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

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

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.

WAYA-Wilderness

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

WAYA-Holiday

Sture Espwall

Mats Jong, PhD

Miek Jong, PhD

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.

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.

Randomisation (Contact 2)

Written informed consent from the participants will be obtained prior to randomisation. One of the researchers of this study will also sign the informed consent form. After the signed informed consent form has been received, young cancer survivors will be randomised for participation in the study. All data of each randomized participant in the study will be documented in a Case Report Form (CRF) that will be developed for this study. Participants will be contacted by telephone and the following tasks will be carried out:

* Inform participants about the outcome of the randomisation procedure,
* Collect demographic data (DD), medical history (MH), medication use (MU), concomitant medication/therapies, dietary and lifestyle measures,
* Instructions for using the step counter, one week before the start of intervention: All participants that are randomized in the study will be send a step counter, to be used in the week before the intervention,
* Sending the step counter and instructions for use to participants,
* Instruction for measurements and timelines during the study.

Intervention (Visit 1) All participants will travel for the intervention (8 days in total) to Sundsvall, Sweden. At Day 1 of the intervention (Baseline, T=0), participants will perform physical performance/fitness tests at Mid Sweden University under supervision of a test leader from the Sweden Winter Sports Research Centre (Östersund, Sweden). After the tests, participants in the intervention group will be transported to the wilderness site at Höga Kusten, Västernorrland, Sweden. Participants will be provided with outdoor clothes, backpack, tent, sleeping pads and sleeping bag. All other necessary outdoor equipment will be made available through the facilitators. Participants in the control group will be transported to a Wellness Center in Västernorrland. Before leaving for home, a plan for activities in the three-month home program will be discussed with participants in the wilderness program group.

Three-months at home (Contact 3 and 4)

Participants in both groups will be followed during a 3-month period after the one-week intervention. During this period, participants will be contacted by a facilitator via telephone or other media after one month (Contact 3) and two months (Contact 4). The following tasks will be carried out:

* Documentation of concomitant medication/therapy use, dietary and lifestyle measures,
* Documentation of adverse events that may have occurred,
* Filling in the IPAQ,
* Results of the step counter during the week before Contact 3 and 4,
* Adherence and transference of participants to the agreed and planned activities at home (wilderness program group only).

Intervention (Visit 2; Re-visit) After three months, participants will return to Mid Sweden University for follow up measures (T=2), as well as for two additional nights outdoor at Höga Kusten to re-connect (intervention group) or two holiday nights at the Wellness canter (Control group).

One year follow-up One year after start of the intervention (T=3), participants in both groups will be contacted to fill in online self-reported questionnaires. Concomitant medications/therapies, dietary and lifestyle measures will be documented as well as a recent one-week measurement of step counts.

Sample size No sample size calculation is needed for a pilot RCT.

Randomization Participants will be randomized according to a randomization list as generated by the Random Allocation Software Program using a random block size of 2 in order to guarantee a balanced allocation. The two interventions (wilderness therapy versus attention-control are assigned to intervention A and intervention B and upon intake participants will receive a screening number ranging from 01 to 100. Participants who drop out of the study before being randomized will keep their screening number without receiving an intervention. On enrolment in the study, participants that are randomized receive an intervention number (01-110). The study numbers are sequentially allocated to the participants in the order of inclusion in the randomized intervention period. Each participant will receive only that intervention which is labeled with the study number allocated to him/her. Participants will be stratified according to age group (16-22 and 23-30 and 31-39) and gender (male/female) in order to achieve equal distribution among the two groups. Per stratification, separate randomization lists will be generated.

Statistics Regular descriptive statistics will be calculated with regard to demographical and categorical data and mean scores and standard deviations of the numerical variables will be calculated using SPSS (version 25.0). As a first step, preliminary mean differences between, and within groups (over time changes) will be calculated using students t-test, related samples t-test, and R-ANOVA analysis. As a second step, the Aickin separation test will be applied to the domains of the MMQL and other outcome measures to determine whether there are indications of differences, even if obtained p-values are non-significant. If indications of differences are identified with the Aickin separation test it provides information whether a further larger RCT is warranted. The Aickin separation test is used for early phase trials to determine whether the data are 1) in the hypothesized direction, 2) counter to the hypothesized direction or 3) equivocal. Results in the hypothesized direction warrant further research with adequate power to test for effectiveness.

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

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.

Gender will be expressed in terms of self-representation

Wilderness Program for Adolescent and Young Adult Cancer Survivors

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

Raw confidential data can be shared upon request after publication in scientific journal

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

A textual description of what participants would expect to experience from participation in either intervention group.

Willingness of participants to be randomized (Yes/No)

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

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

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

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

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

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.

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.

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:

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:

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.

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.

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.

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.

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

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

Steps - mean steps per day during one week. at baseline prior to intervention, prior to 3 month follow up, and after one year

UiT The Arctic University of Norway

University of California, San Francisco

See You At The Summit

Sörlandet Hospital, Norway

The Swedish Winter Sports Research Centre

Mid Sweden University

Nature-centered therapy in a near-natural area

Conventional therapy in rooms mainly in a hospital building

Interventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme

Nature-near integrative day care unit programme

Conventional integrative day care unit programme

The aim of this study is to investigate the effects of a nature-centred integrative oncology day care unit programme ("outdoor concept") compared with an already established integrative oncology day care unit programme ("indoor concept").

Evaluation of a Oncology Day Care Unit Programme With Two Different Focuses

Integrative Oncology - Evaluation of a Oncology Day Care Unit Programme With Two Different Focuses

Qualitative assessment will be carried out in qualitative interviews in 20 patients participating in the study. The interviews will be recorded, transcribed and analyzed with qualitative content analysis.

Assessing full scale, range 0-108, higher score meaning a better outcome

Assessing full scale, range 0-40, higher score meaning a better outcome

Assessing full scale, range 0-52, higher score meaning a better outcome

Assessing full scale, range 0-25, higher score meaning a better outcome

mean score of the 11 items, range 1-7, lower score meaning a better outcome

Assessing full scale, range 0-40, lower score meaning a better outcome

Assessing full scale, range 0-42, lower score meaning a better outcome

Assessing full scale, range 8-56, higher score meaning a better outcome

Assessing full scale, range 0-56, higher score meaning a better outcome

Assessing full scale, range 0-28, lower score meaning a better outcome

mean score of 12 items, range 1-5, higher score meaning a better outcome

Number of alcoholic beverages on average per week in the last month

Relaxation behavior on average per week in the last month in minutes

Number of cigarettes on average per week in the last month in minutes

Age, gender, education level, household income, employment status, marital status, complete family history, current and previous diseases and co-morbidities, current medication intake

For intervention 1 and intervention 2 on a 5-point likert scale from 1 (nothing at all) to 5 (very strong)

Sports behavior on average per week in the last month in minutes

Charite University, Berlin, Germany

Prof. Dr. med.

Nature-based immersive VR program, completion of questionnaires, and saliva and blood sample submission.

Nature-based non-immersive VR program, completion of questionnaires, and saliva and blood sample submission.

Sham VR

Active VR

Chantal M Gerrard

Lena Jumin Lee (Park), Ph.D.

NIH Clinical Center Office of Patient Recruitment (OPR)

Background:

People who receive an allogeneic hematopoietic stem cell transplant (HSCT) require long-term care at home afterwards. Their caregivers often experience high levels of stress, which can lead to symptoms such as depression, anxiety, poor sleep, fatigue, and difficulties with concentration and memory.

Objective: To explore whether a nature-based immersive virtual reality (VR) program helps reduce stress in people who care for HSCT patients.

Eligibility:

People aged 18 and older who are primary caregivers of HSCT patients.

Design:

This is a two-phase study. Participants will be enrolled for 4 weeks. They will have 2 clinic visits.

Participants will have a physical exam at the beginning of the study. They will be asked to provide a saliva sample in Phase 1, and saliva and blood samples in Phase 2.

Participants will be given a VR headset. This is a device that looks like a pair of goggles worn over the eyes. They will be asked to wear the headset for 20 minutes per day. They will see 360 (Infinite) high-definition videos of nature and hear nature sounds.

Participants will record the time they spend using the VR headset in a daily diary. They will take surveys with questions about any stress and symptoms they feel once a week. This will take up to 5 minutes. Participants will have a short regular follow-up visit by phone one week after starting their participation.

At the end of the intervention study, participants will return for another physical exam. They will give saliva and/or blood samples again.

Researchers will also look at the medical records of the HSCT patients; the HSCT patients must consent to this.

...

Study Description:

This is an interventional protocol to decrease stress and symptoms with a four-week nature-based VR intervention in family caregivers of allogeneic HSCT recipients. This study is a two-phase study: Phase I will be a single arm pre-post design focused on assessing the feasibility and acceptability of the four-week nature-based immersive VR program. Phase II will be a prospective randomized controlled group design to examine the effectiveness of the four-week nature-based immersive VR program (Active VR) on stress and symptoms compared to a four-week nature-based non-immersive VR program (Sham VR) in the target population.

Objectives:

Phase I

Primary Objective: To evaluate the feasibility and acceptability of the nature-based immersive VR program in HSCT caregivers.

Secondary Objectives: To examine the level of perceived restorativeness, perceived stress, and symptoms (fatigue, sleep disturbance, depression, anxiety, cognitive impairment) in HSCT caregivers participating in the nature-based immersive VR program.

Exploratory Objectives: To examine relationships among variables including but not limited to perceived stress, symptoms, HSCT caregiver characteristics, HSCT recipient characteristics, and biomarkers.

Phase II

Primary Objective: To examine whether HSCT caregivers participating in Active VR demonstrate improved levels of perceived stress compared to those participating in Sham VR.

Secondary Objectives:

1. To examine whether HSCT caregivers participating in Active VR demonstrate improved levels of symptoms (fatigue, sleep disturbance, depression, anxiety, cognitive impairment) compared to those participating in Sham VR.
2. To examine the acceptability of Active and Sham VR programs in HSCT caregivers.

Exploratory Objectives: To examine relationships among variables including but not limited to perceived stress, symptoms, HSCT caregiver characteristics, HSCT recipient characteristics, and biomarkers.

Endpoints: Phase I

Primary Endpoints: Feasibility (recruitment, retention, and adherence rates) and acceptability (satisfaction, usability) measured at Time 4 (Day 28); acceptability (safety) from Time 0 (Baseline; Day 0) to Time 4

Secondary Endpoints: Perceived restorativeness measured at Time 4; changes in perceived stress from Time 0 to Time 4; changes in symptoms (fatigue, sleep disturbance, depression, anxiety, cognitive impairment) from Time 0 to Time 4

Phase II

Primary Endpoint: Changes in perceived stress from Time 0 to Time 4

Secondary Endpoints: Changes in symptoms (fatigue, sleep disturbance, depression, anxiety, cognitive impairment) from Time 0 to Time 4; acceptability (satisfaction, usability) measured at Time 4; acceptability (safety) from Time 0 to Time 4

A Nature-Based Virtual Reality (VR) Intervention in Family Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients

A Pilot Study of a Nature-Based Virtual Reality (VR) Intervention in Family Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients

The outcome will be used to assess the effects of the Active VR compared to the Sham VR.

National Institutes of Health Clinical Center (CC)

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Immune System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Prostatic Neoplasms

Breast Neoplasms

Lymphoma

Leukemia

Hematologic Neoplasms

Thyroid Neoplasms

Thyroid Diseases

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Breast Diseases

Skin Diseases

Hematologic Diseases

Lymphosarcoma

Participants will be asked to complete a 12 week exercise program

Participants will engage in three months of moderate intensity PA, consisting of three 50-minute walking sessions per week (5-minute warm-up, 40 minute walk, 5 minute cool-down and stretch) with an exercise physiologist for 12 weeks.

Nature based exercise

Celina Shirazipour, PhD

Arash Asher, M.D.

The purpose of this study is to examine whether nature-based activities provide benefits for breast cancer survivors. The investigators want to know whether a nature-based exercise program is feasible. Women who were diagnosed with breast cancer and have completed cancer treatment will be recruited for the main study. The main study will enroll up to 20 breast cancer subjects in total.

This intervention will also include a sub-study examining the same outcomes among adolescents and young adult (AYA) subjects who were diagnosed with cancer (any type) and have completed cancer treatment. The sub-study will enroll up to 20 AYA (ages 18-39) subjects.

This is a single-arm pilot study

MAIN STUDY Breast cancer survivors (n=20) will engage in three months of moderate intensity walking sessions three times a week in a nature and park conservation area. All walks will be supervised by certified clinical Exercise Physiologists (EP). Participants will be encouraged to keep the same days and walk session times throughout the intervention.

Sessions will be 50-minutes in total (5-minute warm-up, 40 minute walk, 5 minute cool-down and stretch). Session intensity will be tracked with Fitbits. Participants will be asked to reach a moderate intensity heart rate, defined as 40%-59% heart rate reserve.

Participants will complete surveys, physical assessments and collection of biomarkers at baseline and at end of study. Participants also have the option to participate in a 1 hr qualitative exit interview about their participation experiences.

Note. Based on any COVID pandemic restrictions at the time of a walk, sessions will be socially distanced one-on-one with an EP. When no restrictions are in place, they will take place in small groups (3-5 participants).

SUB-STUDY Adolescent and young adult (AYA) (ages 18-39) survivors (n=20) will complete all of the components of the Main-Study described above.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Wilderness Program for Adolescent and Young Adult Cancer Survivors	NCT04761042	Cancer	WAYA-Wilderness WAYA-Holiday	16 Years - 39 Years	Mid Sweden University
Evaluation of a Oncology Day Care Unit Programme With Two Different Focuses	NCT04411251	Cancer	Nature-near int... Conventional in...	18 Years - 85 Years	Charite University, Berlin, Germany
A Nature-Based Virtual Reality (VR) Intervention in Family Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients	NCT05909202	Neoplasm Caregivers	Sham VR Active VR	18 Years - 100 Years	National Institutes of Health Clinical Center (CC)
IIT2020-20-SHIRAZIP-WALK: Nature Walks	NCT04896580	Breast Cancer Cancer Lymphoma Leukemia Prostate Cancer Thyroid Cancer Hematologic Mal... Non-hodgkin Lym...	Nature based ex...	18 Years -	Cedars-Sinai Medical Center

Spots Global Cancer Trial Database for nature

Every month we try and update this database with for nature cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nature

Every month we try and update this database with for nature cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nature cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.