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

NCT04713449 | Active Not Recruiting DMC

• 2 other identifiers: 132004Pro2020000768
• Study Type: interventional
• Target: 643
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Cancer; Oropharyngeal Cancer; Head and Neck Cancer

Outcome Measures

Primary Outcomes (3)

• Self-efficacy score

  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.

  Baseline, two and 6 months post-baseline

• Preparedness for survivorship

  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.

  Baseline, two and 6 months post-baseline

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

  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.

  Baseline, two and 6 months post-baseline

Secondary Outcomes (4)

• Performance of oral self-exam, past month

  Baseline, two and 6 months post-baseline

• Comprehensiveness is the number of areas checked (11 areas) during the oral self-exam

  Baseline, two and 6 months post-baseline

• Performance of exercises to improve swallowing, past month (yes/no)

  Baseline, two and 6 months post-baseline

• Performance of head/neck exercises, past month (yes/no)

  Baseline, two and 6 months post-baseline

Other Outcomes (8)

• Action and Planning Coping

  Baseline, two and 6 months post-baseline

• Patient activation

  Baseline, two and 6 months post-baseline

• Information Needs

  Baseline, two and 6 months post-baseline

Study Arms (2)

Empowered Survivor online

EXPERIMENTAL

The online intervention, called Empowered Survivor (ES) is a self-management intervention for patients with head and neck cancer. The intervention contains the following modules: Introduction; Difficulty Swallowing and Muscle Strength; Oral Care; Long-term Follow-Up Care/Oral exams; Calm and Connect; and Maintaining.

Other: Empowered Survivor Online; Other: Survey Administration

Springboard Beyond Cancer

ACTIVE COMPARATOR

Springboard Beyond Cancer is a general resource for survivors of all cancer. It is a free self-management program for cancer survivors developed by trusted sources, the ACS and the NCI.

Other: Springboard Beyond Cancer; Other: Survey Administration

Interventions

Survey Administration OTHER

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

Empowered Survivor online; Springboard Beyond Cancer

Empowered Survivor Online OTHER

Informational online intervention for head and neck cancer survivors

Empowered Survivor online

Springboard Beyond Cancer OTHER

Informational online intervention for all cancer survivors

Springboard Beyond Cancer

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18 years;
• Diagnosed with a first primary invasive oral or oropharyngeal cancer between 1 and 3 years ago;
• Currently cancer free (but can have experienced a recurrence);
• Has internet access;
• Read English;
• Has sufficient vision to read a survey and complete an online intervention

Sponsors & Collaborators

• The Cancer Registry of Greater California: collaborator
• The New Jersey State Cancer Registry: collaborator
• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (1)

• Manne SL, Imanguli M, Kashy D, Pesanelli M, Frederick S, Van Cleave JH, Paddock L, Hudson S, Steinberg M, Clifford P, Domider M, Singh N. Enhancing Self-care Among Oral Cancer Survivors: Protocol for the Empowered Survivor Trial. JMIR Res Protoc. 2023 Jan 20;12:e39996. doi: 10.2196/39996.

  PMID: 36662561 DERIVED

MeSH Terms

Conditions

Mouth Neoplasms; Oropharyngeal Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Behavioral Sciences

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 19, 2021
• Study Start: January 19, 2021
• Primary Completion: August 28, 2025
• Study Completion (Estimated): February 28, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)