Self-Care Support Tools for Oral Cancer Survivors

Overseen By Sharon Manne, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively an online self-care tool assists oral cancer survivors in managing their daily health. Researchers will compare a new tool, Empowered Survivor Online, with an existing program, Springboard Beyond Cancer, developed by the National Cancer Institute and the American Cancer Society. Participants will use either the Empowered Survivor tool, which addresses specific issues like swallowing difficulties and oral care, or the more general Springboard program. Suitable candidates for this trial are cancer-free adults diagnosed with oral or oropharyngeal cancer 1 to 3 years ago who have internet access. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance self-care tools for future cancer survivors.

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that these self-care support tools are safe for oral cancer survivors?

Research has shown that the Empowered Survivor online tool helps oral cancer survivors improve self-care. Although specific safety details are not provided, studies indicate that users found the tool beneficial and it enhanced their self-management skills. This suggests the tool is generally well-received and safe.

Springboard Beyond Cancer, developed by the National Cancer Institute and the American Cancer Society, is a trusted and safe resource. It is a free tool for cancer survivors and is widely used.

Both tools are online programs designed to help cancer survivors manage their care. No evidence suggests any harmful side effects from using them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Empowered Survivor online program because it offers a tailored self-management approach specifically for head and neck cancer survivors. Unlike general support resources, this program includes targeted modules such as Difficulty Swallowing and Muscle Strength, Oral Care, and Calm and Connect, addressing specific challenges faced by oral cancer survivors. This personalized focus potentially enhances the quality of life and long-term care for these patients, setting it apart from more generic cancer survivor resources like Springboard Beyond Cancer.

What evidence suggests that these self-care support tools are effective for oral cancer survivors?

Research has shown that Empowered Survivor (ES), one of the tools studied in this trial, boosts confidence in managing personal care. Users of ES reported feeling better prepared to address their health needs. This online tool is specifically designed for individuals with head and neck cancer, offering customized sections such as oral care and long-term follow-up.

Springboard Beyond Cancer is another tool evaluated in this trial. It is a general program for all cancer survivors, created by trusted organizations like the National Cancer Institute and the American Cancer Society, to help manage their health. Both tools aim to support self-care, but ES has demonstrated specific benefits for those with oral cancer. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for English-reading adults over 18 who are currently cancer-free, even if they've had a recurrence. They must have been diagnosed with their first invasive oral or oropharyngeal cancer between 1 and 3 years ago, have internet access, and be able to read surveys and online content.

Inclusion Criteria

I am older than 18 years.

Has internet access

I am currently cancer-free, though I may have had cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline measures and are randomly assigned to either the Empowered Survivor or Springboard Beyond Cancer intervention

1 week

1 visit (virtual)

Intervention

Participants engage with the assigned online self-management intervention

6 months

Ongoing virtual engagement

Follow-up

Participants are monitored for changes in self-care, quality of life, and other outcomes

6 months

Assessments at 2 and 6 months post-baseline

What Are the Treatments Tested in This Trial?

Interventions

• Empowered Survivor Online
• Springboard Beyond Cancer

Trial Overview The study compares an online tool called Empowered Survivor (ES) created by the research team with Springboard Beyond Cancer, another free online self-management tool developed for cancer survivors. Participants will use these tools and complete surveys.

How Is the Trial Designed?

Group I: Empowered Survivor online Experimental Treatment 2 Interventions

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 II: Springboard Beyond Cancer Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

The Cancer Registry of Greater California

Collaborator

Trials

1

Recruited

600+

The New Jersey State Cancer Registry

Collaborator

Trials

1

Recruited

600+

Published Research Related to This Trial

Cancer survivors often experience low self-confidence after primary treatment, which can hinder their ability to manage their health and well-being effectively.

A conceptual framework was developed to highlight the importance of self-management support from various sources, including health professionals and peers, to help rebuild confidence and address the everyday impacts of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recovery and self-management support following primary cancer treatment. Foster, C., Fenlon, D.[2023]

Oral cancer survivors and their caregivers expressed a strong need for practical advice on managing side effects and desired a platform to connect with others for support, highlighting the importance of tailored information.

A web-based intervention was developed and tested, receiving a high usability score of 80/100, indicating that users found it attractive and easy to navigate, which is crucial for improving the quality of life for both survivors and caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and usability testing of a web-based self-management intervention for oral cancer survivors and their family caregivers. Badr, H., Lipnick, D., Diefenbach, MA., et al.[2023]

This study will evaluate the effectiveness of the Empowered Survivor (ES) program compared to a general web-based program, Springboard Beyond Cancer, in improving self-efficacy, preparedness for survivorship, and health-related quality of life in 600 cancer survivors diagnosed with oral cavity or oropharyngeal cancer.

The randomized controlled trial aims to identify how the ES program impacts these outcomes over time and will explore factors that may influence its effectiveness, potentially leading to future implementation in oncology settings if successful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Self-care Among Oral Cancer Survivors: Protocol for the Empowered Survivor Trial. Manne, SL., Imanguli, M., Kashy, D., et al.[2023]

A total of 602 head and neck cancer survivors provided patient-reported outcomes through an Internet-based survivorship care plan program, highlighting the effectiveness of this approach in gathering valuable data.

The most common treatment-related toxicities reported were difficulty swallowing (61.5%) and changes in skin color/texture (49.7%), indicating that these issues, along with fatigue, are significant concerns that need to be addressed in survivorship care planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes in head and neck cancer: prospective multi-institutional patient-reported toxicity. Peach, MS., Trifiletti, DM., Vachani, C., et al.[2022]

The review identified 33 questionnaires measuring empowerment in cancer patients, but only four were specifically designed to assess empowerment, highlighting a significant gap in comprehensive tools for this purpose.

Most of the included questionnaires focused on related concepts like patient-centered care and self-efficacy, indicating that while there are tools available, they may not fully capture the unique aspects of patient empowerment in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient empowerment: a systematic review of questionnaires measuring empowerment in cancer patients. Eskildsen, NB., Joergensen, CR., Thomsen, TG., et al.[2022]

A study of 342 oral cancer survivors revealed significant unmet supportive care needs, particularly in the emotional domain, highlighting the ongoing challenges they face after completing treatment.

Survivors expressed a strong interest in various supportive care services, such as support groups and informational resources, indicating a demand for enhanced support systems to address their needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive care needs of oral cancer survivors: Prevalence and correlates. Lee, MS., Nelson, AM., Thompson, LM., et al.[2016]

A study of 93 oral cancer survivors revealed that significant functional problems, such as dental health and range of motion issues, are linked to higher levels of depression (10%) and anxiety (16%) within a year after radiotherapy.

Most survivors (83%) used the Internet for health-related information, with major unmet needs including guidance on healthy living post-treatment (87%) and coping strategies for eating and speaking difficulties (81%), highlighting the potential for online psychoeducational interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survivorship Challenges and Information Needs after Radiotherapy for Oral Cancer. Badr, H., Lipnick, D., Gupta, V., et al.[2023]

An online interactive workshop for oncology nurses effectively introduced Canadian data on the unmet needs of cancer survivors, emphasizing the critical role nurses play in survivorship care.

Participants provided positive feedback on the workshop, suggesting that online learning is a valuable method for enhancing cancer nursing education, especially for those with limited access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowering Oncology Nurses through Knowledge and Practice to Improve Transitions Following Treatment and Survivorship Care. Watson, L., Maheu, C., Champ, S., et al.[2022]

The Cancer Patient Empowerment Questionnaire (CPEQ) was developed through a comprehensive process involving theories of empowerment, qualitative interviews with 18 cancer patients, and input from both patients and experts, resulting in a final version with 67 items that measure various aspects of empowerment.

The CPEQ is validated for assessing cancer patients' levels of empowerment, their desire for empowerment, and the factors that enable it, paving the way for future research and potential clinical applications in cancer follow-up care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and content validation of a questionnaire measuring patient empowerment in cancer follow-up. Eskildsen, NB., Ross, L., Bulsara, C., et al.[2020]

The 'Empowered Survivor' (ES) web-based self-management tool showed positive evaluations from participants and improved self-management self-efficacy, preparedness for survivorship care, and quality of life among oral and oropharyngeal cancer survivors.

Preliminary results indicated that ES increased engagement in oral self-exams and head and neck strengthening exercises, while also helping survivors address barriers and reducing their information and support needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

e-Health self-management intervention for oral and oropharyngeal cancer survivors: design and single-arm pilot study of empowered survivor. Manne, S., Hudson, S., Frederick, S., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36662561/

Enhancing Self-care Among Oral Cancer Survivors - PubMed Objective: The aim of this study is to describe the rationale and methodology for a randomized controlled trial evaluating Empowered Survivor ( ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04713449

Enhancing Self Care Among Oral Cancer Survivors: The ... Project's goal is evaluate an online tool the research team created called Empowered Survivor (ES) against a free online self-management intervention ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9898837/

Enhancing Self-care Among Oral Cancer Survivors The aim of this study is to describe the rationale and methodology for a randomized controlled trial evaluating Empowered Survivor (ES) versus Springboard ...

4. researchwithrutgers.com researchwithrutgers.com/en/projects/enhancing-self-care-among-oral-cancer-survivors-the-empowered-sur-2

Enhancing Self Care Among Oral Cancer Survivors Our results indicated that Empowered Survivor was well-utilized and resulted in significant improvements in self-efficacy in managing care, greater preparedness ...

5. maps.cancer.gov maps.cancer.gov/overview/DCCPSGrants/abstract.jsp?applId=10347328&term=CA240344

Division of Cancer Control & Population Sciences - Grant Details Our results indicated that Empowered Survivor was well-utilized and resulted in significant improvements in self-efficacy in managing care, greater preparedness ...

6. withpower.com withpower.com/trial/phase-3-mouth-neoplasms-2021-1eef4

Self-Care Support Tools for Oral Cancer Survivors The available research does not explicitly mention safety data for the 'Empowered Survivor' or related self-care support tools. However, the studies focus on ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9247862/

design and single-arm pilot study of empowered survivor This article described the development of ES, an online self-management intervention designed to foster effective self-management for survivors of oral and ...