MelanomaNCT00510302
Melanoma Risk-Reduction Among Patients and Family Members
An observational study of Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: To conduct semi-structured interviews with melanoma patients and family members to collect descriptive information on their UVR exposure, UVR exposure-reduction practices, melanoma early detection practices, knowledge, psychosocial variables related to melanoma risk-reduction (e.g., self-efficacy… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma
- What is being tested?
- Questionnaire and Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2002to 14 Sep 2020
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with melanoma, their spouses/partners, and first-degree relatives (FDRs).
Who may be able to join
- (FDRs will include siblings and adult children.) Melanoma patients are eligible if they were diagnosed with in situ, localized, or regional melanoma after January 1, 1997.
- Melanoma patients, their spouses/partners, and their first-degree relatives (FDRs) 18 years of age or older are eligible.
- Melanoma patients, their spouses/partners, and FDRs are eligible if they can speak, read, and write English.
- Melanoma patients, their spouses/partners, and FDRs are eligible if they provide informed consent.
- Spouses/partners and FDRs of melanoma patients are eligible if the patient gives permission for them to be contacted for recruitment.
- A melanoma patient's FDR is eligible if he/she is a sibling or child of the melanoma patient.
Who cannot join
- Melanoma patients, spouses/partners of patients, and FDRs of patients are not eligible if they cannot provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Melanoma Risk-Reduction Practices Among Melanoma Patients and Their Family Members
Primary Objectives:
- To conduct semi-structured interviews with melanoma patients and family members to collect descriptive information on their UVR exposure, UVR exposure-reduction practices, melanoma early detection practices, knowledge, psychosocial variables related to melanoma risk-reduction (e.g., self-efficacy, norms, and expectations), and experiences surrounding the diagnosis of melanoma in the family. Melanoma patients and family members with children will be asked about the UVR exposure and UVR exposure-reduction practices of their children, and parental practices to reduce UVR exposure among children.
- To develop behavioral and attitudinal questionnaires based on data collected during semi-structured interviews, and evaluate the appropriateness of these questionnaires using cognitive interviewing techniques.
- To develop tailored messages aimed at promoting strategies to reduce UVR exposure (e.g., wearing protective clothing, minimizing midday UVR exposure, minimizing duration of UVR exposure, using shade and sunscreen, avoiding sun lamps, and avoiding intentional tanning) and improving adherence to surveillance and screening guidelines. Messages will be developed to correspond to responses to questionnaire items.
- To assess tailored messages for their relevance, appropriateness, attractiveness and appeal, credibility, and perceived behavioral impact among melanoma patients and their family members.
Read the detailed description
Participants in Part 1 of the study will be asked to be interviewed about topics related to melanoma risk-reduction, including opinions, attitudes, beliefs, and practices related to ultraviolet radiation exposure, melanoma prevention, and melanoma detection.
Participants in Part 2 of the study will be asked to complete a written questionnaire on melanoma risk-reduction and then be interviewed to obtain feedback on how the questionnaire may be refined.
Participants in Part 3 of the study will be asked to be interviewed by telephone. Participants then will receive educational material in the form of a newsletter tailored to their interview responses. Participants then will be asked to be interviewed to obtain feedback for refining the educational material. In each part of the study, the patient/family member will receive a letter describing the study and the Consent Statement for Questionnaire and Interview Studies.
Prior to the start of the interview, the Consent Statement will be read to the patient/family member. Patients/family members may or may not choose to have the interview tape-recorded. Participants may stop the interview or questionnaire at any time and may refuse to answer any questions. At any time, the patient/family member may refuse to have the interview tape-recorded. There is no treatment associated with this study.
- Conditions
- Melanoma
- Being tested
- Questionnaire, Interview
- Keywords
- Ultraviolet Radiation, Melanoma, Questionnaire, Survey, First Degree Relative, Interview
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Questionnaire regarding melanoma risk-reduction.
InterviewBehavioural
Interview via telephone about topics related to melanoma risk-reduction.
| Study group | Role | What they receive |
|---|---|---|
| Melanoma Risk-Reduction | Patients with melanoma, their spouses/partners, and first-degree relatives (FDRs). Receives: Behavioral: Questionnaire; Behavioral: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Information on ultraviolet radiation (UVR-E) reduction + early detection practices of melanoma patients and family members
Measured: 8 Years
Secondary outcomes (1)
Development of questionnaires + tailored intervention messages on melanoma risk-reduction in a high-risk population
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study start18 Nov 2002
- Primary completion14 Sep 2020
- Study completion14 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Peterson, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510302
- Sponsor's protocol ID
- ID02-452
- Status last verified
- Sep 2020
- First submitted
- 31 Jul 2007
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melanoma Risk-Reduction Practices Among Melanoma Patients and Their Family Members
- ClinicalTrials.gov ID
- NCT00510302
- Acronym / sponsor ID
- ID02-452
- Conditions
- Melanoma
- Keywords
- Ultraviolet Radiation, Melanoma, Questionnaire, Survey, First Degree Relative, Interview
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 18 Nov 2002 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 2 Aug 2007 (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.
Primary Objectives:
- To conduct semi-structured interviews with melanoma patients and family members to collect descriptive information on their UVR exposure, UVR exposure-reduction practices, melanoma early detection practices, knowledge, psychosocial variables related to melanoma risk-reduction (e.g., self-efficacy, norms, and expectations), and experiences surrounding the diagnosis of melanoma in the family. Melanoma patients and family members with children will be asked about the UVR exposure and UVR exposure-reduction practices of their children, and parental practices to reduce UVR exposure among children.
- To develop behavioral and attitudinal questionnaires based on data collected during semi-structured interviews, and evaluate the appropriateness of these questionnaires using cognitive interviewing techniques.
- To develop tailored messages aimed at promoting strategies to reduce UVR exposure (e.g., wearing protective clothing, minimizing midday UVR exposure, minimizing duration of UVR exposure, using shade and sunscreen, avoiding sun lamps, and avoiding intentional tanning) and improving adherence to surveillance and screening guidelines. Messages will be developed to correspond to responses to questionnaire items.
- To assess tailored messages for their relevance, appropriateness, attractiveness and appeal, credibility, and perceived behavioral impact among melanoma patients and their family members.
Detailed description
Participants in Part 1 of the study will be asked to be interviewed about topics related to melanoma risk-reduction, including opinions, attitudes, beliefs, and practices related to ultraviolet radiation exposure, melanoma prevention, and melanoma detection.
Participants in Part 2 of the study will be asked to complete a written questionnaire on melanoma risk-reduction and then be interviewed to obtain feedback on how the questionnaire may be refined.
Participants in Part 3 of the study will be asked to be interviewed by telephone. Participants then will receive educational material in the form of a newsletter tailored to their interview responses. Participants then will be asked to be interviewed to obtain feedback for refining the educational material. In each part of the study, the patient/family member will receive a letter describing the study and the Consent Statement for Questionnaire and Interview Studies.
Prior to the start of the interview, the Consent Statement will be read to the patient/family member. Patients/family members may or may not choose to have the interview tape-recorded. Participants may stop the interview or questionnaire at any time and may refuse to answer any questions. At any time, the patient/family member may refuse to have the interview tape-recorded. There is no treatment associated with this study.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melanoma Risk-Reduction | – | Behavioral: Questionnaire, Behavioral: InterviewPatients with melanoma, their spouses/partners, and first-degree relatives (FDRs). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with melanoma, their spouses/partners, and first-degree relatives (FDRs).
Key inclusion criteria (6 listed)
- (FDRs will include siblings and adult children.) Melanoma patients are eligible if they were diagnosed with in situ, localized, or regional melanoma after January 1, 1997.
- Melanoma patients, their spouses/partners, and their first-degree relatives (FDRs) 18 years of age or older are eligible.
- Melanoma patients, their spouses/partners, and FDRs are eligible if they can speak, read, and write English.
- Melanoma patients, their spouses/partners, and FDRs are eligible if they provide informed consent.
- Spouses/partners and FDRs of melanoma patients are eligible if the patient gives permission for them to be contacted for recruitment.
Key exclusion criteria (1 listed)
- Melanoma patients, spouses/partners of patients, and FDRs of patients are not eligible if they cannot 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 |
|---|---|---|
| QuestionnaireAlso: SurveyQuestionnaire regarding melanoma risk-reduction. | Behavioural | Melanoma Risk-Reduction |
| InterviewInterview via telephone about topics related to melanoma risk-reduction. | Behavioural | Melanoma Risk-Reduction |
Primary outcome
Information on ultraviolet radiation (UVR-E) reduction + early detection practices of melanoma patients and family members
Time frame: 8 Years
1 secondary outcome
Development of questionnaires + tailored intervention messages on melanoma risk-reduction in a high-risk population
Time frame: 8 years
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 Sep 2020.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Susan Peterson, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by M.D. Anderson 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 6 inclusion and 1 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 Sep 2020. 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?
Information on ultraviolet radiation (UVR-E) reduction + early detection practices of melanoma patients and family members (time frame: 8 Years). 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 16 Sep 2020.