Head and Neck CancerBIHNCNCT04830488
Body Image After Head and Neck Cancer Treatment
A study testing e-learning didactic module and Personal reflection activities in people with Head and Neck Cancer, run by Bethany Rhoten at 1 site in United States.
Trial summary
This is a pilot study of the Body Image after Head and Neck Cancer Treatment Program [BIHNC]. It is a six-week, psychoeducational, web-based program that includes e-learning didactic modules and personal reflection activities for participants to complete. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- e-learning didactic module and Personal reflection activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2021to 4 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completion of any form of head and neck cancer treatment between 3 and 24 months previously at study enrollment
- Answer in the affirmative to at least one of two questions concerning dissatisfaction with the way their body looks or function
- Have clinically significant body image concerns as defined by (BIS score > 10)
Who cannot join
- Undergoing head and neck cancer treatment at time of study enrollment
- Cognitive impairment that would preclude ability to provide informed consent
- Unable to read text on a computer screen
- Not able to read and understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Pilot Testing of the Body Image After Head and Neck Cancer Treatment (BIHNC) Program
This is a pilot study of the Body Image after Head and Neck Cancer Treatment Program [BIHNC]. It is a six-week, psychoeducational, web-based program that includes e-learning didactic modules and personal reflection activities for participants to complete.
Read the detailed description
Specific Aim 1: To assess the feasibility and acceptability of [BIHNC] in patients who have completed treatment for head and neck cancer and who have body image concerns.
H1a: Eighty percent of enrolled study participants who complete baseline self-report measures will complete the BIHNC Program.
H1b: Eighty percent of study participants completing the BIHNC Program will rate it acceptable on the intervention evaluation form.
Specific Aim 2: To assess the preliminary efficacy of BIHNC for reducing body image concerns in patients who have completed treatment for head and neck cancer and who have body image concerns.
H2: Body image scores will improve from pre- to post- intervention
- Conditions
- Head and Neck Cancer
- Being tested
- e-learning didactic module, Personal reflection activities
- Keywords
- body image
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-learning didactic moduleBehavioural
Participants utilize e-learning
Personal reflection activitiesBehavioural
Participants complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Body Image after Head and Neck Cancer Treatment | Experimental | Not described Receives: Behavioral: e-learning didactic module; Behavioral: Personal reflection activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who complete program
Measured: Approximately 6 weeks
Percentage of participants who will rate program as acceptable
Measured: Approximately 6 weeks
Secondary outcomes (1)
Percentage of participants with improvement in body image indicators
Measured: Approximately 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start5 Apr 2021
- Primary completion4 Mar 2024
- Study completion4 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bethany Rhoten
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bethany Rhoten, Vanderbilt-Ingram Cancer Center
- Investigators
- Bethany Rhoten, PhD, Principal investigator, Vanderbilt Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830488
- Sponsor's protocol ID
- VICC HN 2123
- Acronym
- BIHNC
- Status last verified
- Aug 2024
- First submitted
- 29 Mar 2021
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing of the Body Image After Head and Neck Cancer Treatment (BIHNC) Program
- ClinicalTrials.gov ID
- NCT04830488
- Acronym / sponsor ID
- BIHNC / VICC HN 2123
- Conditions
- Head and Neck Cancer
- Keywords
- body image
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Bethany RhotenUniversity, hospital or other
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 5 Apr 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.
This is a pilot study of the Body Image after Head and Neck Cancer Treatment Program [BIHNC]. It is a six-week, psychoeducational, web-based program that includes e-learning didactic modules and personal reflection activities for participants to complete.
Detailed description
Specific Aim 1: To assess the feasibility and acceptability of [BIHNC] in patients who have completed treatment for head and neck cancer and who have body image concerns.
H1a: Eighty percent of enrolled study participants who complete baseline self-report measures will complete the BIHNC Program.
H1b: Eighty percent of study participants completing the BIHNC Program will rate it acceptable on the intervention evaluation form.
Specific Aim 2: To assess the preliminary efficacy of BIHNC for reducing body image concerns in patients who have completed treatment for head and neck cancer and who have body image concerns.
H2: Body image scores will improve from pre- to post- intervention
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Body Image after Head and Neck Cancer Treatment | Experimental | Behavioral: e-learning didactic module, Behavioral: Personal reflection activities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Completion of any form of head and neck cancer treatment between 3 and 24 months previously at study enrollment
- Answer in the affirmative to at least one of two questions concerning dissatisfaction with the way their body looks or function
- Have clinically significant body image concerns as defined by (BIS score > 10)
Key exclusion criteria (4 listed)
- Undergoing head and neck cancer treatment at time of study enrollment
- Cognitive impairment that would preclude ability to provide informed consent
- Unable to read text on a computer screen
- Not able to read and understand English
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 |
|---|---|---|
| e-learning didactic moduleParticipants utilize e-learning | Behavioural | Body Image after Head and Neck Cancer Treatment |
| Personal reflection activitiesParticipants complete questionnaires | Behavioural | Body Image after Head and Neck Cancer Treatment |
Primary outcome
Percentage of participants who complete program
Time frame: Approximately 6 weeks
Percentage of participants who will rate program as acceptable
Time frame: Approximately 6 weeks
1 secondary outcome
Percentage of participants with improvement in body image indicators
Time frame: Approximately 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- 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.
Bethany Rhoten, PhD principal investigator
Vanderbilt Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-learning didactic module and Personal reflection activities in people with Head and Neck Cancer, run by Bethany Rhoten 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 9 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of participants who complete program (time frame: Approximately 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.