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

Not Applicable

Completed

• Conditions: Malignant Neoplasm; Psychosocial Effects of Cancer and Its Treatment
• Interventions: Procedure: psychosocial assessment and care; Other: educational intervention; Other: communication skills training; Other: questionnaire administration

• Registration Number: NCT01817335
• Lead Sponsor: City of Hope Medical Center

Brief 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

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 Timeline

• Study First Submitted: 2013-03-19
• Study First Submitted QC: 2013-03-20
• Study First Posted: 2013-03-25
• Study Start: 2013-08
• Status Verified: 2015-05
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-29
• Last Update Posted: 2015-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (psycho-educational program)	psychosocial assessment and care	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.
Supportive care (psycho-educational program)	educational intervention	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.
Supportive care (psycho-educational program)	communication skills training	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.
Supportive care (psycho-educational program)	questionnaire administration	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.

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who are unable to attend all the sessions	Up to 30 days

Secondary Outcome Measures

Name	Time	Method
Mean of the YA (Young Adult) Patient Satisfaction evaluations	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.
Mean of the Pre/Post Test Knowledge Questionnaire	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.

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States