MelanomaNCT00816374
Tailored Intervention for Melanoma Patient's Families
A study testing Reading materials and discussions and Questionnaires in people with Melanoma, run by Fox Chase Cancer Center at 3 sites in United States.
Trial summary
The purpose of the investigators' study is to find the best way to provide information about sun protection and skin cancer detection. The investigators want to see which of two methods most improves sun protection and screening attitudes and practices. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma
- What is being tested?
- Reading materials and discussions and Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 553 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2005to May 2011
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Newly diagnosed with cutaneous malignant melanoma (CMM) within the past 2 years but more than 3 months prior to being approached
- Seen at FCCC, FCCC Network, Temple, MCC, or HUP patient clinics
- Greater than 18 years of age
- English speaking
- Able to give meaningful informed consent
- Does NOT have a first-degree relative with CMM
Show all 13Show fewer
- Current age of at least 21 years
- One or more of the following additional risk factors; blonde or red hair; marked freckling on the upper back; history of 3 or more blistering sunburns prior to age 20; 3 or more years of an outdoor summer job as a teenager; Actinic keratosis
- Able to give informed consent
- English speaking
- Has residential phone service
- No personal history of CMM or non-melanoma skin cancer
- No personal history of dysplastic nevi
Who cannot join
- 2 or more first degree relatives with CMM
- Has had a total cutaneous examination (TCE) in the past 3 years AND has done skin self-examination (SSE) more than once in the past year AND has a sun protection habits mean score greater than or equal to 4 (often). We are selecting a set participants who are NOT compliant with TCE and are inconsistent/minimal performers of SSE and sun protection practices.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
The purpose of the investigators' study is to find the best way to provide information about sun protection and skin cancer detection. The investigators want to see which of two methods most improves sun protection and screening attitudes and practices. The investigators hope to improve these attitudes and practices among people who are at higher risk for melanoma. People at higher risk for melanoma are first degree relatives (mother, father, sibling or child) of people diagnosed with melanoma.
Read the detailed description
Eligible patients will be contacted to find out whether they have any living first degree relatives that we may contact to discuss their participation in our study.
Eligible first degree relatives (FDRs) will participate in our study as outlined under Interventions.
- Conditions
- Melanoma
- Being tested
- Reading materials and discussions, Questionnaires
- Keywords
- cutaneous malignant melanoma, CMM, total cutaneous examination, TCE, skin self-examination, SSE, first degree relatives, FDR, skin cancer protection, skin cancer screening
- Medical subject headings
- Melanoma, Melanoma, Cutaneous Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reading materials and discussionsOther
Also called Supportive Care Intervention, Behavioral
We will send 3 sets of materials via mail, containing information about melanoma prevention and detection, 1 set each month for 3 months. Materials published by:
- The American Cancer Society
- The American Academy of Dermatology
- The Skin Cancer Foundation
The pamphlets contain information about ways to reduce risk for skin cancer including:
- Sun protection practices
- Risk factors for melanoma
- Information about what melanoma looks like
- How to do skin self-examinations
There will also be a telephone discussion with a health educator, discussing melanoma and other information contained in the pamphlets.
Reading materials and discussionsOther
Also called Supportive Care Intervention, Behavioral
We will send 3 separate pamphlets created specifically for participants. We will send 1 pamphlet each month for 3 months. The information in the pamphlets will be based on answers from the first survey. These pamphlets will contain information about:
- Melanoma and skin cancer protection guidelines
- The benefits of skin screening practices
- Ways to protect yourself from the sun
In addition to these pamphlets, there will be a telephone discussion with a health educator to discuss melanoma and other information contained in the pamphlets.
QuestionnairesOther
Also called Supportive Care Intervention, Behavioral
Both groups will complete 3 surveys; at the beginning, 3 months later, 6 months after the second survey. Each survey will ask about:
- knowledge of melanoma
- current and past skin cancer screening practices
- current and past sun protection practices
- attitudes about skin cancer and sun protection
- feelings about relative's melanoma diagnosis and treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Group I Receives: Other: Reading materials and discussions; Other: Questionnaires |
| 2 | Other | Group II Receives: Other: Reading materials and discussions; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of generic print and phone counseling vs. tailored print and phone counseling interventions on the engagement in total cutaneous examination (TCE) and self-skin examination (SSE) among first degree relatives (FDRs) at increased risk for CMM.
Measured: approximately 9 months per participant
Secondary outcomes (1)
Determine whether the interventions have an impact on attitudinal factors and whether these attitudinal factors mediate the expected association between the interventions and skin surveillance and sun exposure/protection.
Measured: approximately 9 months per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2009 (estimated)
- Study startAug 2005
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 553 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Paul Jacobsen, Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research InstituteSharon L Manne, PhD, Principal investigator, Fox Chase Cancer CenterMichael Ming, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816374
- Sponsor's protocol ID
- FCCC- 05-805
- Other IDs
- IRB 05-805
- Status last verified
- May 2014
- First submitted
- 31 Dec 2008
- Last updated
- 16 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Coups EJ, Manne SL, Jacobsen PB, Ming ME, Heckman CJ, Lessin SR. Skin surveillance intentions among family members of patients with melanoma. BMC Public Health. 2011 Nov 14;11:866. doi: 10.1186/1471-2458-11-866.
PubMed 22082038Manne S, Jacobsen PB, Ming ME, Winkel G, Dessureault S, Lessin SR. Tailored versus generic interventions for skin cancer risk reduction for family members of melanoma patients. Health Psychol. 2010 Nov;29(6):583-93. doi: 10.1037/a0021387.
PubMed 21090893Manne SL, Coups EJ, Jacobsen PB, Ming M, Heckman CJ, Lessin S. Sun protection and sunbathing practices among at-risk family members of patients with melanoma. BMC Public Health. 2011 Feb 21;11:122. doi: 10.1186/1471-2458-11-122.
PubMed 21338483
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Intervention for Melanoma Patient's Families
- ClinicalTrials.gov ID
- NCT00816374
- Acronym / sponsor ID
- FCCC- 05-805
- Conditions
- Melanoma
- Keywords
- cutaneous malignant melanoma, CMM, total cutaneous examination, TCE, skin self-examination, SSE, first degree relatives, FDR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 553 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2005
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 1 Jan 2009 (estimated)
- 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.
The purpose of the investigators' study is to find the best way to provide information about sun protection and skin cancer detection. The investigators want to see which of two methods most improves sun protection and screening attitudes and practices. The investigators hope to improve these attitudes and practices among people who are at higher risk for melanoma. People at higher risk for melanoma are first degree relatives (mother, father, sibling or child) of people diagnosed with melanoma.
Detailed description
Eligible patients will be contacted to find out whether they have any living first degree relatives that we may contact to discuss their participation in our study.
Eligible first degree relatives (FDRs) will participate in our study as outlined under Interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Reading materials and discussions, Other: QuestionnairesGroup I |
| 2 | Other | Other: Reading materials and discussions, Other: QuestionnairesGroup II |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Newly diagnosed with cutaneous malignant melanoma (CMM) within the past 2 years but more than 3 months prior to being approached
- Seen at FCCC, FCCC Network, Temple, MCC, or HUP patient clinics
- Greater than 18 years of age
- English speaking
- Able to give meaningful informed consent
Key exclusion criteria (2 listed)
- 2 or more first degree relatives with CMM
- Has had a total cutaneous examination (TCE) in the past 3 years AND has done skin self-examination (SSE) more than once in the past year AND has a sun protection habits mean score greater than or equal to 4 (often). We are selecting a set participants who are NOT compliant with TCE and are inconsistent/minimal performers of SSE and sun protection practices.
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 |
|---|---|---|
| Reading materials and discussionsAlso: Supportive Care Intervention, BehavioralWe will send 3 sets of materials via mail, containing information about melanoma prevention and detection, 1 set each month for 3 months. Materials published by: * The American Cancer Society * The American Academy of Dermatology * The Skin Cancer Foundation The pamphlets contain information about ways to reduce risk for skin cancer including: * Sun protection practices * Risk factors for melanoma * Information about what melanoma looks like * How to do skin self-examinations There will also be a telephone discussion with a health educator, discussing melanoma and other information contained in the pamphlets. | Other | 1 |
| Reading materials and discussionsAlso: Supportive Care Intervention, BehavioralWe will send 3 separate pamphlets created specifically for participants. We will send 1 pamphlet each month for 3 months. The information in the pamphlets will be based on answers from the first survey. These pamphlets will contain information about: * Melanoma and skin cancer protection guidelines * The benefits of skin screening practices * Ways to protect yourself from the sun In addition to these pamphlets, there will be a telephone discussion with a health educator to discuss melanoma and other information contained in the pamphlets. | Other | 2 |
| QuestionnairesAlso: Supportive Care Intervention, BehavioralBoth groups will complete 3 surveys; at the beginning, 3 months later, 6 months after the second survey. Each survey will ask about: * knowledge of melanoma * current and past skin cancer screening practices * current and past sun protection practices * attitudes about skin cancer and sun protection * feelings about relative's melanoma diagnosis and treatment | Other | 1, 2 |
Primary outcome
Impact of generic print and phone counseling vs. tailored print and phone counseling interventions on the engagement in total cutaneous examination (TCE) and self-skin examination (SSE) among first degree relatives (FDRs) at increased risk for CMM.
Time frame: approximately 9 months per participant
1 secondary outcome
Determine whether the interventions have an impact on attitudinal factors and whether these attitudinal factors mediate the expected association between the interventions and skin surveillance and sun exposure/protection.
Time frame: approximately 9 months per participant
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 16 May 2014.
- Background: PubMed 22082038Coups EJ, Manne SL, Jacobsen PB, Ming ME, Heckman CJ, Lessin SR. Skin surveillance intentions among family members of patients with melanoma. BMC Public Health. 2011 Nov 14;11:866. doi: 10.1186/1471-2458-11-866.
- Results publication: PubMed 21090893Manne S, Jacobsen PB, Ming ME, Winkel G, Dessureault S, Lessin SR. Tailored versus generic interventions for skin cancer risk reduction for family members of melanoma patients. Health Psychol. 2010 Nov;29(6):583-93. doi: 10.1037/a0021387.
- Results publication: PubMed 21338483Manne SL, Coups EJ, Jacobsen PB, Ming M, Heckman CJ, Lessin S. Sun protection and sunbathing practices among at-risk family members of patients with melanoma. BMC Public Health. 2011 Feb 21;11:122. doi: 10.1186/1471-2458-11-122.
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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.
Paul Jacobsen, Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
Sharon L Manne, PhD principal investigator
Fox Chase Cancer Center
Michael Ming, MD principal investigator
University of Pennsylvania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reading materials and discussions and Questionnaires in people with Melanoma, run by Fox Chase Cancer Center 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 13 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: finished, as of the sponsor's last update on 16 May 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?
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?
Impact of generic print and phone counseling vs. tailored print and phone counseling interventions on the engagement in total cutaneous examination (TCE) and self-skin examination (SSE) among first degree relatives (FDRs) at increased risk for CMM. (time frame: approximately 9 months per participant). 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 NCT00816374, which also lists 3 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 16 May 2014.