Back to resultsMentored Community Gardening for Individuals With Skin Cancer (H4H2-AZ)
Primary Purpose
Melanoma, Cancer Survivorship, Skin Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mentored Community Gardening
Sponsored by
About this trial
This is an interventional other trial for Melanoma focused on measuring Nutrition, UV, Physical Activity, Gardening
Eligibility Criteria
Inclusion Criteria: 18 years of age or older at their last birthday & in good general health. Clinical diagnosis of skin cancer (including in situ). Has access to a phone or tablet with a camera and internet. Currently living in Pima County Arizona. Ability to understand and speak English. Ability to provide written informed consent document. Ability to physically participate in gardening activities (including kneeling, sitting, bending, and carrying up to 10 pounds) with or without the use of mobility assistive devices. Exclusion Criteria: Currently immunosuppressed by virtue of medication or disease. Has a diagnosed and uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Sites / Locations
- University of Arizona Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mentored Community Gardening
Arm Description
This arm will consist of gardening at least once per week, meeting with a master gardener mentor bi-monthly, and attending a gardening informational workshop once monthly.
Outcomes
Primary Outcome Measures
Mean number of scheduled sessions a participant attends during intervention
Adherence will be measured by attendance to the number of sessions (including weekly gardening, meetings with mentors, and group workshops) a participant attends.
Secondary Outcome Measures
UV Exposure
Dosimeter (Scienterra) measured cumulative UV exposure [Units: Watts per square meter (W/m^2), UV Index (UVI), Standard Erythema Dose (SED), or Minimal Erythema Dose (MED)]
Fruit and Vegetable Servings
Dietary fruit and vegetable intake (average total servings/day) assessed by 24-hour dietary recall
Total sedentary time
Sedentary time (inactive minutes/day) measured by accelerometer (Actigraph Link GT9X)
Full Information
NCT ID
NCT05648604
First Posted
November 18, 2022
Last Updated
July 14, 2023
Sponsor
University of Arizona
Collaborators
Banner University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05648604
Brief Title
Mentored Community Gardening for Individuals With Skin Cancer
Acronym
H4H2-AZ
Official Title
An Adapted Evidenced-Based Mentored Community Gardening Intervention for Skin Cancer Survivors: A Single-Arm Feasibility Study (Harvest for Health Together Arizona)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona
Collaborators
Banner University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators will conduct a single-arm pilot feasibility trial of mentored community gardening for melanoma survivors integrating dosimeters and accelerometers. Harvest for Health Together Arizona (H4H2-AZ) is an evidence-based program adapted for arid desert gardening that also addresses sun safety through group workshops and peer education. The primary aim is to evaluate adherence to the intervention.
Detailed Description
In collaboration with Banner Health, University of Arizona Cancer Center, Community Gardens of Tucson, and UArizona Pima County Cooperative Extension Master Gardeners, the investigators will conduct a pilot feasibility study of community gardening in melanoma survivors integrating UV sensors. Harvest for Health Together Arizona (H4H2-AZ) is an evidence-based program adapted for arid desert gardening that also addresses sun safety through experiential workshops and education. The investigators propose to evaluate adherence to and acceptability of the intervention. The investigators aim to see if H4H2-AZ may improve cancer preventive health behaviors (including diet, physical activity, energy balance, and UV protection) and quality of life among melanoma survivors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Cancer Survivorship, Skin Cancer, Basal Cell Carcinoma, Squamous Cell Carcinoma, Melanoma (Skin)
Keywords
Nutrition, UV, Physical Activity, Gardening
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mentored Community Gardening
Arm Type
Experimental
Arm Description
This arm will consist of gardening at least once per week, meeting with a master gardener mentor bi-monthly, and attending a gardening informational workshop once monthly.
Intervention Type
Behavioral
Intervention Name(s)
Mentored Community Gardening
Intervention Description
This arm will consist of gardening at least once per week, meeting with a master gardening mentor twice monthly, and attending a gardening informational workshop once monthly.
Primary Outcome Measure Information:
Title
Mean number of scheduled sessions a participant attends during intervention
Description
Adherence will be measured by attendance to the number of sessions (including weekly gardening, meetings with mentors, and group workshops) a participant attends.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
UV Exposure
Description
Dosimeter (Scienterra) measured cumulative UV exposure [Units: Watts per square meter (W/m^2), UV Index (UVI), Standard Erythema Dose (SED), or Minimal Erythema Dose (MED)]
Time Frame
6 months
Title
Fruit and Vegetable Servings
Description
Dietary fruit and vegetable intake (average total servings/day) assessed by 24-hour dietary recall
Time Frame
6 months
Title
Total sedentary time
Description
Sedentary time (inactive minutes/day) measured by accelerometer (Actigraph Link GT9X)
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Health Related Quality of Life (HR-QOL)
Description
Functional Assessment of Cancer Therapy - Melanoma (FACT-M) is a melanoma specific questionnaire which will measure HR-QOL in participants. Items are measured on a 0-4 Likert scale.The FACT-M consists of 51 items with a total score ranging from 0-204. A higher score indicates better HR-QOL.
Time Frame
6 months
Title
Average acceptability of intervention
Description
Acceptability of intervention and sensors will be assessed using the Acceptability of Intervention Measure which includes 12 items on a 1-5 scale and summed. Scores range 12-60; higher scores reflect greater acceptability.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 years of age or older at their last birthday & in good general health.
Clinical diagnosis of skin cancer (including in situ).
Has access to a phone or tablet with a camera and internet.
Currently living in Pima County Arizona.
Ability to understand and speak English.
Ability to provide written informed consent document.
Ability to physically participate in gardening activities (including kneeling, sitting, bending, and carrying up to 10 pounds) with or without the use of mobility assistive devices.
Exclusion Criteria:
Currently immunosuppressed by virtue of medication or disease.
Has a diagnosed and uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meghan B Skiba, PhD
Phone
5206219036
Email
mbskiba@arizona.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dylan Miller, MPH
Phone
(480) 788-2549
Email
dylanmiller@arizona.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meghan B Skiba, PhD
Organizational Affiliation
University of Arizona College of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth McPeak, MPH
Phone
520-626-1155
Email
emcpeak@uacc.arizona.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Mentored Community Gardening for Individuals With Skin Cancer
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