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Trial Title:
Eating Experience at the Comprehensive Cancer Center Wards - a Qualitative Study
NCT ID:
NCT05614323
Condition:
Cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Interview and determining taste and smell with taste strips and Sniffin' Sticks
Description:
The Patient-Generated Subjective Global Assessment (PG-SGA) Short Form will be filled in
by the participants. Next, a semi-structured in-depth interview will be performed in a
quiet environment. The interview will take a maximum of one hour and will take place
once. Topics that will be discussed are eating-related problems, the taste and smell of
the offered hospital food, the choice in hospital food, the ambience during the eating
moments, the use of protein-enriched snacks, the difference between eating at home and at
the hospital, personal tips- and-tricks to maintain adequate nutritional intake, and how
patients' think that food enjoyment can be improved in the hospital. The interview will
be recorded. At last, taste and smell will be objectively determined with respectively
taste strips and Sniffin' Sticks.
Summary:
In hospitalized patients with cancer treated with systemic therapy, semi-structured
in-depth interviews will be performed. Topics that will be discussed are eating-related
complaints, the taste and smell of the offered hospital food, the choice in hospital
food, the ambience during the eating moments, the use of protein-enriched snacks, the
difference between eating at home and at the hospital, and personal tips-and-tricks to
maintain adequate nutritional intake and improve food enjoyment in the hospital. Patients
will be included until data saturation is reached. The interviews will be recorded and
analyzed according to the principles of thematic analysis.
Detailed description:
This qualitative study will be performed in all patients with cancer admitted to the
Comprehensive Cancer Center (CCC) wards in the UMCG: medical oncology (D2) and hematology
(E2). Potential participants are identified by the medical oncologists and dietitians who
are part of the study team. Patients with pathologically confirmed diagnosis of all-types
of cancer, treated with systemic therapy will be included. These patients are contacted
during their hospital stay by their treating physician or nurse. They will introduce the
study to the patient and will ask the patient permission for a visit by the
investigators. The investigators will, when permission has been given, visit the patient
and inform the patient about the study. Patients have to be hospitalized more than two
days, as they will then have had multiple meals in a hospital environment.
Potential participants are given verbal information about the study and, if they are
interested, also written study information. The potential participants are contacted by
the investigators three days later for written informed consent, and setting a date for
the interview, possibly during hospitalization.
At the agreed date, first, the Patient-Generated Subjective Global Assessment (PG-SGA)
Short Form will be filled in by the participants. This questionnaire consists of four
questions regarding weight, food intake, symptoms and activities/function. Next, a
semi-structured in-depth interview will be performed in a quiet environment. The
interview will take a maximum of one hour and will take place once. Topics that will be
discussed are eating-related problems, the taste and smell of the offered hospital food,
the choice in hospital food, the ambience during the eating moments, the use of
protein-enriched snacks, the difference between eating at home and at the hospital,
personal tips-and-tricks to maintain adequate nutritional intake, and how patients' think
that food enjoyment can be improved in the hospital. The interview will be recorded. At
last, taste and smell will be objectively determined with respectively taste strips and
Sniffin' Sticks. Taste strips with an impregnated taste solution will be placed in the
participants' mouth. The taste solutions contain the basic tastes bitter, sweet, sour and
salty in four different concentrations, thus 16 tests will be performed. The strips will
randomly be administered and participants are asked which taste they notice. A right
answer gives one point and a total of 16 point can be obtained. Sniffin' Sticks are pens
filled with liquid odorants, which are presented to the participants' nose. Participants
will smell 16 different scents with an interval of minimal 30 seconds to prevent
desensitization. For each scent, participants will choose between four options from a
multiple choice card.
At last, the participants will be asked if topics were missed and if questions or topics
were clear and are asked if they can be contacted for future studies. After the
conversation, the background of the participant will be collected from the patients
electronic file, including stage and location of primary tumor, type and status of
treatment, duration of treatment, age, gender, days of hospitalization, current diet
(including tube feeding and drink feeding), weight (loss), and medical history affecting
taste, smell or mouthfeel.
Participants will be included until data saturation is reached, i.e., no new insights or
themes are reported by the participants (15-20 participants). By purposive sampling, a
varied group of participants will be included. Patients are excluded if contra-indication
for oral food intake exist or oral food intake is perceived as painful by the patient.
The interviews will be audio recorded, transcribed verbatim, and analyzed according to
the principles of thematic analysis, with Atlas-ti. The audio recordings will be saved on
the Research Drive of the UMCG and will be destroyed after transcribing. The baseline
characteristics will be saved in REDCap (Research Electronic Data Capture, Version
10.0.23), an application to support data capture in a safe web-based environment, hosted
by the UMCG.
Criteria for eligibility:
Study pop:
Patients with cancer admitted to the Comprehensive Cancer Center wards in the UMCG:
Medical Oncology and Hematology
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Pathologically confirmed diagnosis of cancer
- Able to understand spoken and written Dutch
- > 18 years
- Systemic treated for cancer in a clinical setting
Exclusion Criteria:
- Contra-indication for oral food intake
- Oral food intake perceived as painful by patient
- Uncertainty about the willingness or ability of the patient to comply with the
protocol requirements
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Medical Center Groningen
Address:
City:
Groningen
Zip:
9713 GZ
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Jacco J de Haan, MD, PhD
Phone:
+31 50 361 2821
Email:
j.j.de.haan@umcg.nl
Investigator:
Last name:
Jacco J de Haan, MD, PhD
Email:
Principal Investigator
Start date:
November 16, 2022
Completion date:
January 2025
Lead sponsor:
Agency:
University Medical Center Groningen
Agency class:
Other
Source:
University Medical Center Groningen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05614323