Back to resultsNew Food Solutions for Cancer Patients (Oncofood)
Primary Purpose
Cancer Patients, Taste Disorders, Food Selection
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Texture-modified foods for cancer patients (Stage 2)
Taste-optimised foods for cancer patients (Stage 3)
Sponsored by
About this trial
This is an interventional other trial for Cancer Patients focused on measuring taste & smell alterations, texture-modified foods, taste-optimised foods, cancer patients
Eligibility Criteria
Inclusion Criteria:
Stage 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.
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.
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.
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).
Sites / Locations
- Sensory Science Centre, Department of Food and Nutritional Sciences, University of Reading
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Stage 1: Interviews and focus group sessions
Stage 2: Texture-modified foods for cancer patients
Stage 3: Taste-optimised foods for cancer patients
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Acceptability of developed texture-modified food 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
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
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 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
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".
Acceptability of developed taste-optimised food 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".
Secondary Outcome Measures
Food diary
Record of all that is eaten or drunk and any problems encountered during/after eating from cancer patients and relatives/caregivers of cancer patients.
Interviews
Discussion on food related issues faced by cancer patients requiring texture-modified diets / having taste & smell alterations via interviews.
Focus group
Discussion on food related issues faced by cancer patients requiring texture-modified diets / having taste & smell alterations with relatives/caregivers of cancer patients via a focus group session.
Focus group
Discussion on food related issues faced by cancer patients requiring texture-modified diets / having taste & smell alterations with healthcare professionals of cancer patients via a focus group session.
Full Information
NCT ID
NCT04302792
First Posted
February 28, 2020
Last Updated
June 11, 2021
Sponsor
University of Reading
Collaborators
AZTI Spain, Maspex Poland, Natural Machines Spain, University of Warsaw
1. Study Identification
Unique Protocol Identification Number
NCT04302792
Brief Title
New Food Solutions for Cancer Patients
Acronym
Oncofood
Official Title
Oncofood: New Food Solutions for Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 9, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Reading
Collaborators
AZTI Spain, Maspex Poland, Natural Machines Spain, University of Warsaw
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Patients, Taste Disorders, Food Selection
Keywords
taste & smell alterations, texture-modified foods, taste-optimised foods, cancer patients
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
Participant
Masking Description
All samples provided to the participant are labelled with 3 digit random codes.
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stage 1: Interviews and focus group sessions
Arm Type
No Intervention
Arm Description
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.
Arm Title
Stage 2: Texture-modified foods for cancer patients
Arm Type
Experimental
Arm Description
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.
Arm Title
Stage 3: Taste-optimised foods for cancer patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Texture-modified foods for cancer patients (Stage 2)
Intervention Description
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
Intervention Name(s)
Taste-optimised foods for cancer patients (Stage 3)
Intervention Description
Participants (cancer patients with taste & smell alterations) will be expected to evaluate three foods at home over a period of one month.
Primary Outcome Measure Information:
Title
Acceptability of developed texture-modified food 1
Description
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".
Time Frame
1 hour on Stage 2 visit day 1
Title
Acceptability of developed texture-modified food 2
Description
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".
Time Frame
1 hour on Stage 2 visit day 2
Title
Acceptability of developed texture-modified food 3
Description
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".
Time Frame
1 hour on Stage 2 visit day 3
Title
Acceptability of developed taste-optimised food 1
Description
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".
Time Frame
1 hour on Stage 3 visit day 1
Title
Acceptability of developed taste-optimised food 2
Description
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".
Time Frame
1 hour on Stage 3 visit day 2
Title
Acceptability of developed taste-optimised food 3
Description
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".
Time Frame
1 hour on Stage 3 visit day 3
Secondary Outcome Measure Information:
Title
Food diary
Description
Record of all that is eaten or drunk and any problems encountered during/after eating from cancer patients and relatives/caregivers of cancer patients.
Time Frame
7 consecutive days
Title
Interviews
Description
Discussion on food related issues faced by cancer patients requiring texture-modified diets / having taste & smell alterations via interviews.
Time Frame
1 hour session on Stage 1 visit day 1
Title
Focus group
Description
Discussion on food related issues faced by cancer patients requiring texture-modified diets / having taste & smell alterations with relatives/caregivers of cancer patients via a focus group session.
Time Frame
2 hour session on Stage 1 visit day 2
Title
Focus group
Description
Discussion on food related issues faced by cancer patients requiring texture-modified diets / having taste & smell alterations with healthcare professionals of cancer patients via a focus group session.
Time Frame
2 hour session on Stage 1 visit day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage 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.
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.
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.
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stella Lignou, PhD
Organizational Affiliation
University of Reading
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sensory Science Centre, Department of Food and Nutritional Sciences, University of Reading
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG6 6AP
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No personal identification data will be shared. The study is not under an obligation to share data, however it is possible that some of the individual (unliked / non identifiable) data will be useful in a meta analysis and, hence sharing individual participant data (IPD) will be considered.
Citations:
PubMed Identifier
29168190
Citation
Tueros I, Uriarte M. Innovative food products for cancer patients: future directions. J Sci Food Agric. 2018 Mar;98(5):1647-1652. doi: 10.1002/jsfa.8789. Epub 2017 Dec 6.
Results Reference
background
PubMed Identifier
10337648
Citation
Wickham RS, Rehwaldt M, Kefer C, Shott S, Abbas K, Glynn-Tucker E, Potter C, Blendowski C. Taste changes experienced by patients receiving chemotherapy. Oncol Nurs Forum. 1999 May;26(4):697-706.
Results Reference
background
PubMed Identifier
16114007
Citation
Lovell SJ, Wong HB, Loh KS, Ngo RY, Wilson JA. Impact of dysphagia on quality-of-life in nasopharyngeal carcinoma. Head Neck. 2005 Oct;27(10):864-72. doi: 10.1002/hed.20250.
Results Reference
background
PubMed Identifier
29855774
Citation
Amezaga J, Alfaro B, Rios Y, Larraioz A, Ugartemendia G, Urruticoechea A, Tueros I. Assessing taste and smell alterations in cancer patients undergoing chemotherapy according to treatment. Support Care Cancer. 2018 Dec;26(12):4077-4086. doi: 10.1007/s00520-018-4277-z. Epub 2018 May 31.
Results Reference
background
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New Food Solutions for Cancer Patients
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