Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00491842
Other study ID # 999907179
Secondary ID 07-HG-N179
Status Completed
Phase
First received
Last updated
Start date June 22, 2007
Est. completion date September 29, 2023

Study information

Verified date September 2023
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will examine the ways in which people reveal their status as a carrier of Huntington s disease (HD) or of being at risk for the disease. It will explore factors that influence decisions about disclosure and how disclosure is made to family members, partners, and close friends. HD is an inherited, progressive disease. It causes nerve degeneration, motor disturbance, loss of awareness, and psychiatric symptoms. Currently, no effective treatment is available to prevent or delay HD progression. The mean age of onset is 35 to 44 years, and the median survival rate after onset is 15 to 18 years. HD affects about 1 in 10,000 people in the United States, so about 30,000 have HD and more than 200,000 are at risk. Predictive testing for HD has been available since 1993. It can be a life-changing event to learn of being at risk for HD. Disclosure has been studied among people with HD and other diseases, but knowledge about the extent of nondisclosure and disclosure is limited. There is evidence that a person s psychological adaptation to AD may be a factor. Adaptation involves processes that help a person search for meaning in what has happened, attempt to gain control of his or her life, and improve self-esteem in light of the threatening situation. Participants ages 18 and older who have had a positive genetic test result more than 6 months earlier regarding HD or who have a family history of HD but no predictive testing and who do not have symptoms of HD may be eligible for this study. Recruitment is done through HD clinics, support groups, and online websites and mailing listservs. About 260 people will be in the study. Participants will complete a survey taking 30 to 40 minutes to do. Two survey versions are available: for those who are gene carriers and for those at risk. Participants are asked to complete the version applying to them. The survey can be done online or through a hard copy to complete at home and send to NIH. This survey is anonymous. Participants will list the adults with whom they have a relationship and up to 10 people they interact with. They will indicate those who know about the HD gene or risk status. They will also list those to whom they have personally made disclosure. The goal is to distinguish if knowing the status or the act of disclosure is more important. Questions also involve discussing the inheritance and features of HD, and participants feelings or concerns about HD gene or risk status. Participants will be asked about their first disclosure experience, most recent experience of it, and timing of disclosure the time between learning of HD status and telling another person about it. There are also questions on decisions of nondisclosure, negative and positive aspects of disclosure for participants, and what health care professionals can do to help participants disclosure decisions.


Description:

The proposed study aims to describe presymptomatic and at-risk individuals' patterns of disclosure about Huntington's disease (HD) and HD risk to family and friends, and to investigate whether an association exists between disclosure about HD and psychological adaptation to HD. HD is reported to be one of the conditions most frequently involved in cases of nondisclosure about genetic risk. Little is known about the extent of disclosure and the process of disclosure within the HD population. Evidence suggests that a relationship may exist between disclosure of one's condition to others and psychological adaptation to the condition; however, this theory has never been tested. The conceptual framework of the study is informed by Shelly Taylor's Theory of Cognitive Adaptation. We will use a cross-sectional survey to 1) investigate individuals' patterns of disclosure about HD and 2) assess psychological adaptation to HD. Participants will be recruited from HD clinics, HD support groups, HD websites, and HD online mailing listservs. Eligible participants will be asked to complete either a web-based or a paper survey. The main outcome measure is psychological adaptation to HD.


Recruitment information / eligibility

Status Completed
Enrollment 315
Est. completion date September 29, 2023
Est. primary completion date March 27, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - INCLUSION CRITERIA: - Men and women who self-report: - Testing positive for the HD gene expansion, or - Not having undergone predictive genetic testing, but having a grandparent, parent, or sibling who has been clinically diagnosed with HD or has tested positive for the HD gene expansion - Ability to read and write English EXCLUSION CRITERIA: - Children younger than 18 - Manifesting HD symptoms, based on self-report - Received predictive genetic testing within the past 6 months - Received predictive genetic test result indicating the absence of the gene expansion

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Human Genome Research Institute (NHGRI), 9000 Rockville Pike Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Human Genome Research Institute (NHGRI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Clarke A, Richards M, Kerzin-Storrar L, Halliday J, Young MA, Simpson SA, Featherstone K, Forrest K, Lucassen A, Morrison PJ, Quarrell OW, Stewart H. Genetic professionals' reports of nondisclosure of genetic risk information within families. Eur J Hum Genet. 2005 May;13(5):556-62. doi: 10.1038/sj.ejhg.5201394. — View Citation

Craufurd D, Dodge A, Kerzin-Storrar L, Harris R. Uptake of presymptomatic predictive testing for Huntington's disease. Lancet. 1989 Sep 9;2(8663):603-5. doi: 10.1016/s0140-6736(89)90722-8. — View Citation

Figueiredo MI, Fries E, Ingram KM. The role of disclosure patterns and unsupportive social interactions in the well-being of breast cancer patients. Psychooncology. 2004 Feb;13(2):96-105. doi: 10.1002/pon.717. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Social Network Measure Developed Specifically for this Study To explore what factors influence decisions about disclosure of HD carrier or risk status in the target population Enrollment
Primary Social Network Measure Developed Specifically for this Study To explore relationships between the three domains of disclosure: to whom individuals are disclosing their HD carrier or risk status, when individuals are disclosing their HD carrier or risk status, and what specific information individuals are disclosing to family members, partners, and close friends. Enrollment
Primary Social Network Measure Developed Specifically for this Study To describe patterns of disclosure in the target population Enrollment
Primary Psychological Adaptation Scale To examine the relationship between individuals patterns of disclosure about HD and HD risk and their psychological adaptation to HD, taking into account other covariates (gender, age, ethnicity, marital status, level of education, known positive gene carrier versus at-risk, and recruitment source). Enrollment
See also
  Status Clinical Trial Phase
Recruiting NCT04120493 - Safety and Proof-of-Concept (POC) Study With AMT-130 in Adults With Early Manifest Huntington's Disease Phase 1/Phase 2
Completed NCT02956148 - Follow-up Measurement of Brain PDE10A Enzyme Levels in Huntington´s Disease Gene Expansion Carriers Early Phase 1
Terminated NCT02494778 - A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's Disease Phase 2
Completed NCT02208934 - Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 in Healthy Young Male Volunteers Phase 1
Completed NCT02216474 - Brain Stimulation in Movement Disorders N/A
Completed NCT02197130 - Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's Disease Phase 2
Completed NCT01806896 - Study Evaluating The Safety, Tolerability And Brain Function Of 2 Doses Of PF-0254920 In Subjects With Early Huntington's Disease Phase 2
Completed NCT01502046 - Neuroprotection by Cannabinoids in Huntington's Disease Phase 2
Terminated NCT00712426 - Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E) Phase 3
Completed NCT00670709 - Examination of Quantitative Electroencephalographic (QEEG) Biomarkers in Huntington's Disease
Completed NCT00029874 - Minocycline in Patients With Huntington's Disease Phase 1/Phase 2
Terminated NCT02231580 - Study Exploring Safety, Pharmacokinetic and Pharmacodynamic of BN82451 in Male Huntington's Disease Patients Phase 2
Completed NCT02215616 - A Clinical Study in Participants With Huntington's Disease (HD) to Assess Efficacy and Safety of Three Oral Doses of Laquinimod Phase 2
Not yet recruiting NCT02551705 - Functional Imaging of Social Cognition in Premanifest Huntington's Disease N/A
Active, not recruiting NCT02101957 - Multicentric Trial of the Treatment of Huntington's Disease by Cysteamine (RP103) Phase 2/Phase 3
Completed NCT01521832 - Escalating Dose Study in Healthy Volunteers With SEN0014196 Phase 1
Completed NCT00990613 - A Study Evaluating The Absorption Of Dimebon Into The Body From A Dimebon Solution Applied To The Skin Phase 1
Completed NCT00975481 - A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users Phase 1
Completed NCT00387270 - Safety Study of the Novel Drug Dimebon to Treat Patients With Huntington's Disease Phase 1/Phase 2
Completed NCT00095355 - Effects of Lithium and Divalproex`on Brain-Derived Neurotrophic Factor in Huntington's Disease Phase 2