| Literature DB >> 35534081 |
Miek C Jong1,2, Eric Mulder2, Agnete E Kristoffersen3, Trine Stub3, Heléne Dahlqvist2, Eija Viitasara2, E Anne Lown4, Winnie Schats5, Mats Jong2.
Abstract
INTRODUCTION: The majority of childhood, adolescent and young adult (AYA) cancer survivors suffer from long-term and late effects such as fatigue, psychological distress or comorbid diseases. Effective health promotion strategies are needed to support the health of this vulnerable group. This protocol provides a methodological description of a study that aims to examine the feasibility and safety of performing a randomised clinical trial (RCT) on a wilderness programme that is developed to support the health of AYA cancer survivors. METHODS AND ANALYSIS: The pilot RCT study has a mixed-method design, including quantitative and qualitative evaluations. Participants are AYAs, aged 16-39 years, that have been diagnosed with cancer during childhood, adolescence or young adulthood. A total of 40 participants will be randomly assigned to a wilderness programme (n=20) or a holiday programme (n=20). Both arms include participation in an 8-day summer programme, followed by a 4-day programme 3 months later. Primary outcomes are feasibility and safety parameters such as time to recruitment, willingness to be randomised, programme adherence and adverse effects. Secondary outcomes include self-reported health such as self-esteem, quality of life, self-efficacy and lived experiences. Descriptive statistics will be used to analyse outcomes and explore indications of differences between the programmes. Interviews are analysed by directed content analysis and hermeneutic phenomenology. A convergent parallel mixed-method analysis design will be applied to integrate quantitative and qualitative data. Results of this feasibility study will inform the preparation for a larger RCT with AYA cancer survivors. ETHICS AND DISSEMINATION: The study protocol is approved by the Swedish Ethical Review Authority (reference: 2020-00239). This study will be performed between January 2021 and December 2023. Results will be published in international peer-reviewed journals, presented at conferences and disseminated to participants, cancer societies, healthcare professionals and outdoor instructors. TRIAL REGISTRATION NUMBER: NCT04761042. © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.Entities:
Keywords: adult oncology; mental health; paediatric oncology
Mesh:
Year: 2022 PMID: 35534081 PMCID: PMC9086645 DOI: 10.1136/bmjopen-2022-061502
Source DB: PubMed Journal: BMJ Open ISSN: 2044-6055 Impact factor: 3.006
Eligibility criteria
| Inclusion criteria | Exclusion criteria |
| Any sex | Active cancer treatment for which participation in the study can involve unwanted risks (as evaluated by the treating physician/oncologist) |
| Aged 16–39 | Medical condition that prevents safe travel to, or participation in the programme |
| Diagnosed with any type of cancer at some point in their life | Inadequate understanding of the Swedish language |
| Ability to walk 2 km without pausing (walking aids permitted) | Cannot be reached by telephone |
Content of the wilderness programme for adolescent and young adults
| Category | Activities |
| 1. Physical movement | Hiking, backpacking |
| 2. Challenge/risk activities | Sea-kayaking, rock climbing |
| 3. Experiential activities | Camping, outdoor skills, mapping/compass/orienting, trail cooking, safety skills training, equipment planning, foraging, ‘Allemansrätten’*, leave no trace |
| 4. (Nature) reflective practice | Mindfulness, meditation, forest bathing, journaling |
| 5. Free time/leisure activities | Singing, swim/bath, fishing, campfire, reading, taking pictures, phone, playing games |
*The Swedish Right of Public Access allows people the right to walk, cycle, ride, ski and camp on any land with the exception of private gardens, near a dwelling house or land under cultivation.
Data collection in the study
| Measurement | Intake | Randomisation | 8-day programme | 3 months at home | 4-day programme | 1 year | ||
| Contact | Contact | Day 1 | Day 8 | Contact | Contact | |||
| P-pref | X | |||||||
| P-exp | X | X | X | |||||
| P-willingness | X | |||||||
| DD/MH/MU | X | |||||||
| M/T/D/LM | X | X | X | X | X | X | X | |
| P-adherence | X | X | X | X | X | |||
| MMQL | X | X | X | X | ||||
| GSE | X | X | X | X | ||||
| RSES | X | X | X | X | ||||
| NRS | X | X | X | X | ||||
| IPAQ | X | X | X | X | ||||
| Step counter | X | X | X | X | ||||
| 6MWT | X | X | ||||||
| VO2max | X | X | ||||||
| BP/HR | X | X | ||||||
| AE | X | X | X | X | ||||
| Interviews | X | |||||||
AE, adverse effects; BP/HR, blood pressure/heart rate; DD, demographic data; GSE, Generalised Self-Efficacy Scale; IPAQ, International Physical Activity Questionnaire; MH, medical history; MMQL, Minneapolis Manchester Quality of Life instrument; M/T/D/LM, Other Medication/Therapies/Dietary or Lifestyle measures; MU, medication use; 6MWT, 6-minute walking test; NRS, Nature Relatedness Scale; P-adherence, participants’ adherence; P-exp, participants’ expectations; P-pref, participants’ preference; P-willingness, participants’ willingness to be randomised; RSES, Rosenberg Self-Esteem Scale; VO2max, maximal oxygen consumption.