The Effectiveness of an Online Support Group in Enhancing Recovery Identity and Health-Related Quality of Life

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06145295
• Other study ID #: 507079
• Status: Completed
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2023
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: November 1, 2023
• Est. primary completion date: October 25, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• were currently participating in or had previously participated in other mental treatment groups

• had been diagnosed with any other type of cancer.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Shanghai Jiao Tong Universiy	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	Data collection occurred at three time points: before the intervention, immediately after the intervention, and at a three-month follow-up