Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Behaviors and Mental Disorders

Rare Diseases

Ovarian Neoplasms

Uterine Cervical Neoplasms

Endometrial Neoplasms

Vaginal Neoplasms

Vulvar Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Fallopian Tube Neoplasms

Urogenital Neoplasms

Sexual Dysfunctions, Psychological

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Endocrine System Diseases

Gonadal Disorders

Uterine Cervical Diseases

Uterine Diseases

Mental Disorders

Psychotic Disorders

Ovarian Cancer

Vaginal Cancer

Vulvar Cancer

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

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

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

GyneGals Support Group

Catherine C. Classen, PhD

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.

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

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

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

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

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

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

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

University Health Network, Toronto

Sunnybrook Health Sciences Centre

Tom Baker Cancer Centre

Cross Cancer Institute

Vancouver Coastal Health Research Institute

Memorial Sloan Kettering Cancer Center

Women's College Hospital

Caregiver Burden

Stress, Psychological

Behavioral Symptoms

Quality of Life

4 week psycho-educational support group focusing on topics specific to psychosocial and emotional aspects of the cancer caregiving role

Weekly sessions lasting 60 minutes. Topics addressed each week:

Week 1: Coping with the diagnosis of loved one and dealing with uncertainty

Week 2: Caring for the carer 1: Feeding your body (self-care, stress management, mindfulness concepts)

Week 3: Caring for the carer 2: Feeding your mind (challenging negative thinking habits)

Week 4: The emotions of caregiving (handling emotional reactivity)

Psycho-educational support group therapy

Joyce Tan

Rathi Mahendran

This is a study to determine the effectiveness of a Group Therapy that provides psycho-education and support for caregivers of cancer patients. Caregivers must be between 21 and 64 years of age and be willing to attend a one-hour a week program for four weeks. The sessions will be in English, and a set of questionnaires (demographic data, some information about your family member with cancer, and scales: Caregiver Quality of Life-Cancer Scale (CQOLC), Perceived Stress Scale and the Hospital Anxiety Depression Scale (HADS)) will be completed at the start, at 4 weeks, at 8 weeks and at 12 weeks. Some participants placed on a wait-list to start the Group Therapy 4 weeks later will also complete the set of questionnaires at this point. A Feedback and Satisfaction Questionnaire will be completed at the end of the 4 week program. In addition, at the end of the 4 week program, some participants will go through a 15-minute interview.

Participants Study participants are caregivers, recruited from the Medical Oncology Clinic (under NCIS) at NUH.

Intervention and Evaluation of the Psycho-educational Support Group Therapy This is a pre and post-intervention study with a control group design. The strength of this design is its experimental nature but without randomization, thereby avoiding the problems related to randomization. Instead, a wait-list is used as the control group.

Consecutive family caregivers who agree to participate will be placed in the first group (Group 1a) till a group size of ten is reached. The next ten will be put on a wait-list and form the control group (Group 1b), who will still be able to benefit from the program at a later time. In this manner subsequent treatment and control groups will be recruited.

The Intervention consists of weekly Psycho-educational Support Groups focusing on topics specific to psychosocial and emotional aspects of the cancer caregiving role. The Intervention is over a short duration of 4 weeks so as to appeal to caregivers and reduce the attrition rate. The proposed intervention is exploratory in nature but is hypothesized to be beneficial in helping to recognize and handle the difficult and often tumultuous journey of cancer caregiving. The planned Intervention was developed in discussions and consensus views using the Delphi method and adapted the brief integrative psychological therapy developed by Kua et al and psycho-educational programs at overseas centres. The CQOLC, the Perceived Stress Scale, and the HADS will be administered to participants at 4 time points: T1 (week 0), T2 (end of week 4), T3 (end of week 8) and T4 (end of week 12). The fourth time point is to evaluate whether the effects of the intervention are sustained. A Satisfaction and Feedback Questionnaire will be administered to participants at T2, immediately upon completion of the intervention. Some participants who have gone through the program will be invited to take part in a 15 minute interview. The purpose of the interview is to obtain feedback on the ways in which the program has been beneficial. The participants in the control group will complete a set of the same questionnaires when they are entered into the wait list; they will complete the questionnaires 5 times.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Randomized Controlled Trial of an Online Support Group for Sexual Distress Due to Gynecologic Cancer	NCT01654458	Sexual Dysfunct... Uterine Cervica... Ovarian Neoplas... Uterine Neoplas... Genital Neoplas...	GyneGals Suppor...	18 Years -	Women's College Hospital
Investigating the Effects of a Psycho-educational Support Group Therapy on Cancer Caregivers' Burden and Quality of Life	NCT02120183	The Effect of a...	Psycho-educatio...	21 Years - 64 Years	National University Hospital, Singapore
A Randomized Controlled Trial of an Online Support Group for Sexual Distress Due to Gynecologic Cancer	NCT01654458	Sexual Dysfunct... Uterine Cervica... Ovarian Neoplas... Uterine Neoplas... Genital Neoplas...	GyneGals Suppor...	18 Years -	Women's College Hospital

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