Occupational Therapy and Horticulture for Cancer Survivors With Chronic Pain

March 12, 2020 updated by: Julie Kugel, Loma Linda University

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Loma Linda, California, United States, 92350
        • Loma Linda University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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

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.
Change between baseline and three months
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.
Change between baseline and three months
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Julie Kugel, OTD, Loma Linda University Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 8, 2019

Primary Completion (ACTUAL)

November 23, 2019

Study Completion (ACTUAL)

February 10, 2020

Study Registration Dates

First Submitted

April 16, 2019

First Submitted That Met QC Criteria

May 14, 2019

First Posted (ACTUAL)

May 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 13, 2020

Last Update Submitted That Met QC Criteria

March 12, 2020

Last Verified

March 1, 2020

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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