Wilderness Program for Adolescent and Young Adult Cancer Survivors

NCT04761042 | Unknown

• 1 other identifier: Dnr 2019-67
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 16-39) 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.

Conditions

Cancer

Keywords

wilderness therapy; adventure therapy; recreational therapy; outdoor therapy; nature; adolescent; young adult; childhood cancer survivors; health promotion; positive health

Outcome Measures

Primary Outcomes (9)

• Feasibility - Participant Preferences

  Participant Preferences (P-Pref) regarding intervention arms (no pref, slight pref, strong preference)

  At prestudy screening - prior to inclusion

• 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

• Feasibility - Participant willingness to be randomized

  Willingness of participants to be randomized (Yes/No)

  At prestudy screening - prior to inclusion

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (10)

• Minneapolis Manchester Quality of Life - MMQL

  Baseline, 2 weeks post intervention, 3-month, and 12 month follow up

• International Physical Activity Questionnaire

  Baseline, 2 weeks post intervention, 3-month, and 12 month follow up

• Generalized Self-Efficacy Scale

  Baseline, 2 weeks post intervention, 3-month, and 12 month follow up

• Rosenberg Self-Esteem Scale RSES

  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

Study Arms (2)

Wilderness program

EXPERIMENTAL

A one-week (8 days) wilderness program, 3-month online support, and a follow-up visit for four days.

Other: WAYA-Wilderness

Holiday program (Attention control)

OTHER

A one-week (8 days) holiday program, 3-month online contact, and a follow-up visit for four days.

Other: WAYA-Holiday

Interventions

WAYA-Wilderness OTHER

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.

Wilderness program

WAYA-Holiday OTHER

An attention control group (information in "Detailed description")

Holiday program (Attention control)

Eligibility Criteria

• Age: 16 Years - 39 Years
• Gender Eligibility Details: Gender will be expressed in terms of self-representation
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mid Sweden University: lead
• UiT The Arctic University of Norway: collaborator
• University of California, San Francisco: collaborator
• See You At The Summit: collaborator
• Sörlandet Hospital, Norway: collaborator
• The Swedish Winter Sports Research Centre: collaborator

Study Sites (1)

Mid Sweden University, department of Health Sciences

Sundsvall, 85170, Sweden

RECRUITING

Related Publications (2)

• Jong MC, Dahlqvist H, Lown EA, Schats W, Beckman L, Jong M. A randomized controlled pilot study assessing feasibility and safety of a wilderness program for childhood, adolescent, and young adult cancer survivors: the WAYA study. BMC Public Health. 2023 Aug 8;23(1):1504. doi: 10.1186/s12889-023-16408-x.

  PMID: 37553637 DERIVED

• Jong MC, Mulder E, Kristoffersen AE, Stub T, Dahlqvist H, Viitasara E, Lown EA, Schats W, Jong M. Protocol of a mixed-method randomised controlled pilot study evaluating a wilderness programme for adolescent and young adult cancer survivors: the WAYA study. BMJ Open. 2022 May 9;12(5):e061502. doi: 10.1136/bmjopen-2022-061502.

  PMID: 35534081 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Mats Jong, PhD

  Dep of Health Sciences/Public Health, Mid Sweden University, Sundsvall, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sture Espwall

CONTACT

+4610142 79 93; sture.espwall@miun.se

Mats Jong, PhD

CONTACT

+46101428966; mats.jong@miun.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Randomized control design where participants are randomized to one of the two groups, stratification is made for gender and age (older/younger).

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: February 18, 2021
• Study Start: January 1, 2021
• Primary Completion: October 30, 2023
• Study Completion: December 31, 2023
• Last Updated: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

SE (1)