A randomized controlled pilot study assessing feasibility and safety of a wilderness program for childhood, adolescent, and young adult cancer survivors: the WAYA study

Abstract

Background The majority of childhood, Adolescent and Young Adult (AYA) cancer survivors suffers from long-lasting health issues following cancer treatment. It is therefore critical to explore effective health promotion strategies to address their needs. Exposure to nature is a promising approach to support the needs of young cancer survivors. This study investigated whether it is feasible to conduct a randomized controlled trial (RCT) of a wilderness program for childhood and AYA cancer survivors. Methods Eligible participants were aged 16–39 years, had a cancer diagnosis, and met minimal criteria. Seventy-one individuals expressed interest and 59 were randomized to either a wilderness or a holiday program. The wilderness program involved an 8-day expedition including backpacking, sea kayaking, gorge climbing, camping, bush-craft skills, and mindfulness-practices. It was followed by a 4-day basecamp after 3 months. The comparison was an 8-day holiday program at a Spa-hotel followed by a 4-day holiday program at the same hotel after 3 months. Primary outcome was study feasibility and safety. Results Ultimately, 19 AYAs participated in the wilderness and 23 in the holiday program. All completed the study at one-year follow-up. Participants were mostly female (70%) and represented diverse cancers. Clinical characteristics were similar between study arms excepting greater age at cancer diagnosis in the wilderness program (age 19.1 vs. 12.5; p = 0.024). Program adherence and data completeness was high (> 90%) in both arms. Adverse Effects (AEs) in the wilderness vs. the holiday program were similar (Relative Risk: 1.0, 95% Confidence Interval 0.8–1.3). The most frequent AE was tiredness, all were mild to moderate in severity, and serious AEs were not reported. Nature connectedness significantly increased over time in the wilderness program participants, but not in the holiday program (p < 0.001). No differences were found between the two study arms regarding quality of life, self-esteem, or self-efficacy. Conclusion It is feasible to conduct a RCT and a supervised wilderness adventure is equally safe for childhood and AYA cancer survivors as a holiday program. This pilot study lays the foundation for a larger RCT to investigate the effectiveness of wilderness programs on the health of young cancer survivors. Trial registration date and number 18/02/2021, NCT04761042 (clinicaltrials.gov).

Protocol of a randomised controlled multicentre trial investigating the effectiveness and safety of a wilderness programme on the mental and physical well-being of adolescents and young adults affected by cancer: the WAYA-2 study

“… 26 The aims of the WAYA programme and underlying process to support self-realisation via nature connectedness are hypothesised to contribute to a chain of actions that impacts the six domains of Positive Health. 25 The WAYA programme is a complex intervention and may potentially impact multiple factors. Therefore, in line with guidance and instructions for RCTs on complex interventions, more than one primary outcome is chosen in relation to the research questions.…”

“… 33 The NRS is a 21-item scale that measures the ‘affective, cognitive and physical relationship individuals’ have with the natural world. For the purpose of the previous pilot study, 25 the NRS was translated and validated in the Swedish language (results not published).…”

“…A significant increase in NRS has previously been demonstrated in childhood and AYA cancer survivors after participation in the WAYA programme compared with the hotel stay. 25 …”

“… 24 We demonstrated that it was feasible and safe to conduct a pilot RCT. 25 None of the 42 AYAs that participated in the interventions dropped out of the study, and adherence to programme interventions and data completeness after 1-year follow-up was high. The WAYA programme was found to be just as safe for AYAs affected by cancer as a hotel stay.…”

“…The relative frequency of reported adverse effects (AE) was similar in both study arms (relative risk (RR) 1.0, 95% CI 0.8 to 1.3), and all AEs were non-serious, mild or moderate of severity, and resolved during the study period. 25 Furthermore, the WAYA programme appeared to be acceptable, developmentally appropriate and of interest to AYA affected by cancer. 24 25 Based on these observations, we recommended for a future larger RCT to (1) apply additional recruitment strategies for participants, (2) to stratify for the inclusion of cancer survivorship (childhood cancer vs AYA cancer), (3) to optimise the content of the WAYA programme and (4) to select health-related outcomes based on the lived experiences of participants in the WAYA programme.…”