Telehealth for the Self-Management of Dietary Quality of Life in Patients After Stomach Cancer Surgery

City of Hope

Status: Active, not recruiting

Conditions: Gastric Carcinoma; Gastroesophageal Junction Adenocarcinoma

Treatments: Other: Questionnaire Administration; Other: Telemedicine Visit; Other: Best Practice

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05203627

19220

P30CA033572 (U.S. NIH Grant/Contract)

NCI-2021-12909 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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53 participants in 2 patient groups

Arm I (telehealth session, guidebook)

Experimental group

Description:

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

Treatment:

Other: Telemedicine Visit

Other: Questionnaire Administration

Arm II (standard nutritional support)

Active Comparator group

Description:

Patients receive standard nutritional support.

Treatment:

Other: Best Practice

Other: Questionnaire Administration