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

Women's College Hospital

Status: Completed

Conditions: Ovarian Neoplasms; Uterine Cervical Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Sexual Dysfunctions, Psychological

Treatments: Behavioral: GyneGals Support Group

Study type: Interventional

Funder types: Other

Identifiers

NCT01654458

12-0427-CE (Other Identifier)

216-2012 (Other Identifier)

OVA-120243

1009695 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 398 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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398 participants in 2 patient groups

Immediate Treatment Condition

Experimental group

Description:

Receives the 12-week GyneGals Support Group within a month of completing the baseline assessment.

Treatment:

Behavioral: GyneGals Support Group

Waitlist Control Condition

No Intervention group

Description:

Waitlist control group receives the 12-week GyneGals Support Group only after its involvement in the study has ended, as a courtesy.