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Completed

NCT Number: NCT01654458

A Randomized Controlled Trial of an Online Support Group for Sexual Distress Due to Gynecologic Cancer

There is a high prevalence of sexual and body image problems among women treated for gynecologic cancer, which can lead to considerable distress. Given the sensitive and highly personal nature of these problems, women are often reluctant to speak to their doctors about these concerns and have few resources for support and information. The research team will conduct a prospective randomized controlled trail (RCT) to test the benefits of "GyneGals," a 12-week online (i.e. Internet-based) support group intervention for women who are sexually distressed due to gynecologic cancer and its treatment.

The primary aim of this study is to determine whether a professionally-facilitated, information-rich, online support group is beneficial for women who are sexually distressed due to gynecologic cancer and the side effects of treatment.

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Key information

Conditions

Sexual Dysfunctions, Psychological Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Neoplasms Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vaginal Diseases Vaginal Neoplasms Vulvar Diseases Vulvar Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tom Baker Cancer Centre, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Received surgical, radiation or chemotherapy treatments for any gynecologic cancer
  • Not receiving active treatment
  • Currently disease-free for a minimum of 3 months
  • No more than 5 years post-diagnosis
  • Distressed due to psychosexual concerns related to cancer
  • Willing to discuss psychosexual concerns
  • 18 years or older
  • Has access to a computer and the Internet
  • Speaks, reads, and writes in English
  • Provides informed consent

Exclusion criteria

  • Acutely suicidal (i.e., actively suicidal within the previous 3 months)
  • Has a major psychiatric illness

Treatment and study plan

GyneGals Support Group

Behavioral

12-week online (i.e. Internet-based), professionally-facilitated support group

Primary outcomes

  1. Psychosexual distress, as measured by the Revised Female Sexual Distress Scale (FSDS-R).

    Time frame: 9 months

    13-item self-report scale that measures sexually-related distress in women.

Secondary outcomes

  1. Sexual function, as measured by the Sexual Function Questionnaire (SFQ).

    Time frame: 9 months (at months 1, 5, and 9)

    25-item measure developed for cancer patients and can be completed by women regardless of sexual orientation or whether they have a partner.

  2. Body image, as measured by the Sexual Adjustment and Body Image Scale - Gynecologic Cancer (SABIS-G).

    Time frame: 9 months (at months 1, 5, and 9)

    Consists of two independent scales designed to assess changes in sexuality and body image before and after diagnosis.

  3. Depression and anxiety symptoms, as measured by the Hospital Anxiety and Depression Scale (HADS).

    Time frame: 9 months (at months 1, 5, and 9)

    14-item self-report questionnaire for detecting depression and anxiety in a hospital outpatient setting.

  4. Relationship satisfaction, as measured by the Relationship Assessment Scale (RAS).

    Time frame: 9 months (at months 1, 5, and 9)

    7-item measure assessing satisfaction with an individual's romantic relationship.

  5. Perceived social support, as measured by MOS Social Support Survey (MOS-SS).

    Time frame: 9 months (at months 1, 5, and 9)

    19 items and assesses emotional/informational support, tangible support, affectionate support, and positive social interaction, as well as providing an overall functional support index.

Sponsors and collaborators

Lead sponsor

Women's College Hospital

Other

Collaborators

  • Cross Cancer Institute
  • Memorial Sloan Kettering Cancer Center
  • Sunnybrook Health Sciences Centre
  • Tom Baker Cancer Centre
  • University Health Network, Toronto
  • Vancouver Coastal Health Research Institute

Registry information

Important dates

Study start
2012
Primary completion
2018
Study completion
2019
First posted
Jul 31, 2012
Registry last updated
Mar 18, 2021

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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