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Completed NA INTERVENTIONAL NCT04713449

Enhancing Self Care Among Oral Cancer Survivors: The Empowered Survival Trial

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

Project's goal is evaluate an online tool the research team created called Empowered Survivor (ES) against a free online self-management intervention developed for cancer survivors by the National Cancer Institute and the American Cancer Society called Springboard Beyond Cancer.

Detailed Description

600 patients who have completed treatment between one and three years ago and are currently cancer-free will be recruited via the New Jersey State Cancer Registry or the Cancer Registry of Greater California and randomly assigned to ES or Springboard Beyond Cancer. Participants will complete measures at baseline, 2, and 6-months post-baseline. The investigators will also complete a process evaluation of Empowered Survivor.

Interventions

Name: Empowered Survivor Online

Type: OTHER

Description: Informational online intervention for head and neck cancer survivors

Name: Springboard Beyond Cancer

Type: OTHER

Description: Informational online intervention for all cancer survivors

Name: Survey Administration

Type: OTHER

Description: Survey measures administered at BL, two and 6 months post-baseline

Primary Outcomes

Measure: Self-efficacy score

TimeFrame: Baseline, two and 6 months post-baseline

Description: Change in self- efficacy measured with the Self-efficacy scale (22 items) which targets confidence in managing aspects of self-care (e.g., dry mouth, swallowing, oral self-exam, communicating with providers, emotions). Administered at multiple time points to measure effect of the intervention. Ratings range from 1 (not at all confident) to 5 (very confident). An item average will be calculated.

Measure: Preparedness for survivorship

TimeFrame: Baseline, two and 6 months post-baseline

Description: Change in preparedness for survivorship. The Preparedness for survivorship scale (10 items) developed by the investigator assesses whether information received about survivorship was sufficient, helpful, comprehensive, and covered self-care tasks. Administered at multiple time points to measure effect of the intervention. Items are rated on a 4-point Likert scale (1 = strongly disagree, 4 = strongly agree). Higher score indicate better preparedness.

Measure: Quality of Life score measured using the The European Organization for Research and Treatment of Cancer (EORTC)- Head and Neck

TimeFrame: Baseline, two and 6 months post-baseline

Description: Change in QOL score over time. The European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire- Head and Neck-43. The European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire- Head and Neck-43 is the updated version of the EORTC H\&N 35, used in the researcher's pilot work. The EORTC QLQ-HN is the most widely-used measure of Head and Neck QOL. The investigators use the total score in analyses, but will evaluate subscales. Administered at multiple time points to measure effect of the intervention. Items are rated on 1 (not at all)-4 (very much) Likert scale and higher scores indicate worse QOL.

Trial Information

NCT ID

NCT04713449

Status

Completed

Study Type

INTERVENTIONAL

Phases

Sponsor

Rutgers, The State University of New Jersey

Last Updated

December 15, 2025