Discovering Factors in Head and Neck Cancer Patients' Clinical Study Experiences

NCT05801770 | Not Yet Recruiting

• 1 other identifier: 80513342
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Enrollment in clinical trials usually favors a particular demographic group. But there is limited research available to explain what study attributes affect the completion of these specific demographic groups. This trial will evaluate the safety and efficacy of head and neck cancer treatments. The focus will be on tracking the rates of completion and withdrawal among these individuals. It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future head and neck cancer studies.

Conditions

Head and Neck Cancer

Keywords

head and neck cancer

Outcome Measures

Primary Outcomes (2)

• Rate of patients who decide to enroll in a clinical study.

  3 months

• Number of study participants who remain in clinical trial until completion.

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who are actively considering involvement in an observational head and neck cancer clinical trial, but have not yet completed enrollment and registration.

You may qualify if:

• Patient is at least 18 years of age
• Patient is able and willing to comply with the treatment/follow-up schedule and requirements
• Patient must provide written informed consent

You may not qualify if:

• Participants who are vulnerable to any intervention
• Women who are pregnant, intend to become pregnant, or are lactating
• Inability to perform regular electronic reporting

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Related Publications (3)

• Kaanders JHAM, van den Bosch S, Kleijnen J. Comparison of Patients With Head and Neck Cancer in Randomized Clinical Trials and Clinical Practice: A Systematic Review. JAMA Otolaryngol Head Neck Surg. 2022 Jul 1;148(7):670-676. doi: 10.1001/jamaoto.2022.0890.

  PMID: 35587353 BACKGROUND

• Simon C, Caballero C. Quality Assurance and Improvement in Head and Neck Cancer Surgery: From Clinical Trials to National Healthcare Initiatives. Curr Treat Options Oncol. 2018 May 24;19(7):34. doi: 10.1007/s11864-018-0552-y.

  PMID: 29797284 BACKGROUND

• Argiris A, Karamouzis MV, Raben D, Ferris RL. Head and neck cancer. Lancet. 2008 May 17;371(9625):1695-709. doi: 10.1016/S0140-6736(08)60728-X.

  PMID: 18486742 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

415-900-4227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 6, 2023
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: April 6, 2023

Record last verified: 2023-03