Sexual Dysfunction Clinical Trial
— KISOfficial title:
A Randomized Study of an Internet-based Cognitive Behavioral Therapy Program for Sexuality and Intimacy Problems in Women Treated for Breast Cancer.
Verified date | October 2016 |
Source | The Netherlands Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the efficacy and cost-effectiveness of an internet-based cognitive behavioural therapy program in alleviating problems with intimacy and sexuality in women treated for breast cancer.
Status | Completed |
Enrollment | 160 |
Est. completion date | December 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Woman. - Between 18 and 65 years of age. - Diagnosis of histologically confirmed primary breast cancer. - Received treatment in one of the participating hospitals. - Completed treatment for breast cancer(with the exception of endocrine therapy). - Diagnosis of breast cancer between 6 months and 5 years prior to study entry. - Disease-free at time of study entry. - Presence of sexuality and intimacy problems. Exclusion Criteria: - Lacks basic proficiency in Dutch. - No access to the internet. - Serious cognitive or psychiatric problems (i.e. depression, alcohol dependency, or psychotic disorders). - Severe relationship problems for which the internet-based program is not designed (and which need to be addressed prior to undergoing sex therapy). - Participation in a concurrent therapy program to alleviate sexuality/intimacy problems. - Treated for another type of cancer beside breast cancer (with the exception of cervical carcinoma in situ and basal cell carcinoma). |
Country | Name | City | State |
---|---|---|---|
Netherlands | Netherlands Cancer Institute | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
The Netherlands Cancer Institute | Dutch Cancer Society, Pink Ribbon Inc. |
Netherlands,
Basson R, Leiblum S, Brotto L, Derogatis L, Fourcroy J, Fugl-Meyer K, Graziottin A, Heiman JR, Laan E, Meston C, Schover L, van Lankveld J, Schultz WW. Revised definitions of women's sexual dysfunction. J Sex Med. 2004 Jul;1(1):40-8. — View Citation
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Dutch Comprehensive Cancer Centre. Breast cancer survival in the Netherlands. 2011. Ref Type: Report
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sexuality problems | Sexuality problems are assessed using the Sexual Activity Questionnaire, Female Sexual Function Scale, and Female Sexual Distress Scale. | Baseline | |
Primary | Intimacy problems. | Intimacy problems are assessed using the Personal Assessment of Intimacy in Relationships (PAIR) Inventory. | Baseline | |
Primary | Sexuality problems | Sexuality problems are assessed using the Sexual Activity Questionnaire, Female Sexual Function Scale, and Female Sexual Distress Scale. | T1: 10 weeks after start of therapy (intervention group) or 13 weeks after completion of baseline (control group) | |
Primary | Sexuality problems | Sexuality problems are assessed using the Sexual Activity Questionnaire, Female Sexual Function Scale, and Female Sexual Distress Scale. | T2: 20-24 weeks after start of therapy (intervention group) or 23 weeks after completion of baseline (control group) | |
Primary | Sexuality problems | Sexuality problems are assessed using the Sexual Activity Questionnaire, Female Sexual Function Scale, and Female Sexual Distress Scale. | T3: 3 months after T2 (intervention group) | |
Primary | Intimacy problems. | Intimacy problems are assessed using the Personal Assessment of Intimacy in Relationships (PAIR) Inventory. | T1: 10 weeks after start of therapy (intervention group) or 13 weeks after completion of baseline (control group) | |
Primary | Intimacy problems. | Intimacy problems are assessed using the Personal Assessment of Intimacy in Relationships (PAIR) Inventory. | T2: 20-24 weeks after start of therapy (intervention group) or 23 weeks after completion of baseline (control group) | |
Primary | Intimacy problems. | Intimacy problems are assessed using the Personal Assessment of Intimacy in Relationships (PAIR) Inventory. | T3: 3 months after T2 (intervention group) | |
Primary | Sexuality problems | Sexuality problems are assessed using the Sexual Activity Questionnaire, Female Sexual Function Scale, and Female Sexual Distress Scale. | T4: 6 months after T3 (intervention group) | |
Primary | Intimacy problems | Intimacy problems are assessed using the Personal Assessment of Intimacy in Relationships (PAIR) Inventory. | T4: 6 months after T3 (intervention group) | |
Secondary | Body image. | Body image is assessed using the QLQ-BR23. | Baseline | |
Secondary | Menopausal symptoms. | Menopausal symptoms are assessed using the FACT-ES. | Baseline | |
Secondary | Marital functioning. | Marital functioning is assessed using the Maudsley marital Questionnaire. | Baseline | |
Secondary | Psychological distress | Psychological distress is assessed using the Hospital Anxiety and Depression Scale. | Baseline | |
Secondary | Health-related quality of life | Health-related quality of life is assessed using the MOS SF-36. | Baseline | |
Secondary | Body image. | Body image is assessed using the QLQ-BR23. | T1: 10 weeks after start of therapy (intervention group) or 13 weeks after completion of baseline (control group) | |
Secondary | Body image. | Body image is assessed using the QLQ-BR23. | T2: 20-24 weeks after start of therapy (intervention group) or 23 weeks after completion of baseline (control group) | |
Secondary | Body image. | Body image is assessed using the QLQ-BR23. | T3: 3 months after T2 (intervention group) | |
Secondary | Menopausal symptoms. | Menopausal symptoms are assessed using the FACT-ES. | T1: 10 weeks after start of therapy (intervention group) or 13 weeks after completion of baseline (control group) | |
Secondary | Menopausal symptoms. | Menopausal symptoms are assessed using the FACT-ES. | T2: 20-24 weeks after start of therapy (intervention group) or 23 weeks after completion of baseline (control group) | |
Secondary | Menopausal symptoms. | Menopausal symptoms are assessed using the FACT-ES. | T3: 3 months after T2 (intervention group) | |
Secondary | Marital functioning. | Marital functioning is assessed using the Maudsley Marital Questionnaire. | T1: 10 weeks after start of therapy (intervention group) or 13 weeks after completion of baseline (control group) | |
Secondary | Marital functioning. | Marital functioning is assessed using the Maudsley Marital Questionnaire. | T2: 20-24 weeks after start of therapy (intervention group) or 23 weeks after completion of baseline (control group) | |
Secondary | Marital functioning. | Marital functioning is assessed using the Maudsley Marital Questionnaire. | T3: 3 months after T2 (intervention group) | |
Secondary | Psychological distress | Psychological distress is assessed using the Hospital Anxiety and Depression Scale. | T1: 10 weeks after start of therapy (intervention group) or 13 weeks after completion of baseline (control group) | |
Secondary | Psychological distress | Psychological distress is assessed using the Hospital Anxiety and Depression Scale. | T2: 20-24 weeks after start of therapy (intervention group) or 23 weeks after completion of baseline (control group) | |
Secondary | Psychological distress | Psychological distress is assessed using the Hospital Anxiety and Depression Scale. | T3: 3 months after T2 (intervention group) | |
Secondary | Health-related quality of life | Health-related quality of life is assessed using the MOS SF-36. | T1: 10 weeks after start of therapy (intervention group) or 13 weeks after completion of baseline (control group) | |
Secondary | Health-related quality of life | Health-related quality of life is assessed using the MOS SF-36. | T2: 20-24 weeks after start of therapy (intervention group) or 23 weeks after completion of baseline (control group) | |
Secondary | Health-related quality of life | Health-related quality of life is assessed using the MOS SF-36. | T3: 3 months after T2 (intervention group) |
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