Impact of a Personalized Empowerment Program on Patients with Gastrointestinal Cancer

Investigating the Impact of a Personalized Empowerment Program with an Artificial Intelligence Agent on Symptom Management, Self-Efficacy, Patient Activation, Anxiety, and Depression in Patients with Gastrointestinal Cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220728055574N2

Enrollment

Registered

2026-01-21

Start date

2026-04-21

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with gastrointestinal cancer. Malignant neoplasm of ill-defined sites within the digestive system

Interventions

Intervention 1: Control group: These patients will not receive any intervention from the researcher and, after the initial session, will receive routine care during chemotherapy for gastrointestinal c

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Medical diagnosis of stage 1, 2, or 3 gastrointestinal cancer more than one month ago Undergoing chemotherapy during the study period Patient's awareness of their disease Ability to read and write Persian language Ability to communicate Access and ability to use smart phone Absence of diagnosed mental and cognitive disorders Absence of any other serious illness, including serious cardiovascular and neurological diseases

Exclusion criteria

Exclusion criteria: Patient entry into the acute phase of the disease Being unable to continue study Unwillingness to cooperation in the empowerment program

Design outcomes

Primary

Measure	Time frame
Symptom management. Timepoint: Before the intervention and immediately after the intervention (12th week). Method of measurement: Edmonton Symptom Assessment System (ESAS).;Self-efficacy. Timepoint: Before the intervention and immediately after the intervention (12th week). Method of measurement: Self-Efficacy for Managing Chronic Disease 6-item Scale _ General (SES6G).;Patient activation. Timepoint: Before the intervention and immediately after the intervention (12th week). Method of measurement: Patient Activation Measure 13-item (PAM-13).	—

Measure

Time frame

Symptom management. Timepoint: Before the intervention and immediately after the intervention (12th week). Method of measurement: Edmonton Symptom Assessment System (ESAS).;Self-efficacy. Timepoint: Before the intervention and immediately after the intervention (12th week). Method of measurement: Self-Efficacy for Managing Chronic Disease 6-item Scale _ General (SES6G).;Patient activation. Timepoint: Before the intervention and immediately after the intervention (12th week). Method of measurement: Patient Activation Measure 13-item (PAM-13).

—

Secondary

Measure	Time frame
Anxiety. Timepoint: Before the intervention and immediately after the intervention (12th week). Method of measurement: Hospital Anxiety and Depression Scale (HADS).;Depression. Timepoint: Before the intervention and immediately after the intervention (12th week). Method of measurement: Hospital Anxiety and Depression Scale (HADS).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Khanipour-Kencha

Tehran University of Medical Sciences

ali.khanipour76@gmail.com+98 21 6105 4000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026