MelanomaNCT01013844

Partner Assistance in Learning and Performing Skin Self-Examination

A study testing Skin Self Examination Information and ABCDE Rule in people with Melanoma, run by Northwestern University at 3 sites 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

This study is a behavioral science study designed to identify aspects of the dyadic relationship that promote Skin Self-Examination (SSE) in patients at high risk of developing melanoma. The patient is randomized to receive the educational intervention either as a solo learner or with the partner. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Melanoma
What is being tested?: Skin Self Examination Information and ABCDE Rule
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 130 participants
Where: 3 sitesUnited States
Study dates: Dec 2003to Nov 2010
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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Personal or family history of melanoma. If a personal history of melanoma, the patient was treated at least 1 month ago
Evidence of dysplastic nevus syndrome or a large number of moles (Greater than 50)
Able to see to read a newspaper, can read at an eighth grade level
Speaks English
18 to 70 years old with a spouse or cohabitating partner

Who cannot join

Under 18 years of age
Patient overburden by other co-morbid diseases such as chronic immunosuppression from organ transplantation
Have insufficient vision to to read a newspaper
Unable to read English
Have insufficient cognitive skills to follow instructions provided at an eighth grade language level

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Northwestern University
Chicago, Illinois, 60611
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Loyola University
Maywood, Illinois, 60153

Other trials in United States

About this study

Conditions: Melanoma
Being tested: Skin Self Examination Information and ABCDE Rule
Keywords: skin self-examination, SSE, melanoma
Medical subject headings: Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Skin Self Examination Information and ABCDE RuleBehavioural
Card with condensed information about skin self examination (SSE) and color illustrations of the ABCDE (asymmetry of shape, border irregularity, color variation, diameter > or equal to 6 mm, and evolution of the lesion) rule. A research assistant gave a skill demonstration using a magnifying lens.

Study groups in NCT01013844
Study group	Role	What they receive
Solo Learning	Active comparator	Participant learning alone (without partner). Receives: Behavioral: Skin Self Examination Information and ABCDE Rule
Dyadic Learning	Active comparator	Participant and partner learning together. Receives: Behavioral: Skin Self Examination Information and ABCDE Rule

What is being measured

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

Mean Number of Skin Examinations Without Partner Over 4 Months
Behavioral outcome was measured by assessing the number of times that participants examined their skin in the last 4 months.
Measured: 4 months
Mean Number of Skin Examinations With Partner Over 4 Months
Behavioral outcome was measured by assessing the number of times that participants examined their skin with a partner in the last 4 months.
Measured: 4 months
Mean Number of Times Reviewed Skin Self Examination Guidelines Over 4 Months
Behavioral outcome was measured by assessing the number of times that participants reviewed skin self examination guidelines in the last 4 months.
Measured: 4 months

Timeline

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

Dec 2003Nov 2010

First posted16 Nov 2009 (estimated)
Study startDec 2003
Primary completionNov 2010
Study completionNov 2010

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 (11)Papers the sponsor has linked to this study.
Other trials for MelanomaStudies of the same condition, open and under way.
More trials run by Northwestern 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01013844
Sponsor's protocol ID: 2003-01
Status last verified: Sep 2014
First submitted: 11 Nov 2009
Last updated: 2 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Robinson JK, Stapleton J, Turrisi R. Relationship and partner moderator variables increase self-efficacy of performing skin self-examination. J Am Acad Dermatol. 2008 May;58(5):755-62. doi: 10.1016/j.jaad.2007.12.027. Epub 2008 Feb 6.
PubMed 18258332
Robinson JK, Turrisi R. Skills training to learn discrimination of ABCDE criteria by those at risk of developing melanoma. Arch Dermatol. 2006 Apr;142(4):447-52. doi: 10.1001/archderm.142.4.447.
PubMed 16618863
Robinson JK, Turrisi R, Stapleton J. Efficacy of a partner assistance intervention designed to increase skin self-examination performance. Arch Dermatol. 2007 Jan;143(1):37-41. doi: 10.1001/archderm.143.1.37.
PubMed 17224540
Robinson JK, Turrisi R, Stapleton J. Examination of mediating variables in a partner assistance intervention designed to increase performance of skin self-examination. J Am Acad Dermatol. 2007 Mar;56(3):391-7. doi: 10.1016/j.jaad.2006.10.028. Epub 2006 Dec 4.
PubMed 17147966
Glanz K, Yaroch AL, Dancel M, Saraiya M, Crane LA, Buller DB, Manne S, O'Riordan DL, Heckman CJ, Hay J, Robinson JK. Measures of sun exposure and sun protection practices for behavioral and epidemiologic research. Arch Dermatol. 2008 Feb;144(2):217-22. doi: 10.1001/archdermatol.2007.46.
PubMed 18283179
Robinson JK, Ortiz S. Use of photographs illustrating ABCDE criteria in skin self-examination. Arch Dermatol. 2009 Mar;145(3):332-3. doi: 10.1001/archdermatol.2008.604. No abstract available.
PubMed 19289774
Boone SL, Stapleton J, Turrisi R, Ortiz S, Robinson JK, Mallett KA. Thoroughness of skin examination by melanoma patients: influence of age, sex and partner. Australas J Dermatol. 2009 Aug;50(3):176-80. doi: 10.1111/j.1440-0960.2009.00533.x.
PubMed 19659978
Robinson JK, Mallett KA, Turrisi R, Stapleton J. Engaging patients and their partners in preventive health behaviors: the physician factor. Arch Dermatol. 2009 Apr;145(4):469-73. doi: 10.1001/archdermatol.2009.2. No abstract available.
PubMed 19380671
Robinson JK, Mallett KA. The duty to inspect the skin and counsel those at risk to develop melanoma. JAMA. 2009 Apr 22;301(16):1702-4. doi: 10.1001/jama.2009.542. No abstract available.
PubMed 19388140
Robinson JK, Turrisi R, Mallett K, Stapleton J, Pion M. Comparing the efficacy of an in-person intervention with a skin self-examination workbook. Arch Dermatol. 2010 Jan;146(1):91-4. doi: 10.1001/archdermatol.2009.350. No abstract available.
PubMed 20083705
Robinson JK, Gaber R, Hultgren B, Eilers S, Blatt H, Stapleton J, Mallett K, Turrisi R, Duffecy J, Begale M, Martini M, Bilimoria K, Wayne J. Skin self-examination education for early detection of melanoma: a randomized controlled trial of Internet, workbook, and in-person interventions. J Med Internet Res. 2014 Jan 13;16(1):e7. doi: 10.2196/jmir.2883.
PubMed 24418949

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 Melanoma trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Partner Assistance in Learning and Performing Skin Self-Examination
ClinicalTrials.gov ID: NCT01013844
Acronym / sponsor ID: 2003-01
Conditions: Melanoma
Keywords: skin self-examination, SSE, melanoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Collaborators: Loyola University, Dartmouth-Hitchcock Medical Center
Study start: Dec 2003
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 16 Nov 2009 (estimated)
Results: Posted 10 Mar 2011

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Solo Learning	Active comparator	Behavioral: Skin Self Examination Information and ABCDE RuleParticipant learning alone (without partner).
Dyadic Learning	Active comparator	Behavioral: Skin Self Examination Information and ABCDE RuleParticipant and partner learning together.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Personal or family history of melanoma. If a personal history of melanoma, the patient was treated at least 1 month ago
Evidence of dysplastic nevus syndrome or a large number of moles (Greater than 50)
Able to see to read a newspaper, can read at an eighth grade level
Speaks English
18 to 70 years old with a spouse or cohabitating partner

Key exclusion criteria (5 listed)

Under 18 years of age
Patient overburden by other co-morbid diseases such as chronic immunosuppression from organ transplantation
Have insufficient vision to to read a newspaper
Unable to read English
Have insufficient cognitive skills to follow instructions provided at an eighth grade language level

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
Skin Self Examination Information and ABCDE RuleCard with condensed information about skin self examination (SSE) and color illustrations of the ABCDE (asymmetry of shape, border irregularity, color variation, diameter > or equal to 6 mm, and evolution of the lesion) rule. A research assistant gave a skill demonstration using a magnifying lens.	Behavioural	Dyadic Learning, Solo Learning

Primary outcome

Mean Number of Skin Examinations Without Partner Over 4 Months
Time frame: 4 months
Behavioral outcome was measured by assessing the number of times that participants examined their skin in the last 4 months.
Mean Number of Skin Examinations With Partner Over 4 Months
Time frame: 4 months
Behavioral outcome was measured by assessing the number of times that participants examined their skin with a partner in the last 4 months.
Mean Number of Times Reviewed Skin Self Examination Guidelines Over 4 Months
Time frame: 4 months
Behavioral outcome was measured by assessing the number of times that participants reviewed skin self examination guidelines in the last 4 months.

Results and safety

Results posted to the registry on 10 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Solo Learning	65	65
Dyadic Learning	65	65

Primary outcome: Mean Number of Skin Examinations Without Partner Over 4 Months

Time frame: 4 months. Mean (Standard Deviation). Unit: Times examined skin by self

Measure	Solo Learning Baseline n = 65	Dyadic Learning Baseline n = 65	Solo Learning Immediate Follow-up n = 65	Dyadic Learning Immediate Follow-up n = 65	Solo Learning 4-Month Follow-up n = 65	Dyadic Learning 4-Month Follow-up n = 65
Value	0.02 (0.12)	0.00 (0.00)	0.02 (0.12)	0.00 (0.00)	0.23 (0.42)	0.80 (0.74)

Primary outcome: Mean Number of Skin Examinations With Partner Over 4 Months

Time frame: 4 months. Mean (Standard Deviation). Unit: Times examined skin with a partner

Measure	Solo Learning Baseline n = 65	Dyadic Learning Baseline n = 65	Solo Learning Immediate Follow-up n = 65	Dyadic Learning Immediate Follow-up n = 65	Solo Learning 4-Month Follow-up n = 65	Dyadic Learning 4-Month Follow-up n = 65
Value	0.0 (0.0)	0.0 (0.0)	0.0 (0.0)	0.0 (0.0)	0.23 (0.42)	0.81 (0.72)

Primary outcome: Mean Number of Times Reviewed Skin Self Examination Guidelines Over 4 Months

Time frame: 4 months. Mean (Standard Deviation). Unit: Number of times reviewed SSE guidelines

Measure	Solo Learning Baseline n = 65	Dyadic Learning Baseline n = 65	Solo Learning Immediate Follow-up n = 65	Dyadic Learning Immediate Follow-up n = 65	Solo Learning 4-Month Follow-up n = 65	Dyadic Learning 4-Month Follow-up n = 65
Value	.03 (0.17)	0.0 (0.0)	0.08 (0.27)	0.0 (0.0)	0.55 (0.53)	0.91 (0.68)

Adverse events

Time frame: 4 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Solo Learning	0 of 65 (0%)	0 of 65 (0%)	Not reported
Dyadic Learning	0 of 65 (0%)	0 of 65 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18258332Robinson JK, Stapleton J, Turrisi R. Relationship and partner moderator variables increase self-efficacy of performing skin self-examination. J Am Acad Dermatol. 2008 May;58(5):755-62. doi: 10.1016/j.jaad.2007.12.027. Epub 2008 Feb 6.
Results publication: PubMed 16618863Robinson JK, Turrisi R. Skills training to learn discrimination of ABCDE criteria by those at risk of developing melanoma. Arch Dermatol. 2006 Apr;142(4):447-52. doi: 10.1001/archderm.142.4.447.
Results publication: PubMed 17224540Robinson JK, Turrisi R, Stapleton J. Efficacy of a partner assistance intervention designed to increase skin self-examination performance. Arch Dermatol. 2007 Jan;143(1):37-41. doi: 10.1001/archderm.143.1.37.
Results publication: PubMed 17147966Robinson JK, Turrisi R, Stapleton J. Examination of mediating variables in a partner assistance intervention designed to increase performance of skin self-examination. J Am Acad Dermatol. 2007 Mar;56(3):391-7. doi: 10.1016/j.jaad.2006.10.028. Epub 2006 Dec 4.
Results publication: PubMed 18283179Glanz K, Yaroch AL, Dancel M, Saraiya M, Crane LA, Buller DB, Manne S, O'Riordan DL, Heckman CJ, Hay J, Robinson JK. Measures of sun exposure and sun protection practices for behavioral and epidemiologic research. Arch Dermatol. 2008 Feb;144(2):217-22. doi: 10.1001/archdermatol.2007.46.
Results publication: PubMed 19289774Robinson JK, Ortiz S. Use of photographs illustrating ABCDE criteria in skin self-examination. Arch Dermatol. 2009 Mar;145(3):332-3. doi: 10.1001/archdermatol.2008.604. No abstract available.
Results publication: PubMed 19659978Boone SL, Stapleton J, Turrisi R, Ortiz S, Robinson JK, Mallett KA. Thoroughness of skin examination by melanoma patients: influence of age, sex and partner. Australas J Dermatol. 2009 Aug;50(3):176-80. doi: 10.1111/j.1440-0960.2009.00533.x.
Results publication: PubMed 19380671Robinson JK, Mallett KA, Turrisi R, Stapleton J. Engaging patients and their partners in preventive health behaviors: the physician factor. Arch Dermatol. 2009 Apr;145(4):469-73. doi: 10.1001/archdermatol.2009.2. No abstract available.
Results publication: PubMed 19388140Robinson JK, Mallett KA. The duty to inspect the skin and counsel those at risk to develop melanoma. JAMA. 2009 Apr 22;301(16):1702-4. doi: 10.1001/jama.2009.542. No abstract available.
Results publication: PubMed 20083705Robinson JK, Turrisi R, Mallett K, Stapleton J, Pion M. Comparing the efficacy of an in-person intervention with a skin self-examination workbook. Arch Dermatol. 2010 Jan;146(1):91-4. doi: 10.1001/archdermatol.2009.350. No abstract available.
Derived from this study: PubMed 24418949Robinson JK, Gaber R, Hultgren B, Eilers S, Blatt H, Stapleton J, Mallett K, Turrisi R, Duffecy J, Begale M, Martini M, Bilimoria K, Wayne J. Skin self-examination education for early detection of melanoma: a randomized controlled trial of Internet, workbook, and in-person interventions. J Med Internet Res. 2014 Jan 13;16(1):e7. doi: 10.2196/jmir.2883.

Related trials for Melanoma

Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
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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.

Dennis P West, PhD study director

Northwestern University

June K Robinson, MD principal investigator

Northwestern University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Skin Self Examination Information and ABCDE Rule in people with Melanoma, run by Northwestern University at 3 sites 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 5 inclusion and 5 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 2 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 10 Mar 2011). 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?

Mean Number of Skin Examinations Without Partner Over 4 Months (time frame: 4 months). The study lists 3 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 NCT01013844, which also lists 11 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 2 Oct 2014.