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Completed

NCT Number: NCT06145295

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

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Jiao Tong Universiy

Shanghai, Shanghai Municipality, 200021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mobile online support group (experiment group)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

    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.

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 24, 2023
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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