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NCT Number: NCT01764802

Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer

This randomized phase II trial studies how well psychosexual intervention works in patients with stage I-III gynecologic or breast cancer. Psychosexual intervention may improve sexual and psychosocial function.

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Key information

Conditions

Ovarian Sarcoma Adnexal Diseases Breast Cancer Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Ovarian Epithelial 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 Gestational Trophoblastic Disease Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Ovarian Stromal Cancer Pregnancy Complications Pregnancy Complications, Neoplastic Skin Diseases Skin and Connective Tissue Diseases Stage I Uterine Sarcoma Stage I Vaginal Cancer Stage I Vulvar Cancer Stage IA Cervical Cancer Stage IA Endometrial Carcinoma Stage IA Fallopian Tube Cancer Stage IA Ovarian Epithelial Cancer Stage IA Ovarian Germ Cell Tumor Stage IA Primary Peritoneal Cavity Cancer Stage IB Cervical Cancer Stage IB Endometrial Carcinoma Stage IB Fallopian Tube Cancer Stage IB Ovarian Epithelial Cancer Stage IB Ovarian Germ Cell Tumor Stage IB Primary Peritoneal Cavity Cancer Stage IC Fallopian Tube Cancer Stage IC Ovarian Epithelial Cancer Stage IC Ovarian Germ Cell Tumor Stage IC Primary Peritoneal Cavity Cancer Stage II Endometrial Carcinoma Stage II Gestational Trophoblastic Tumor Stage II Uterine Sarcoma Stage II Vaginal Cancer Stage II Vulvar Cancer Stage IIA Cervical Cancer Stage IIA Fallopian Tube Cancer Stage IIA Ovarian Epithelial Cancer Stage IIA Ovarian Germ Cell Tumor Stage IIA Primary Peritoneal Cavity Cancer Stage IIB Cervical Cancer Stage IIB Fallopian Tube Cancer Stage IIB Ovarian Epithelial Cancer Stage IIB Ovarian Germ Cell Tumor Stage IIB Primary Peritoneal Cavity Cancer Stage IIC Fallopian Tube Cancer Stage IIC Ovarian Epithelial Cancer Stage IIC Ovarian Germ Cell Tumor Stage IIC Primary Peritoneal Cavity Cancer Stage III Gestational Trophoblastic Tumor Stage III Uterine Sarcoma Stage III Vaginal Cancer Stage III Vulvar Cancer Stage IIIA Cervical Cancer Stage IIIA Endometrial Carcinoma Stage IIIA Fallopian Tube Cancer Stage IIIA Ovarian Epithelial Cancer Stage IIIA Ovarian Germ Cell Tumor Stage IIIA Primary Peritoneal Cavity Cancer Stage IIIB Cervical Cancer Stage IIIB Endometrial Carcinoma Stage IIIB Fallopian Tube Cancer Stage IIIB Ovarian Epithelial Cancer Stage IIIB Ovarian Germ Cell Tumor Stage IIIB Primary Peritoneal Cavity Cancer Stage IIIC Endometrial Carcinoma Stage IIIC Fallopian Tube Cancer Stage IIIC Ovarian Epithelial Cancer Stage IIIC Ovarian Germ Cell Tumor Stage IIIC Primary Peritoneal Cavity Cancer Trophoblastic 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

21 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

About this study

PRIMARY OBJECTIVES:

I. Efficacy for reducing the severity of sexual distress, difficulty, and dysfunction in a phase II randomized clinical trial (RCT).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (Enhanced standard care): Patients participate in enhanced standard care intervention comprising stress reduction, information delivery regarding gynecologic or breast cancer treatments and sexuality, and provision of a survivorship care plan (SCP) created using OncoLink over 1 hour following baseline assessment and before 6 months.

ARM II (Psychological intervention): Patients participate in individual or group therapy over 1.5 hours weekly for 4 weeks, bi-weekly for 8 weeks, and monthly for 2 months and complete assessment interviews.

After completion of study treatment, patients are followed up at 3, 6, and 9 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Stage I-III gynecologic (any site) or breast cancer
  • Able to speak/read English
  • Able to give informed consent

Exclusion criteria

  • Prior non-gynecologic/breast cancer diagnosis
  • Refusal of any cancer treatment(s)
  • Non-ambulatory
  • Concurrent diagnosis of organic brain syndrome, dementia, mental retardation, or significant sensory deficit
  • Major mental illness (e.g, schizophrenia, major depressive disorder)
  • Current/recent (prior 12 months) pregnancy
  • Residence > 70 miles from research site

Treatment and study plan

Behavioral, Psychological or Informational Intervention

Other

Participate in enhanced standard care

Primary outcomes

  1. Sexual behavior/repertoire (kissing, intercourse, etc.) graded using the Sexual Experiences Scale (SES)

    Time frame: Up to 2 months

    Multilevel modeling will be used to model time effects compared to repeated-measures analysis of variance (ANOVA) because it allows not only fitting different patterns of average change (i.e., linear, quadratic), but also estimates individual variability in the rate of change. Both linear and quadratic change models will be tested and an optimal model will be determined. 95% confidence intervals will be obtained.

  2. Sexual responsiveness (desire, arousal, orgasm) using the Female Sexual Functioning Index (FSFI)

    Time frame: Up to 4 weeks

    Principal components analysis yields six subscales: desire, arousal, lubrication, orgasm, satisfaction, and pain. Items are rated using the Likert scales. 95% confidence intervals will be obtained.

  3. Sexual satisfaction graded using the global evaluation from the Derogatis Sexual Function Inventory (DSFI)

    Time frame: Up to 2 months

    95% confidence intervals will be obtained.

  4. Sexual distress graded using the female Sexual Distress Scale (FSDS)

    Time frame: Up to 4 weeks

    The Likert scale will be used. 95% confidence intervals will be obtained.

  5. Sexual pain graded using the International Pelvic Pain Society Pelvic Pain Assessment, patient/physician version

    Time frame: Up to 9 months

Secondary outcomes

  1. Emotional distress graded using the Profile of Mood States (POMS)

    Time frame: Up to 9 months

    The Likert scale will be used. 95% confidence intervals will be obtained.

  2. Depressive symptoms graded using the Center for Epidemiologic Studies Depression Scale (CES-D)

    Time frame: Up to 9 months

    The Likert scale will be used. 95% confidence intervals will be obtained.

  3. Health-related quality of life graded according to the RAND Medical Outcomes Study, Short-form 12 (SF-12)

    Time frame: Up to 9 months

    The eight primary subscales are summarized into two component scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).

  4. Cancer-related stress graded according to the Impact of Events Scale-Revised (IES-R)

    Time frame: Up to 9 months

  5. Body change stress graded according to the Impact of Treatment Scale (ITS)

    Time frame: Up to 9 months

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Psychosexual Intervention for Gynecologic and Breast Cancer Patients

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Jan 10, 2013
Registry last updated
May 30, 2018

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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