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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00001186
Other study ID # 830022
Secondary ID 83-C-0022
Status Recruiting
Phase
First received
Last updated
Start date February 15, 1983

Study information

Verified date June 3, 2024
Source National Institutes of Health Clinical Center (CC)
Contact Tammara Jenkins, R.N.
Phone (240) 760-6550
Email tjenkins@mail.nih.gov
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background: - Cancer has an enormous impact on the psychological and social well-being of the family unit. The life-threatening connotations of cancer single out the ill child from his peer/family group as one who is different, and often unable to maintain a normal lifestyle. Physical sequelae of cancer and its treatment accentuate the differences between these children and their normal peers/siblings. - It is important that children with cancer be prepared to function outside of protected situations and begin to develop skills of separation and independence. For healthy children, some of these latter skills are acquired by a camping experience. Such an experience for the patient with cancer is frequently precluded by their dependence on medical facilities and the physical limitations of their activities. - The goal of this study will be to assess the short and long term benefits of the "normalized" camping experience, provided in conjunction with Special Love, Inc., on the patients and staff. In particular, we will seek to determine whether such a comprehensive experience is capable of influencing the attitudes and life experiences of patients and staff in a positive manner. Objectives: -To evaluate the impact of an enriched normalized camping experience on the quality of life of the pediatric cancer patient. In particular, attempts will be made to measure the manner in which this experience influences the child's sense of well-being and self-esteem as well as his or her relationship with parents, family, and peers. Eligibility: - Children 7-17 years of age who are currently being treated for cancer or are up to 3 years post therapy OR Young adults with cancer (YACers) 18-25 years of age who are acting as counselors at Camp Fantastic - All children/young adults will be selected for camp after careful screening by a multidisciplinary committee consisting of medical and program directors. - At the discretion of the multidisciplinary committee consisting of medical and program directors, special exceptions may be made for children with extenuating circumstances. Design: - Assessment of benefit may include interviews with children and families before, during and following camp. Observational data on the child's performance at camp will be noted. - Medical and nursing personnel will consist of staff from the Pediatric Branch at the NCI, other units within the NIH, and participating institutions. - Special Love members, the Program Director at the 4-H Center camp (site of the camp) and Pediatric Branch staff at the NCI will coordinate the camp program, taking into account the medical needs of each camper. - Every attempt will be made to provide a full agenda of age appropriate activities for the patients. - The length of the camping experience for children with cancer will be for 7 days beginning on a Sunday and extending through the following Saturday morning. Patients will be transported to the camp from the NIH Clinical Center and the Virginia hospitals by bus.


Description:

Background: - Cancer has an enormous impact on the psychological and social well-being of the family unit. The life-threatening connotations of cancer single out the ill child from his peer/family group as one who is different, and often unable to maintain a normal lifestyle. Physical sequelae of cancer and its treatment accentuate the differences between these children and their normal peers/siblings. - It is important that children with cancer be prepared to function outside of protected situations and begin to develop skills of separation and independence. For healthy children, some of these latter skills are acquired by a camping experience. Such an experience for the patient with cancer is frequently precluded by their dependence on medical facilities and the physical limitations of their activities. - The goal of this study will be to assess the short and long term benefits of the "normalized" camping experience, provided in conjunction with Special Love, Inc., on the patients and staff. In particular, we will seek to determine whether such a comprehensive experience is capable of influencing the attitudes and life experiences of patients and staff in a positive manner. Objectives: -To evaluate the impact of an enriched normalized camping experience on the quality of life of the pediatric cancer patient. In particular, attempts will be made to measure the manner in which this experience influences the child's sense of well-being and self-esteem as well as his or her relationship with parents, family, and peers. Eligibility: - Children 7-17 years of age who are currently being treated for cancer or are up to 5 years post therapy OR Young adults with cancer (YACers) 18-25 years of age who are acting as counselors at Camp Fantastic and are enrolled in another NIH protocol. - All children/young adults will be selected for camp after careful screening by a multidisciplinary committee consisting of medical and program directors. - At the discretion of the multidisciplinary committee consisting of medical and program directors, special exceptions may be made for children with extenuating circumstances. Design: - Assessment of benefit may include interviews with children and families before, during and following camp. Observational data on the child's performance at camp will be collected. - Medical and nursing personnel will consist of staff from the Pediatric Oncology Branch at the NCI, other units within the NIH, and participating institutions. - Special Love members, the Program Director at the 4-H Center camp (site of the camp) and Pediatric Oncology Branch staff at the NCI will coordinate the camp program, taking into account the medical needs of each camper. - Every attempt will be made to provide a full agenda of age appropriate activities for the patients. - The length of the camping experience for children with cancer will be for 7 days beginning on a Sunday and extending through the following Saturday morning. Patients will be transported to the camp from the NIH Clinical Center and the Virginia hospitals by bus.


Other known NCT identifiers
  • NCT00018915

Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 7 Years to 25 Years
Eligibility - INCLUSION CRITERIA: - Children 7-17 years of age who are currently being treated for cancer or are up to 5 years post therapy. OR Young adults with cancer (YACers) 18-25 years of age who are acting as counselors at Camp Fantastic. - Children/young adults will be selected for camp after careful screening by a multidisciplinary committee consisting of medical and program directors. While the state of the child s health will certainly be considered there will be no exclusions for: - Patients who are receiving intramuscular, intrathecal, oral or intravenous medications or blood products. - Patients who have had amputations or have other physical defects. - Patients who become febrile and neutropenic at the onset or during the week of camp will stay at camp on antibiotic therapy providing their condition remains stable. - At the discretion of the multidisciplinary committee consisting of medical and program directors, special exceptions may be made for patients with extenuating circumstances. - All children will be officially enrolled and will have an NIH Clinical Center Patient Care Number. The enrollment of a child, signing of protocol consent, and completion of admission paperwork is done in person but under extenuating circumstances it may be done over the phone after the paperwork has been mailed to the parent/guardian. Extenuating circumstances would include a last minute application to camp after the trip for camp screenings in Norfolk or Richmond has been completed. EXCLUSION CRITERIA: -Children with a medical diagnosis other than cancer or their related disorders.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Institutes of Health Clinical Center Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Achenbach TM, Edelbrock CS. The Child Behavior Profile: II. Boys aged 12-16 and girls aged 6-11 and 12-16. J Consult Clin Psychol. 1979 Apr;47(2):223-33. doi: 10.1037//0022-006x.47.2.223. No abstract available. — View Citation

Reinhard SC, Given B, Petlick NH, Bemis A. Supporting Family Caregivers in Providing Care. In: Hughes RG, editor. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Apr. Chapter 14. Available from http://www.ncbi.nlm.nih.gov/books/NBK2665/ — View Citation

Weissman MM, Orvaschel H, Padian N. Children's symptom and social functioning self-report scales. Comparison of mothers' and children's reports. J Nerv Ment Dis. 1980 Dec;168(12):736-40. doi: 10.1097/00005053-198012000-00005. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Increase in self esteem Psychological benefit Ongoing
Secondary Improvement in quality of interactions Psychological benefit ongoing
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