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

NCT ID: NCT04713449

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

643 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-19

Study Completion Date

2025-04-01

Brief Summary

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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

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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

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Oral Cancer Oropharyngeal Cancer Head and Neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Empowered Survivor Online

Intervention Type OTHER

Informational online intervention for head and neck cancer survivors

Survey Administration

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Springboard Beyond Cancer

Intervention Type OTHER

Informational online intervention for all cancer survivors

Survey Administration

Intervention Type OTHER

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

Interventions

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Empowered Survivor Online

Informational online intervention for head and neck cancer survivors

Intervention Type OTHER

Springboard Beyond Cancer

Informational online intervention for all cancer survivors

Intervention Type OTHER

Survey Administration

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

Intervention Type OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

The Cancer Registry of Greater California

UNKNOWN

Sponsor Role collaborator

The New Jersey State Cancer Registry

UNKNOWN

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Sharon Manne, PhD

Chief, Behavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36662561 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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Pro2020000768

Identifier Type: OTHER

Identifier Source: secondary_id

132004

Identifier Type: -

Identifier Source: org_study_id