Thyroid CancerTISCAVNCT06918223
Assessing Patient Satisfaction and Confidence After Use of Educational Video to Augment Surgical Consent for Thyroid Surgery
A study testing Thyroid Informed Surgical Consent Augmenting Video (TISCAV) and Standard Consent in people with Thyroid Cancer, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This study looks at how a short educational video can help people better understand thyroid surgery. Patients who have thyroid nodules and need surgery will be part of the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Thyroid Informed Surgical Consent Augmenting Video (TISCAV) and Standard Consent
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2023to Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English is Primary Language
- ≥18 years old at time of consent
- Eligible for Thyroidectomy, lobectomy, isthmusectomy for any indication
Who cannot join
- History of prior thyroid surgery
- Previously consented for thyroid surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Elizabeth Cottrill Assistant Professor, MD, 215-955-6760, Elizabeth.Cottrill@jefferson.edu
About this study
This study looks at how a short educational video can help people better understand thyroid surgery. Patients who have thyroid nodules and need surgery will be part of the study. Some patients will get the usual information from their doctor, while others will also watch a video that explains the surgery in a simple and clear way. The study will check if the video helps patients feel more confident about their decision, lowers anxiety, and helps them remember important information about their surgery. Patients will answer surveys before surgery, after surgery, and 3 months later.
- Conditions
- Thyroid Cancer
- Being tested
- Thyroid Informed Surgical Consent Augmenting Video (TISCAV), Standard Consent
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid Informed Surgical Consent Augmenting Video (TISCAV)Behavioural
Participants randomized to the intervention group will receive a surgeon-created Thyroid Informed Surgical Consent Augmenting Video (TISCAV). This 8-minute video includes animated visuals and a surgeon voiceover explaining thyroid anatomy, surgical options (lobectomy vs. total thyroidectomy), risks, benefits, and expectations. The TISCAV was designed and reviewed by an endocrine surgery team to improve patient comprehension, confidence, satisfaction, and reduce decision regret compared to standard verbal consent alone.
Standard ConsentBehavioural
Participants receiving the Standard Consent intervention will undergo the routine informed consent process for thyroid surgery provided by their surgeon. This process includes a verbal discussion covering thyroidectomy procedure details, potential risks and complications, benefits, alternatives such as active surveillance, and an opportunity to ask questions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: TISCAV | Experimental | Not described Receives: Behavioral: Thyroid Informed Surgical Consent Augmenting Video (TISCAV) |
| Control: Standard Consent | Placebo comparator | Not described Receives: Behavioral: Standard Consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient knowledge score using a 10-item internally validated Thyroid Surgery Knowledge Assessment
This outcome measures patient knowledge of thyroid surgery, including indications, procedural options, risks, and benefits. A 10-question internally developed and validated multiple-choice questionnaire will be administered before and after the informed consent process. Each correct answer is scored as 1 point, with a total score ranging from 0 to 10. Higher scores indicate greater understanding and retention of surgical information.
Measured: Immediately after study enrollment (pre-consent) and immediately following the surgical consent process (post-consent)
Decisional Conflict Score using the Decisional Conflict Scale (DCS)
This outcome measures patient uncertainty and confidence related to thyroid surgery decision-making using the validated 16-item Decisional Conflict Scale (DCS). The DCS evaluates five subdomains: uncertainty, feeling informed, values clarity, support, and perceived effectiveness of the decision. Each item is scored from 0 (strongly agree) to 4 (strongly disagree), then standardized to a total score ranging from 0 to 100. Higher scores reflect greater decisional conflict and more difficulty with making a decision.
Measured: Preoperatively (after the consent process and before surgery)
Satisfaction with Decision Score using the Satisfaction with Decision Scale (SDS)
This outcome assesses patient satisfaction with their decision to undergo thyroid surgery using the validated 6-item Satisfaction with Decision Scale (SDS). Each item is scored from 1 (not satisfied) to 5 (very satisfied), with a total score ranging from 6 to 30. Higher scores indicate greater satisfaction with the decision-making process and outcome.
Measured: Immediately after consent (Preoperative), Postoperative Day 22, and Postoperative Day 100
Decision Regret Score using the Decision Regret Scale (DRS)
This outcome evaluates postoperative regret related to undergoing thyroid surgery using the validated 5-item Decision Regret Scale (DRS). Each item is scored from 1 (strongly agree) to 5 (strongly disagree), with scores converted to a 0-100 scale. Higher scores reflect greater decision regret.
Measured: Postoperative Day 22 and Postoperative Day 100
Anxiety Score using the Visual Analog Scale for Anxiety (VAS-A)
This outcome measures patients' current level of anxiety using the validated Visual Analog Scale for Anxiety (VAS-A), a single-item scale presented as a 100 mm line ranging from "calm" to "anxious." Participants place a mark on the scale reflecting their current state. The score is recorded as a number from 0 to 100, with higher scores indicating greater anxiety.
Measured: Immediately after consent (Preoperative), Postoperative Day 22, and Postoperative Day 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start10 Nov 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Cottrill Assistant Professor and Program Director, MD, Principal investigator, Assistant Professor and Program Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918223
- Sponsor's protocol ID
- 20E.663
- Other IDs
- STRYKER
- Acronym
- TISCAV
- Status last verified
- Apr 2025
- First submitted
- 18 Mar 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated and analyzed during this study will not be publicly available due to patient confidentiality and institutional data-sharing policies. However, de-identified participant-level data (IPD) may be shared with qualified researchers upon reasonable request to the corresponding author, subject to institutional and ethical approvals. The data will be made available for research purposes related to patient comprehension, decision-making, and informed consent in surgical settings. Access will be granted following approval of a research proposal and a signed data access agreement.
Publications
Levy N, Landmann L, Stermer E, Erdreich M, Beny A, Meisels R. Does a detailed explanation prior to gastroscopy reduce the patient's anxiety? Endoscopy. 1989 Nov;21(6):263-5. doi: 10.1055/s-2007-1012965.
PubMed 2612430Kindler CH, Harms C, Amsler F, Ihde-Scholl T, Scheidegger D. The visual analog scale allows effective measurement of preoperative anxiety and detection of patients' anesthetic concerns. Anesth Analg. 2000 Mar;90(3):706-12. doi: 10.1097/00000539-200003000-00036.
PubMed 10702461Thomas T, Robinson C, Champion D, McKell M, Pell M. Prediction and assessment of the severity of post-operative pain and of satisfaction with management. Pain. 1998 Apr;75(2-3):177-85. doi: 10.1016/s0304-3959(97)00218-2.
PubMed 9583753McCleane GJ, Cooper R. The nature of pre-operative anxiety. Anaesthesia. 1990 Feb;45(2):153-5. doi: 10.1111/j.1365-2044.1990.tb14285.x.
PubMed 2321720Domar AD, Everett LL, Keller MG. Preoperative anxiety: is it a predictable entity? Anesth Analg. 1989 Dec;69(6):763-7.
PubMed 2589657D'Souza V, Blouin E, Zeitouni A, Muller K, Allison PJ. Do multimedia based information services increase knowledge and satisfaction in head and neck cancer patients? Oral Oncol. 2013 Sep;49(9):943-949. doi: 10.1016/j.oraloncology.2013.06.005. Epub 2013 Jul 16.
PubMed 23870712Hakimi AA, Standiford L, Chang E, Wong BJ. Development and Assessment of a Video-Based Intervention to Improve Rhinoplasty Informed Consent. Facial Plast Surg. 2021 Oct;37(5):585-589. doi: 10.1055/s-0041-1722912. Epub 2021 Feb 25.
PubMed 33634455Siu JM, Rotenberg BW, Franklin JH, Sowerby LJ. Multimedia in the informed consent process for endoscopic sinus surgery: A randomized control trial. Laryngoscope. 2016 Jun;126(6):1273-8. doi: 10.1002/lary.25793. Epub 2015 Nov 30.
PubMed 26615812Nehme J, El-Khani U, Chow A, Hakky S, Ahmed AR, Purkayastha S. The use of multimedia consent programs for surgical procedures: a systematic review. Surg Innov. 2013 Feb;20(1):13-23. doi: 10.1177/1553350612446352. Epub 2012 May 14.
PubMed 22589017Sudore RL, Landefeld CS, Williams BA, Barnes DE, Lindquist K, Schillinger D. Use of a modified informed consent process among vulnerable patients: a descriptive study. J Gen Intern Med. 2006 Aug;21(8):867-73. doi: 10.1111/j.1525-1497.2006.00535.x.
PubMed 16881949Burns P, Keogh I, Timon C. Informed consent: a patients' perspective. J Laryngol Otol. 2005 Jan;119(1):19-22. doi: 10.1258/0022215053222860.
PubMed 15807957Hekkenberg RJ, Irish JC, Rotstein LE, Brown DH, Gullane PJ. Informed consent in head and neck surgery: how much do patients actually remember? J Otolaryngol. 1997 Jun;26(3):155-9.
PubMed 9176798Oosthuizen JC, Burns P, Timon C. The changing face of informed surgical consent. J Laryngol Otol. 2012 Mar;126(3):236-9. doi: 10.1017/S0022215111003021. Epub 2011 Nov 4.
PubMed 22051081Kessels RP. Patients' memory for medical information. J R Soc Med. 2003 May;96(5):219-22. doi: 10.1177/014107680309600504. No abstract available.
PubMed 12724430Sherlock A, Brownie S. Patients' recollection and understanding of informed consent: a literature review. ANZ J Surg. 2014 Apr;84(4):207-10. doi: 10.1111/ans.12555.
PubMed 24812707
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Patient Satisfaction and Confidence After Use of Educational Video to Augment Surgical Consent for Thyroid Surgery
- ClinicalTrials.gov ID
- NCT06918223
- Acronym / sponsor ID
- TISCAV / 20E.663
- Conditions
- Thyroid Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Apr 2025 (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 study looks at how a short educational video can help people better understand thyroid surgery. Patients who have thyroid nodules and need surgery will be part of the study. Some patients will get the usual information from their doctor, while others will also watch a video that explains the surgery in a simple and clear way. The study will check if the video helps patients feel more confident about their decision, lowers anxiety, and helps them remember important information about their surgery. Patients will answer surveys before surgery, after surgery, and 3 months later.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: TISCAV | Experimental | Behavioral: Thyroid Informed Surgical Consent Augmenting Video (TISCAV) |
| Control: Standard Consent | Placebo comparator | Behavioral: Standard Consent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English is Primary Language
- ≥18 years old at time of consent
- Eligible for Thyroidectomy, lobectomy, isthmusectomy for any indication
Key exclusion criteria (2 listed)
- History of prior thyroid surgery
- Previously consented for thyroid surgery
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 |
|---|---|---|
| Thyroid Informed Surgical Consent Augmenting Video (TISCAV)Participants randomized to the intervention group will receive a surgeon-created Thyroid Informed Surgical Consent Augmenting Video (TISCAV). This 8-minute video includes animated visuals and a surgeon voiceover explaining thyroid anatomy, surgical options (lobectomy vs. total thyroidectomy), risks, benefits, and expectations. The TISCAV was designed and reviewed by an endocrine surgery team to improve patient comprehension, confidence, satisfaction, and reduce decision regret compared to standard verbal consent alone. | Behavioural | Intervention: TISCAV |
| Standard ConsentParticipants receiving the Standard Consent intervention will undergo the routine informed consent process for thyroid surgery provided by their surgeon. This process includes a verbal discussion covering thyroidectomy procedure details, potential risks and complications, benefits, alternatives such as active surveillance, and an opportunity to ask questions. | Behavioural | Control: Standard Consent |
Primary outcome
Patient knowledge score using a 10-item internally validated Thyroid Surgery Knowledge Assessment
Time frame: Immediately after study enrollment (pre-consent) and immediately following the surgical consent process (post-consent)
This outcome measures patient knowledge of thyroid surgery, including indications, procedural options, risks, and benefits. A 10-question internally developed and validated multiple-choice questionnaire will be administered before and after the informed consent process. Each correct answer is scored as 1 point, with a total score ranging from 0 to 10. Higher scores indicate greater understanding and retention of surgical information.
Decisional Conflict Score using the Decisional Conflict Scale (DCS)
Time frame: Preoperatively (after the consent process and before surgery)
This outcome measures patient uncertainty and confidence related to thyroid surgery decision-making using the validated 16-item Decisional Conflict Scale (DCS). The DCS evaluates five subdomains: uncertainty, feeling informed, values clarity, support, and perceived effectiveness of the decision. Each item is scored from 0 (strongly agree) to 4 (strongly disagree), then standardized to a total score ranging from 0 to 100. Higher scores reflect greater decisional conflict and more difficulty with making a decision.
Satisfaction with Decision Score using the Satisfaction with Decision Scale (SDS)
Time frame: Immediately after consent (Preoperative), Postoperative Day 22, and Postoperative Day 100
This outcome assesses patient satisfaction with their decision to undergo thyroid surgery using the validated 6-item Satisfaction with Decision Scale (SDS). Each item is scored from 1 (not satisfied) to 5 (very satisfied), with a total score ranging from 6 to 30. Higher scores indicate greater satisfaction with the decision-making process and outcome.
Decision Regret Score using the Decision Regret Scale (DRS)
Time frame: Postoperative Day 22 and Postoperative Day 100
This outcome evaluates postoperative regret related to undergoing thyroid surgery using the validated 5-item Decision Regret Scale (DRS). Each item is scored from 1 (strongly agree) to 5 (strongly disagree), with scores converted to a 0-100 scale. Higher scores reflect greater decision regret.
Anxiety Score using the Visual Analog Scale for Anxiety (VAS-A)
Time frame: Immediately after consent (Preoperative), Postoperative Day 22, and Postoperative Day 100
This outcome measures patients' current level of anxiety using the validated Visual Analog Scale for Anxiety (VAS-A), a single-item scale presented as a 100 mm line ranging from "calm" to "anxious." Participants place a mark on the scale reflecting their current state. The score is recorded as a number from 0 to 100, with higher scores indicating greater anxiety.
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 13 Apr 2025.
- Background: PubMed 2612430Levy N, Landmann L, Stermer E, Erdreich M, Beny A, Meisels R. Does a detailed explanation prior to gastroscopy reduce the patient's anxiety? Endoscopy. 1989 Nov;21(6):263-5. doi: 10.1055/s-2007-1012965.
- Background: PubMed 10702461Kindler CH, Harms C, Amsler F, Ihde-Scholl T, Scheidegger D. The visual analog scale allows effective measurement of preoperative anxiety and detection of patients' anesthetic concerns. Anesth Analg. 2000 Mar;90(3):706-12. doi: 10.1097/00000539-200003000-00036.
- Background: PubMed 9583753Thomas T, Robinson C, Champion D, McKell M, Pell M. Prediction and assessment of the severity of post-operative pain and of satisfaction with management. Pain. 1998 Apr;75(2-3):177-85. doi: 10.1016/s0304-3959(97)00218-2.
- Background: PubMed 2321720McCleane GJ, Cooper R. The nature of pre-operative anxiety. Anaesthesia. 1990 Feb;45(2):153-5. doi: 10.1111/j.1365-2044.1990.tb14285.x.
- Background: PubMed 2589657Domar AD, Everett LL, Keller MG. Preoperative anxiety: is it a predictable entity? Anesth Analg. 1989 Dec;69(6):763-7.
- Background: PubMed 23870712D'Souza V, Blouin E, Zeitouni A, Muller K, Allison PJ. Do multimedia based information services increase knowledge and satisfaction in head and neck cancer patients? Oral Oncol. 2013 Sep;49(9):943-949. doi: 10.1016/j.oraloncology.2013.06.005. Epub 2013 Jul 16.
- Background: PubMed 33634455Hakimi AA, Standiford L, Chang E, Wong BJ. Development and Assessment of a Video-Based Intervention to Improve Rhinoplasty Informed Consent. Facial Plast Surg. 2021 Oct;37(5):585-589. doi: 10.1055/s-0041-1722912. Epub 2021 Feb 25.
- Background: PubMed 26615812Siu JM, Rotenberg BW, Franklin JH, Sowerby LJ. Multimedia in the informed consent process for endoscopic sinus surgery: A randomized control trial. Laryngoscope. 2016 Jun;126(6):1273-8. doi: 10.1002/lary.25793. Epub 2015 Nov 30.
- Background: PubMed 22589017Nehme J, El-Khani U, Chow A, Hakky S, Ahmed AR, Purkayastha S. The use of multimedia consent programs for surgical procedures: a systematic review. Surg Innov. 2013 Feb;20(1):13-23. doi: 10.1177/1553350612446352. Epub 2012 May 14.
- Background: PubMed 16881949Sudore RL, Landefeld CS, Williams BA, Barnes DE, Lindquist K, Schillinger D. Use of a modified informed consent process among vulnerable patients: a descriptive study. J Gen Intern Med. 2006 Aug;21(8):867-73. doi: 10.1111/j.1525-1497.2006.00535.x.
- Background: PubMed 15807957Burns P, Keogh I, Timon C. Informed consent: a patients' perspective. J Laryngol Otol. 2005 Jan;119(1):19-22. doi: 10.1258/0022215053222860.
- Background: PubMed 9176798Hekkenberg RJ, Irish JC, Rotstein LE, Brown DH, Gullane PJ. Informed consent in head and neck surgery: how much do patients actually remember? J Otolaryngol. 1997 Jun;26(3):155-9.
- Individual participant dataSharing planned: Yes. The datasets generated and analyzed during this study will not be publicly available due to patient confidentiality and institutional data-sharing policies. However, de-identified participant-level data (IPD) may be shared with qualified researchers upon reasonable request to the corresponding author, subject to institutional and ethical approvals. The data will be made available for research purposes related to patient comprehension, decision-making, and informed consent in surgical settings. Access will be granted following approval of a research proposal and a signed data access agreement.
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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.
Elizabeth Cottrill Assistant Professor and Program Director, MD principal investigator
Assistant Professor and Program Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thyroid Informed Surgical Consent Augmenting Video (TISCAV) and Standard Consent in people with Thyroid Cancer, run by Thomas Jefferson University 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 2 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: looking for participants now, as of the sponsor's last update on 13 Apr 2025. 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. Some participants in this study may receive a placebo. 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?
Contact Annie Moroco Assistant Professor, MD (215-955-6826, Annie.Moroco@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient knowledge score using a 10-item internally validated Thyroid Surgery Knowledge Assessment (time frame: Immediately after study enrollment (pre-consent) and immediately following the surgical consent process (post-consent)). The study lists 5 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 NCT06918223, which also lists 16 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 13 Apr 2025.