Occupational Therapy and Horticulture for Cancer Survivors With Chronic Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03951922|
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cancer Survivor Chronic Pain||Behavioral: Horticultural activity||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exploring the Effect of Occupational Therapy and Horticulture for Cancer Survivors With Chronic Pain|
|Estimated Study Start Date :||May 2019|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||February 20, 2020|
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.
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951922
|Contact: Yuko Mori, MS||909 558 4628 ext email@example.com|
|United States, California|
|Loma Linda University||Recruiting|
|Loma Linda, California, United States, 92350|
|Contact: Julie Kugel, OTD 909-558-4628 firstname.lastname@example.org|
|Contact: Yuko Mori, MS 626-818-0826 email@example.com|
|Principal Investigator:||Julie Kugel, OTD||Loma Linda University Health|