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A Feasibility Study to Determine Whether the Botanical Garden Become a Region of Forest Therapy for Cancer Survivors

Primary Purpose

Neoplasms, Cancer, Mental Health Disorder

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Forest Therapy
Sponsored by
Taipei City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neoplasms focused on measuring Forest therapy, Forest healing, Cancer Survivors, Mental Health Disorder

Eligibility Criteria

36 Years - 82 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Over 20 year-old Cancer patients finished cancer treatments more than 6 months (regardless hormone therapy) Voluntary attendance Exclusion Criteria: People who unable to walk for at least 120 minutes People who still smoking, chewing betel nut or drinking alcohol (over five standard cups in any situation) People who addicted to medicine People who attend another clinical trial at the same time or in the follow-up period of an interventional trial Pregnant women or breast feeding Other conditions that participants unable to cooperate with

Sites / Locations

  • Taipei city hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Forest Therapy

Arm Description

This is a pretest-posttest designed experiment. A two-hour guided forest healing activity was used as an intervention method. For the purpose of comparison, an urban area adjacent to the Taipei Botanical Garden, specifically the Wanhua district, was selected. This choice ensures the exclusion of extensive green spaces commonly used for walking.

Outcomes

Primary Outcome Measures

questionnaire: POMS2-A short (Fushan botanical garden)
Change of the Profile of Mood States 2nd Edition-Adult short at Fushan botanical garden
questionnaire: POMS2-A short (Taipei botanical garden)
Change of the Profile of Mood States 2nd Edition-Adult short at Taipei botanical garden
questionnaire: POMS2-A short (urban region)
Change of the Profile of Mood States 2nd Edition-Adult short at urban region
questionnaire: BAI (Fushan botanical garden)
Change of The Beck Anxiety Inventory at Fushan botanical garden
questionnaire: BAI (Taipei botanical garden)
Change of The Beck Anxiety Inventory at Taipei botanical garden
questionnaire: BAI (urban region)
Change of The Beck Anxiety Inventory at urban region
questionnaire: BDI-II (Fushan botanical garden)
Change of The Beck Depression Inventory II at Fushan botanical garden
questionnaire: BDI-II (Taipei botanical garden)
Change of baseline The Beck Depression Inventory II at Taipei botanical garden
questionnaire: BDI-II (urban region)
Change of baseline The Beck Depression Inventory II at urban region
questionnaire: WHOQOL-BREF (Fushan botanical garden)
Change of World Health Organization Quality of Life-Brief (Taiwan version) at Fushan botanical garden
questionnaire: WHOQOL-BREF (Taipei botanical garden)
Change of World Health Organization Quality of Life-Brief (Taiwan version) at Taipei botanical garden
questionnaire: WHOQOL-BREF (urban region)
Change of World Health Organization Quality of Life-Brief (Taiwan version) at urban region
physiological indicator: alpha-amylase activity in salivary (Fushan botanical garden)
Change of alpha-amylase activity in salivary by using commercial kits (Salimetrics®) at Fushan botanical garden
physiological indicator: alpha-amylase activity in salivary (Taipei botanical garden)
Change of alpha-amylase activity in salivary by using commercial kits (Salimetrics®) at Taipei botanical garden
physiological indicator: alpha-amylase activity in salivary (urban region)
Change of alpha-amylase activity in salivary by using commercial kits (Salimetrics®) at urban region
physiological indicator: cortisol concentration in salivary (Fushan botanical garden)
Change of cortisol concentration in salivary by using commercial kits (Salimetrics®) at Fushan botanical garden
physiological indicator: cortisol concentration in salivary (Taipei botanical garden)
Change of cortisol concentration in salivary by using commercial kits (Salimetrics®) at Taipei botanical garden
physiological indicator: cortisol concentration in salivary (urban region)
Change of cortisol concentration in salivary by using commercial kits (Salimetrics®) at urban region
physiological indicator: HRV (Heart Rate Variability) (Fushan botanical garden)
Change of HRV by using wrist monitors (ANSWatch®) to measure heart rate, heart rate variability (related to activities of the autonomic nervous system ANS), irregular heartbeats (IRRHB), and 5-minute continuous pulse wave at Fushan botanical garden
physiological indicator: HRV (Heart Rate Variability) (Taipei botanical garden)
Change of HRV by using wrist monitors (ANSWatch®) to measure heart rate, heart rate variability (related to activities of the autonomic nervous system ANS), irregular heartbeats (IRRHB), and 5-minute continuous pulse wave at Taipei botanical garden
physiological indicator: HRV (Heart Rate Variability) (urban region)
Change of HRV by using wrist monitors (ANSWatch®) to measure heart rate, heart rate variability (related to activities of the autonomic nervous system ANS), irregular heartbeats (IRRHB), and 5-minute continuous pulse wave at urban region
physiological indicator: blood pressures (systolic and diastolic) (Fushan botanical garden)
Change of blood pressures by using wrist monitors (ANSWatch®) to measure blood pressures (systolic and diastolic) at Fushan botanical garden
physiological indicator: blood pressures (systolic and diastolic) (Taipei botanical garden)
Change of blood pressures by using wrist monitors (ANSWatch®) to measure blood pressures (systolic and diastolic) at Taipei botanical garden
physiological indicator: blood pressures (systolic and diastolic) (urban region)
Change of blood pressures by using wrist monitors (ANSWatch®) to measure blood pressures (systolic and diastolic) at urban region

Secondary Outcome Measures

Full Information

First Posted
August 14, 2023
Last Updated
August 19, 2023
Sponsor
Taipei City Hospital
Collaborators
Taiwan Forestry Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT06001723
Brief Title
A Feasibility Study to Determine Whether the Botanical Garden Become a Region of Forest Therapy for Cancer Survivors
Official Title
A Feasibility Study to Determine Whether the Botanical Garden Become a Region of Forest Therapy for Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 4, 2022 (Actual)
Primary Completion Date
January 20, 2023 (Actual)
Study Completion Date
January 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei City Hospital
Collaborators
Taiwan Forestry Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The forest healing system is an important topic of alternative therapy in recent years. To investigates forest therapy's effectiveness in alleviating negative emotions among post-cancer patients. It compares therapy outcomes at Taipei Botanical Garden and Fushan Botanical Garden. Utilizing a pretest-posttest experimental design, a two-hour guided forest healing activity serves as the intervention method. Data collection involves instrumental tests and saliva samples.
Detailed Description
Introduction: Cancer's global impact persists, ranking among the top three causes of death in Taiwan. Despite improved survival rates after cancer surgery, negative emotions among patients remain a challenge. Post-cancer depression adversely affects treatment outcomes and overall quality of life. Forest therapy, a natural healing approach, has gained attention for its potential to reduce stress, mitigate negative emotions, and enhance well-being. Objectives: This study investigates forest therapy's effectiveness in alleviating negative emotions among post-cancer patients. It compares therapy outcomes at Taipei Botanical Garden and Fushan Botanical Garden. Additionally, the study explores the lasting emotional benefits of forest therapy. Methods: Utilizing a pretest-posttest experimental design, this study is conducted at the Botanical Garden in Fushan, Taipei. Participants are cancer patients who are six months post-treatment. A two-hour guided forest healing activity serves as the intervention method. Data collection involves instrumental tests and saliva samples. A comparable location adjacent to Taipei Botanical Garden, excluding urban areas, is selected for comparison activities. Portable heart rhythm monitors track data, and saliva samples are analyzed for salivary α-amylase enzyme kinetics and cortisol concentrations. The study employs questionnaires including the Profile of Mood States 2nd Edition-Adult short (POMS2-A short), Beck Depression Inventory-Second edition (BDI-II), Beck Anxiety Inventory (BAI), and the abbreviated Taiwan version of the World Health Organization Quality of Life-Brief (WHOQOL-BREF).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Cancer, Mental Health Disorder, Depression
Keywords
Forest therapy, Forest healing, Cancer Survivors, Mental Health Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Forest Therapy
Arm Type
Experimental
Arm Description
This is a pretest-posttest designed experiment. A two-hour guided forest healing activity was used as an intervention method. For the purpose of comparison, an urban area adjacent to the Taipei Botanical Garden, specifically the Wanhua district, was selected. This choice ensures the exclusion of extensive green spaces commonly used for walking.
Intervention Type
Behavioral
Intervention Name(s)
Forest Therapy
Intervention Description
Forest healing activities are guided by professionals, allowing participants to engage in a two-hour sensory experience within the forest environment. This includes activities such as stacking leaves and stones, closing their eyes to listen to sounds, engaging in physical stretches, blindfolded tree identification, connecting with tree companions, creating earth mandalas, and partaking in tea ceremonies and sharing insights.
Primary Outcome Measure Information:
Title
questionnaire: POMS2-A short (Fushan botanical garden)
Description
Change of the Profile of Mood States 2nd Edition-Adult short at Fushan botanical garden
Time Frame
per-test → 2 hours intervention at Fushan botanical garden → post-test immediately after the intervention
Title
questionnaire: POMS2-A short (Taipei botanical garden)
Description
Change of the Profile of Mood States 2nd Edition-Adult short at Taipei botanical garden
Time Frame
per-test → 2 hours intervention at Taipei botanical garden → post-test immediately after the intervention
Title
questionnaire: POMS2-A short (urban region)
Description
Change of the Profile of Mood States 2nd Edition-Adult short at urban region
Time Frame
per-test → 2 hours intervention at urban region → post-test immediately after the intervention
Title
questionnaire: BAI (Fushan botanical garden)
Description
Change of The Beck Anxiety Inventory at Fushan botanical garden
Time Frame
per-test → 2 hours intervention at Fushan botanical garden → post-test immediately after the intervention
Title
questionnaire: BAI (Taipei botanical garden)
Description
Change of The Beck Anxiety Inventory at Taipei botanical garden
Time Frame
per-test → 2 hours intervention at Taipei botanical garden → post-test immediately after the intervention
Title
questionnaire: BAI (urban region)
Description
Change of The Beck Anxiety Inventory at urban region
Time Frame
per-test → 2 hours intervention at urban region → post-test immediately after the intervention
Title
questionnaire: BDI-II (Fushan botanical garden)
Description
Change of The Beck Depression Inventory II at Fushan botanical garden
Time Frame
per-test → 2 hours intervention at Fushan botanical garden → post-test immediately after the intervention
Title
questionnaire: BDI-II (Taipei botanical garden)
Description
Change of baseline The Beck Depression Inventory II at Taipei botanical garden
Time Frame
per-test → 2 hours intervention at Taipei botanical garden → post-test immediately after the intervention
Title
questionnaire: BDI-II (urban region)
Description
Change of baseline The Beck Depression Inventory II at urban region
Time Frame
per-test → 2 hours intervention at urban region → post-test immediately after the intervention
Title
questionnaire: WHOQOL-BREF (Fushan botanical garden)
Description
Change of World Health Organization Quality of Life-Brief (Taiwan version) at Fushan botanical garden
Time Frame
per-test → 2 hours intervention at Fushan botanical garden → post-test immediately after the intervention
Title
questionnaire: WHOQOL-BREF (Taipei botanical garden)
Description
Change of World Health Organization Quality of Life-Brief (Taiwan version) at Taipei botanical garden
Time Frame
per-test → 2 hours intervention at Taipei botanical garden → post-test immediately after the intervention
Title
questionnaire: WHOQOL-BREF (urban region)
Description
Change of World Health Organization Quality of Life-Brief (Taiwan version) at urban region
Time Frame
per-test → 2 hours intervention at urban region → post-test immediately after the intervention
Title
physiological indicator: alpha-amylase activity in salivary (Fushan botanical garden)
Description
Change of alpha-amylase activity in salivary by using commercial kits (Salimetrics®) at Fushan botanical garden
Time Frame
per-test → 2 hours intervention at Fushan botanical garden → post-test immediately after the intervention
Title
physiological indicator: alpha-amylase activity in salivary (Taipei botanical garden)
Description
Change of alpha-amylase activity in salivary by using commercial kits (Salimetrics®) at Taipei botanical garden
Time Frame
per-test → 2 hours intervention at Taipei botanical garden → post-test immediately after the intervention
Title
physiological indicator: alpha-amylase activity in salivary (urban region)
Description
Change of alpha-amylase activity in salivary by using commercial kits (Salimetrics®) at urban region
Time Frame
per-test → 2 hours intervention at urban region → post-test immediately after the intervention
Title
physiological indicator: cortisol concentration in salivary (Fushan botanical garden)
Description
Change of cortisol concentration in salivary by using commercial kits (Salimetrics®) at Fushan botanical garden
Time Frame
per-test → 2 hours intervention at Fushan botanical garden → post-test immediately after the intervention
Title
physiological indicator: cortisol concentration in salivary (Taipei botanical garden)
Description
Change of cortisol concentration in salivary by using commercial kits (Salimetrics®) at Taipei botanical garden
Time Frame
per-test → 2 hours intervention at Taipei botanical garden → post-test immediately after the intervention
Title
physiological indicator: cortisol concentration in salivary (urban region)
Description
Change of cortisol concentration in salivary by using commercial kits (Salimetrics®) at urban region
Time Frame
per-test → 2 hours intervention at urban region → post-test immediately after the intervention
Title
physiological indicator: HRV (Heart Rate Variability) (Fushan botanical garden)
Description
Change of HRV by using wrist monitors (ANSWatch®) to measure heart rate, heart rate variability (related to activities of the autonomic nervous system ANS), irregular heartbeats (IRRHB), and 5-minute continuous pulse wave at Fushan botanical garden
Time Frame
per-test → 2 hours intervention at Fushan botanical garden → post-test immediately after the intervention
Title
physiological indicator: HRV (Heart Rate Variability) (Taipei botanical garden)
Description
Change of HRV by using wrist monitors (ANSWatch®) to measure heart rate, heart rate variability (related to activities of the autonomic nervous system ANS), irregular heartbeats (IRRHB), and 5-minute continuous pulse wave at Taipei botanical garden
Time Frame
per-test → 2 hours intervention at Taipei botanical garden → post-test immediately after the intervention
Title
physiological indicator: HRV (Heart Rate Variability) (urban region)
Description
Change of HRV by using wrist monitors (ANSWatch®) to measure heart rate, heart rate variability (related to activities of the autonomic nervous system ANS), irregular heartbeats (IRRHB), and 5-minute continuous pulse wave at urban region
Time Frame
per-test → 2 hours intervention at urban region → post-test immediately after the intervention
Title
physiological indicator: blood pressures (systolic and diastolic) (Fushan botanical garden)
Description
Change of blood pressures by using wrist monitors (ANSWatch®) to measure blood pressures (systolic and diastolic) at Fushan botanical garden
Time Frame
per-test → 2 hours intervention at Fushan botanical garden → post-test immediately after the intervention
Title
physiological indicator: blood pressures (systolic and diastolic) (Taipei botanical garden)
Description
Change of blood pressures by using wrist monitors (ANSWatch®) to measure blood pressures (systolic and diastolic) at Taipei botanical garden
Time Frame
per-test → 2 hours intervention at Taipei botanical garden → post-test immediately after the intervention
Title
physiological indicator: blood pressures (systolic and diastolic) (urban region)
Description
Change of blood pressures by using wrist monitors (ANSWatch®) to measure blood pressures (systolic and diastolic) at urban region
Time Frame
per-test → 2 hours intervention at urban region → post-test immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
36 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over 20 year-old Cancer patients finished cancer treatments more than 6 months (regardless hormone therapy) Voluntary attendance Exclusion Criteria: People who unable to walk for at least 120 minutes People who still smoking, chewing betel nut or drinking alcohol (over five standard cups in any situation) People who addicted to medicine People who attend another clinical trial at the same time or in the follow-up period of an interventional trial Pregnant women or breast feeding Other conditions that participants unable to cooperate with
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chung-Hua Hsu, MD. PHD.
Organizational Affiliation
Branch of Chinese Medicine, Taipei City Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Taipei city hospital
City
Taipei
ZIP/Postal Code
10845
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

A Feasibility Study to Determine Whether the Botanical Garden Become a Region of Forest Therapy for Cancer Survivors

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