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Completed

NCT Number: NCT01817335

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

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

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

psychosocial assessment and care

Procedure

Participate in psycho-educational program

Other names: psychosocial assessment, psychosocial assessment/care, psychosocial care, psychosocial care/assessment, psychosocial studies

Educational Intervention

Other

Participate in psycho-educational program

Other names: intervention, educational

communication skills training

Other

Participate in psycho-educational program

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Proportion of subjects who are unable to attend all the sessions

    Time frame: Up to 30 days

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 25, 2013
Registry last updated
Jun 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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