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

February 19, 2026 updated by: Sharon Manne, PhD, Rutgers, The State University of New Jersey

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
643

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Cancer Institute of New Jersey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Empowered Survivor online
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
Informational online intervention for head and neck cancer survivors
Other: Survey Administration
Survey measures administered at BL, two and 6 months post-baseline
Active Comparator: Springboard Beyond Cancer
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: Survey Administration
Survey measures administered at BL, two and 6 months post-baseline
Other: Springboard Beyond Cancer
Informational online intervention for all cancer survivors

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-efficacy score
Time Frame: Baseline, two and 6 months post-baseline
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
Time Frame: Baseline, two and 6 months post-baseline
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
Time Frame: Baseline, two and 6 months post-baseline
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Performance of oral self-exam, past month
Time Frame: Baseline, two and 6 months post-baseline
1 item asking the participant if he/she has performed an oral self-exam, past month. Yes/No. Administered at multiple time points to measure effect of the intervention.
Baseline, two and 6 months post-baseline
Comprehensiveness is the number of areas checked (11 areas) during the oral self-exam
Time Frame: Baseline, two and 6 months post-baseline
Change in comprehensiveness of exams over time. 11 items will list the areas to check and ask participant to indicate Yes/No if the participant checked that area during the oral self-exam. Administered at multiple time points to measure effect of the intervention.
Baseline, two and 6 months post-baseline
Performance of exercises to improve swallowing, past month (yes/no)
Time Frame: Baseline, two and 6 months post-baseline
One question asking participants if they have completed exercises to improve swallowing in the past month. Administered at multiple time points to measure effect of the intervention.
Baseline, two and 6 months post-baseline
Performance of head/neck exercises, past month (yes/no)
Time Frame: Baseline, two and 6 months post-baseline
One question asking participants if they have completed head and neck exercises in the past month. Administered at multiple time points to measure effect of the intervention.
Baseline, two and 6 months post-baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Action and Planning Coping
Time Frame: Baseline, two and 6 months post-baseline
Change in Action and Planning coping score. The scale (8 items) assesses the degree to which a detailed plan is made for self-care tasks. Administered at multiple time points to measure effect of the intervention. Items are rated on a 5-point Likert scale(1 = strongly disagree, 5 = strongly agree). Mean scale score will be reported. Higher score = higher action coping.
Baseline, two and 6 months post-baseline
Patient activation
Time Frame: Baseline, two and 6 months post-baseline
Change in Patient activation scale score. Patient Activation Scale (13 items) assesses the active role in cancer care. Administered at multiple time points to measure effect of the intervention. Items are rated on a 4-point scale (1 = Disagree strongly, 4 = Agree strongly). Higher score = higher activation.
Baseline, two and 6 months post-baseline
Information Needs
Time Frame: Baseline, two and 6 months post-baseline
Change in score over time. Information needs (23 items) is adapted from the FOCUS Health-Related Topics measure. Administered at multiple time points to measure effect of the intervention. Participants reported if they would like more information on each topic (yes/no). The number of " yes" responses are averaged.
Baseline, two and 6 months post-baseline
Support needs
Time Frame: Baseline, two and 6 months post-baseline
Change in Support needs. The support needs scale (34 items) assesses physical, psychological, and health care needs. Administered at multiple time points to measure effect of the intervention. Participants are asked to indicate the extent to which they needed help in the past month (1 = No Need; Not applicable, "This is not a problem",2 = No need; Satisfied, "I did need help but my need was satisfied," 3 = Low need; "It caused me concern and I had little need for additional help," 4 = Moderate need-"It caused me concern and I had some need for additional help," 5 = High need; -"It caused me concern and I had a strong need for additional help"). Support needs that are rated as "moderate"(4) or "high" need (5) will be summed, with a range of 0 to 34.
Baseline, two and 6 months post-baseline
Concerns about recurrence scale
Time Frame: Baseline, two and 6 months post-baseline
Change in concerns about recurrence. The first 4 items from the concerns about recurrence scale are measured on a 1-6 scale. with lower scores indicating less concerns or worry. The additional 21 items are rated on 0 (not at all) to 4 (extremely) with higher scores indicating more concerns or worry. Administered at multiple time points to measure effect of the intervention.
Baseline, two and 6 months post-baseline
Moderator-Race/ethnicity
Time Frame: Baseline only
Race/ethnicity will be assessed.
Baseline only
Moderator-Receipt of survivorship care plan
Time Frame: Baseline only
Yes/No did the participant receive a survivorship care plan
Baseline only
Moderator- Baseline self-efficacy score
Time Frame: Baseline Only
The baseline score on the scale will be (22 items) examined. The scale targets confidence in managing aspects of self-care (e.g., dry mouth, swallowing, oral self-exam, communicating with providers, emotions). Ratings are 1- 5
Baseline Only

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rutgers, The State University of New Jersey

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
The Cancer Registry of Greater California
The New Jersey State Cancer Registry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 28, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 132004 (Rutgers Cancer Institute of New Jersey)
  • Pro2020000768 (Other Identifier: Rutgers Cancer Institute of New Jersey)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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