Oral CancerNCT04713449
Enhancing Self Care Among Oral Cancer Survivors: The Empowered Survival Trial
A study testing Empowered Survivor Online, Springboard Beyond Cancer and Survey Administration in people with Oral Cancer and Oropharyngeal Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Oral Cancer, Oropharyngeal Cancer, Head and Neck Cancer
- What is being tested?
- Empowered Survivor Online, Springboard Beyond Cancer and Survey Administration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 643 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2021to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
About this study
Official title: 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.
Read the 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.
- Conditions
- Oral Cancer, Oropharyngeal Cancer, Head and Neck Cancer
- Being tested
- Empowered Survivor Online, Springboard Beyond Cancer, Survey Administration
- Medical subject headings
- Mouth Neoplasms, Oropharyngeal Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowered Survivor OnlineOther
Informational online intervention for head and neck cancer survivors
Springboard Beyond CancerOther
Informational online intervention for all cancer survivors
Survey AdministrationOther
Survey measures administered at BL, two and 6 months post-baseline
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Springboard Beyond Cancer; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, two and 6 months post-baseline
Secondary outcomes (4)
Performance of oral self-exam, past month
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.
Measured: Baseline, two and 6 months post-baseline
Comprehensiveness is the number of areas checked (11 areas) during the oral self-exam
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.
Measured: Baseline, two and 6 months post-baseline
Performance of exercises to improve swallowing, past month (yes/no)
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.
Measured: Baseline, two and 6 months post-baseline
Performance of head/neck exercises, past month (yes/no)
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.
Measured: Baseline, two and 6 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start19 Jan 2021
- Primary completion28 Aug 2025
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 643 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), The Cancer Registry of Greater California, The New Jersey State Cancer Registry
- Responsible party
- Principal investigator, Sharon Manne, PhD, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713449
- Sponsor's protocol ID
- 132004
- Other IDs
- Pro2020000768
- Status last verified
- Feb 2026
- First submitted
- 12 Jan 2021
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Manne SL, Hudson SV, Van Cleave JH, Grosso M, Frederick S, Pesanelli M, Singh N, Solleder J, O'Malley DM, Handorf E, Lu SE. Enhancing Self Care Among Oral Cancer Survivors Using a Digital Approach: The Empowered Survivor Trial. Psychooncology. 2026 Sep;35(9):e70579. doi: 10.1002/pon.70579.
PubMed 42655903Manne 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.
PubMed 36662561
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Self Care Among Oral Cancer Survivors: The Empowered Survivor Trial
- ClinicalTrials.gov ID
- NCT04713449
- Acronym / sponsor ID
- 132004
- Conditions
- Oral Cancer, Oropharyngeal Cancer, Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 643 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), The Cancer Registry of Greater California, The New Jersey State Cancer Registry
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empowered Survivor online | Experimental | Other: Empowered Survivor Online, Other: Survey AdministrationThe 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. |
| Springboard Beyond Cancer | Active comparator | Other: Springboard Beyond Cancer, Other: Survey AdministrationSpringboard 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empowered Survivor OnlineInformational online intervention for head and neck cancer survivors | Other | Empowered Survivor online |
| Springboard Beyond CancerInformational online intervention for all cancer survivors | Other | Springboard Beyond Cancer |
| Survey AdministrationSurvey measures administered at BL, two and 6 months post-baseline | Other | Empowered Survivor online, Springboard Beyond Cancer |
Primary outcome
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.
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.
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.
4 secondary outcomes
Performance of oral self-exam, past month
Time frame: 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
Performance of exercises to improve swallowing, past month (yes/no)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Derived from this study: PubMed 42655903Manne SL, Hudson SV, Van Cleave JH, Grosso M, Frederick S, Pesanelli M, Singh N, Solleder J, O'Malley DM, Handorf E, Lu SE. Enhancing Self Care Among Oral Cancer Survivors Using a Digital Approach: The Empowered Survivor Trial. Psychooncology. 2026 Sep;35(9):e70579. doi: 10.1002/pon.70579.
- Derived from this study: PubMed 36662561Manne 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowered Survivor Online, Springboard Beyond Cancer and Survey Administration in people with Oral Cancer and Oropharyngeal Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-efficacy score (time frame: Baseline, two and 6 months post-baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04713449, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.