Malignant NeoplasmNCT01817335
Psycho-Educational Program in Increasing Knowledge and Satisfaction and Decreasing Distress in Younger Patients With Cancer Receiving Treatment
A study testing psychosocial assessment and care, educational intervention and communication skills training in people with Malignant Neoplasm and Psychosocial Effects of Cancer and Its Treatment, run by City of Hope Medical Center at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Malignant Neoplasm, Psychosocial Effects of Cancer and Its Treatment
- What is being tested?
- psychosocial assessment and care, educational intervention and communication skills training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2013to 16 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Pilot Study of Psycho-Educational Group for Young Adults (YA) on Treatment: Impact on Knowledge, Distress, and Satisfaction
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
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- psychosocial assessment and care, educational intervention, communication skills training, questionnaire administration
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychosocial assessment and careProcedure or surgery
Also called psychosocial assessment, psychosocial assessment/care, psychosocial care, psychosocial care/assessment
Participate in psycho-educational program
educational interventionOther
Also called intervention, educational
Participate in psycho-educational program
communication skills trainingOther
Participate in psycho-educational program
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: psychosocial assessment and care; Other: educational intervention; Other: communication skills training; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who are unable to attend all the sessions
Measured: Up to 30 days
Secondary outcomes (2)
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.
Measured: Up to 30 days
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.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2013 (estimated)
- Study start30 Aug 2013
- Primary completion16 Mar 2021
- Study completion16 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jeanelle Folbrecht, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817335
- Sponsor's protocol ID
- 13128
- Other IDs
- NCI-2013-00589
- Status last verified
- Oct 2026
- First submitted
- 19 Mar 2013
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Psycho-Educational Group for Young Adults (YA) on Treatment: Impact on Knowledge, Distress, and Satisfaction
- ClinicalTrials.gov ID
- NCT01817335
- Acronym / sponsor ID
- 13128
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Aug 2013 (actual)
- Primary completion
- 16 Mar 2021 (actual)
- Study completion
- 16 Mar 2021 (actual)
- First posted
- 25 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (psycho-educational program) | Experimental | Procedure: psychosocial assessment and care, Other: educational intervention, Other: communication skills training, Other: questionnaire administrationPatients 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychosocial assessment and careAlso: psychosocial assessment, psychosocial assessment/care, psychosocial care, psychosocial care/assessmentParticipate in psycho-educational program | Procedure or surgery | Supportive care (psycho-educational program) |
| educational interventionAlso: intervention, educationalParticipate in psycho-educational program | Other | Supportive care (psycho-educational program) |
| communication skills trainingParticipate in psycho-educational program | Other | Supportive care (psycho-educational program) |
| questionnaire administrationAncillary studies | Other | Supportive care (psycho-educational program) |
Primary outcome
Proportion of subjects who are unable to attend all the sessions
Time frame: Up to 30 days
2 secondary outcomes
Mean of the YA (Young Adult) Patient Satisfaction evaluations
Time frame: Up to 30 days
Mean of the Pre/Post Test Knowledge Questionnaire
Time frame: Up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanelle Folbrecht principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychosocial assessment and care, educational intervention and communication skills training in people with Malignant Neoplasm and Psychosocial Effects of Cancer and Its Treatment, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects who are unable to attend all the sessions (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.