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

• Sponsor: Taipei City Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT06001723
• Collaborator: Taiwan Forestry Research Institute (Other)
• Enrollment: 50
• Location: 1
• Arm: 1
• Actual Duration (Months): 5.6
• Patients Per Site Per Month: 9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms; Cancer; Mental Health Disorder; Depression	Behavioral: Forest Therapy	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Feasibility Study to Determine Whether the Botanical Garden Become a Region of Forest Therapy for Cancer Survivors
• Actual Study Start Date: Aug 4, 2022
• Actual Primary Completion Date: Jan 20, 2023
• Actual Study Completion Date: Jan 20, 2023

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Forest Therapy 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.

Behavioral: Forest Therapy; 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.

Outcome Measures

Primary Outcome Measures

1. questionnaire: POMS2-A short (Fushan botanical garden) [per-test → 2 hours intervention at Fushan botanical garden → post-test immediately after the intervention]

   Change of the Profile of Mood States 2nd Edition-Adult short at Fushan botanical garden

2. questionnaire: POMS2-A short (Taipei botanical garden) [per-test → 2 hours intervention at Taipei botanical garden → post-test immediately after the intervention]

   Change of the Profile of Mood States 2nd Edition-Adult short at Taipei botanical garden

3. questionnaire: POMS2-A short (urban region) [per-test → 2 hours intervention at urban region → post-test immediately after the intervention]

   Change of the Profile of Mood States 2nd Edition-Adult short at urban region

4. questionnaire: BAI (Fushan botanical garden) [per-test → 2 hours intervention at Fushan botanical garden → post-test immediately after the intervention]

   Change of The Beck Anxiety Inventory at Fushan botanical garden

5. questionnaire: BAI (Taipei botanical garden) [per-test → 2 hours intervention at Taipei botanical garden → post-test immediately after the intervention]

   Change of The Beck Anxiety Inventory at Taipei botanical garden

6. questionnaire: BAI (urban region) [per-test → 2 hours intervention at urban region → post-test immediately after the intervention]

   Change of The Beck Anxiety Inventory at urban region

7. questionnaire: BDI-II (Fushan botanical garden) [per-test → 2 hours intervention at Fushan botanical garden → post-test immediately after the intervention]

   Change of The Beck Depression Inventory II at Fushan botanical garden

8. questionnaire: BDI-II (Taipei botanical garden) [per-test → 2 hours intervention at Taipei botanical garden → post-test immediately after the intervention]

   Change of baseline The Beck Depression Inventory II at Taipei botanical garden

9. questionnaire: BDI-II (urban region) [per-test → 2 hours intervention at urban region → post-test immediately after the intervention]

   Change of baseline The Beck Depression Inventory II at urban region

10. questionnaire: WHOQOL-BREF (Fushan botanical garden) [per-test → 2 hours intervention at Fushan botanical garden → post-test immediately after the intervention]

    Change of World Health Organization Quality of Life-Brief (Taiwan version) at Fushan botanical garden

11. questionnaire: WHOQOL-BREF (Taipei botanical garden) [per-test → 2 hours intervention at Taipei botanical garden → post-test immediately after the intervention]

    Change of World Health Organization Quality of Life-Brief (Taiwan version) at Taipei botanical garden

12. questionnaire: WHOQOL-BREF (urban region) [per-test → 2 hours intervention at urban region → post-test immediately after the intervention]

    Change of World Health Organization Quality of Life-Brief (Taiwan version) at urban region

13. physiological indicator: alpha-amylase activity in salivary (Fushan botanical garden) [per-test → 2 hours intervention at Fushan botanical garden → post-test immediately after the intervention]

    Change of alpha-amylase activity in salivary by using commercial kits (Salimetrics®) at Fushan botanical garden

14. physiological indicator: alpha-amylase activity in salivary (Taipei botanical garden) [per-test → 2 hours intervention at Taipei botanical garden → post-test immediately after the intervention]

    Change of alpha-amylase activity in salivary by using commercial kits (Salimetrics®) at Taipei botanical garden

15. physiological indicator: alpha-amylase activity in salivary (urban region) [per-test → 2 hours intervention at urban region → post-test immediately after the intervention]

    Change of alpha-amylase activity in salivary by using commercial kits (Salimetrics®) at urban region

16. physiological indicator: cortisol concentration in salivary (Fushan botanical garden) [per-test → 2 hours intervention at Fushan botanical garden → post-test immediately after the intervention]

    Change of cortisol concentration in salivary by using commercial kits (Salimetrics®) at Fushan botanical garden

17. physiological indicator: cortisol concentration in salivary (Taipei botanical garden) [per-test → 2 hours intervention at Taipei botanical garden → post-test immediately after the intervention]

    Change of cortisol concentration in salivary by using commercial kits (Salimetrics®) at Taipei botanical garden

18. physiological indicator: cortisol concentration in salivary (urban region) [per-test → 2 hours intervention at urban region → post-test immediately after the intervention]

    Change of cortisol concentration in salivary by using commercial kits (Salimetrics®) at urban region

19. physiological indicator: HRV (Heart Rate Variability) (Fushan botanical garden) [per-test → 2 hours intervention at Fushan botanical garden → post-test immediately after the intervention]

    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

20. physiological indicator: HRV (Heart Rate Variability) (Taipei botanical garden) [per-test → 2 hours intervention at Taipei botanical garden → post-test immediately after the intervention]

    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

21. physiological indicator: HRV (Heart Rate Variability) (urban region) [per-test → 2 hours intervention at urban region → post-test immediately after the intervention]

    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

22. physiological indicator: blood pressures (systolic and diastolic) (Fushan botanical garden) [per-test → 2 hours intervention at Fushan botanical garden → post-test immediately after the intervention]

    Change of blood pressures by using wrist monitors (ANSWatch®) to measure blood pressures (systolic and diastolic) at Fushan botanical garden

23. physiological indicator: blood pressures (systolic and diastolic) (Taipei botanical garden) [per-test → 2 hours intervention at Taipei botanical garden → post-test immediately after the intervention]

    Change of blood pressures by using wrist monitors (ANSWatch®) to measure blood pressures (systolic and diastolic) at Taipei botanical garden

24. physiological indicator: blood pressures (systolic and diastolic) (urban region) [per-test → 2 hours intervention at urban region → post-test immediately after the intervention]

    Change of blood pressures by using wrist monitors (ANSWatch®) to measure blood pressures (systolic and diastolic) at urban region

Eligibility Criteria

Criteria

• Ages Eligible for Study: 36 Years to 82 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei city hospital	Taipei		Taiwan	10845

Sponsors and Collaborators

• Taipei City Hospital
• Taiwan Forestry Research Institute

Investigators

• Study Director: Chung-Hua Hsu, MD. PHD., Branch of Chinese Medicine, Taipei City Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chung-Hua Hsu, director of the hospital, Taipei City Hospital
• ClinicalTrials.gov Identifier: NCT06001723
• Other Study ID Numbers: TCHIRB-11104010
• First Posted: Aug 21, 2023
• Last Update Posted: Aug 23, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Chung-Hua Hsu, director of the hospital, Taipei City Hospital: Forest therapy; Forest healing; Cancer Survivors; Mental Health Disorder
• Additional relevant MeSH terms: Mental Disorders

Study Results

No Results Posted as of Aug 23, 2023