Head and Neck CancerPROMsNCT06662929
Arabic PRO Measures for Head and Neck Cancer Radiotherapy.
An observational study of Head and Neck Cancer and Head and Neck Neoplasms, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
The goal of Arabic patient-reported outcome measures during radiotherapy for head and neck cancer is to test the patient-reported outcome measure (PROM) tools. PROM tools are not validated cross-culturally in Arabic-speaking patient populations, which limits their use in our clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Radiation
- Type of treatment
- Surgery or procedure
- How many people
- 125 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 May 2023to 1 Oct 2025
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Target Population: The study is targeting males and females aged 18 years or above, and receiving radiotherapy for the HNC at the King Saud University Medical City.
Who may be able to join
- Adults aged 18 or above and who is planned for receiving and who is currently receiving and who had already received radiotherapy for the HNC at King Saud University Medical City.
Who cannot join
- Individuals who are less than 18 years, presence of debilitating disease (e.g. heart failure) or who lack the capacity to read, understand and sign the informed consent and those.
Trial locations and contacts
1 site in 1 country.
Saif A Aljabab, DABR contact
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Saud University Medical City
Riyadh
Abdullah M Alsoghier, PhD, +966114677423, aalsoghier@ksu.edu.sa
Saif M Aljabab, DABR, MBA, saljabab@ksu.edu.sa
About this study
Official title: Arabic Patient-reported Outcome Measures During Radiotherapy for Head and Neck Cancer: a Validation Study
The goal of Arabic patient-reported outcome measures during radiotherapy for head and neck cancer is to test the patient-reported outcome measure (PROM) tools. PROM tools are not validated cross-culturally in Arabic-speaking patient populations, which limits their use in our clinical setting. Validation of these PROM tools will allow clinicians to identify the concerns related to our patient population and measure the outcome of our interventions. Main objectives are:
- To further validate (cross-culture) the PROM instruments related to head and neck cancer (HNC) in Arabic patients.
- To investigate the prevalence and severity of the patient-reported concerns and their relevance with demographics and clinical characteristics.
The participants will be given tasks to complete 6 tools survey before, during, and after radiotherapy.
- Conditions
- Head and Neck Cancer, Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma, Oropharynx Cancer, Nasopharyngeal Cancer, Oral Cancer
- Being tested
- Radiation
- Keywords
- PROMs, Head and Neck Cancer, Radiotherapy, COSMIN, Cancer
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Oropharyngeal Neoplasms, Nasopharyngeal Neoplasms, Mouth Neoplasms, Tongue Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
Radiotherapy for the Head \& Neck Cancer
| Study group | Role | What they receive |
|---|---|---|
| Adult aged 18 years or above, and receiving radiotherapy for the HNC. | A non-interventional, questionnaire-based cross-sectional study for Arabic-speaking males and females, aged 18 years or above who is planned for receiving and who is currently receiving and who had already received radiotherapy for the Head \& Neck Cancer at King Saud University Medical City. Receives: Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summated Xerostomia Inventory (SXI)
The study aimed to assess the validity (face, content and construct) and reliability (internal consistency and test-retest) of this inventory in patients who received radiotherapy for head and neck cancer. These will be conducted in line with COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.
Measured: 24 months
Patient-Reported Oral Mucositis Symptom (PROM) scale
The study aimed to assess the validity (face, content and construct) and reliability (internal consistency and test-retest) of this inventory in patients who received radiotherapy for head and neck cancer. These will be conducted in line with COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.
Measured: 24 months
The Arabic University of Washington questionnaire (UW-QOL v4)
The study aimed to assess the validity (face, content and construct) and reliability (internal consistency and test-retest) of this inventory in patients who received radiotherapy for head and neck cancer. These will be conducted in line with COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.
Measured: 24 months
The Arabic Brief Fatigue Inventory (ArBFI)
The study aimed to assess the validity (face, content and construct) and reliability (internal consistency and test-retest) of this inventory in patients who received radiotherapy for head and neck cancer. These will be conducted in line with COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.
Measured: 24 months
Patient Concerns Inventory - Head and Neck (PCI-HNC)
The study aimed to assess the validity (face, content and construct) and reliability (internal consistency and test-retest) of this inventory in patients who received radiotherapy for head and neck cancer. These will be conducted in line with COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.
Measured: 24 months
Secondary outcomes (1)
To investigate the prevalence and severity of the patient-reported concerns and their relevance with demographics and clinical characteristics.
Descriptive statistics [frequencies with percentage (%) for categorical variables, and the mean (±SD) and median for numerical variables collected] will be used to for patients' demographic and clinical characteristics and study measures using SPSS v.22 (IBM, Armonk, New York). Level of significance will be set at or below 0.05. Correlations between study findings will be assessed using Pearson or Spearman's correlation coefficients - based on normality of data. Regression analyses for patient characteristics and measurement variables.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 May 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Mohamed Alsoghier, PhD, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662929
- Sponsor's protocol ID
- E-23-7571
- Acronym
- PROMs
- Status last verified
- Oct 2024
- First submitted
- 19 Oct 2023
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aguilar ML, Sandow P, Werning JW, Brenneman L, Psoter WJ. The Head and Neck Cancer Patient Concern Inventory(c) : Patient Concerns' Prevalence, Dental Concerns' Impact, and Relationships of Concerns with Quality of Life Measures. J Prosthodont. 2017 Apr;26(3):186-195. doi: 10.1111/jopr.12496. Epub 2017 Feb 21.
PubMed 28220985Alhazzazi TY, Alghamdi FT. Head and Neck Cancer in Saudi Arabia: a Systematic Review. Asian Pac J Cancer Prev. 2016;17(8):4043-8.
PubMed 27644659Alqaryan S, Aldrees T, Almatrafi S, Alharbi A, Alhumaid H. Awareness of head and neck cancers in Saudi Arabia. A questionnaire based study. Saudi Med J. 2020 Apr;41(4):400-405. doi: 10.15537/smj.2020.4.24990.
PubMed 32291427Berger AM, Abernethy AP, Atkinson A, Barsevick AM, Breitbart WS, Cella D, Cimprich B, Cleeland C, Eisenberger MA, Escalante CP, Jacobsen PB, Kaldor P, Ligibel JA, Murphy BA, O'Connor T, Pirl WF, Rodler E, Rugo HS, Thomas J, Wagner LI. NCCN Clinical Practice Guidelines Cancer-related fatigue. J Natl Compr Canc Netw. 2010 Aug;8(8):904-31. doi: 10.6004/jnccn.2010.0067. No abstract available.
PubMed 20870636Black N. Patient reported outcome measures could help transform healthcare. BMJ. 2013 Jan 28;346:f167. doi: 10.1136/bmj.f167.
PubMed 23358487Catania G, Bell C, Ottonelli S, Marchetti M, Bryce J, Grossi A, Costantini M. Cancer-related fatigue in Italian cancer patients: validation of the Italian version of the Brief Fatigue Inventory (BFI). Support Care Cancer. 2013 Feb;21(2):413-9. doi: 10.1007/s00520-012-1539-z. Epub 2012 Jul 13.
PubMed 22790224Cruz FM, Munhoz BA, Alves BC, Gehrke FS, Fonseca FL, Kuniyoshi RK, Cubero D, Peppone LJ, Del Giglio A. Biomarkers of fatigue related to adjuvant chemotherapy for breast cancer: evaluation of plasma and lymphocyte expression. Clin Transl Med. 2015 Feb 14;4:4. doi: 10.1186/s40169-015-0051-8. eCollection 2015.
PubMed 25852820Dirix P, Nuyts S, Van den Bogaert W. Radiation-induced xerostomia in patients with head and neck cancer: a literature review. Cancer. 2006 Dec 1;107(11):2525-34. doi: 10.1002/cncr.22302.
PubMed 17078052Hamilton SN, Tran E, Ho C, Berthelet E, Wu J, DeVries K, LaPointe V, Bowman A, Lagman M, Olson R. Patient-reported outcome measures in patients undergoing radiotherapy for head and neck cancer. Support Care Cancer. 2021 May;29(5):2537-2547. doi: 10.1007/s00520-020-05778-2. Epub 2020 Sep 19.
PubMed 32949298Kanatas A, Lowe D, Rogers SN. Health-related quality of life at 3 months following head and neck cancer treatment is a key predictor of longer-term outcome and of benefit from using the patient concerns inventory. Cancer Med. 2022 Apr;11(8):1879-1890. doi: 10.1002/cam4.4558. Epub 2022 Feb 17.
PubMed 35178880Kingsley C, Patel S. Patient-reported outcome measures and patient-reported experience measures. BJA Education. 2017;17(4):137-44.
Kushner JA, Lawrence HP, Shoval I, Kiss TL, Devins GM, Lee L, Tenenbaum HC. Development and validation of a Patient-Reported Oral Mucositis Symptom (PROMS) scale. J Can Dent Assoc. 2008 Feb;74(1):59.
PubMed 18298885Mehanna H, Paleri V, West CM, Nutting C. Head and neck cancer--Part 1: Epidemiology, presentation, and prevention. BMJ. 2010 Sep 20;341:c4684. doi: 10.1136/bmj.c4684. No abstract available.
PubMed 20855405Mody MD, Rocco JW, Yom SS, Haddad RI, Saba NF. Head and neck cancer. Lancet. 2021 Dec 18;398(10318):2289-2299. doi: 10.1016/S0140-6736(21)01550-6. Epub 2021 Sep 22.
PubMed 34562395Okuyama T, Wang XS, Akechi T, Mendoza TR, Hosaka T, Cleeland CS, Uchitomi Y. Validation study of the Japanese version of the brief fatigue inventory. J Pain Symptom Manage. 2003 Feb;25(2):106-17. doi: 10.1016/s0885-3924(02)00596-1.
PubMed 12590026
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arabic Patient-reported Outcome Measures During Radiotherapy for Head and Neck Cancer: a Validation Study
- ClinicalTrials.gov ID
- NCT06662929
- Acronym / sponsor ID
- PROMs / E-23-7571
- Conditions
- Head and Neck Cancer, Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma, Oropharynx Cancer, Nasopharyngeal Cancer, Oral Cancer
- Keywords
- PROMs, Head and Neck Cancer, Radiotherapy, COSMIN, Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of Arabic patient-reported outcome measures during radiotherapy for head and neck cancer is to test the patient-reported outcome measure (PROM) tools. PROM tools are not validated cross-culturally in Arabic-speaking patient populations, which limits their use in our clinical setting. Validation of these PROM tools will allow clinicians to identify the concerns related to our patient population and measure the outcome of our interventions. Main objectives are:
- To further validate (cross-culture) the PROM instruments related to head and neck cancer (HNC) in Arabic patients.
- To investigate the prevalence and severity of the patient-reported concerns and their relevance with demographics and clinical characteristics.
The participants will be given tasks to complete 6 tools survey before, during, and after radiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult aged 18 years or above, and receiving radiotherapy for the HNC. | – | Radiation: RadiationA non-interventional, questionnaire-based cross-sectional study for Arabic-speaking males and females, aged 18 years or above who is planned for receiving and who is currently receiving and who had already received radiotherapy for the Head \& Neck Cancer at King Saud University Medical City. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Target Population: The study is targeting males and females aged 18 years or above, and receiving radiotherapy for the HNC at the King Saud University Medical City.
Key inclusion criteria (1 listed)
- Adults aged 18 or above and who is planned for receiving and who is currently receiving and who had already received radiotherapy for the HNC at King Saud University Medical City.
Key exclusion criteria (1 listed)
- Individuals who are less than 18 years, presence of debilitating disease (e.g. heart failure) or who lack the capacity to read, understand and sign the informed consent and those.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiationRadiotherapy for the Head \& Neck Cancer | Radiation | Adult aged 18 years or above, and receiving radiotherapy for the HNC. |
Primary outcome
Summated Xerostomia Inventory (SXI)
Time frame: 24 months
The study aimed to assess the validity (face, content and construct) and reliability (internal consistency and test-retest) of this inventory in patients who received radiotherapy for head and neck cancer. These will be conducted in line with COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.
Patient-Reported Oral Mucositis Symptom (PROM) scale
Time frame: 24 months
The study aimed to assess the validity (face, content and construct) and reliability (internal consistency and test-retest) of this inventory in patients who received radiotherapy for head and neck cancer. These will be conducted in line with COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.
The Arabic University of Washington questionnaire (UW-QOL v4)
Time frame: 24 months
The study aimed to assess the validity (face, content and construct) and reliability (internal consistency and test-retest) of this inventory in patients who received radiotherapy for head and neck cancer. These will be conducted in line with COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.
The Arabic Brief Fatigue Inventory (ArBFI)
Time frame: 24 months
The study aimed to assess the validity (face, content and construct) and reliability (internal consistency and test-retest) of this inventory in patients who received radiotherapy for head and neck cancer. These will be conducted in line with COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.
Patient Concerns Inventory - Head and Neck (PCI-HNC)
Time frame: 24 months
The study aimed to assess the validity (face, content and construct) and reliability (internal consistency and test-retest) of this inventory in patients who received radiotherapy for head and neck cancer. These will be conducted in line with COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.
1 secondary outcome
To investigate the prevalence and severity of the patient-reported concerns and their relevance with demographics and clinical characteristics.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Background: PubMed 28220985Aguilar ML, Sandow P, Werning JW, Brenneman L, Psoter WJ. The Head and Neck Cancer Patient Concern Inventory(c) : Patient Concerns' Prevalence, Dental Concerns' Impact, and Relationships of Concerns with Quality of Life Measures. J Prosthodont. 2017 Apr;26(3):186-195. doi: 10.1111/jopr.12496. Epub 2017 Feb 21.
- Background: PubMed 27644659Alhazzazi TY, Alghamdi FT. Head and Neck Cancer in Saudi Arabia: a Systematic Review. Asian Pac J Cancer Prev. 2016;17(8):4043-8.
- Background: PubMed 32291427Alqaryan S, Aldrees T, Almatrafi S, Alharbi A, Alhumaid H. Awareness of head and neck cancers in Saudi Arabia. A questionnaire based study. Saudi Med J. 2020 Apr;41(4):400-405. doi: 10.15537/smj.2020.4.24990.
- Background: PubMed 20870636Berger AM, Abernethy AP, Atkinson A, Barsevick AM, Breitbart WS, Cella D, Cimprich B, Cleeland C, Eisenberger MA, Escalante CP, Jacobsen PB, Kaldor P, Ligibel JA, Murphy BA, O'Connor T, Pirl WF, Rodler E, Rugo HS, Thomas J, Wagner LI. NCCN Clinical Practice Guidelines Cancer-related fatigue. J Natl Compr Canc Netw. 2010 Aug;8(8):904-31. doi: 10.6004/jnccn.2010.0067. No abstract available.
- Background: PubMed 23358487Black N. Patient reported outcome measures could help transform healthcare. BMJ. 2013 Jan 28;346:f167. doi: 10.1136/bmj.f167.
- Background: PubMed 22790224Catania G, Bell C, Ottonelli S, Marchetti M, Bryce J, Grossi A, Costantini M. Cancer-related fatigue in Italian cancer patients: validation of the Italian version of the Brief Fatigue Inventory (BFI). Support Care Cancer. 2013 Feb;21(2):413-9. doi: 10.1007/s00520-012-1539-z. Epub 2012 Jul 13.
- Background: PubMed 25852820Cruz FM, Munhoz BA, Alves BC, Gehrke FS, Fonseca FL, Kuniyoshi RK, Cubero D, Peppone LJ, Del Giglio A. Biomarkers of fatigue related to adjuvant chemotherapy for breast cancer: evaluation of plasma and lymphocyte expression. Clin Transl Med. 2015 Feb 14;4:4. doi: 10.1186/s40169-015-0051-8. eCollection 2015.
- Background: PubMed 17078052Dirix P, Nuyts S, Van den Bogaert W. Radiation-induced xerostomia in patients with head and neck cancer: a literature review. Cancer. 2006 Dec 1;107(11):2525-34. doi: 10.1002/cncr.22302.
- Background: PubMed 32949298Hamilton SN, Tran E, Ho C, Berthelet E, Wu J, DeVries K, LaPointe V, Bowman A, Lagman M, Olson R. Patient-reported outcome measures in patients undergoing radiotherapy for head and neck cancer. Support Care Cancer. 2021 May;29(5):2537-2547. doi: 10.1007/s00520-020-05778-2. Epub 2020 Sep 19.
- Background: PubMed 35178880Kanatas A, Lowe D, Rogers SN. Health-related quality of life at 3 months following head and neck cancer treatment is a key predictor of longer-term outcome and of benefit from using the patient concerns inventory. Cancer Med. 2022 Apr;11(8):1879-1890. doi: 10.1002/cam4.4558. Epub 2022 Feb 17.
- BackgroundKingsley C, Patel S. Patient-reported outcome measures and patient-reported experience measures. BJA Education. 2017;17(4):137-44.
- Background: PubMed 18298885Kushner JA, Lawrence HP, Shoval I, Kiss TL, Devins GM, Lee L, Tenenbaum HC. Development and validation of a Patient-Reported Oral Mucositis Symptom (PROMS) scale. J Can Dent Assoc. 2008 Feb;74(1):59.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saif A Aljabab, DABR contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Head and Neck Neoplasms, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdullah M Alsoghier, PhD (+966114677423, aalsoghier@ksu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summated Xerostomia Inventory (SXI) (time frame: 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06662929, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.