Ovarian CancerNCT06145295
The Effectiveness of an Online Support Group in Enhancing Recovery Identity and Health-Related Quality of Life
A study testing mobile online support group (experiment group) in people with Ovarian Cancer, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Background Ovarian cancer poses challenges for middle-aged and older patients, impacting physical and self-conceptual aspects. A research gap exists on the impact of online support groups (SPs) on identity synthesis and Health-Related Quality of Life (HRQOL) for these patients. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- mobile online support group (experiment group)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 Nov 2023
- 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 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 44 years old
- diagnosis of ovarian cancer
- expected survival time of greater than four months
- fluent in using smartphones and the WeChat mini program
- normal cognitive function
- capability to participate in follow-up surveys.
Who cannot join
- were currently participating in or had previously participated in other mental treatment groups
- had been diagnosed with any other type of cancer.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiao Tong Universiy
Shanghai, Shanghai Municipality, 200021
About this study
Official title: Understanding the Effectiveness of an Online Support Group in Enhancing Recovery Identity and Health-Related Quality of Life of Middle-aged and Older Ovarian Cancer Patients: A Randomized Controlled Trial
Background Ovarian cancer poses challenges for middle-aged and older patients, impacting physical and self-conceptual aspects. A research gap exists on the impact of online support groups (SPs) on identity synthesis and Health-Related Quality of Life (HRQOL) for these patients.
Objective To assess the feasibility and efficacy of an online SG in influencing recovery identity and HRQOL in middle-aged and older ovarian cancer patients (MDOCP).
Method A four-week randomized controlled trial, followed by a three-month evaluation, was conducted, employing a mobile online SG and an offline SG both grounded in The Social Identity Model of Identity Change. Recovery identity, HRQOL, and participant engagement were utilized to evaluate the feasibility and efficacy of interventions.
- Conditions
- Ovarian Cancer
- Being tested
- mobile online support group (experiment group), offline support group (control group)
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile online support group (experiment group)Behavioural
The experimental group engaged with the mobile application use for four weeks, with specific tasks including completing the four mandatory courses within one month and submitting at least two health records and online posts every week.
offline support group (control group)Behavioural
The control group participates in the offline group intervention that last for four weeks. Participants in the control group will participant in four weekly workshop that last between 1 hour to 1.5 hours.
| Study group | Role | What they receive |
|---|---|---|
| experiment group (online support group) | Experimental | The experimental group engaged with the mobile application use for four weeks, with specific tasks including completing the four mandatory courses within one month and submitting at least two health records and online posts every week. Receives: Behavioral: mobile online support group (experiment group) |
| control group | Other | The control group participates in the offline group intervention that last for four weeks. Participants in the control group will participant in four weekly workshop that last between 1 hour to 1.5 hours. Receives: Behavioral: offline support group (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Illness identity
The acceptance of illness identity was measured using the Illness Identity Questionnaire's acceptance sub-scale, consisting of 6 items (Oris et al., 2016).
Measured: Data collection occurred at three time points: before the intervention, immediately after the intervention, and at a three-month follow-up
Maintenance of identity
The maintenance of former social identities was measured using the Maintenance of Group Memberships sub-scale of Exeter Identity Transition Scales (Haslam et al., 2008), encompassing 4 items.
Measured: Data collection occurred at three time points: before the intervention, immediately after the intervention, and at a three-month follow-up
New identity
The new meaningful social identity was measured using the New Group Memberships sub-scale of the Exeter Identity Transition Scales, which includes 4 questions. Responses were rated on a scale from 1 to 5, with higher scores indicating a higher level of acceptance of the identity.
Measured: Data collection occurred at three time points: before the intervention, immediately after the intervention, and at a three-month follow-up
Secondary outcomes (1)
Health related quality of life
Health related quality of life was measured using the Short Form Health Survey 12 (SF-12) (Jakobusson, 2007), which includes twelve questions. Each item is transformed into a scale ranging from 0 to 100 according to a specific scoring algorithm. These scores are then aggregated to generate two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The resulting scores are norm-based, comparing an individual's health status to population norms. Health related quality of life is calculate as the summary of PCS and MCS. Higher scores indicate better health related quality of life, with scores around 50 representing the average.
Measured: Data collection occurred at three time points: before the intervention, immediately after the intervention, and at a three-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start1 Jun 2023
- Primary completion25 Oct 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianan Zhao, Shanghai Jiao Tong University School of Medicine
- Investigators
- Ting Han, Ph.D., Study chair, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145295
- Sponsor's protocol ID
- 507079
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request to the researcher (the private information of the participant will be removed).
Publications
Zhao J, Zhu D, Yang Y, Tian C, Liu C, Chang F, Han T. Understanding the effectiveness of an online support group in enhancing recovery identity and health-related quality of life of middle-aged and older ovarian cancer patients: A randomized controlled trial. Psychol Trauma. 2025 Jun;17(Suppl 1):S196-S205. doi: 10.1037/tra0001929.
PubMed 40569778
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Effectiveness of an Online Support Group in Enhancing Recovery Identity and Health-Related Quality of Life of Middle-aged and Older Ovarian Cancer Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06145295
- Acronym / sponsor ID
- 507079
- Conditions
- Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 25 Oct 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 24 Nov 2023 (actual)
- 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.
Background Ovarian cancer poses challenges for middle-aged and older patients, impacting physical and self-conceptual aspects. A research gap exists on the impact of online support groups (SPs) on identity synthesis and Health-Related Quality of Life (HRQOL) for these patients.
Objective To assess the feasibility and efficacy of an online SG in influencing recovery identity and HRQOL in middle-aged and older ovarian cancer patients (MDOCP).
Method A four-week randomized controlled trial, followed by a three-month evaluation, was conducted, employing a mobile online SG and an offline SG both grounded in The Social Identity Model of Identity Change. Recovery identity, HRQOL, and participant engagement were utilized to evaluate the feasibility and efficacy of interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experiment group (online support group) | Experimental | Behavioral: mobile online support group (experiment group)The experimental group engaged with the mobile application use for four weeks, with specific tasks including completing the four mandatory courses within one month and submitting at least two health records and online posts every week. |
| control group | Other | Behavioral: offline support group (control group)The control group participates in the offline group intervention that last for four weeks. Participants in the control group will participant in four weekly workshop that last between 1 hour to 1.5 hours. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Older than 44 years old
- diagnosis of ovarian cancer
- expected survival time of greater than four months
- fluent in using smartphones and the WeChat mini program
- normal cognitive function
Key exclusion criteria (2 listed)
- were currently participating in or had previously participated in other mental treatment groups
- had been diagnosed with any other type of 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 |
|---|---|---|
| mobile online support group (experiment group)The experimental group engaged with the mobile application use for four weeks, with specific tasks including completing the four mandatory courses within one month and submitting at least two health records and online posts every week. | Behavioural | experiment group (online support group) |
| offline support group (control group)The control group participates in the offline group intervention that last for four weeks. Participants in the control group will participant in four weekly workshop that last between 1 hour to 1.5 hours. | Behavioural | control group |
Primary outcome
Illness identity
Time frame: Data collection occurred at three time points: before the intervention, immediately after the intervention, and at a three-month follow-up
The acceptance of illness identity was measured using the Illness Identity Questionnaire's acceptance sub-scale, consisting of 6 items (Oris et al., 2016).
Maintenance of identity
Time frame: Data collection occurred at three time points: before the intervention, immediately after the intervention, and at a three-month follow-up
The maintenance of former social identities was measured using the Maintenance of Group Memberships sub-scale of Exeter Identity Transition Scales (Haslam et al., 2008), encompassing 4 items.
New identity
Time frame: Data collection occurred at three time points: before the intervention, immediately after the intervention, and at a three-month follow-up
The new meaningful social identity was measured using the New Group Memberships sub-scale of the Exeter Identity Transition Scales, which includes 4 questions. Responses were rated on a scale from 1 to 5, with higher scores indicating a higher level of acceptance of the identity.
1 secondary outcome
Health related quality of life
Time frame: Data collection occurred at three time points: before the intervention, immediately after the intervention, and at a three-month follow-up
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 24 Nov 2023.
- Derived from this study: PubMed 40569778Zhao J, Zhu D, Yang Y, Tian C, Liu C, Chang F, Han T. Understanding the effectiveness of an online support group in enhancing recovery identity and health-related quality of life of middle-aged and older ovarian cancer patients: A randomized controlled trial. Psychol Trauma. 2025 Jun;17(Suppl 1):S196-S205. doi: 10.1037/tra0001929.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request to the researcher (the private information of the participant will be removed).
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
Ting Han, Ph.D. study chair
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile online support group (experiment group) in people with Ovarian Cancer, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 6 inclusion and 2 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 24 Nov 2023. 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 China. 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?
Illness identity (time frame: Data collection occurred at three time points: before the intervention, immediately after the intervention, and at a three-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06145295, which also lists 1 linked publication.
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 24 Nov 2023.