NCT05648604

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 2, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

May 4, 2025

Status Verified

April 1, 2025

Enrollment Period

1.9 years

First QC Date

November 18, 2022

Last Update Submit

April 30, 2025

Conditions

MelanomaCancer SurvivorshipSkin CancerBasal Cell CarcinomaSquamous Cell CarcinomaMelanoma (Skin)

Keywords

NutritionUVPhysical ActivityGardening

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • UV Exposure

    6 months

  • Fruit and Vegetable Servings

    6 months

  • Total sedentary time

    6 months

Other Outcomes (2)

  • Health Related Quality of Life (HR-QOL)

    6 months

  • Average acceptability of intervention

    6 months

Study Arms (1)

Mentored Community Gardening

EXPERIMENTAL

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

Interventions

Mentored Community GardeningBEHAVIORAL

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.

Mentored Community Gardening

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Related Publications (1)

  • Skiba MB, Miller D, Stratton DB, Hall CA, McKenna S, Blair CK, Demark-Wahnefried W. Adaptation and study protocol for harvest for health together Arizona: A mentored community garden intervention for survivors of cancer. Contemp Clin Trials Commun. 2024 Mar 28;39:101290. doi: 10.1016/j.conctc.2024.101290. eCollection 2024 Jun.

    PMID: 38595771BACKGROUND

MeSH Terms

Conditions

MelanomaSkin NeoplasmsCarcinoma, Basal CellCarcinoma, Squamous CellMotor Activity

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Basal CellNeoplasms, Squamous CellBehavior

Study Officials

  • Meghan B Skiba, PhD

    University of Arizona College of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 18, 2022

First Posted

December 13, 2022

Study Start

February 2, 2023

Primary Completion

December 15, 2024

Study Completion

December 15, 2024

Last Updated

May 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)