New Food Solutions for Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-09

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cancer Patients Taste Disorders Food Selection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a 3 stage study design. The first stage will be a qualitative part with interviews and focus group sessions. In the second and third stages participants will evaluate food products. The second and third stages of the study will be conducted single blind as it is not feasible to blind the researcher.

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

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

Study Groups

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Stage 1: Interviews and focus group sessions

Group A: Cancer patients (requiring or have required texture-modified foods and/or experiencing or have experienced taste\&smell alterations in the last 12 months) will be required to attend a one-hour online interview.

Group B: Relatives of cancer patients (requiring texture-modified foods and/or experiencing taste\&smell alterations) will be required to attend a 2-hour online focus group session.

Group C: Healthcare professionals with a minimum of a year's experience with oncological patients that require texture-modified foods and/or have taste \& smell alteration will be required to attend a 2-hour online focus group session.

A food diary will be given to Group A and B to complete for 7-days prior to their session. Topics to be discussed during the interview and the focus group sessions will include the food requirements of cancer patients, the barriers of the current food products, possible solutions to these requirements if any and their expectations towards new food solutions.

Group Type NO_INTERVENTION

No interventions assigned to this group

Stage 2: Texture-modified foods for cancer patients

The study will involve conducting a tasting trial over a 2-weeks period where participants will be required to consume a maximum of three 3D printed texture-modified food based on the findings from Stage 1 and evaluate the food product by completing a structured questionnaire. Key questions areas covered by the questionnaire include appetite, sensory characteristics of the product (taste, flavour, mouthfeel/texture and smell), liking and acceptability, purchase intent and best place to buy the products; questions will involve rating scales as well as qualitative comments.

Group Type EXPERIMENTAL

Texture-modified foods for cancer patients (Stage 2)

Intervention Type BEHAVIORAL

Participants (cancer patients that require texture-modified foods) will be expected to evaluate a maximum of three meals over a 2-weeks period.

Stage 3: Taste-optimised foods for cancer patients

The study will involve conducting a home test over a one-month period where participants will be required to consume taste-optimised products based on the findings from Stage 1 and evaluate the food product by completing a structured questionnaire. Key questions areas covered by the questionnaire include appetite, sensory characteristics of the product (taste, flavour, mouthfeel/texture and smell), liking and acceptability, purchase intent and best place to buy the products; questions will involve rating scales as well as qualitative comments.

Group Type EXPERIMENTAL

Taste-optimised foods for cancer patients (Stage 3)

Intervention Type BEHAVIORAL

Participants (cancer patients with taste \& smell alterations) will be expected to evaluate three foods at home over a period of one month.

Interventions

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Texture-modified foods for cancer patients (Stage 2)

Participants (cancer patients that require texture-modified foods) will be expected to evaluate a maximum of three meals over a 2-weeks period.

Intervention Type BEHAVIORAL

Taste-optimised foods for cancer patients (Stage 3)

Participants (cancer patients with taste \& smell alterations) will be expected to evaluate three foods at home over a period of one month.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Stage 1

1. 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.
2. 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.
3. 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.
2. Stage 2

* 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.
3. Stage 3

* 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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No