Cervical CarcinomaNCT02412124
Peer-to-Peer Support Program in Improving Quality of Life Outcomes in Patients With Gynecologic Cancer and Their Caregivers
A study testing Supportive Care, Quality-of-Life Assessment and Questionnaire Administration in people with Cervical Carcinoma and Ovarian Carcinoma, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This pilot clinical trial studies a peer-to-peer support program in improving quality of life outcomes in patients with gynecologic cancer and their caregivers. Peer-to-peer support and mentoring may help improve quality of life and reduce symptoms of distress in gynecologic cancer patients and their families. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Carcinoma, Ovarian Carcinoma, Uterine Corpus Cancer
- What is being tested?
- Supportive Care, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2015to 26 Apr 2018
- 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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PATIENT PARTICIPANTS
- Patients with newly diagnosed or recurrent gynecologic cancer (ovarian, uterine, cervical, vaginal, vulvar) actively undergoing treatment (chemotherapy, surgery, or radiation therapy) at COH (including Duarte and South Pasadena campuses)
- English-speaking patients
- PEER MENTORS
- Peer mentors will be past gynecologic cancer patients not currently undergoing treatment for their cancer, and considered without evidence of disease
- Over age 18
- PEER MENTORS: English-speaking patients
- This study is open to patients of all races and ethnicities
Who cannot join
- PEER MENTORS:
- Major psychiatric disease
- Currently undergoing treatment for active gynecologic cancer
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: Quality of Life Outcomes From a Peer-to-Peer Support Program for Women With Gynecologic Cancer
This pilot clinical trial studies a peer-to-peer support program in improving quality of life outcomes in patients with gynecologic cancer and their caregivers. Peer-to-peer support and mentoring may help improve quality of life and reduce symptoms of distress in gynecologic cancer patients and their families.
Read the detailed description
PRIMARY OBJECTIVES:
- To test the feasibility and acceptability of a Woman-to-Woman (W2W) program for patients with gynecologic cancer at City of Hope (COH). Address the following descriptive research questions: were patients, mentors, and patients' family caregivers satisfied with the timing, format, and content of the program? Did the program benefit patients, mentors, and patients' family caregivers?
OUTLINE:
Patients participate in the W2W program for which they are matched with a trained mentor and followed throughout treatment by phone, email, and/or in person.
After completion of study, patients are followed up at 6 and 12 months.
- Conditions
- Cervical Carcinoma, Ovarian Carcinoma, Uterine Corpus Cancer, Vaginal Carcinoma, Vulvar Carcinoma
- Being tested
- Supportive Care, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Uterine Cervical Neoplasms, Ovarian Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive CareProcedure or surgery
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Complete W2W mentoring program
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Complete the FACT-G
Questionnaire AdministrationOther
Complete the W2W Patient Survey
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (W2W program) | Experimental | Patients participate in the W2W program for which they are matched with a trained mentor and followed throughout treatment by phone, email, and/or in person. Receives: Procedure: Supportive Care; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life benefits for patients, as assessed by the FACT-G
Changes from baseline will be tested using paired t-tests. Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data. Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed. Written comments from all open ended questions analyzed using content analysis methods.
Measured: Baseline to up to 12 months
Satisfaction of patients with the timing, content, and format of the program, as assessed by the W2W Patient Survey
Changes from baseline will be tested using paired t-tests. Descriptive statistics on participants' satisfaction with the timing, content, and format of the intervention will be presented through summary statistics of data from the satisfaction tools. Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data.
Measured: Up to 12 months
Satisfaction of mentors with the timing, content, and format of the program, as assessed by the W2W Volunteer/Mentor Survey
Descriptive statistics on participants' satisfaction with the timing, content, and format of the intervention will be presented through summary statistics of data from the satisfaction tools.
Measured: Up to 12 months
Satisfaction of patients' family caregivers with the timing, content, and format of the program
Changes from baseline will be tested using paired t-tests. Descriptive statistics on participants' satisfaction with the timing, content, and format of the intervention will be presented through summary statistics of data from the satisfaction tools.
Measured: Up to 12 months
Benefits for patients' family caregivers after participating in the program, as assessed by the Modified Caregiver Strain Index
Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data. Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed. Written comments from all open ended questions analyzed using content analysis methods.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study start23 Jul 2015
- Primary completion26 Apr 2018
- Study completion26 Apr 2018
Why it stopped: Feasibility issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CarcinomaStudies 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
- 3 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
- Thanh Dellinger, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412124
- Sponsor's protocol ID
- 14359
- Other IDs
- NCI-2015-00467, 14359
- Status last verified
- Oct 2026
- First submitted
- 3 Apr 2015
- 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
- Quality of Life Outcomes From a Peer-to-Peer Support Program for Women With Gynecologic Cancer
- ClinicalTrials.gov ID
- NCT02412124
- Acronym / sponsor ID
- 14359
- Conditions
- Cervical Carcinoma, Ovarian Carcinoma, Uterine Corpus Cancer, Vaginal Carcinoma, Vulvar Carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Feasibility issues
- Enrolment
- 3 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Jul 2015 (actual)
- Primary completion
- 26 Apr 2018 (actual)
- Study completion
- 26 Apr 2018 (actual)
- First posted
- 8 Apr 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 a peer-to-peer support program in improving quality of life outcomes in patients with gynecologic cancer and their caregivers. Peer-to-peer support and mentoring may help improve quality of life and reduce symptoms of distress in gynecologic cancer patients and their families.
Detailed description
PRIMARY OBJECTIVES:
- To test the feasibility and acceptability of a Woman-to-Woman (W2W) program for patients with gynecologic cancer at City of Hope (COH). Address the following descriptive research questions: were patients, mentors, and patients' family caregivers satisfied with the timing, format, and content of the program? Did the program benefit patients, mentors, and patients' family caregivers?
OUTLINE:
Patients participate in the W2W program for which they are matched with a trained mentor and followed throughout treatment by phone, email, and/or in person.
After completion of study, patients are followed up at 6 and 12 months.
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 (W2W program) | Experimental | Procedure: Supportive Care, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients participate in the W2W program for which they are matched with a trained mentor and followed throughout treatment by phone, email, and/or in person. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- PATIENT PARTICIPANTS
- Patients with newly diagnosed or recurrent gynecologic cancer (ovarian, uterine, cervical, vaginal, vulvar) actively undergoing treatment (chemotherapy, surgery, or radiation therapy) at COH (including Duarte and South Pasadena campuses)
- English-speaking patients
- PEER MENTORS
- Peer mentors will be past gynecologic cancer patients not currently undergoing treatment for their cancer, and considered without evidence of disease
Key exclusion criteria (3 listed)
- PEER MENTORS:
- Major psychiatric disease
- Currently undergoing treatment for active gynecologic cancer
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 |
|---|---|---|
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveComplete W2W mentoring program | Procedure or surgery | Supportive care (W2W program) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentComplete the FACT-G | Other | Supportive care (W2W program) |
| Questionnaire AdministrationComplete the W2W Patient Survey | Other | Supportive care (W2W program) |
Primary outcome
Change in quality of life benefits for patients, as assessed by the FACT-G
Time frame: Baseline to up to 12 months
Changes from baseline will be tested using paired t-tests. Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data. Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed. Written comments from all open ended questions analyzed using content analysis methods.
Satisfaction of patients with the timing, content, and format of the program, as assessed by the W2W Patient Survey
Time frame: Up to 12 months
Changes from baseline will be tested using paired t-tests. Descriptive statistics on participants' satisfaction with the timing, content, and format of the intervention will be presented through summary statistics of data from the satisfaction tools. Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data.
Satisfaction of mentors with the timing, content, and format of the program, as assessed by the W2W Volunteer/Mentor Survey
Time frame: Up to 12 months
Descriptive statistics on participants' satisfaction with the timing, content, and format of the intervention will be presented through summary statistics of data from the satisfaction tools.
Satisfaction of patients' family caregivers with the timing, content, and format of the program
Time frame: Up to 12 months
Changes from baseline will be tested using paired t-tests. Descriptive statistics on participants' satisfaction with the timing, content, and format of the intervention will be presented through summary statistics of data from the satisfaction tools.
Benefits for patients' family caregivers after participating in the program, as assessed by the Modified Caregiver Strain Index
Time frame: Up to 12 months
Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data. Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed. Written comments from all open ended questions analyzed using content analysis methods.
Results and safety
The study was stopped early (reason given: Feasibility issues). Results are not available in the source record.
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.
Thanh Dellinger, MD 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 Supportive Care, Quality-of-Life Assessment and Questionnaire Administration in people with Cervical Carcinoma and Ovarian 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 8 inclusion and 3 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: stopped early, 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 was stopped early (reason given: Feasibility issues). Results are not available in the source record.
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?
Change in quality of life benefits for patients, as assessed by the FACT-G (time frame: Baseline to up to 12 months). The study lists 5 primary outcomes in all. 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.