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Occupational Therapy and Horticulture for Cancer Survivors With Chronic Pain

Primary Purpose

Cancer Survivor, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Horticultural activity
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer Survivor

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Loma Linda University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Therapeutic Horticulture Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
April 16, 2019
Last Updated
March 12, 2020
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT03951922
Brief Title
Occupational Therapy and Horticulture for Cancer Survivors With Chronic Pain
Official Title
Exploring the Effect of Occupational Therapy and Horticulture for Cancer Survivors With Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 8, 2019 (Actual)
Primary Completion Date
November 23, 2019 (Actual)
Study Completion Date
February 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Survivor, Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Horticulture Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Horticultural activity
Intervention Description
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 Measure Information:
Title
Salivary Cortisol Test
Description
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.
Time Frame
Change between baseline and three months
Secondary Outcome Measure Information:
Title
Lower body strength
Description
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.
Time Frame
Change between baseline and three months
Title
Upper body strength
Description
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.
Time Frame
Change between baseline and three months
Title
Endurance
Description
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.
Time Frame
Change between baseline and three months
Title
Lower body flexibility
Description
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.
Time Frame
Change between baseline and three months
Title
Upper body flexibility
Description
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.
Time Frame
Change between baseline and three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Kugel, OTD
Organizational Affiliation
Loma Linda University Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Occupational Therapy and Horticulture for Cancer Survivors With Chronic Pain

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