NCT01817335

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 2, 2015

Status Verified

May 1, 2015

Enrollment Period

1.7 years

First QC Date

March 19, 2013

Last Update Submit

May 29, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects who are unable to attend all the sessions

    Up to 30 days

Secondary Outcomes (2)

  • Mean of the YA (Young Adult) Patient Satisfaction evaluations

    Up to 30 days

  • Mean of the Pre/Post Test Knowledge Questionnaire

    Up to 30 days

Study Arms (1)

Supportive care (psycho-educational program)

EXPERIMENTAL

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.

Procedure: psychosocial assessment and careOther: educational interventionOther: communication skills trainingOther: questionnaire administration

Interventions

Participate in psycho-educational program

Also known as: psychosocial assessment, psychosocial assessment/care, psychosocial care, psychosocial care/assessment, psychosocial studies
Supportive care (psycho-educational program)

Participate in psycho-educational program

Also known as: intervention, educational
Supportive care (psycho-educational program)

Participate in psycho-educational program

Supportive care (psycho-educational program)

Ancillary studies

Supportive care (psycho-educational program)

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Psychiatric RehabilitationEarly Intervention, EducationalMethods

Intervention Hierarchy (Ancestors)

RehabilitationTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesChild Health ServicesCommunity Health ServicesPreventive Health ServicesInvestigative Techniques

Study Officials

  • Jeanelle Folbrecht

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2013

First Posted

March 25, 2013

Study Start

August 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

June 2, 2015

Record last verified: 2015-05

Locations