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Occupational Therapy and Horticulture for Cancer Survivors With Chronic Pain

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ClinicalTrials.gov Identifier: NCT03951922
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Julie Kugel, Loma Linda University

Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Survivor Chronic Pain Behavioral: Horticultural activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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.
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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Yuko Mori, MS 909 558 4628 ext 47473 ymori@llu.edu

Locations
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United States, California
Loma Linda University Recruiting
Loma Linda, California, United States, 92350
Contact: Julie Kugel, OTD    909-558-4628    jkugel@llu.edu   
Contact: Yuko Mori, MS    626-818-0826    ymori@llu.edu   
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Julie Kugel, OTD Loma Linda University Health

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Responsible Party: Julie Kugel, Program director of Occupational Therapy Doctorate Program, Loma Linda University
ClinicalTrials.gov Identifier: NCT03951922     History of Changes
Other Study ID Numbers: 5180419
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms