- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03951922
Occupational Therapy and Horticulture for Cancer Survivors With Chronic Pain
Exploring the Effect of Occupational Therapy and Horticulture for Cancer Survivors With Chronic Pain
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
California
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Loma Linda, California, United States, 92350
- Loma Linda University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Therapeutic Horticulture Group
The therapeutic horticulture group will participate in a 6-week horticulture program meeting twice a week for an hour led by an occupational therapist incorporating plant-based activities and education on pain management techniques at a community farm.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Salivary Cortisol Test
Time Frame: Change between baseline and three months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lower body strength
Time Frame: Change between baseline and three months
|
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.
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Change between baseline and three months
|
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Upper body strength
Time Frame: Change between baseline and three months
|
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
|
|
Endurance
Time Frame: Change between baseline and three months
|
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
|
|
Lower body flexibility
Time Frame: Change between baseline and three months
|
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.
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Change between baseline and three months
|
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Upper body flexibility
Time Frame: Change between baseline and three months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julie Kugel, OTD, Loma Linda University Health
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5180419
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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