Cancer Clinical Trial
— WAYAOfficial title:
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
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 31, 2023 |
Est. primary completion date | October 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 39 Years |
Eligibility | Inclusion Criteria: Participants of: - any sex, - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Mid Sweden University, department of Health Sciences | Sundsvall |
Lead Sponsor | Collaborator |
---|---|
Mid Sweden University | See You At The Summit, Sörlandet Hospital, Norway, The Swedish Winter Sports Research Centre, UiT The Arctic University of Norway, University of California, San Francisco |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility - Participant Preferences | Participant Preferences (P-Pref) regarding intervention arms (no pref, slight pref, strong preference) | At prestudy screening - prior to inclusion | |
Primary | Feasibility - Participant expectations | A textual description of what participants would expect to experience from participation in either intervention group. | At prestudy screening - prior to inclusion | |
Primary | Feasibility - Participant willingness to be randomized | Willingness of participants to be randomized (Yes/No) | At prestudy screening - prior to inclusion | |
Primary | Feasibility - Time to recruitment | 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 | Until predetermined number of participants are reached or max up till 18 months | |
Primary | Feasibility - Participant Adherence to Protocol | 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 | through study completion, an average of 1 1/2 year | |
Primary | Feasibility - Logistics and Burden | 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 | Through study completion, an average of 1 1/2 year | |
Primary | Feasibility - Logistics and willingness to complete all planned study-related questionnaires | 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 | Through study completion, an average of 1 1/2 year | |
Primary | Feasibility - Adherence to three month at home program | 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 | up to three months | |
Primary | Feasibility - Occurrence of adverse events | 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. |
up to three months | |
Secondary | Minneapolis Manchester Quality of Life - MMQL | Minneapolis Manchester Quality of Life instrument - MMQL, at baseline prior to intervention, prior to 3 month follow up, and after one year. The MMQL-Adolescent form is a quality of life questionnaire specifically designed for young cancer survivors (age 13-20 years old) and consists of seven quality of life domains; physical, cognitive, psychological and social functioning, body image, intimate relations, and outlook on life. Scoring on the MMQL ranges from 1 to 5; 5 indicates maximal HRQL. An overall quality-of-life (QOL) score is also computed. Includes 45 items, total sum ranging between 45 and 225 The instruments has good psychometric characteristics and is translated and validated in the Swedish context. |
Baseline, 2 weeks post intervention, 3-month, and 12 month follow up | |
Secondary | International Physical Activity Questionnaire | International Physical Activity Questionnaire (IPAQ), at baseline prior to intervention, prior to 3 month follow up, and after one year. Subjective reporting of time spent on performing different levels of physical activity, reported in days, hours, and minutes. An instrument evaluated as having good psychometric properties, and also translated into Swedish language: |
Baseline, 2 weeks post intervention, 3-month, and 12 month follow up | |
Secondary | Generalized Self-Efficacy Scale | Generalized Self-Efficacy Scale (GSE), data collected at baseline prior to intervention, prior to 3 month follow up, and after one year. The GSE scale consists of 10 items rated on a four-point (1-4) Likert scale (''not at all true'' to ''exactly true''). Means are calculated as the sum of all answers divided by ten (the total number of items). An instrument evaluated as having good/acceptable psychometric properties, and also translated into Swedish language: |
Baseline, 2 weeks post intervention, 3-month, and 12 month follow up | |
Secondary | Rosenberg Self-Esteem Scale RSES | Rosenberg Self-Esteem Scale (RSES) at baseline prior to intervention, prior to 3 month follow up, and after one year The scale has four-graded (1-4) Likert-type responses where a rating of one represents the worst and four the best self-esteem. Minimal score10 maximum 40. An instrument evaluated as having good psychometric properties, and also translated into Swedish language. |
Baseline, 2 weeks post intervention, 3-month, and 12 month follow up | |
Secondary | Nature Relatedness Scale | Nature Relatedness Scale (NRS), at baseline prior to intervention, prior to 3 month follow up, and after one year The scale has 21 items that have five-graded (1-5) Likert-type responses where a rating of one represents the least agreement with item statement and five full agreement. An overall NRS score is calculated where means are calculated as the sum of all answers divided by 21 (the total number of items). The scale also has three subscale that can be extracted and calculated in the same way as the total sum. An instrument evaluated as having good psychometric properties in English. Previously not used in Swedish language but now translated and re-translated by the research group and the scale is presently undergoing psychometric testing. |
Baseline, 2 weeks post intervention, 3-month, and 12 month follow up | |
Secondary | Physical performance - Six Minute Walking Test | Six Minute Walking Test - Will be collected during the first day of the 8 day program, and the first day of three month follow up. A frequently used test where participant walks on a standardized path, trail, track for six minutes, and the outcome is expressed in number of meters walked. |
Baseline, 3-month | |
Secondary | Physical performance -Oxygen uptake | Oxygen uptake - The Ekholm-Bak submaximal test for oxygen (VO2max) uptake will be collected during the first day of the 8 day program, and the first day of three month follow up. Outcome- VO2max comprises and is expressed as: L/min, ml/kg/min, but is calculated by combining measures of Maximal heartrate (HRmax) - beats/min, and perceived exertion (Borg Scale 6-20, where a 6 represents a very light exertion and 20 an extremely (too hard) exertion. The Ekholm-Bak test is submaximal cycle ergometer aerobic fitness test evaluated as being valid, reliable and safe to use in vulnerable populations. |
Baseline, 3-month | |
Secondary | Heart Rate | Heart rate - Resting heart rate (Beat/min) will be recorded during the first day of the 8 day program, and the first day of three month follow up | Baseline, 3-month | |
Secondary | Blood Pressure | BP - Resting systolic and diastolic blood pressure (mmHg) will be recorded during the first day of the 8 day program, and the first day of three month follow up | Baseline, 3-month | |
Secondary | Physical performance - Level of Physical activity | Steps - mean steps per day during one week. at baseline prior to intervention, prior to 3 month follow up, and after one year | Baseline, 2 weeks post intervention, 3-month, and 12 month follow up |
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