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Wilderness Program for Adolescent and Young Adult Cancer Survivors (WAYA)

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ClinicalTrials.gov Identifier: NCT04761042
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : February 18, 2021
Sponsor:
Collaborators:
UiT The Arctic University of Norway
University of California, San Francisco
See You At The Summit
Sörlandet Hospital, Norway
Ekhagastiftelsen
Sjöbergstiftelsen
The Swedish Winter Sports Research Centre
Information provided by (Responsible Party):
Mid Sweden University

Brief Summary:

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 16-30) 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.


Condition or disease Intervention/treatment Phase
Cancer Other: WAYA-Wilderness Other: WAYA-Holiday Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A Randomized control design where participants are randomized to one of the two groups, stratification is made for gender and age (older/younger).
Masking: Single (Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Other
Official 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
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : October 30, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Wilderness program
A one-week (8 days) wilderness program, 3-month online support, and a follow-up visit for four days.
Other: WAYA-Wilderness

The wilderness intervention includes challenging tasks in order to help participants' overcome and master new physical and psychological challenges in an unknown environment, with the idea to support self-efficacy, self-esteem, and ability to recover from adversity. The program is designed to encourage participants to connect with nature as to experience gratitude for the richness of the natural world, a sense of calmness and trust upon spending time in nature, and to be more physically active in nature.

Elements previously described Participants will continue in a three-month program at home (on-line supported) after the initial 8-days in order to empower participants to incorporate elements of the onsite wilderness program into their daily life. An individualized a plan for activities will be developed together with the participant.

After three months, there will be a re-visit with follow up on outcome measures and reconnection.


Holiday program (Attention control)
A one-week (8 days) holiday program, 3-month online contact, and a follow-up visit for four days.
Other: WAYA-Holiday
An attention control group (information in "Detailed description")




Primary Outcome Measures :
  1. Feasibility - Participant Preferences [ Time Frame: At prestudy screening - prior to inclusion ]
    Participant Preferences (P-Pref) regarding intervention arms (no pref, slight pref, strong preference)

  2. Feasibility - Participant expectations [ Time Frame: At prestudy screening - prior to inclusion ]
    A textual description of what participants would expect to experience from participation in either intervention group.

  3. Feasibility - Participant willingness to be randomized [ Time Frame: At prestudy screening - prior to inclusion ]
    Willingness of participants to be randomized (Yes/No)

  4. Feasibility - Time to recruitment [ Time Frame: 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

  5. Feasibility - Participant Adherence to Protocol [ Time Frame: 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

  6. Feasibility - Logistics and Burden [ Time Frame: 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

  7. Feasibility - Logistics and willingness to complete all planned study-related questionnaires [ Time Frame: 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

  8. Feasibility - Adherence to three month at home program [ Time Frame: 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

  9. Feasibility - Occurrence of adverse events [ Time Frame: 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.



Secondary Outcome Measures :
  1. Minneapolis Manchester Quality of Life - MMQL [ Time Frame: Baseline, 3-month, and 12 month follow up ]

    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.


  2. International Physical Activity Questionnaire [ Time Frame: Baseline, 3-month, and 12 month follow up ]

    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:


  3. Generalized Self-Efficacy Scale [ Time Frame: Baseline, 3-month, and 12 month follow up ]

    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:


  4. Rosenberg Self-Esteem Scale RSES [ Time Frame: Baseline, 3-month, and 12 month follow up ]

    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.


  5. Nature Relatedness Scale [ Time Frame: Baseline, 3-month, and 12 month follow up ]

    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.


  6. Physical performance - Six Minute Walking Test [ Time Frame: Baseline, 3-month ]

    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.


  7. Physical performance -Oxygen uptake [ Time Frame: Baseline, 3-month ]

    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.


  8. Heart Rate [ Time Frame: Baseline, 3-month ]
    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

  9. Blood Pressure [ Time Frame: Baseline, 3-month ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Gender will be expressed in terms of self-representation
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participants of:

  • any sex,
  • aged 16-30,
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04761042


Contacts
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Contact: Sture Espwall +4610142 79 93 sture.espwall@miun.se
Contact: Mats Jong, PhD +46101428966 mats.jong@miun.se

Locations
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Sweden
Mid Sweden University, department of Health Sciences Recruiting
Sundsvall, Sweden, 85170
Contact: Sture Espwall    +461014279 93    sture.espwall@miun.se   
Contact: Mats Jong, PhD    +46101428966    mats.jong@miun.se   
Principal Investigator: Mats Jong, PhD         
Sub-Investigator: Miek Jong, PhD         
Sponsors and Collaborators
Mid Sweden University
UiT The Arctic University of Norway
University of California, San Francisco
See You At The Summit
Sörlandet Hospital, Norway
Ekhagastiftelsen
Sjöbergstiftelsen
The Swedish Winter Sports Research Centre
Investigators
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Principal Investigator: Mats Jong, PhD Dep of Health Sciences/Public Health, Mid Sweden University, Sundsvall, Sweden
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Responsible Party: Mid Sweden University
ClinicalTrials.gov Identifier: NCT04761042    
Other Study ID Numbers: Dnr 2019-67
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Raw confidential data can be shared upon request after publication in scientific journal
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: can be shared upon request after publication in scientific journal: Earliest Spring 2024
Access Criteria: By Swedish Law, research data must be provided if authorized researchers request it. By definition that corresponds to someone who has research training and an academic doctoral degree.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mid Sweden University:
wilderness therapy
adventure therapy
recreational therapy
outdoor therapy
nature
adolescent
young adult
childhood cancer survivors
health promotion
positive health