Psycho-Educational Program in Increasing Knowledge and Satisfaction and Decreasing Distress in Younger Patients With Cancer Receiving Treatment

Malignant Neoplasm Clinical Trial

Official title:

Pilot Study of Psycho-Educational Group for Young Adults (YA) on Treatment: Impact on Knowledge, Distress, and Satisfaction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01817335
• Other study ID #: 13128
• Secondary ID: NCI-2013-00589
• Status: Completed
• Phase: N/A
• First received: March 19, 2013
• Last updated: May 29, 2015
• Start date: August 2013
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This pilot clinical trial studies psycho-educational program in increasing knowledge and satisfaction and decreasing distress in younger patients with cancer receiving treatment. Psycho-educational program may increase knowledge and satisfaction and decrease distress in younger patients with cancer receiving treatment

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms
• Psychosocial Effects of Cancer and Its Treatment

Intervention

Procedure:
• psychosocial assessment and care
Participate in psycho-educational program

Other:
• educational intervention
Participate in psycho-educational program
• communication skills training
Participate in psycho-educational program
• questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who are unable to attend all the sessions		Up to 30 days	No
Secondary	Mean of the YA (Young Adult) Patient Satisfaction evaluations	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	No
Secondary	Mean of the Pre/Post Test Knowledge Questionnaire	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	No