Follow Up Care ◽  
Shared Care Model ◽  
Related Quality ◽  
Health Related

Abstract Background: Survival rates for lymphoma are highest amongst hematological malignancies. In 2019, it was estimated that over 6,400 Australians were diagnosed with lymphoma, a group of hematological malignancies with a high 5-year survival rate of ~76%. There is an increased focus on the promotion of wellness in survivorship and active approaches to reducing morbidity related to treatment; however, current models of follow-up care heavily rely on hospital-based specialist-led care.Maximizing the potential of general practitioners (GPs) in the ongoing management of cancer is consistent with the national health reform principles, and the Cancer Council Australia’s Optimal Care Pathways. GPs are well positioned to provide guideline-based follow-up care and are more likely to address comorbidities, psychosocial issues and promote healthy lifestyle behaviors. This study aims to test the feasibility of the GOSPEL 1 intervention for implementing an integrated, shared-care model in which cancer center specialists and community-based GPs collaborate to provide survivorship care for patients with lymphoma.Methods: We describe a protocol for a phase II, randomized controlled trial with two parallel arms and a 1:1 allocation. Sixty patients with Hodgkin’s and Non-Hodgkin’s lymphoma will be randomized to usual specialist-led follow-up care (as determined by the treating hematologists) or a shared follow-up care intervention (i.e., GOSPEL 1). GOSPEL 1 is a nurse-enabled, pre-specified shared-care pathway with follow-up responsibilities shared between cancer center specialists (i.e., hematologists and specialist cancer nurses) and GPs. Outcome measures assess feasibility as well as a range of patient reported outcomes including health-related quality of life as measured by the Functional Assessment of Cancer Therapy – Lymphoma, patient experience of care, symptom distress, comorbidity burden, dietary intake, physical activity behaviors, financial distress/interference and satisfaction of care. Safety indicators including hospital admission and unscheduled lymphoma clinic visits as well as process outcomes such as intervention fidelity and economic indicators will be analyzed.Discussion: This trial is designed to explore the feasibility and acceptability of a new model of shared-care for lymphoma survivors. Patient reported outcomes as well as potential barriers to implementation will be also analyzed to inform a larger definitive clinical trial testing the effects of a shared-care model on health-related quality of life of lymphoma survivors.Trial registration: Australia and New Zealand Clinical Trials Registry, Registration number: ACTRN12620000594921, Date registered: 22/05/2020, registration link: https://www.anzctr.org.au/ACTRN12620000594921.aspx

scholarly journals Implementing a Nurse-Enabled, Integrated, Shared-Care Model Involving Specialists and General Practitioners in Breast Cancer Post-Treatment Follow-Up: A Study Protocol for a Phase II Randomised Controlled Trial (The EMINENT Trial)

2020 ◽  
Author(s):  
Raymond Chan ◽  
Jon Emery ◽  
Katharine Cuff ◽  
Laisa Teleni ◽  
Camilla Simonsen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
General Practitioners ◽  
Controlled Trial ◽  
Shared Care ◽  
Trial Registration ◽  
Cancer Center ◽  
Care Model ◽  
Follow Up Care ◽  
Shared Care Model

Abstract Background: Due to advances in early detection and cancer treatment, 5-year relative survival rates for early breast cancer surpass 90% in developed nations. There is increasing focus on promotion of wellness in survivorship and active approaches to reducing morbidity related to treatment; however, current models of follow-up care are heavily reliant on hospital-based specialist-led care. This study aims to test the feasibility of the EMINENT intervention for implementing an integrated, shared-care model involving both cancer center specialists and community-based general practitioners for early breast cancer post-treatment follow-up.Methods: We describe a protocol for a phase II, randomized controlled trial with two parallel arms and 1:1 allocation. A total of 60 patients with early stage breast cancer will be randomized to usual, specialist-led, follow-up care (as determined by the treating surgeons, medical oncologists, and radiation oncologists) or shared follow-up care intervention (i.e., EMINENT). EMINENT is a nurse-enabled, pre-specified shared-care pathway with follow-up responsibilities divided between cancer center specialists (i.e., surgeons and oncologists) and general practitioners. Primary outcome is health-related quality of life as measured by the Functional Assessment of Cancer Therapy-Breast Cancer. Secondary outcomes include patient experience, acceptance, and satisfaction of care; dietary, physical activity and sedentary behaviors; financial toxicity; adherence; health resource utilization; and adverse events.Discussion: The trial is designed to identify the barriers to implementing a shared-care model for breast cancer survivors following treatment. Results of this study will inform a definitive trial testing the effects of shared-care model on health-related quality of life of breast cancer survivors, as well as its ability to alleviate the growing demands on the healthcare system.Trial registration: Trial registration: Australia and New Zealand Clinical Trials Registry, ACTRN12619001594112). Registered 19 November 2019, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378690&isReview=true.

Effectiveness of a Guided Internet- and Mobile-Based Intervention for Patients with Chronic Back Pain and Depression (WARD-BP): A Multicenter, Pragmatic Randomized Controlled Trial

2020 ◽  
pp. 1-14
Author(s):  
Harald Baumeister ◽  
Sarah Paganini ◽  
Lasse Bosse Sander ◽  
Jiaxi Lin ◽  
Sandra Schlicker ◽  
...  
Keyword(s):  
Care Setting ◽  
Chronic Back Pain ◽  
Controlled Trial ◽  
Work Capacity ◽  
Routine Care ◽  
Randomized Controlled ◽  
Related Quality ◽  
Health Related

<b><i>Introduction:</i></b> There is neither strong evidence on effective treatments for patients with chronic back pain (CBP) and depressive disorder nor sufficiently available mental health care offers. <b><i>Objective:</i></b> The aim is to assess the effectiveness of internet- and mobile-based interventions (IMI) as a scalable approach for treating depression in a routine care setting. <b><i>Methods:</i></b> This is an observer-masked, multicenter, pragmatic randomized controlled trial with a randomization ratio of 1:1.<b><i></i></b>Patients with CBP and diagnosed depressive disorder (mild to moderate severity) were recruited from 82 orthopedic rehabilitation clinics across Germany. The intervention group (IG) received a guided depression IMI tailored to CBP next to treatment-as-usual (TAU; including medication), while the control group (CG) received TAU. The primary outcome was observer-masked clinician-rated Hamilton depression severity (9-week follow-up). The secondary outcomes were: further depression outcomes, pain-related outcomes, health-related quality of life, and work capacity. Biostatistician blinded analyses using regression models were conducted by intention-to-treat and per protocol analysis. <b><i>Results:</i></b> Between October 2015 and July 2017, we randomly assigned 210 participants (IG, <i>n</i> = 105; CG, <i>n</i> = 105), mostly with only a mild pain intensity but substantial pain disability. No statistically significant difference in depression severity between IG and CG was observed at the 9-week follow-up (β = –0.19, 95% CI –0.43 to 0.05). Explorative secondary depression (4/9) and pain-related (4/6) outcomes were in part significant (<i>p</i> &#x3c; 0.05). Health-related quality of life was significantly higher in the IG. No differences were found in work capacity. <b><i>Conclusion:</i></b> The results indicate that an IMI for patients with CBP and depression in a routine care setting has limited impact on depression. Benefits in pain and health-related outcomes suggest that an IMI might still be a useful measure to improve routine care.

scholarly journals Patient-Physician Communication About Health-Related Quality-of-Life Problems: Are Non-Hodgkin Lymphoma Survivors Willing to Talk?

2013 ◽  
Vol 31 (31) ◽  
pp. 3964-3970 ◽  
Author(s):  
Neeraj K. Arora ◽  
Roxanne E. Jensen ◽  
Nadiyah Sulayman ◽  
Ann S. Hamilton ◽  
Arnold L. Potosky
Keyword(s):  
Quality Of Life ◽  
Sexual Functioning ◽  
Daily Functioning ◽  
Health Related Quality ◽  
Non Hodgkin Lymphoma ◽  
Follow Up Care ◽  
Related Quality ◽  
Health Related

Purpose To investigate non-Hodgkin lymphoma (NHL) survivors' willingness to discuss health-related quality-of-life (HRQOL) problems with their follow-up care physician. Patients and Methods Willingness to discuss HRQOL problems (physical, daily, emotional, social, and sexual functioning) was examined among 374 NHL survivors, 2 to 5 years postdiagnosis. Survivors were asked if they would bring up HRQOL problems with their physician and indicate reasons why not. Logistic regression models examined the association of patient sociodemographics, clinical characteristics, follow-up care variables, and current HRQOL scores with willingness to discuss HRQOL problems. Results Overall, 94%, 82%, 76%, 43%, and 49% of survivors would initiate discussions of physical, daily, emotional, social, and sexual functioning, respectively. Survivors who indicated their physician “always” spent enough time with them or rated their care as “excellent” were more willing to discuss HRQOL problems (P < .05). Survivors reporting poorer physical health were less willing to discuss their daily functioning problems (P < .001). Men were more willing to discuss sexual problems than women (P < .001). One in three survivors cited “nothing can be done” as a reason for not discussing daily functioning problems, and at least one in four cited “this was not their doctor's job” and a preference to “talk to another clinician” as reasons for not discussing emotional, social, and sexual functioning. Conclusion NHL survivors' willingness to raise HRQOL problems with their physician varied by HRQOL domain. For some domains, even when survivors were experiencing problems, they may not discuss them. To deliver cancer care for the whole patient, interventions that facilitate survivor-clinician communication about survivors' HRQOL are needed.

scholarly journals Phase III Comparison of Tamoxifen Versus Tamoxifen Plus Ovarian Function Suppression in Premenopausal Women With Node-Negative, Hormone Receptor–Positive Breast Cancer (E-3193, INT-0142): A Trial of the Eastern Cooperative Oncology Group

2014 ◽  
Vol 32 (35) ◽  
pp. 3948-3958 ◽  
Author(s):  
Amye J. Tevaarwerk ◽  
Molin Wang ◽  
Fengmin Zhao ◽  
John H. Fetting ◽  
David Cella ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Premenopausal Women ◽  
Menopausal Symptoms ◽  
Phase Iii ◽  
Health Related Quality ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related

Purpose The effects of ovarian function suppression (OFS) on survival and patient-reported outcomes were evaluated in a phase III trial in which premenopausal women were randomly assigned to tamoxifen with or without OFS. Patients and Methods Premenopausal women with axillary node-negative, hormone receptor–positive breast cancer tumors measuring ≤ 3 cm were randomly assigned to tamoxifen alone versus tamoxifen plus OFS; adjuvant chemotherapy was not permitted. Primary end points were disease-free survival (DFS) and overall survival (OS). Secondary end points included toxicity and patient-reported outcomes. Patient-reported outcome data included health-related quality of life, menopausal symptoms, and sexual function. These were evaluated at baseline, 6 months, 12 months, and then annually for up to 5 years after registration. Results In all, 345 premenopausal women were enrolled: 171 on tamoxifen alone and 174 on tamoxifen plus OFS. With a median follow-up of 9.9 years, there was no significant difference between arms for DFS (5-year rate: 87.9% v 89.7%; log-rank P = .62) or OS (5-year rate: 95.2% v 97.6%; log-rank P = .67). Grade 3 or higher toxicity was more common in the tamoxifen plus OFS arm (22.4% v 12.3%; P = .004). Patients treated with tamoxifen plus OFS had more menopausal symptoms, lower sexual activity, and inferior health-related quality of life at 3-year follow-up (P < .01 for all). Differences diminished with further follow-up. Conclusion When added to tamoxifen, OFS results in more menopausal symptoms and sexual dysfunction, which contributes to inferior self-reported health-related quality of life. Because of early closure, this study is underpowered for drawing conclusions about the impact on survival when adding OFS to tamoxifen.

scholarly journals The extent of endoscopic sinus surgery in patients with severe chronic rhinosinusitis with nasal polyps (AirGOs Operative)

2021 ◽  
Vol 4 (4) ◽  
pp. 154-160
Author(s):  
M.J. Lilja ◽  
P. Virkkula ◽  
S. Hammaren-Malmi ◽  
A. Laulajainen-Hongisto ◽  
L. Hafren ◽  
...  
Keyword(s):  
Nasal Polyps ◽  
Controlled Trial ◽  
Sinus Surgery ◽  
Health Related Quality ◽  
Randomized Controlled ◽  
Related Quality ◽  
Health Related ◽  
Snot 22

Background: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a chronic inflammatory disease of the nose and paranasal sinuses characterized by intense inflammation, decreased health-related quality of life (HRQoL), and in severe cases high frequency of co-morbidities and recurrence despite treatment. Conservative treatment consists of nasal lavage, intranasal corticosteroids, and courses of oral corticosteroids, and antibiotics in exacerbations. Endoscopic sinus surgery (ESS) and/or biological therapy is considered if appropriate conservative treatment is not sufficient. The optimal extent of ESS in recalcitrant CRSwNP is not known. The aim of this randomized controlled trial is to evaluate and compare the efficacy and safety of limited ESS with partial ethmoidectomy with extended ESS with total ethmoidectomy in patients with severe CRSwNP. Methods: AirGOs Operative is a randomized controlled trial. It is an investigator-driven multicenter trial led by Helsinki University Hospital. The two surgery arms are compared. The primary outcome is the change in the SNOT-22 score at the 12-month follow-up. Secondary outcomes include the change in the SNOT-22 score at 24-months follow-up, the changes in polyp score, Lund-Mackay (LM) CT score, health-related quality of life (HRQoL), loss of productivity, nasal patency (peak nasal inspiratory flow (PNIF) ± acoustic rhinometry (ARM), olfaction test (Sniffin’ Sticks, identification), lung function (spirometry and PEF) and findings in pathological analysis at 12/24-months follow-up. Discussion: AirGOs Operative trial will lead to a better understanding of the optimal extent of ethmoidectomy in the treatment of recalcitrant severe CRSwNP.

scholarly journals A randomised, controlled trial of the effects of a mobile telehealth intervention on clinical and patient-reported outcomes in people with poorly controlled diabetes

2016 ◽  
Vol 23 (2) ◽  
pp. 207-216 ◽  
Author(s):  
Justine S Baron ◽  
Shashivadan Hirani ◽  
Stanton P Newman
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Blood Pressure ◽  
Standard Care ◽  
Controlled Trial ◽  
Health Related Quality ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related

Objective The objective of this research is to determine the effects of mobile telehealth (MTH) on glycosylated haemoglobin (HbA1c) and other clinical and patient-reported outcomes in insulin-requiring people with diabetes. Methods A nine-month randomised, controlled trial compared standard care to standard care supplemented with MTH (self-monitoring, mobile-phone data transmissions, graphical and nurse-initiated feedback, and educational calls). Clinical (HbA1c, blood pressure, daily insulin dose, diabetes outpatient appointments (DOAs)) and questionnaire data (health-related quality of life, depression, anxiety) were collected. Mean group changes over time were compared using hierarchical linear models and Mann-Whitney tests. Results Eighty-one participants with a baseline HbA1c of 8.98% ± 1.82 were randomised to the intervention ( n = 45) and standard care ( n = 36). The Group by Time effect revealed MTH did not significantly influence HbA1c ( p = 0.228), but p values were borderline significant for blood pressure ( p = 0.054) and mental-health related quality of life ( p = 0.057). Examination of effect sizes and 95% confidence intervals for mean group differences at nine months supported the existence of a protective effect of MTH on mental health-related quality of life as well as depression. None of the other measured outcomes were found to be affected by the MTH intervention. Conclusions Findings from this study must be interpreted with caution given the small sample size, but they do not support the widespread adoption of MTH to achieve clinically significant changes in HbA1c. MTH may, however, have positive effects on blood pressure and protective effects on some aspects of mental health.

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