AnxietyNCT02334332
Educational Brochure in Preparing Patients With Gastric Cancer and Their Caregivers for Recovery After Surgery
A study testing Educational Intervention, Standard Follow-Up Care and Quality-of-Life Assessment in people with Anxiety and Gastric Carcinoma, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This pilot clinical trial studies an educational brochure in preparing patients with gastric cancer and their caregivers for recovery after surgery. Giving an educational brochure may help prepare patients and their caregivers by improving knowledge about symptoms after surgery. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Gastric Carcinoma, Stress
- What is being tested?
- Educational Intervention, Standard Follow-Up Care and Quality-of-Life Assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Sep 2015
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients will be accrued using the following inclusion criteria:
- Scheduled to undergo partial or total gastrectomy for treatment of gastric cancer
- Able to read and understand English
- Informal Caregivers will be accrued using the following inclusion criteria:
- The primary informal caregiver as identified by patients participating in the study; this refers to either a family member or friend who will be providing the majority of care following surgery
- Able to read and understand English
- All participants must have the ability to understand the willingness to provide informed consent
Who cannot join
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
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 an Educational Brochure to Prepare Patients and Informal Caregivers for Recovery Following Gastrectomy
This pilot clinical trial studies an educational brochure in preparing patients with gastric cancer and their caregivers for recovery after surgery. Giving an educational brochure may help prepare patients and their caregivers by improving knowledge about symptoms after surgery. It may also improve quality of life and reduce worry after surgery.
Read the detailed description
PRIMARY OBJECTIVES:
- To pilot test an educational intervention in the form of a teaching brochure to prepare patients and informal caregivers for recovery following partial or total gastrectomy.
SECONDARY OBJECTIVES:
- To describe preliminary effect of the intervention on patient-reported outcomes (PROs), informal caregiver-reported outcomes, and clinical/system outcomes.
OUTLINE: Participants are enrolled sequentially to 1 of 2 cohorts.
COHORT I: Participants receive standard post-operative care.
COHORT II: Participants receive a 2-page educational brochure after surgery and prior to discharge home.
After completion of study, participants are followed up for approximately 2 months.
- Conditions
- Anxiety, Gastric Carcinoma, Stress
- Being tested
- Educational Intervention, Standard Follow-Up Care, Quality-of-Life Assessment
- Keywords
- Caregiver
- Medical subject headings
- Anxiety Disorders, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention, Educational
Receive educational brochure
Standard Follow-Up CareProcedure or surgery
Receive standard post-operative care
Quality-of-Life AssessmentProcedure or surgery
Also called Quality of Life Assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Cohort I (standard care) | Active comparator | Participants receive standard post-operative care. Receives: Procedure: Standard Follow-Up Care; Procedure: Quality-of-Life Assessment |
| Cohort II (educational brochure) | Experimental | Participants receive a 2-page educational brochure after surgery and prior to discharge home. Receives: Other: Educational Intervention; Procedure: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient/informal caregiver satisfaction with timing, content, and delivery of the intervention
Descriptive statistics will be presented through summary statistics of data from the satisfaction tools.
Measured: Up to 2 months
Secondary outcomes (1)
Change in mean survey scores
Data will be summarized using descriptive statistics. Statistics will be tabulated for each sequentially enrolled cohort.
Measured: Baseline up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: No accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 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
- Virginia Sun, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334332
- Sponsor's protocol ID
- 14286
- Other IDs
- NCI-2014-02563, 14286
- Status last verified
- Sep 2015
- First submitted
- 6 Jan 2015
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of an Educational Brochure to Prepare Patients and Informal Caregivers for Recovery Following Gastrectomy
- ClinicalTrials.gov ID
- NCT02334332
- Acronym / sponsor ID
- 14286
- Conditions
- Anxiety, Gastric Carcinoma, Stress
- Keywords
- Caregiver
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 8 Jan 2015 (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 an educational brochure in preparing patients with gastric cancer and their caregivers for recovery after surgery. Giving an educational brochure may help prepare patients and their caregivers by improving knowledge about symptoms after surgery. It may also improve quality of life and reduce worry after surgery.
Detailed description
PRIMARY OBJECTIVES:
- To pilot test an educational intervention in the form of a teaching brochure to prepare patients and informal caregivers for recovery following partial or total gastrectomy.
SECONDARY OBJECTIVES:
- To describe preliminary effect of the intervention on patient-reported outcomes (PROs), informal caregiver-reported outcomes, and clinical/system outcomes.
OUTLINE: Participants are enrolled sequentially to 1 of 2 cohorts.
COHORT I: Participants receive standard post-operative care.
COHORT II: Participants receive a 2-page educational brochure after surgery and prior to discharge home.
After completion of study, participants are followed up for approximately 2 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort I (standard care) | Active comparator | Procedure: Standard Follow-Up Care, Procedure: Quality-of-Life AssessmentParticipants receive standard post-operative care. |
| Cohort II (educational brochure) | Experimental | Other: Educational Intervention, Procedure: Quality-of-Life AssessmentParticipants receive a 2-page educational brochure after surgery and prior to discharge home. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients will be accrued using the following inclusion criteria:
- Informal Caregivers will be accrued using the following inclusion criteria:
- All participants must have the ability to understand the willingness to provide informed consent
Key exclusion criteria (1 listed)
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
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 |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention, EducationalReceive educational brochure | Other | Cohort II (educational brochure) |
| Standard Follow-Up CareReceive standard post-operative care | Procedure or surgery | Cohort I (standard care) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Procedure or surgery | Cohort I (standard care), Cohort II (educational brochure) |
Primary outcome
Patient/informal caregiver satisfaction with timing, content, and delivery of the intervention
Time frame: Up to 2 months
Descriptive statistics will be presented through summary statistics of data from the satisfaction tools.
1 secondary outcome
Change in mean survey scores
Time frame: Baseline up to 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2015.
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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.
Virginia Sun 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 Educational Intervention, Standard Follow-Up Care and Quality-of-Life Assessment in people with Anxiety and Gastric Carcinoma, 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 7 inclusion and 1 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: withdrawn, as of the sponsor's last update on 25 Sep 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
Patient/informal caregiver satisfaction with timing, content, and delivery of the intervention (time frame: Up to 2 months). 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 25 Sep 2015.