NCT06145295

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for not_applicable ovarian-cancer

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable ovarian-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

5 months

First QC Date

November 15, 2023

Last Update Submit

November 21, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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).

    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.

    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.

    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

    Data collection occurred at three time points: before the intervention, immediately after the intervention, and at a three-month follow-up

Study Arms (2)

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.

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.

Behavioral: offline support group (control group)

Interventions

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.

experiment group (online support 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.

control group

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • were currently participating in or had previously participated in other mental treatment groups
  • had been diagnosed with any other type of cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Jiao Tong Universiy

Shanghai, Shanghai Municipality, 200021, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Ting Han, Ph.D.

    Shanghai Jiao Tong University School of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 24, 2023

Study Start

June 1, 2023

Primary Completion

October 25, 2023

Study Completion

November 1, 2023

Last Updated

November 24, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

The data will be available upon reasonable request to the researcher (the private information of the participant will be removed).

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
After the article is accepted
Access Criteria
The data will be available upon reasonable request to the researcher (the private information of the participant will be removed).

Locations