- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01817335
Psycho-Educational Program in Increasing Knowledge and Satisfaction and Decreasing Distress in Younger Patients With Cancer Receiving Treatment
Pilot Study of Psycho-Educational Group for Young Adults (YA) on Treatment: Impact on Knowledge, Distress, and Satisfaction
Study Overview
Status
Detailed Description
PRIMARY OBJECTIVES:
I. Providing a psycho-educational group to young adults while examining the feasibility of such a group with patients on treatment.
II. Examining effectiveness of the program through evaluating pre-post changes in participant distress, evaluating increases in participant' knowledge regarding disease issues and coping, and evaluating participant satisfaction.
OUTLINE:
Patients undergo psycho-educational program comprising medical/symptom management and communication with a medical team, coping skills, self image, and relationships and communication for 1.5 hours once weekly for 6 weeks.
After completion of study treatment, patients are followed up for 30 days.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Duarte, California, United States, 91010
- City of Hope Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Currently in active treatment (diagnosed and receiving treatment within 2 weeks of initial study enrollment; active treatment includes currently receiving any of the following: chemotherapy, radiation therapy, maintenance drugs, surgery, clinical trial enrollment, or current relapse/secondary malignancy)
- Inpatient or outpatient
- Cancer diagnosis
- Physician approval
- Informed consent
Exclusion Criteria:
- Significant psychiatric or developmental issues, as determined by screening interview conducted by psychologist or clinical social worker
- Currently off treatment (longer than 2 weeks at the time of enrollment)
- In isolation or with isolation precautions
- Non-English speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Supportive care (psycho-educational program)
Patients participate in a psycho-educational program focused on medical/symptom management and communication with a medical team, coping skills, self image, and relationships and communication for 1.5 hours once weekly for 6 weeks.
|
Ancillary studies
Participate in psycho-educational program
Other Names:
Participate in psycho-educational program
Other Names:
Participate in psycho-educational program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of subjects who are unable to attend all the sessions
Time Frame: Up to 30 days
|
Up to 30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean of the YA (Young Adult) Patient Satisfaction evaluations
Time Frame: Up to 30 days
|
A questionnaire was developed to measure participant satisfaction with the format and material of the psycho-educational program.
Satisfaction measures will be provided for completion at the end of sessions 2 through 5 and 30 days post intervention.
Changes in the mean of the Questionnaire responses will be analyzed using a paired t-test and calculations of simple frequency and descriptive statistics will be used to summarize the data and program evaluations.
|
Up to 30 days
|
Mean of the Pre/Post Test Knowledge Questionnaire
Time Frame: Up to 30 days
|
A questionnaire was developed based on the psycho-educational material to assess increases in knowledge and retention.
The questionnaire will be administered pre-intervention and 30 days post-intervention.
Additionally, relevant items from the questionnaire will be administered at the end of the relevant educational session.
For instance, self image questions from the questionnaire will be administered at the end of the self-image session in addition to the pre and post administration of the entire questionnaire.
Changes in the mean of the Questionnaire responses will be analyzed using a paired t-test and calculations of simple frequency and descriptive statistics will be used to summarize the data and program evaluations.
|
Up to 30 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeanelle Folbrecht, City of Hope Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13128
- NCI-2013-00589 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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