NCT03951922

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 16, 2019

Completed
23 days until next milestone

Study Start

First participant enrolled

June 8, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2020

Completed
Last Updated

March 13, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

April 16, 2019

Last Update Submit

March 12, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change between baseline and three months

Secondary Outcomes (5)

  • Lower body strength

    Change between baseline and three months

  • Upper body strength

    Change between baseline and three months

  • Endurance

    Change between baseline and three months

  • Lower body flexibility

    Change between baseline and three months

  • Upper body flexibility

    Change between baseline and three months

Study Arms (1)

Therapeutic Horticulture Group

EXPERIMENTAL

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

Interventions

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

Therapeutic Horticulture Group

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Uncontrolled seizure disorder
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Julie Kugel, OTD

    Loma Linda University Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program director of Occupational Therapy Doctorate Program

Study Record Dates

First Submitted

April 16, 2019

First Posted

May 16, 2019

Study Start

June 8, 2019

Primary Completion

November 23, 2019

Study Completion

February 10, 2020

Last Updated

March 13, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations