Clinical trial NCT05203627: Telehealth for the Self-Management of Dietary Quality of Life in Patients After Stomach Cancer Surgery
Official title: Telehealth Intervention for Self-Management of Dietary Quality of Life After Gastric Cancer Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gastric Carcinoma
Gastroesophageal Junction Adenocarcinoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-01-24
Enrollment: 53
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial test whether taking part in a diet support intervention will help with patients nutrition and quality of life after surgery for esophagus or stomach cancer. The information learned by doing this research study may help patients get more information and/or support on eating after esophagus and stomach cancer surgery.

Detailed description: PRIMARY OBJECTIVES:

I. Assess the feasibility, retention, and satisfaction of the Telehealth Intervention for Self-Management of Eating after Gastric Surgery (TIMES) intervention as measured by the percentage of patients who a) agree to participate; b) complete a majority of the intervention (at least 2 sessions); and c) report satisfaction with the intervention (through structured exit interviews).

II. Assess the preliminary efficacy of TIMES for patient reported outcomes for quality of life (QOL), dietary symptoms, and self-management.

III. Assess the preliminary efficacy of TIMES for objective measures of patient nutrition.

OUTLINE: Patients are randomized in to 1 of 2 arms.

ARM I: Patients receive 4 telehealth sessions over 1 hour each over 4 months. Patients also receive an intervention guidebook.

ARM II: Patients receive standard nutritional support.

After completion of study, patients are followed up for 6 months.

Eligibility criteria: Inclusion Criteria:

* The ability to understand English or Spanish.
* Undergone curative intent surgery for gastric or gastroesophageal (GE) junction cancer.
* Began oral intake within the past month.
* Aged 21 years and older.
* Able to participate in telehealth sessions.
* This study will be conducted in patients aged 21 years or older who have undergone curative intent surgery for gastric or GE junction cancer.
* Age criterion for this trial is based on the National Institute of Health (NIH')s age criteria, which defines an adult as individuals aged 21 years and over. There are no restrictions related to performance status or life expectancy.
* All subjects must have the ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.

Primary outcomes:
measure: Feasibility of the Telehealth Intervention - Percent Participation
timeFrame: Up to 6 months
measure: Feasibility of the Telehealth Intervention - Percent Completion
timeFrame: Up to 6 months
measure: Retention of the TIMES intervention
timeFrame: Up to 6 months
measure: Satisfaction of the TIMES intervention
timeFrame: Up to 6 months
measure: Patient reported outcomes - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ30):
timeFrame: Up to 6 months
measure: Patient reported outcomes - EORTC-Oesophago-Gastric Cancer Module
timeFrame: Up to 6 months
measure: Patient reported outcomes - Patient Activation Measure (PAM)
timeFrame: Up to 6 months
measure: Patient reported outcomes - General Self-Efficacy Scale
timeFrame: Up to 6 months
measure: Patient reported outcomes - The Post-Gastrectomy Nutrition Questionnaire
timeFrame: Up to 6 months
measure: Objective measures of patient nutrition - Weight
timeFrame: Up to 6 months
measure: Objective measures of patient nutrition - Body Mass Index (BMI)
timeFrame: Up to 6 months
measure: Objective measures of patient nutrition - Albumin levels
timeFrame: Up to 6 months
measure: Objective measures of patient nutrition - Skeletal mass Index
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Jae Y Kim
role: PRINCIPAL_INVESTIGATOR
References: