Mentored Community Gardening for Individuals With Skin Cancer

Melanoma Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05648604
• Other study ID #: 00002169
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: University of Arizona
• Contact: Meghan B Skiba, PhD
• Phone: 5206219036
• Email: mbskiba[@]arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Cancer Survivorship
• Carcinoma
• Carcinoma, Basal Cell
• Melanoma
• Melanoma (Skin)
• Skin Cancer
• Skin Neoplasms
• Squamous Cell Carcinoma

Intervention

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.

Locations

Country	Name	City	State
United States	University of Arizona Cancer Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	Banner University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health Related Quality of Life (HR-QOL)	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
Other	Average acceptability of intervention	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
Primary	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.	6 months
Secondary	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)]	6 months
Secondary	Fruit and Vegetable Servings	Dietary fruit and vegetable intake (average total servings/day) assessed by 24-hour dietary recall	6 months
Secondary	Total sedentary time	Sedentary time (inactive minutes/day) measured by accelerometer (Actigraph Link GT9X)	6 months