MelanomaNCT00745862
Illness Related Distress in Women With Clinically Localized Cutaneous Melanoma
An observational study of Melanoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to examine the experiences and quality of life of women who have been treated for melanoma. By quality of life, we mean how they are feeling about different aspects of their life. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Melanoma
- What is being tested?
- questionnaire on-line or if uncomfortable with a computer interface, paper copies will be provided
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Jul 2013
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female melanoma patients during their regularly scheduled surgical clinic appointment at MSKCC.
Who may be able to join
- Age 18 years or older
- Clinically node-negative primary cutaneous melanoma.
- Patients participating must be female
- Patients must have completed surgical treatment for melanoma at least 10 days ago and less than 2 years at the time of study entry.
Who cannot join
- Prior history of cancer with the exception of squamous or basal cell carcinoma of the skin.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to examine the experiences and quality of life of women who have been treated for melanoma. By quality of life, we mean how they are feeling about different aspects of their life. In this study, we are especially interested in their feelings about survival, physical appearance and any family concerns. We will administer a series of QOL questionnaires, data sheets with many questions, to get their response to measure their feelings about these issues.
- Conditions
- Melanoma
- Being tested
- questionnaire on-line or if uncomfortable with a computer interface, paper copies will be provided
- Keywords
- Skin
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire on-line or if uncomfortable with a computer interface, paper copies will be providedBehavioural
This pilot study will measure illness related distress in female patients undergoing surgical treatment of cutaneous melanoma within two years of diagnosis and treatment. Areas of particular focus will be survival anxiety, family functioning/childbearing concerns, and aesthetic impact of surgery. Patients will complete a one time only set of quality of life assessments these questionnaires will take 30-45 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| 1 | female patients undergoing surgical treatment of cutaneous melanoma within two years of diagnosis and treatment Receives: Behavioral: questionnaire on-line or if uncomfortable with a computer interface, paper copies will be provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure illness related distress regarding survival, family planning and functioning, and aesthetic satisfaction and QOL in post-surgical female patients diagnosed with clinically localized primary cutaneous melanoma.
Measured: conclusion of study
Secondary outcomes (1)
To examine the impact of illness related distress on QOL in women treated for clinically localized primary cutaneous melanoma.
Measured: conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Sue Brady, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745862
- Sponsor's protocol ID
- 08-096
- Status last verified
- Jul 2013
- First submitted
- 22 Aug 2008
- Last updated
- 25 Jul 2013
- Results posted
- No
Publications
Atkinson TM, Noce NS, Hay J, Rafferty BT, Brady MS. Illness-related distress in women with clinically localized cutaneous melanoma. Ann Surg Oncol. 2013 Feb;20(2):675-9. doi: 10.1245/s10434-012-2635-5. Epub 2012 Sep 11.
PubMed 22965568
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Illness Related Distress in Women With Clinically Localized Cutaneous Melanoma
- ClinicalTrials.gov ID
- NCT00745862
- Acronym / sponsor ID
- 08-096
- Conditions
- Melanoma
- Keywords
- Skin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 3 Sep 2008 (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 this study is to examine the experiences and quality of life of women who have been treated for melanoma. By quality of life, we mean how they are feeling about different aspects of their life. In this study, we are especially interested in their feelings about survival, physical appearance and any family concerns. We will administer a series of QOL questionnaires, data sheets with many questions, to get their response to measure their feelings about these issues.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: questionnaire on-line or if uncomfortable with a computer interface, paper copies will be providedfemale patients undergoing surgical treatment of cutaneous melanoma within two years of diagnosis and treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female melanoma patients during their regularly scheduled surgical clinic appointment at MSKCC.
Key inclusion criteria (4 listed)
- Age 18 years or older
- Clinically node-negative primary cutaneous melanoma.
- Patients participating must be female
- Patients must have completed surgical treatment for melanoma at least 10 days ago and less than 2 years at the time of study entry.
Key exclusion criteria (1 listed)
- Prior history of cancer with the exception of squamous or basal cell carcinoma of the skin.
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 |
|---|---|---|
| questionnaire on-line or if uncomfortable with a computer interface, paper copies will be providedThis pilot study will measure illness related distress in female patients undergoing surgical treatment of cutaneous melanoma within two years of diagnosis and treatment. Areas of particular focus will be survival anxiety, family functioning/childbearing concerns, and aesthetic impact of surgery. Patients will complete a one time only set of quality of life assessments these questionnaires will take 30-45 minutes to complete. | Behavioural | 1 |
Primary outcome
To measure illness related distress regarding survival, family planning and functioning, and aesthetic satisfaction and QOL in post-surgical female patients diagnosed with clinically localized primary cutaneous melanoma.
Time frame: conclusion of study
1 secondary outcome
To examine the impact of illness related distress on QOL in women treated for clinically localized primary cutaneous melanoma.
Time frame: conclusion of study
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 25 Jul 2013.
- Derived from this study: PubMed 22965568Atkinson TM, Noce NS, Hay J, Rafferty BT, Brady MS. Illness-related distress in women with clinically localized cutaneous melanoma. Ann Surg Oncol. 2013 Feb;20(2):675-9. doi: 10.1245/s10434-012-2635-5. Epub 2012 Sep 11.
- Memorial Sloan-Kettering Cancer CenterLink 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.
Mary Sue Brady, MD principal investigator
Memorial Sloan Kettering 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 Memorial Sloan Kettering 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 4 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 25 Jul 2013. 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?
To measure illness related distress regarding survival, family planning and functioning, and aesthetic satisfaction and QOL in post-surgical female patients diagnosed with clinically localized primary cutaneous melanoma. (time frame: conclusion of study). 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 NCT00745862, which also lists 1 linked publication.
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 25 Jul 2013.