Mentored Community Gardening for Individuals With Skin Cancer (H4H2-AZ)

April 30, 2025 updated by: Meghan Skiba, University of Arizona

An Adapted Evidenced-Based Mentored Community Gardening Intervention for Skin Cancer Survivors: A Single-Arm Feasibility Study (Harvest for Health Together Arizona)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

29

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

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona Cancer Center

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mentored Community Gardening
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.
Behavioral: Mentored Community Gardening
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean number of scheduled sessions a participant attends during intervention
Time Frame: 6 months
Adherence will be measured by attendance to the number of sessions (including weekly gardening, meetings with mentors, and group workshops) a participant attends.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UV Exposure
Time Frame: 6 months
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)]
6 months
Fruit and Vegetable Servings
Time Frame: 6 months
Dietary fruit and vegetable intake (average total servings/day) assessed by 24-hour dietary recall
6 months
Total sedentary time
Time Frame: 6 months
Sedentary time (inactive minutes/day) measured by accelerometer (Actigraph Link GT9X)
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Related Quality of Life (HR-QOL)
Time Frame: 6 months
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.
6 months
Average acceptability of intervention
Time Frame: 6 months
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.
6 months

Collaborators and Investigators

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

Sponsor

University of Arizona

Collaborators

Banner University Medical Center

Investigators

  • Principal Investigator: Meghan B Skiba, PhD, University of Arizona College of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 2, 2023

Primary Completion (Actual)

December 15, 2024

Study Completion (Actual)

December 15, 2024

Study Registration Dates

First Submitted

November 18, 2022

First Submitted That Met QC Criteria

December 8, 2022

First Posted (Actual)

December 13, 2022

Study Record Updates

Last Update Posted (Actual)

May 4, 2025

Last Update Submitted That Met QC Criteria

April 30, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00002169

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

product manufactured in and exported from the U.S.

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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