Therapeutic horticulture for well-being and stress in people with cancer

ISRCTN	ISRCTN12004576
DOI	https://doi.org/10.1186/ISRCTN12004576
Ethics committee trial registration number (Comitato Etico della Romagna, CET-CEROM)	3826
Horizon Europe (GreenME project) number	101084198
Protocol Code	3354
UK Research and Innovation (UKRI) number	10082340
Sponsor	University of Bologna
Funders	HORIZON EUROPE Framework Programme, UK Research and Innovation

Submission date: 09/11/2026
Registration date: 13/11/2026
Last edited: 13/11/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Marta Bernile
Principal investigator, Scientific

Department of Agricultural and Food Sciences (DISTAL), University of Bologna, Viale Fanin 44
Bologna
40127
Italy

Phone	+393891831163
Email	marta.bernile2@unibo.it

Prof Giuseppina Pennisi
Scientific, Public

Department of Agricultural and Food Sciences (DISTAL), University of Bologna, Viale Fanin 44
Bologna
40127
Italy

Phone	+393933795999
Email	giuseppina.pennisi@unibo.it

Study information

Primary study design	Interventional
Allocation	N/A: single arm study
Masking	Open (masking not used)
Control	Uncontrolled
Assignment	Single
Purpose	Supportive care
Scientific title	Evaluation of the effects of a therapeutic horticulture program on well-being and stress levels in cancer patients: a non-pharmacological interventional pilot study
Study objectives	Primary objective: To evaluate changes in the general well-being of cancer patients following participation in a therapeutic horticulture program at the IOR PRIME Center (Cesena, Italy) Secondary objectives: 1. To evaluate changes in salivary cortisol levels, as an indirect measure of stress, following therapeutic horticulture activities 2. To evaluate the feasibility of therapeutic horticulture in an oncology setting as delivered at the PRIME Center 3. To explore the relationship between self-assessed well-being and salivary cortisol levels 4. To explore the measures in relation to the type of horticultural activity performed in each session
Ethics approval(s)	Approved 20/02/2025, Territorial Ethics Committee for the Romagna Wide Area (Comitato Etico Territoriale Area Vasta Romagna (CET-CEROM)) (c/o IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori", Via Piero Maroncelli 40/42, Meldola, 47014, Italy; +39 0543 739941; segreteriascientifica.ceav@irst.emr.it), ref: 849/2025
Health condition(s) or problem(s) studied	Psychological well-being and stress in adults with cancer (any type and stage) receiving integrative oncology care
Intervention	Participants take part in a therapeutic horticulture program consisting of four weekly group sessions of two hours each over one month, delivered in the outdoor garden of the IOR PRIME Center and led by an agronomist trained in therapeutic horticulture in collaboration with a psychologist. Activities include sowing, transplanting, manual weeding, irrigation, harvesting, and plant propagation, with pre-planned alternatives (including indoor activities using natural materials) chosen according to weather conditions and participants’ needs. Each session includes an introduction, a practical activity phase, and a closing/reflection moment. Participants are offered an optional experiential journal. The program is delivered in repeated cycles, and participants may join subsequent cycles. Assessments include the self-assessment of well-being and salivary cortisol sampling before and after each session, salivary cortisol reference samples collected at home on the three days before the program, and the Psychological General Well-Being Index (PGWBI), Connectedness to Nature Scale (CNS), and “Pollice Verde” questionnaire at baseline and after the program.
Intervention type	Behavioural
Primary outcome measure(s)	Self-assessed general well-being measured using a single-item self-assessment on a 6-point facial scale (lower scores indicate better well-being) at immediately before and after each of the four weekly therapeutic horticulture sessions Psychological general well-being measured using the Psychological General Well-Being Index (PGWBI), 22 items, Italian version, at baseline (within seven days before the first session) and at the final consultation after the four-session program Connectedness to nature measured using the Connectedness to Nature Scale (CNS), Italian version, 5-point Likert scale, at baseline and at the final consultation after the four-session program Gardening experience, attitudes and perceived benefits measured using the "Pollice Verde" questionnaire (15 items, non-validated) at baseline and at the final consultation after the four-session program
Key secondary outcome measure(s)	Salivary cortisol concentration (indirect measure of stress) measured using an electrochemiluminescence immunoassay at immediately before and after each of the four sessions; reference samples at 10:00 and 12:00 on each of the three days before the program Feasibility of the therapeutic horticulture program, measured using the number of sessions attended relative to the number of sessions offered; recruitment, retention and completeness of data collection were also recorded, throughout the four-session program, and collected at the end of the study
Completion date	31/03/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	15
Total final enrolment	7
Key inclusion criteria	1. Adults aged 18 years or older 2. Diagnosis of cancer 3. Able to provide written informed consent
Key exclusion criteria	Eastern Cooperative Oncology Group (ECOG) Performance Status ≥3
Date of first enrolment	02/04/2025
Date of final enrolment	03/10/2025

Locations

Countries of recruitment

Italy

Study participating centre

IOR PRIME Center

Via San Cristoforo 4200
Cesena (FC)
47522
Italy

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan	Anonymized individual participant data will be deposited in AMS Acta (https://amsacta.unibo.it/), the institutional open access repository of the University of Bologna, upon publication of the study results. Before deposit, data are available from the corresponding author (Giuseppina Pennisi, giuseppina.pennisi@unibo.it) upon reasonable request. Data sharing complies with participants’ informed consent and applicable data protection regulations.

Individual participant data (IPD) Intention to share

Yes

IPD sharing plan

Anonymized individual participant data will be deposited in AMS Acta (https://amsacta.unibo.it/), the institutional open access repository of the University of Bologna, upon publication of the study results. Before deposit, data are available from the corresponding author (Giuseppina Pennisi, giuseppina.pennisi@unibo.it) upon reasonable request. Data sharing complies with participants’ informed consent and applicable data protection regulations.

Editorial Notes

09/11/2026: Study’s existence confirmed by the Territorial Ethics Committee for the Romagna Wide Area (Comitato Etico Territoriale Area Vasta Romagna (CET-CEROM)), Italy.