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

Sponsor
Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT06145295
Collaborator
(none)
68
1
2
5
13.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: mobile online support group (experiment group)
  • Behavioral: offline support group (control group)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Jun 1, 2023
Actual Primary Completion Date :
Oct 25, 2023
Actual Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: experiment group (online support 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.

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.

Other: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Illness identity [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).

  2. Maintenance of identity [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.

  3. New identity [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.

Secondary Outcome Measures

  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]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Jiao Tong Universiy Shanghai Shanghai China 200021

Sponsors and Collaborators

  • Shanghai Jiao Tong University School of Medicine

Investigators

  • Study Chair: Ting Han, Ph.D., Shanghai Jiao Tong University School of Medicine

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Jianan Zhao, Principal Investigator, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT06145295
Other Study ID Numbers:
  • 507079
First Posted:
Nov 24, 2023
Last Update Posted:
Nov 24, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 24, 2023