Trial Outcomes & Findings for Feasibility Study of the Head and Neck Survivorship Tool: Assessment and Recommendations (HN-STAR) (NCT NCT02571673)

NCT ID: NCT02571673

Last Updated: 2024-04-15

Results Overview

Using data from survivors in Aim 1: Part 2 (N=45), we will abstract data on health care actions from both the medical record and HN-STAR. Such data include receipt of appropriate oncologic surveillance, identification and management of symptoms, and appropriate preventive health services, as indicated by referrals, prescriptions, and recommendations in both clinic notes and the HN-STAR Survivor Self-Assessment. For each participant, HN-STAR generates a Treatment Summary/TS for the clinician to review and verify its accuracy compared with clinical documentation with the participant medical record.

Recruitment status

COMPLETED

Target enrollment

65 participants

Primary outcome timeframe

2 years

Results posted on

2024-04-15

Participant Flow

Participant milestones

Participant milestones
Measure
Survivors of Head and Neck Cancer
Participants must have completed treatment for head and neck cancer at least 1 year prior to survivorship visit and have no evidence of disease.
Overall Study
STARTED
65
Overall Study
COMPLETED
65
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility Study of the Head and Neck Survivorship Tool: Assessment and Recommendations (HN-STAR)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Survivors of Head and Neck Cancer
n=65 Participants
Participants must have completed treatment for head and neck cancer at least 1 year prior to survivorship visit and have no evidence of disease.
Age, Continuous
60 years
n=99 Participants
Sex: Female, Male
Female
13 Participants
n=99 Participants
Sex: Female, Male
Male
52 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
65 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
Race (NIH/OMB)
Asian
2 Participants
n=99 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=99 Participants
Race (NIH/OMB)
White
57 Participants
n=99 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants
n=99 Participants
Region of Enrollment
United States
65 Participants
n=99 Participants

PRIMARY outcome

Timeframe: 2 years

Using data from survivors in Aim 1: Part 2 (N=45), we will abstract data on health care actions from both the medical record and HN-STAR. Such data include receipt of appropriate oncologic surveillance, identification and management of symptoms, and appropriate preventive health services, as indicated by referrals, prescriptions, and recommendations in both clinic notes and the HN-STAR Survivor Self-Assessment. For each participant, HN-STAR generates a Treatment Summary/TS for the clinician to review and verify its accuracy compared with clinical documentation with the participant medical record.

Outcome measures

Outcome measures
Measure
Survivors of Head and Neck Cancer
n=45 Participants
Participants must have completed treatment for head and neck cancer at least 1 year prior to survivorship visit and have no evidence of disease.
Recommendations for Cancer Surveillance (Patient-reported Outcomes From the Survivor Self-Assessment)
93 % of pts w/accurate TS for primary site

Adverse Events

Survivors of Head and Neck Cancer

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Talya Salz, PhD

Memorial Sloan Kettering Cancer Center

Phone: 646-227-3646

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place