scholarly journals A study protocol for a multicenter randomized pilot trial of a dyadic, tailored, web-based, psychosocial, and physical activity self-management program (TEMPO) for men with prostate cancer and their caregivers

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Sylvie D. Lambert ◽  
Lindsay R. Duncan ◽  
Janet Ellis ◽  
John Wellesley Robinson ◽  
Carly Sears ◽  
...  

Abstract Background Prostate cancer predisposes patients and caregivers to a wide range of complex physical and psychosocial challenges, and interventions must incorporate a wide range of self-management strategies to help patients and their caregivers effectively cope with cancer challenges. To palliate this need, our team recently developed and evaluated the initial acceptability of a dyadic, Tailored, wEb-based, psychosocial, and physical activity self-Management PrOgram (TEMPO). TEMPO is a 10-week, interactive, web-based intervention consisting of five modules designed to help dyads manage their physical and psychosocial needs. It aims to teach dyads new self-management strategies and encourages them to increase their physical activity (PA) levels, mainly through walking and strength-based exercises. Initial acceptability evaluation of TEMPO revealed high user satisfaction, in addition to having a number of potential benefits for participants. After integrating suggested changes to TEMPO, the proposed pilot study aims to further test the acceptability and feasibility of TEMPO. Methods This study is a multicenter, stratified, parallel, two-group, pilot randomized control trial (RCT), where patient–caregiver dyads are randomized (stratified by anxiety level) to receive (a) TEMPO or (b) usual care. Participants (n goal = 40) are recruited across Canada at participating cancer centers and through self-referral (e.g., online recruitment). Patient inclusion criteria are (a) having received prostate cancer treatment within the past 2 years or scheduled to receive treatment, (b) identified a primary caregiver willing to participate in the study, and (c) has access to the Internet. Eligible caregivers are those identified by the patient as his primary source of support. Dyads complete a baseline questionnaire (T1) and another one 3 months later (T2) assessing various aspects of physical and emotional functioning (e.g., the Medical Outcomes Study (MOS) 12-item Short Form Health Survey (SF-12), the Hospital Anxiety and Depression Scale (HADS), and the Perceived Stress Scale (PSS)), self-management behaviors (e.g., the Health Education Impact Questionnaire (heiQ)), physical activity (the International Physical Activity Questionnaires (IPAQ) and the Multidimensional Self-efficacy for Exercise Scale (MSES)), and dyadic coping (the Dyadic Coping Inventory (DCI)). Dyads that used TEMPO are also asked to participate in a semi-structured exit interview exploring their overall experience with the program. Discussion This feasibility analysis will begin to develop the knowledge base on TEMPO’s value for men with prostate cancer and their caregivers to inform a larger trial. Trial registration NCT04304196

2020 ◽  
Vol 9 (10) ◽  
pp. 3244
Author(s):  
Laura Hallward ◽  
Keryn Chemtob ◽  
Sylvie D. Lambert ◽  
Lindsay R. Duncan

Both men with prostate cancer and their caregivers report experiencing a number of challenges and health consequences, and require programs to help support the cancer patient–caregiver dyad. A tailored, web-based, psychosocial and physical activity self-management program (TEMPO), which implements behavior change techniques to help facilitate behavior change for the dyads was created and its acceptability was tested in a qualitative study. The purpose of this secondary analysis was to explore the dyads’ experiences using behavior change techniques to change behavior and address current needs and challenges while enrolled in TEMPO. Multiple semi-structured interviews were conducted with 19 prostate cancer-caregiver dyads over the course of the program, resulting in 46 transcripts that were analyzed using an inductive thematic analysis. Results revealed four main themes: (1) learning new behavior change techniques, (2) engaging with behavior change techniques learned in the past, (3) resisting full engagement with behavior change techniques, and (4) experiencing positive outcomes from using behavior change techniques. The dyads’ discussions of encountering behavior change techniques provided unique insight into the process of learning and implementing behavior change techniques through a web-based self-management program, and the positive outcomes that resulted from behavior changes.


2020 ◽  
Vol 9 (10) ◽  
pp. 3284
Author(s):  
Sylvie D. Lambert ◽  
Lindsay Rosamond Duncan ◽  
Janet Ellis ◽  
Jamie Lynn Schaffler ◽  
Ekaterina Loban ◽  
...  

Caregivers of men with prostate cancer report high burden, and there is a need to develop cost-effective programs to support them in their roles. This study reports on the acceptability of a dyadic, Tailored, wEb-based, psychosocial and physical activity (PA) self-Management PrOgram called TEMPO. TEMPO was accessed by a convenience sample of 19 men with prostate cancer and their caregivers (n = 18), as well as six health care professionals (HCPs). User feedback was gathered via semi-structured qualitative interviews. Data were analyzed using thematic analysis. Most dyads were satisfied with TEMPO, particularly with the dyadic feature of TEMPO, the focus on goal setting to integrate self-management, and the extensive health library. The patients and caregivers motivated each other as they worked through TEMPO. Most goals to achieve during TEMPO pertained to increasing PA, followed by learning physical symptom management. One unanticipated benefit of TEMPO for the dyads was improved communication. HCPs agreed that TEMPO was a novel approach to online cancer self-management and they echoed the benefits reported by dyads. Key suggestions for improving TEMPO were to reduce repetition, tailor content, add more exercise ideas, and have more printing options. This study provides a strong foundation on which to plan a larger trial.


2000 ◽  
Vol 31 (2) ◽  
pp. 365-379 ◽  
Author(s):  
Brian E. Saelens ◽  
Christine A. Gehrman ◽  
James F. Sallis ◽  
Karen J. Calfas ◽  
Julie A. Sarkin ◽  
...  

Author(s):  
Farzan Kamdin ◽  
Kruti Khemani ◽  
Annamma Varghese

Background: Coronavirus (COVID-19) has spread rapidly throughout the world leading to an emergency global pandemic. Among the varied affected sections of the population and healthcare, physiotherapy is no exception. To what extent, both the physical activity and anxiety levels have been affected amongst the physiotherapy practitioners, teaching faculty and students is not completely known. Hence, this study was undertaken.Methods: Among a potential 400 participants, 357 responded (response rate=89.25%). Cross-sectional web based open e-survey was sent using google forms via emails and social media platforms such as Whatsapp, facebook, instagram and linkedin messenger. The primary outcome measures were international physical activity questionnaire-short form (IPAQ-SF) for self-reported physical activity and general anxiety disorder (GAD-7) questionnaire for measuring self-reported anxiety.Results: Out of the 357 participants, 40 were inactive (<600 METs/week), 175 were minimally active (600-3000 METs/week) and 142 were health enhancing physically active (>3000 METs/week). The GAD-7 score showed a significant proportion of participants (74%) to have mild to moderate anxiety and only 26% had moderately severe to severe anxiety. Physiotherapy students were found to do least amount of physical activity in a week (mean METs/week of 2590) and were also more anxious with an average GAD-7 score of 7.7. Practicing physiotherapists and teachers had better scores of 3285 and 3028 METs/week and also better mean GAD-7 scores at 6.4 and 5.3, respectively.Conclusions: The lockdown caused by the COVID-19 pandemic has affected the physical activity levels and mental wellbeing of physiotherapy students more than the physiotherapy practitioners and teaching faculty.


2022 ◽  
Author(s):  
Erin E Michalak ◽  
Steven J Barnes ◽  
Emma Morton ◽  
Heather O'Brien ◽  
Greg Murray ◽  
...  

BACKGROUND Quality of life (QoL) is increasingly recognised as a key outcome of self-management interventions for bipolar disorder (BD). Mobile phone applications (apps) can increase access to evidence-based self-management strategies and provide real-time support. However, while individuals with lived experience desire support with monitoring and improving broader health domains, existing BD apps largely target mood symptoms only. Further, evidence from the broader mHealth literature has shown that the desires and goals of end-users are not adequately taken into account during app development, and as a result engagement with mental health apps is suboptimal. To capitalise on the potential of apps to optimise wellness in BD, there is a need for interventions developed in consultation with real-world users that are designed to support QoL self-monitoring and self-management. Objective: This mixed methods pilot study is designed to evaluate the beta version of the newly developed PolarUs app, which aims to support QoL self-monitoring and self-management in people with BD. Developed using a community-based participatory research framework, the PolarUs app builds on the web-based adaptation of a BD-specific QoL self-assessment measure, and integrates material from a web-based portal providing information on evidence-informed self-management strategies in BD. OBJECTIVE The primary objectives of this project are to: (1) evaluate PolarUs app feasibility (via behavioral usage metrics); (2) evaluate PolarUs impact (via the Brief Quality of Life in Bipolar Disorders, QoL.BD scale, our primary outcomes measure); and (3) explore engagement with the PolarUs app (via both quantitative and qualitative methods). METHODS Study participants will be North American residents (N=150) aged 18-65 years with a DSM-5 diagnosis of BD-I, BD-II or BD not otherwise specified (NOS) as assessed by a structured diagnostic interview. An embedded mixed-methods research design will be adopted; qualitative interviews with a purposefully selected sub-sample (~n=30) of participants will be conducted to explore in more depth feasibility, impact and engagement with the PolarUs app over the 12-week study period. RESULTS At the time of publication of this protocol, the development of the beta version of the PolarUs app is complete. Participant enrollment is expected to begin in February 2022. Data collection is expected to be completed by December 2022. CONCLUSIONS Beyond contributing knowledge on the feasibility and impacts of a novel app to support QoL and self-management in BD, this study is also expected to provide new knowledge on engagement with mHealth apps. Furthermore, it is expected to function as a case study of successful co-design between individuals living with BD, clinicians who specialise in the treatment of BD, and BD researchers, providing a template for future use of community-based participatory research frameworks in mHealth intervention development. Results will be used to further refine the PolarUs app and inform the design of a larger clinical trial.


2020 ◽  
Vol 91 (8) ◽  
pp. e16.1-e16
Author(s):  
Matthew Butler ◽  
Mathieu Seynaeve ◽  
Susannah Pick ◽  
James Rucker ◽  
Timothy Nicholson

AimsFunctional neurological disorder (FND) is common and often severe. It is poorly understood, and there have been no international large-scale studies of self- management and illness beliefs in FND. We created a patient questionnaire to assess FND demographics, symptom comorbidity, self-management strategies (particularly in relation to prohibited substances), views on novel treatments, and illness beliefs.MethodsThe questionnaire was shared open access over a three-week period.Participants were recruited internationally through social media and patient groups. RESULTS: In total, 1162 respondents from 16 countries took the survey. Of these, 98% reported a formal diagnosis of FND from a consultant neurologist or other suitably trained clinician. Females constituted 86% of respondents, with an average age of 41.7 years (SD=12.50). Mean symptom duration was 7.69 years (SD=9.37) and average time from diagnosis was 2.24 years (SD=3.35), indicating a diagnostic lag of over 5 years. Symptom comorbidity was very high, with respondents reporting current: seizures (50%), gait disturbance (76%), loss of balance (77%), tremors (61%), muscle jerks/spasms (65%), altered sensations (79%), speech difficulties (65%), memory problems (80%), fatigue (93%), and headache (70%). Current psychiatric comorbidities – depression (43%), anxiety (51%), panic (20%), and PTSD (22%) - were also common. Illness beliefs varied, with respondents agreeing most strongly that FND is a combination of physical and stress/trauma-related factors. Respondents rated FND as having a severe effect on their life, with little control felt over their symptoms. Respondents had received a wide range of medical interventions, and many had tried alternative treatments. Prohibited substances such as cannabis, ketamine, and psychedelics had been used by 15% of respondents, with the majority experiencing no or minimal physical (90%) and psychological (95%) sequelae. Many respondents reported that they would be willing to try medically supervised psychedelic therapy if it was found to be safe and effective.ConclusionsThis large international online survey of FND patients indicated a striking co-occurrence of multiple symptoms. As expected, respondents reported that FND severely impacted on their lives, and many had lived with symptoms, which are not well managed by current medical therapies, for years. There was interest in novel putative treatments, such as medically supervised psychedelic therapies, which indicates a strong need to investigate alternative treatments for this poorly served patient group.


2012 ◽  
Vol 52 (7) ◽  
pp. 667-670 ◽  
Author(s):  
Elizabeth Donovan ◽  
Stacey Mehringer ◽  
Lonnie K. Zeltzer

2009 ◽  
Vol 35 (3) ◽  
pp. 439-454 ◽  
Author(s):  
Carmen D. Samuel-Hodge ◽  
Thomas C. Keyserling ◽  
Sola Park ◽  
Larry F. Johnston ◽  
Ziya Gizlice ◽  
...  

Purpose This study developed and tested a culturally appropriate, church-based intervention to improve diabetes self-management. Research Design and Methods This was a randomized trial conducted at 24 African American churches in central North Carolina. Churches were randomized to receive the special intervention (SI; 13 churches, 117 participants) or the minimal intervention (MI; 11 churches, 84 participants). The SI included an 8-month intensive phase, consisting of 1 individual counseling visit, 12 group sessions, monthly phone contacts, and 3 encouragement postcards, followed by a 4-month reinforcement phase including monthly phone contacts. The MI received standard educational pamphlets by mail. Outcomes were assessed at 8 and 12 months; the primary outcome was comparison of 8-month A1C levels. Results At baseline, the mean age was 59 years, A1C 7.8%, and body mass index 35.0 kg/m2; 64% of participants were female. For the 174 (87%) participants returning for 8-month measures, mean A1C (adjusted for baseline and group randomization) was 7.4% for SI and 7.8% for MI, with a difference of 0.4% (95% confidence interval [CI], 0.1-0.6, P = .009). In a larger model adjusting for additional variables, the difference was 0.5% (95% CI, 0.2-0.7, P < .001). At 12 months, the difference between groups was not significant. Diabetes knowledge and diabetes-related quality of life significantly improved in the SI group compared with the MI group. Among SI participants completing an acceptability questionnaire, intervention components and materials were rated as highly acceptable. Conclusions The church-based intervention was well received by participants and improved short-term metabolic control.


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