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Clinical Trials/NCT04302792
NCT04302792CompletedNot Applicable

Oncofood: New Food Solutions for Cancer Patients

University of Reading2 sites in 1 country88 target enrollmentStarted: June 9, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
88
Locations
2
Primary Endpoint
Acceptability of developed texture-modified food 1

Study Overview

Brief Summary

The ONCOFOOD project aims to design and develop new innovative food solutions for cancer patients, taking into account not only their nutritional requirements but also their sensory changes, promoting eating pleasure and preventing malnutrition. Research involving cancer patients but also their families and health care professionals is a key element of this approach to ensure the success of the developed products for the target group.

Detailed Description

The study will be divided into three stages: in Stage 1, individual interviews will be conducted with present and past cancer patients, focus groups with families/care givers of cancer patients and health care professionals (cancer specialist nurses, clinical and medical oncologists, speech and language therapists, dietitians, oncology social workers and counselors). The interviews will help collect data and gain understanding on the needs of cancer patients, barriers to current food proposals and expectations from new solutions. In subsequent stages, semi-quantitative studies will be conducted with cancer patients that require texture-modified foods (Stage 2) and patients with taste & smell alterations (Stage 3). Patients will be required to evaluate texture-modified products (developed using 3D food printing technology) and taste-optimised products (i.e. soups, mousses, fruit and vegetable beverages, dairy desserts and seasonings) developed based on the results obtained from Stage 1 above.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Single (Participant)

Masking Description

All samples provided to the participant are labelled with 3 digit random codes.

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Group A - Patients
  • Adults 18-65 years old.
  • Currently undergoing oncological treatment or have undergone oncological treatment in the last 12 months.
  • Patients that require or have required texture-modified foods and/ or experience or have experienced taste & smell alterations in the last 12 months.
  • Group B - Relatives and caregivers
  • Over 18 years old.
  • Relative or caregiver of an adult oncological patient (that require texture-modified foods and/ or experience taste & smell alterations).
  • Living/caring for someone that is currently undergoing or have undergone oncological treatment.
  • Participates actively in cooking and buying food for a household of which the person currently undergoing oncological treatment is a member.
  • Group C - Healthcare professionals
  • Dietitians, speech and language therapists, medical/clinical oncologists, cancer specialist nurses, and oncology social workers and counselors.
  • Minimum of a year's experience with oncological patients that require texture-modified foods and/or having taste & smell alterations.
  • Adults 18-65 years old.
  • Currently undergoing oncological treatment or have undergone oncological treatment in the last 12 months and require or have required texture-modified foods in the last 12 months.
  • Individuals without dietary allergies or intolerances to the foods that will be tested in the study.
  • Adults 18-65 years old.
  • Currently undergoing oncological treatment or have undergone oncological treatment in the last 12 months and are experiencing or have experienced taste & smell alterations in the last 12 months.
  • Individuals without dietary allergies or intolerances to the foods that will be tested in the study.

Exclusion Criteria

  • Individuals below 18 years old will be excluded from the study.
  • Individuals with dietary intolerances or allergies to the foods that will be tested in the study (Stages 2 and 3 only).
  • Individuals who do not have the ability or capacity to consent.
  • Individuals who are nil by mouth or have nasal gastric tubes of other feeding tubes inserted.
  • Individuals who need modified solid and liquid diets due to problems with swallowing (Stage 3 only).

Outcomes

Primary Outcomes

Acceptability of developed texture-modified food 1

Time Frame: 1 hour on Stage 2 visit day 1

Acceptability of texture-modified food 1 using a questionnaire. Participants will be asked to rate their liking of appearance, aroma, taste, texture and overall using a 9-point hedonic scale where 1 is "dislike extremely" and 9 is "like extremely". They will also be asked to indicate their preference in comparison to usual products using a 5-point scale where 1 is "I much preferred this product to my usual products" and 5 is "I much prefer my usual products to this one". They will be asked to indicate whether they would buy this product using a 5-point scale where 1 is "definitely would buy" and 5 is "definitely would not buy".

Acceptability of developed texture-modified food 2

Time Frame: 1 hour on Stage 2 visit day 2

Acceptability of texture-modified food 2 using a questionnaire. Participants will be asked to rate their liking of appearance, aroma, taste, texture and overall using a 9-point hedonic scale where 1 is "dislike extremely" and 9 is "like extremely". They will also be asked to indicate their preference in comparison to usual products using a 5-point scale where 1 is "I much preferred this product to my usual products" and 5 is "I much prefer my usual products to this one". They will be asked to indicate whether they would buy this product using a 5-point scale where 1 is "definitely would buy" and 5 is "definitely would not buy".

Acceptability of developed texture-modified food 3

Time Frame: 1 hour on Stage 2 visit day 3

Acceptability of texture-modified food 3 using a questionnaire. Participants will be asked to rate their liking of appearance, aroma, taste, texture and overall using a 9-point hedonic scale where 1 is "dislike extremely" and 9 is "like extremely". They will also be asked to indicate their preference in comparison to usual products using a 5-point scale where 1 is "I much preferred this product to my usual products" and 5 is "I much prefer my usual products to this one". They will be asked to indicate whether they would buy this product using a 5-point scale where 1 is "definitely would buy" and 5 is "definitely would not buy".

Acceptability of developed taste-optimised food 3

Time Frame: 1 hour on Stage 3 visit day 3

Acceptability of taste-optimised food 3 using a questionnaire. Participants will be asked to rate their liking of appearance, aroma, taste, texture and overall using a 9-point hedonic scale where 1 is "dislike extremely" and 9 is "like extremely". They will also be asked to indicate their preference in comparison to usual products using a 5-point scale where 1 is "I much preferred this product to my usual products" and 5 is "I much prefer my usual products to this one". They will be asked to indicate whether they would buy this product using a 5-point scale where 1 is "definitely would buy" and 5 is "definitely would not buy".

Acceptability of developed taste-optimised food 1

Time Frame: 1 hour on Stage 3 visit day 1

Acceptability of taste-optimised food 1 using a questionnaire. Participants will be asked to rate their liking of appearance, aroma, taste, texture and overall using a 9-point hedonic scale where 1 is "dislike extremely" and 9 is "like extremely". They will also be asked to indicate their preference in comparison to usual products using a 5-point scale where 1 is "I much preferred this product to my usual products" and 5 is "I much prefer my usual products to this one". They will be asked to indicate whether they would buy this product using a 5-point scale where 1 is "definitely would buy" and 5 is "definitely would not buy".

Acceptability of developed taste-optimised food 2

Time Frame: 1 hour on Stage 3 visit day 2

Acceptability of taste-optimised food 2 using a questionnaire. Participants will be asked to rate their liking of appearance, aroma, taste, texture and overall using a 9-point hedonic scale where 1 is "dislike extremely" and 9 is "like extremely". They will also be asked to indicate their preference in comparison to usual products using a 5-point scale where 1 is "I much preferred this product to my usual products" and 5 is "I much prefer my usual products to this one". They will be asked to indicate whether they would buy this product using a 5-point scale where 1 is "definitely would buy" and 5 is "definitely would not buy".

Secondary Outcomes

  • Food diary(7 consecutive days)
  • Interviews(1 hour session on Stage 1 visit day 1)
  • Focus group(2 hour session on Stage 1 visit day 3)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Stella Lignou

Lecturer in Sensory and Consumer Science

University of Reading

Study Sites (2)

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