Cancer of the Head and NeckNCT02442336

A Web-Based Multimedia Intervention for Head and Neck Cancer Patients

A study testing My Journey AHead in people with Cancer of the Head and Neck, run by Fox Chase Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The overall goal is to develop and examine the acceptability of a web-based (Internet) intervention program for patients with head and neck cancer who have recently completed radiation therapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer of the Head and Neck
What is being tested?: My Journey AHead
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteUnited States
Study dates: 15 Jun 2012to 18 Nov 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Patients with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
Are receiving or have completed radiation therapy within in the past 12 months

Who cannot join

Inability to read and/or communicate in English
Head and neck cancers of non-squamous histology (e.g., adenoid cystic carcinoma, adenocarcinoma, sarcoma)
Blindness or severity of visual impairment that precludes one's ability to view images/text
Inability to provide informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497

Other trials in United States

About this study

Official title: A Web-based Multimedia Intervention for Head and Neck Cancer Patients

The overall goal is to develop and examine the acceptability of a web-based (Internet) intervention program for patients with head and neck cancer who have recently completed radiation therapy.

Read the detailed description

The overall goal is to develop and examine the acceptability of a theory-guided, web-based multimedia intervention program for head and neck cancer patients who have recently completed radiation therapy. The effects of this intervention on patients' quality of life (QOL) will also be evaluated.

Conditions: Cancer of the Head and Neck
Being tested: My Journey AHead
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.

My Journey AHeadBehavioural
The intervention program will contain information and interactive activities around swallowing concerns, proper oral care, healthy eating and nutrition, speech issues, stress and coping with cancer, and pain management.

Study groups in NCT02442336
Study group	Role	What they receive
My Journey AHead	Experimental	Several internet modules will be developed to address mouth and swallowing concerns, oral care, healthy eating, speech problems, coping with cancer, pain management, and physical therapy. Receives: Behavioral: My Journey AHead

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient Distress
Psychological distress will be assessed using the Brief Symptom Inventory-18. The Brief Symptom Inventory-18 (BSI-18) is an 18-item scale widely used to measure psychological distress. The BSI-18 yields a total score (Global Severity Index), which is a measure of overall psychological distress. Raw scores are converted to t-scores (range 0-100) based on gender-specific normative data from cancer patient populations. A t-score of 50 is equal to the mean of the population. Higher scores represent greater levels of distress. The BSI-18 provides a clinical case-rule classifying respondents who have a t-score score ≥ 63 on the GSI as having clinically significant symptoms. Other studies have used a lower cutoff, with a GSI t-score ≥ 57 recommended as a cutoff for clinically significant symptoms in a study of cancer patients.
Measured: Up to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 201218 Nov 2020

First posted13 May 2015 (estimated)
Study start15 Jun 2012
Primary completion31 Aug 2017
Study completion18 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Cancer of the Head and NeckStudies 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: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02442336
Sponsor's protocol ID: IRB11822
Status last verified: Feb 2021
First submitted: 18 Mar 2015
Last updated: 17 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Fang CY, Longacre ML, Manne SL, Ridge JA, Lango MN, Burtness BA. Informational Needs of Head and Neck Cancer Patients. Health Technol (Berl). 2012 Apr 1;2(1):57-62. doi: 10.1007/s12553-012-0020-9. Epub 2012 Feb 14.
PubMed 22518350
Fang CY, Galloway TJ, Egleston BL, Bauman JR, Ebersole B, Chwistek M, Buhler JG, Longacre ML, Ridge JA, Manne SL, Manning C. Development of a Web-Based Supportive Care Program for Patients With Head and Neck Cancer. Front Oncol. 2020 Dec 15;10:602202. doi: 10.3389/fonc.2020.602202. eCollection 2020.
PubMed 33384959

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cancer of the Head and Neck trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Web-based Multimedia Intervention for Head and Neck Cancer Patients
ClinicalTrials.gov ID: NCT02442336
Acronym / sponsor ID: IRB11822
Conditions: Cancer of the Head and Neck
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Fox Chase Cancer CenterUniversity, hospital or other
Study start: 15 Jun 2012 (actual)
Primary completion: 31 Aug 2017 (actual)
Study completion: 18 Nov 2020 (actual)
First posted: 13 May 2015 (estimated)
Results: Posted 22 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The overall goal is to develop and examine the acceptability of a web-based (Internet) intervention program for patients with head and neck cancer who have recently completed radiation therapy.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
My Journey AHead	Experimental	Behavioral: My Journey AHeadSeveral internet modules will be developed to address mouth and swallowing concerns, oral care, healthy eating, speech problems, coping with cancer, pain management, and physical therapy.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
Are receiving or have completed radiation therapy within in the past 12 months

Key exclusion criteria (4 listed)

Inability to read and/or communicate in English
Head and neck cancers of non-squamous histology (e.g., adenoid cystic carcinoma, adenocarcinoma, sarcoma)
Blindness or severity of visual impairment that precludes one's ability to view images/text
Inability to provide informed consent

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
My Journey AHeadThe intervention program will contain information and interactive activities around swallowing concerns, proper oral care, healthy eating and nutrition, speech issues, stress and coping with cancer, and pain management.	Behavioural	My Journey AHead

Primary outcome

Patient Distress
Time frame: Up to 6 weeks
Psychological distress will be assessed using the Brief Symptom Inventory-18. The Brief Symptom Inventory-18 (BSI-18) is an 18-item scale widely used to measure psychological distress. The BSI-18 yields a total score (Global Severity Index), which is a measure of overall psychological distress. Raw scores are converted to t-scores (range 0-100) based on gender-specific normative data from cancer patient populations. A t-score of 50 is equal to the mean of the population. Higher scores represent greater levels of distress. The BSI-18 provides a clinical case-rule classifying respondents who have a t-score score ≥ 63 on the GSI as having clinically significant symptoms. Other studies have used a lower cutoff, with a GSI t-score ≥ 57 recommended as a cutoff for clinically significant symptoms in a study of cancer patients.

Results and safety

Results posted to the registry on 22 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
My Journey AHead	80	44

Primary outcome: Patient Distress

Time frame: Up to 6 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Web-Based Intervention n = 44
Value	66.16 (4.77)

Adverse events

Time frame: A 3- to 6-week period during which participants were on-study (i.e. consented, completed baseline assessment, provided access to the intervention, and completed program evaluation).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
My Journey AHead	0 of 55 (0%)	50 of 55 (90.9%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22518350Fang CY, Longacre ML, Manne SL, Ridge JA, Lango MN, Burtness BA. Informational Needs of Head and Neck Cancer Patients. Health Technol (Berl). 2012 Apr 1;2(1):57-62. doi: 10.1007/s12553-012-0020-9. Epub 2012 Feb 14.
Derived from this study: PubMed 33384959Fang CY, Galloway TJ, Egleston BL, Bauman JR, Ebersole B, Chwistek M, Buhler JG, Longacre ML, Ridge JA, Manne SL, Manning C. Development of a Web-Based Supportive Care Program for Patients With Head and Neck Cancer. Front Oncol. 2020 Dec 15;10:602202. doi: 10.3389/fonc.2020.602202. eCollection 2020.

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RecruitingPhase 1/2
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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.

Carolyn Fang, PhD principal investigator

Fox Chase Cancer 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 My Journey AHead in people with Cancer of the Head and Neck, run by Fox Chase Cancer Center 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 2 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 17 Mar 2021. 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?

Yes. Results are posted in the registry (first posted 22 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Patient Distress (time frame: Up to 6 weeks). 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 NCT02442336, 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 17 Mar 2021.