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BACKGROUND: The design and conduct of research to develop, test, and evaluate complex health care interventions is challenging. Although the existing literature describes key challenges associated with the design and conduct of definitive (evaluation) trials, there is a lack of information concerning specific challenges associated with the intervention development phase and setup of feasibility studies. In particular, the literature is scarce concerning the challenges associated with conducting digital health care research, such as research on internet-administered interventions and research using digital features to support the execution of study procedures (eg, recruitment, consent, retention, and data collection and management). This study is conducted in the context of the intervention development and feasibility study setup phases of an internet-administered, guided, low-intensity cognitive behavioral therapy-based intervention for parents of children previously treated for cancer. OBJECTIVE: The aim of this study is to explore the challenges experienced during the development phase of the internet-administered intervention and digital features to support the execution of the study procedures and a feasibility study setup. METHODS: To explore the key challenges experienced, we conducted a document analysis of written records from all study meetings held by the research team (meeting minutes) between June 7, 2018, and January 10, 2020, guided by a thematic analysis approach. Furthermore, discussion groups with members of the research team were held to develop a more detailed understanding of the key challenges experienced. Methods and results are reported in accordance with the relevant items from the Standards for Reporting Qualitative Research checklist. RESULTS: Six main themes were identified: decision-making and communication, expertise, external constraints, flexibility, planning and scheduling, and technical constraints. CONCLUSIONS: Significant challenges were experienced during the intervention development and setup phases of the feasibility study. Implications are discussed to inform future design, conduct, and planning of internet-administered intervention development and feasibility studies, especially within the context of digital health care research.
ABSTRACT
INTRODUCTION: A subgroup of adolescent and young adult childhood cancer survivors (AYACCS) are at increased risk of psychological distress. Despite this, AYACCS experience difficulties accessing psychological support. E-mental health (e-MH) may offer a solution to reduce this treatment gap. However, research examining e-MH for AYACCS has experienced difficulties with recruitment, retention and adherence. Such difficulties may relate to: (1) help-seeking behaviour and/or (2) e-MH acceptability. The overall study aims are to: (1) examine potential associations between health service use factors, informed by Andersen's behavioural model of health services use, and help-seeking behaviour; (2) examine attitudes towards e-MH interventions; and (3) explore perceived need for mental health support; past experience of receiving mental health support; preferences for support; and barriers and facilitators to help-seeking. METHODS AND ANALYSIS: An online and paper-based cross-sectional self-report survey (98 items) and embedded qualitative interview study across Sweden, with a target sample size of n=365. Participants are aged 16-39 years, diagnosed with cancer when 0-18 years and have completed successful cancer treatment. The survey examines sociodemographic and clinical characteristics, actual help-seeking behaviour, attitudes towards e-MH, stigma of mental illness, mental health literacy, social support and current symptoms of depression, anxiety, and stress. Survey respondents with past and/or current experience of mental health difficulties are invited into the qualitative interview study to explore: (1) perceived need for mental health support; (2) past experience of receiving mental health support; (3) preferences for support; and (4) barriers and facilitators to help-seeking. Potential associations between health service use factors and help-seeking behaviour are examined using univariable and multivariable logistic regressions. Qualitative interviews are analysed using content analysis. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Swedish Ethical Review Authority (Dnr: 2020-06271). Results will be disseminated in scientific publications and academic conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN70570236.
Subject(s)
Help-Seeking Behavior , Mental Disorders , Neoplasms , Adolescent , Cross-Sectional Studies , Humans , Internet , Neoplasms/therapy , Patient Acceptance of Health Care , Surveys and Questionnaires , Sweden , Young AdultABSTRACT
This study investigated whether commercially available compression garments (COMP) exerting a moderate level of pressure and/or neuromuscular electrical stimulation (NMES) accelerate recovery following a cross-country sprint skiing competition compared with a control group (CON) consisting of active recovery only. Twenty-one senior (12 males, 9 females) and 11 junior (6 males, 5 females) Swedish national team skiers performed an outdoor sprint skiing competition involving four sprints lasting â¼3-4 min. Before the competition, skiers were matched by sex and skiing level (senior versus junior) and randomly assigned to COMP (n = 11), NMES (n = 11) or CON (n = 10). Creatine kinase (CK), urea, countermovement jump (CMJ) height, and perceived muscle pain were measured before and 8, 20, 44 and 68â h after competition. Neither COMP nor NMES promoted the recovery of blood biomarkers, CMJ or perceived pain post-competition compared with CON (all P > .05). When grouping all 32 participants, urea and perceived muscle pain increased from baseline, peaking at 8â h (standardised mean difference (SMD), [95% confidence intervals (CIs)]): 2.8 [2.3, 3.2]) and 44â h (odds ratio [95% CI]: 3.3 [2.1, 5.1]) post-competition, respectively. Additionally, CMJ was lower than baseline 44 and 68â h post-competition in both males and females (P < .05). CK increased from baseline in males, peaking at 44â h (SMD: 1.4 [-0.4, 0.9]), but was decreased in females at 20â h post-competition (SMD: -0.8 [-1.4, -0.2]). In conclusion, cross-country sprint skiing induced symptoms of exercise-induced muscle damage peaking 8-44â h post-competition. However, neither COMP nor NMES promoted physiological or perceptual recovery compared with CON.