Occupational Therapy and Horticulture for Cancer Survivors With Chronic Pain

Chronic Pain Clinical Trial

Official title:

Exploring the Effect of Occupational Therapy and Horticulture for Cancer Survivors With Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03951922
• Other study ID #: 5180419
• Status: Completed
• Phase: N/A
• Start date: June 8, 2019
• Est. completion date: February 10, 2020

Study information

• Verified date: March 2020
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this quasi-experimental study is to explore the impact of a therapeutic horticulture program as an occupation-based intervention to address chronic pain symptoms for cancer survivors. The main objectives are to assess participants' perceptions of pain, physical and psychosocial wellness, stress management, and quality of life at pre-, post-, and 3-month follow-up. Quantitative and qualitative data will be synthesized and analyzed to explore this phenomenon.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 10, 2020
• Est. primary completion date: November 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• 18 - 64 years of age

• History of cancer diagnosis

• Chronic pain longer than 3 months

• Have interest in therapeutic horticulture and exercise

• Able to participate in a moderate physical activity in sitting and/or standing for at least one hour twice a week

• Able to provide own transportation to the horticulture site or the supervised exercise program

• Able to comprehend, speak and write in English

Exclusion Criteria:

• Uncontrolled seizure disorder

• Pregnancy

Related Conditions & MeSH terms

• Cancer Survivor
• Chronic Pain

Intervention

Behavioral:
• Horticultural activity
Therapeutic horticulture activities are plant-related activities that include but not limited to digging, watering, planting, weeding, trimming, fertilizing, mulching, harvesting, learning about organic farming, and exploring options to incorporate horticulture into daily activities

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary Cortisol Test	Participant stress level will be determined by salivary cortisol levels. Participant's salivary cortisol level will be measured at awakening, 30 minutes following awakening and bedtime. Typically, there is Cortisol Awakening Response (CAR), which is a steep rise in cortisol output during the first 30 minutes following awakening, followed by a steady decline across the morning, afternoon, and evening hours, with the daily nadir typically occurring around midnight. Flattened diurnal cortisol slope relates to increased emotional and psychosocial stress and related to worse health outcomes.; The typical Cortisol Awakening Response (CAR) is defined as an increase of at least 2.5 nmol/l from the cortisol level taken at awakening. Although there are no agreed norms for the absolute concentrations of free cortisol in saliva it typically ranges between 4.7-18.5 nmol/l for post-awakening, between 8.6-21.9 nmol/l for 30 minutes post-awakening, and 0.3-15.2 nmol/l for bedtime.	Change between baseline and three months
Secondary	Lower body strength	Chair Stand testing measures the strength of the lower body. Average scores for this testing are 15 reps for women and 16 reps for men.	Change between baseline and three months
Secondary	Upper body strength	Arm Curl testing measures the strength of the upper body. Average scores for this testing are 16 reps for women and 19 reps for men.	Change between baseline and three months
Secondary	Endurance	2 Minutes Step testing measures the endurance or physical stamina. Average scores for this testing are 91 times for women and 101 times for men.	Change between baseline and three months
Secondary	Lower body flexibility	Chair Sit and Reach testing measures lower body flexibility, specifically your hamstring flexibility. Average scores for this testing are +2 inches for women and + 0.5 inches for men.	Change between baseline and three months
Secondary	Upper body flexibility	Back Scratch testing measures the flexibility of the upper body. Average scores for this testing are -0.5 inches for women and -3.5 inches for men.	Change between baseline and three months