CLINICAL TRIAL

Internet-Based Intervention for Carcinoma in Situ

Waitlist Available · < 18 · All Sexes · Washington, United States

This study is evaluating whether a web-based physical activity intervention works in improving long term health in children and adolescents with cancer.

See full description

About the trial for Carcinoma in Situ

Eligible Conditions
Carcinoma in Situ · Neoplasms · Hematopoietic and Lymphoid System Neoplasm · Carcinoma In Situ · Malignant Solid Neoplasms

Treatment Groups

This trial involves 2 different treatments. Internet-Based Intervention is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Internet-Based Intervention
OTHER
Medical Device Usage and Evaluation
DEVICE
Laboratory Biomarker Analysis
OTHER
Questionnaire Administration
OTHER
Quality-of-Life Assessment
OTHER
Educational Intervention
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Internet-Based Intervention
OTHER
Medical Device Usage and Evaluation
DEVICE
Laboratory Biomarker Analysis
OTHER
Questionnaire Administration
OTHER
Quality-of-Life Assessment
OTHER
Educational Intervention
OTHER

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Medical Device Usage and Evaluation
2021
N/A
~30

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
At least one parent or guardian can read and write English, Spanish, and/or French; at least one parent or guardian must be able to read and write English, Spanish, and/or French in order to help the patient use their physical activity tracking device account. show original
Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; Lansky performance status =< 16 years of age. show original
The patient or parent/guardian reports less than 420 minutes of moderate to vigorous physical activity over the last week. show original
All patients and/or their parents or legal guardians must sign a written informed consent
All cancer cases with an International Classification of Diseases for Oncology (ICD)-O histologic behavior code of two "2" (carcinoma in situ) or three "3" (malignant), in remission
The patient must have completed their curative therapy within the past 12 months at a Childrens Oncology Group institution. show original
, and documented, before initiation of the study show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 48 weeks post intervention
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 48 weeks post intervention
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 48 weeks post intervention.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Internet-Based Intervention will improve 1 primary outcome and 6 secondary outcomes in patients with Carcinoma in Situ. Measurement will happen over the course of Up to 24 weeks (end of intervention).

Physiologic cost index (PCI)
UP TO 24 WEEKS (END OF INTERVENTION)
Differences in PCI will be compared between groups at the end of the intervention. Intent to treat analysis of variance (either transforming the data or employing a non-parametric equivalent if the data are not normally distributed) controlling for the stratification factors (sex, age, and treatment related risk group) will be used for comparison. General linear mixed models will be utilized to evaluate the effects of group assignment on changes in PCI over time to account for repeated measures on individual children, and for potential random effects such as original treating institution.
UP TO 24 WEEKS (END OF INTERVENTION)
Change in quality of life
BASELINE UP TO 48 WEEKS POST INTERVENTION
Will be assessed using Pediatric Quality of Life (PedsQL) 4.0 Generic Core Scale. The 23-item PedsQL Generic Core Scales were designed to measure the core dimensions of health as delineated by the World Health Organization, as well as role (school) functioning. Scores range from 0-100, higher is better. There are four scales (Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning). Emotional, Social and School Functioning can be combined to create a psychosocial summary (summed and divided by total number of items). Differences between groups and the effects of group assignment on changes over time will be evaluated.
BASELINE UP TO 48 WEEKS POST INTERVENTION
Change in fatigue
BASELINE UP TO 48 WEEKS POST INTERVENTION
Will be assessed using Pediatric Quality of Life Multidimensional Fatigue Scale. The PedsQL Multidimensional Fatigue Scale was designed as a generic symptom-specific instrument to measure fatigue in patients with acute and chronic health conditions as well as healthy school and community populations. It has three dimensions, general fatigue, sleep/rest fatigue and cognitive fatigue. Scores range from 0-100 and items are summed and divided by the total to get the mean. Differences between groups and the effects of group assignment on changes over time will be evaluated.
BASELINE UP TO 48 WEEKS POST INTERVENTION
Change in inflammation
BASELINE UP TO 48 WEEKS POST INTERVENTION
Markers of an Inflammatory state include High sensitivity C-reactive protein, interleukin-6, and tumor necrosis factor alpha. Differences in these markers between groups and the effects of group assignment on changes over time will be evaluated.
BASELINE UP TO 48 WEEKS POST INTERVENTION
Change in markers of cardiometabolic health
BASELINE UP TO 48 WEEKS POST INTERVENTION
Markers of Cardiometabolic health include blood pressure, body mass index, waist to height ration, fasting insulin, glucose, and lipid levels. Differences in these markers between randomized groups and the effects of group assignment on changes over time will be evaluated.
BASELINE UP TO 48 WEEKS POST INTERVENTION
Change in school attendance
BASELINE UP TO 48 WEEKS POST INTERVENTION
Will be assessed using parent report. Differences between groups and the effects of group assignment on changes over time will be evaluated.
BASELINE UP TO 48 WEEKS POST INTERVENTION
See More

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of carcinoma in situ?

Symptoms of carcinoma in situ may include persistent or recurring cough, hoarseness or a husky voice due to fluid collection around soft tissues, or persistent coughing up blood. Signs of carcinoma in situ can sometimes be found in persons who have no known respiratory, oral, or urinary malignancies. They most commonly occur in women with breast cancer, and can be difficult to distinguish from other causes of persistent cough.\n

Anonymous Patient Answer

What causes carcinoma in situ?

A diagnosis of CIS indicates that the lesion was of the transitional epithelial or squamous type. The reason why CIS is found in this area is unknown, but it is possible that it may be related to hormonal and biological factors in the environment of the bladder. CIS can remain here for a long period of time in association with infection, inflammation, or injury.

Anonymous Patient Answer

What are common treatments for carcinoma in situ?

Currently, the most common treatment for carcinoma in situ is curettage alone or excision or cryoablation. Surgical excision may also be used to excise or ablate carcinoma in situ that has spread into a regional lymph node. If carcinoma in situ reaches regional lymph nodes, then lymph node dissection is necessary and has been shown to improve survival rates.

Anonymous Patient Answer

How many people get carcinoma in situ a year in the United States?

About 15% of the population is estimated to be afflicted with invasive breast cancer per year. Among this 15% the incidence of DCIS is about 5 per 100,000 women per year. These data provide an essential basis in the development of prospective screening programs.

Anonymous Patient Answer

What is carcinoma in situ?

If the diagnosis of CIS is made on the basis of a Papanicolaou or needle biopsy, it is most likely to be early invasive carcinoma. Lymph node dissection should be performed for all patients, even with an indeterminate diagnosis on the biopsy, to avoid undertreatment of a potentially life-threatening malignancy or a missed opportunity for adjuvant therapy.

Anonymous Patient Answer

Can carcinoma in situ be cured?

In some patients carcinoma in situ may be a pre-malignant lesion. In situ squamous-cell carcinoma or invasive squamous-cell carcinoma is not necessarily a pre-malignant lesion. A carcinoma in situ should be managed as a high-grade dysplastic lesion.

Anonymous Patient Answer

Is internet-based intervention safe for people?

There were few serious adverse events and no serious adverse events were considered in any of the studies reviewed. The majority of adverse events (80--88%) were non-serious adverse events and no evidence was found to support concerns that these would not have occurred in people using the Internet for an email or social communication function, as they did in many of the studies. In view of the favourable safety findings, the authors did not find any reason to suspend Internet-based interventions in people with cancer, or withhold other treatments for the people prescribed Internet-based interventions.

Anonymous Patient Answer

What is the average age someone gets carcinoma in situ?

A substantial proportion of patients have high grade CIS that is associated with a higher number of positive surgical margins and/or an incomplete resection, both known risk factors for poorer long-term survival in high grade CIS. Younger age may be a risk factor for this high grade CIS. Further work is required to better define the age distribution of the high grade CIS, its association with the prognosis of the overall cohort and the need for more aggressive management in this group of patients.

Anonymous Patient Answer

Have there been other clinical trials involving internet-based intervention?

There was a large proportion of those who completed the questionnaire (34%) did not recall whether they had heard of any other research trials from the Internet. However, those who completed the questionnaires reported positive perceptions about the Internet as a means of disseminating information to a wide group of patients with no prior experience of research trials. The internet could be a potentially exciting means for facilitating future clinical trials.

Anonymous Patient Answer

Who should consider clinical trials for carcinoma in situ?

Cancer in situ is a heterogeneous entity and includes a vast range of biologically and clinically related lesions, many of which differ significantly from c-SCLC, both in terms of the nature and course of disease, and in patient-treatment outcomes. Moreover, the heterogeneity among cancer foci means it is inappropriate to seek a single treatment modality or regimen for all patients with c-SCLC. Therefore, prospective treatment strategies need to take account of both the biologic and clinical characteristics of all lesions of c-SCLC, as well as the patient-treatmnet outcome of each.

Anonymous Patient Answer

What is the primary cause of carcinoma in situ?

Data from a recent study [shows] that carcinoma in situ that was detected by [pathologic examination of a tissue sample] was not significantly associated with any known type of risk factor [for uterine cervical cancer], especially nulliparity. Therefore, carcinoma in situ occurs without a cause, or causes, of cervical cancer.

Anonymous Patient Answer

What are the chances of developing carcinoma in situ?

The risk of developing CIS increases with each stage of disease progression. It may be important to include CIS in evaluation of patients with cervical lesions of the uterine wall, uterine cervical adenocarcinoma (adenocarcinoma in situ) and adenocarcinoma of the cervix.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Carcinoma in Situ by sharing your contact details with the study coordinator.