MelanomaH4H2-AZNCT05648604
Mentored Community Gardening for Individuals With Skin Cancer
A study testing Mentored Community Gardening in people with Melanoma and Cancer Survivorship, run by University of Arizona at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma, Cancer Survivorship, Skin Cancer
- What is being tested?
- Mentored Community Gardening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2023to 15 Dec 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona Cancer Center
Tucson, Arizona, 85724
About this study
Official title: 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.
Read the 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.
- Conditions
- Melanoma, Cancer Survivorship, Skin Cancer, Basal Cell Carcinoma, Squamous Cell Carcinoma, Melanoma (Skin)
- Being tested
- Mentored Community Gardening
- Keywords
- Nutrition, UV, Physical Activity, Gardening
- Medical subject headings
- Melanoma, Skin Neoplasms, Carcinoma, Basal Cell, Carcinoma, Squamous Cell, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentored Community GardeningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mentored Community Gardening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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)]
Measured: 6 months
Fruit and Vegetable Servings
Dietary fruit and vegetable intake (average total servings/day) assessed by 24-hour dietary recall
Measured: 6 months
Total sedentary time
Sedentary time (inactive minutes/day) measured by accelerometer (Actigraph Link GT9X)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start2 Feb 2023
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Banner University Medical Center
- Responsible party
- Principal investigator, Meghan Skiba, University of Arizona
- Investigators
- Meghan B Skiba, PhD, Principal investigator, University of Arizona College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648604
- Sponsor's protocol ID
- 00002169
- Acronym
- H4H2-AZ
- Status last verified
- Apr 2025
- First submitted
- 18 Nov 2022
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38595771
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adapted Evidenced-Based Mentored Community Gardening Intervention for Skin Cancer Survivors: A Single-Arm Feasibility Study (Harvest for Health Together Arizona)
- ClinicalTrials.gov ID
- NCT05648604
- Acronym / sponsor ID
- H4H2-AZ / 00002169
- Conditions
- Melanoma, Cancer Survivorship, Skin Cancer, Basal Cell Carcinoma, Squamous Cell Carcinoma, Melanoma (Skin)
- Keywords
- Nutrition, UV, Physical Activity, Gardening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Banner University Medical Center
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 13 Dec 2022 (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 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mentored Community Gardening | Experimental | Behavioral: Mentored Community GardeningThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Mentored Community GardeningThis 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. | Behavioural | Mentored Community Gardening |
Primary outcome
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.
3 secondary outcomes
UV Exposure
Time frame: 6 months
Fruit and Vegetable Servings
Time frame: 6 months
Total sedentary time
Time frame: 6 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 4 May 2025.
- Background: PubMed 38595771Skiba 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.
- Individual participant dataSharing planned: No
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
Melanoma
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.
Meghan B Skiba, PhD principal investigator
University of Arizona College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mentored Community Gardening in people with Melanoma and Cancer Survivorship, run by University of Arizona 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 4 May 2025. 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?
Mean number of scheduled sessions a participant attends during intervention (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05648604, which also lists 1 linked publication.
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 4 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.