A Randomized Controlled Pilot Study Assessing Feasibility and Impact of a Wilderness Program on Mental and Physical Health of Adolescent and Young Adult Cancer Survivors
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility - Time to recruitment
研究概览
简要总结
Young cancer survivors are at higher risk of cancer reoccurrence, frailty, suicidal ideation, sedentary behaviour, reduced quality of life, and reduced overall life expectancy, compared to their siblings or healthy young persons. Development of new interventions after cancer treatment is urgently needed in order to reduce and diminish these unwanted risks in young cancer survivors. Previous studies have reported that wilderness therapy may reduce anxiety/depression, improve body image and self-efficacy, and increase physical activity in young adult cancer survivors.
High quality randomized controlled studies are lacking and thereby urgently needed to investigate the impact of wilderness programs on mental and physical health of adolescent and young adult cancer survivors. The primary aim of this study is to conduct a pilot randomized controlled trial (RCT) on a wilderness program versus an attention-control activity in adolescent and young adult cancer survivors. We will examine the feasibility of performing a RCT and examine health outcomes, in preparation for a larger RCT with adolescent and young adult cancer survivors.
A total of 40 adolescent and young adult cancer survivors (aged 16-39) will be randomized to a wilderness intervention or an attention-control group. The wilderness intervention is a one-week outdoor program where participants have individualized and group activities such as climbing, hiking, kayaking, bush crafting and mindfulness. After this week, participants continue a 3-month program to incorporate elements of the intervention into their daily life. The control group will join a relaxing one-week holiday at a Wellness Center and will be followed for 3 months to control for attention. Study outcomes will be recruitment speed, willingness to be randomized, study adherence, self-reported mental health using validated scales, and tests of physical activity and health (six-minute walk test, submaximal oxygen uptake, blood pressure, sedentary behaviour and physical activity). Outcomes are measured at the start of the study, 1 week and 3 months after intervention. One year follow up of self-reported outcomes will be online. Findings of the study will provide important insights into the feasibility of a large study as well as on ways by which wilderness therapy can promote health in young cancer survivors.
详细描述
Aim of the study The objective of the present study is to conduct a pilot randomized controlled trial (RCT) on a wilderness program versus an attention-control activity in adolescent and young adult cancer survivors. We will examine the feasibility of performing a RCT, in preparation for a larger RCT with adolescent and young adult cancer survivors, as well as to investigate individuals' experience and safety of the wilderness program. To the best of our knowledge, we are preparing the first RCT that will be undertaken to investigate the impact of a wilderness program in adolescent and young adult cancer survivors.
It is hypothesized that the wilderness program is a highly appreciated and safe health promotion intervention that may substantially benefit adolescent and young adult cancer survivors, and that results of the proposed pilot study warrant further research with adequate power to test for effectiveness in a larger RCT.
RCT - Intake (Contact 1)
Young cancer survivors who are interested in participating will contact the researchers of this study at Mid Sweden University via email or phone. The researchers will provide information about the study, both verbally and written in an information letter to be sent by post or email. The following tasks will be carried out at the intake interview:
- Screening of inclusion and exclusion criteria,
- Explanation/information about the study and informed consent procedures,
- Explanation/information about the interventions and the randomisation procedure,
- Check participants' willingness to be randomized, ask if they have a strong preference for either intervention, and ask about their expectations of the interventions,
- Sending the information letter and informed consent forms, including a postage-paid return envelope.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
After being screened for recruitment by the primary investigator, participant are randomized into the two group. Randomization is made by a second team member that up till then had no contact with participants or knows their names (based on screening numbers).
After being notified of groups assignment the primary investigator again contacts participants to enter the into the study and give information on group assignment.
Outcome data will be entered confidential, and the outcomes assessor will be blinded regarding group assignment and identification of participants.
入排标准
- 年龄范围
- 16 Years 至 39 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants of:
- •aged 16-39,
- •diagnosed with any type of cancer during their course of living
- •can be reached by telephone,
- •have good understanding of the Swedish language.
- •ability to walk 2 km without pausing (walking aids permitted).
- •Participants with various medical conditions, including mobility impairments, amputees, vision impairments and special treatment or diet needs will be included. No prior experience with any outdoor activity is required.
排除标准
- •active cancer treatment for which participation in the study can involve unwanted risks (as evaluated by their treating physician/oncologist),
- •other medical conditions that prevent safe travel to, or participation in the program
结局指标
主要结局
Feasibility - Time to recruitment
时间窗: Until predetermined number of participants are reached or max up till 18 months
A planned n of 40 is planned and documentation of time to reach the goal will be made until predetermined number of participants are reached or max up till 18 months
Feasibility - Participant Adherence to Protocol
时间窗: through study completion, an average of 1 1/2 year
Adherence of the participants to the study protocol. A textual description of participant adherence based on observation and interviews documented in the participants study protocol
Feasibility - Participant willingness to be randomized
时间窗: At prestudy screening - prior to inclusion
Willingness of participants to be randomized (Yes/No)
Feasibility - Logistics and Burden
时间窗: Through study completion, an average of 1 1/2 year
Logistics and Burden (for participants) to perform physical performance/fitness tests. A textual description of participant Log-BurdenPhysbased on observation and interviews documented in the participants study protocol
Feasibility - Logistics and willingness to complete all planned study-related questionnaires
时间窗: Through study completion, an average of 1 1/2 year
Logistics and willingness to complete all planned study-related questionnaires. A textual description of participant Log-WillQuest based on observation and interviews documented in the participants study protocol
Feasibility - Adherence to three month at home program
时间窗: up to three months
The adherence of the participants to the three months at home program and transference of activities in this period. A textual description of participant adherence based on observation and interviews documented in the participants study protocol
Feasibility - Participant Preferences
时间窗: At prestudy screening - prior to inclusion
Participant Preferences (P-Pref) regarding intervention arms (no pref, slight pref, strong preference)
Feasibility - Participant expectations
时间窗: At prestudy screening - prior to inclusion
A textual description of what participants would expect to experience from participation in either intervention group.
Feasibility - Occurrence of adverse events
时间窗: up to three months
Occurrence of adverse events during program execution. A textual description of occurence of AdvEvents based on observation and interviews documented in the participants study protocol. Adverse events will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) and analysed using preferred terms and allocation to system organ class. Safety of the interventions will be measured by analyzing number and type of adverse events reported.
次要结局
- International Physical Activity Questionnaire(Baseline, 2 weeks post intervention, 3-month, and 12 month follow up)
- Physical performance - Six Minute Walking Test(Baseline, 3-month)
- Physical performance -Oxygen uptake(Baseline, 3-month)
- Generalized Self-Efficacy Scale(Baseline, 2 weeks post intervention, 3-month, and 12 month follow up)
- Nature Relatedness Scale(Baseline, 2 weeks post intervention, 3-month, and 12 month follow up)
- Physical performance - Level of Physical activity(Baseline, 2 weeks post intervention, 3-month, and 12 month follow up)
- Minneapolis Manchester Quality of Life - MMQL(Baseline, 2 weeks post intervention, 3-month, and 12 month follow up)
- Blood Pressure(Baseline, 3-month)
- Rosenberg Self-Esteem Scale RSES(Baseline, 2 weeks post intervention, 3-month, and 12 month follow up)
- Heart Rate(Baseline, 3-month)