Cancer SurvivorNCT03951922
Occupational Therapy and Horticulture for Cancer Survivors With Chronic Pain
A study testing Horticultural activity in people with Cancer Survivor and Chronic Pain, run by Loma Linda University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Cancer Survivor, Chronic Pain
- What is being tested?
- Horticultural activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2019to 10 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Uncontrolled seizure disorder
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cancer Survivor, Chronic Pain
- Being tested
- Horticultural activity
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horticultural activityBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Horticultural activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change between baseline and three months
Secondary outcomes (5)
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.
Measured: Change between baseline and three months
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.
Measured: Change between baseline and three months
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.
Measured: Change between baseline and three months
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.
Measured: Change between baseline and three months
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.
Measured: Change between baseline and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start8 Jun 2019
- Primary completion23 Nov 2019
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Kugel, Loma Linda University
- Investigators
- Julie Kugel, OTD, Principal investigator, Loma Linda University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951922
- Sponsor's protocol ID
- 5180419
- Status last verified
- Mar 2020
- First submitted
- 16 Apr 2019
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effect of Occupational Therapy and Horticulture for Cancer Survivors With Chronic Pain
- ClinicalTrials.gov ID
- NCT03951922
- Acronym / sponsor ID
- 5180419
- Conditions
- Cancer Survivor, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 8 Jun 2019 (actual)
- Primary completion
- 23 Nov 2019 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Horticulture Group | Experimental | Behavioral: Horticultural activityThe 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Uncontrolled seizure disorder
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Horticultural activityTherapeutic 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 | Behavioural | Therapeutic Horticulture Group |
Primary outcome
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.
5 secondary outcomes
Lower body strength
Time frame: Change between baseline and three months
Upper body strength
Time frame: Change between baseline and three months
Endurance
Time frame: Change between baseline and three months
Lower body flexibility
Time frame: Change between baseline and three months
Upper body flexibility
Time frame: Change between baseline and three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Kugel, OTD principal investigator
Loma Linda University Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Horticultural activity in people with Cancer Survivor and Chronic Pain, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary Cortisol Test (time frame: Change between baseline and three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2020.