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

• Sponsor: Power Life Sciences Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05801770
• Collaborator: (none)
• Enrollment: 500
• Anticipated Duration (Months): 24

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Case-Crossover
• Time Perspective: Prospective
• Official Title: An Observational Medical Trial Assessing Patterns in Experiences of Participants of Head and Neck Cancer Clinical Trials
• Anticipated Study Start Date: Apr 1, 2024
• Anticipated Primary Completion Date: Apr 1, 2025
• Anticipated Study Completion Date: Apr 1, 2026

Outcome Measures

Primary Outcome Measures

1. Rate of patients who decide to enroll in a clinical study. [3 months]

2. Number of study participants who remain in clinical trial until completion. [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• Participants who are vulnerable to any intervention

• Women who are pregnant, intend to become pregnant, or are lactating

• Inability to perform regular electronic reporting

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Power Life Sciences Inc.

Investigators

• Study Director: Michael B Gill, Power Life Sciences Inc.

Study Documents (Full-Text)

• Informed Consent Form - Mar 24, 2023

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Power Life Sciences Inc.
• ClinicalTrials.gov Identifier: NCT05801770
• Other Study ID Numbers: 80513342
• First Posted: Apr 6, 2023
• Last Update Posted: Apr 6, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Power Life Sciences Inc.: head and neck cancer
• Additional relevant MeSH terms: Head and Neck Neoplasms

Study Results

No Results Posted as of Apr 6, 2023