Trial record 19 of 1677 for:    breast,cancer,treatment | Open Studies

KIS Study: a Study Evaluating the Effectiveness of an Internet-based Therapy Program for Sexuality and Intimacy Problems in Women Treated for Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by The Netherlands Cancer Institute
Sponsor:
Collaborators:
Dutch Cancer Society
Pink Ribbon
Information provided by (Responsible Party):
The Netherlands Cancer Institute
ClinicalTrials.gov Identifier:
NCT02091765
First received: March 7, 2014
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Sexual Dysfunction.
Intimacy Problems.
Breast Cancer Survivors.
Behavioral: Internet-based cognitive behavioral therapy.
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Study of an Internet-based Cognitive Behavioral Therapy Program for Sexuality and Intimacy Problems in Women Treated for Breast Cancer.

Resource links provided by NLM:


Further study details as provided by The Netherlands Cancer Institute:

Primary Outcome Measures:
  • Sexuality problems [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Sexuality problems are assessed using the Sexual Activity Questionnaire, Female Sexual Function Scale, and Female Sexual Distress Scale.

  • Intimacy problems. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Intimacy problems are assessed using the Personal Assessment of Intimacy in Relationships (PAIR) Inventory.

  • Sexuality problems [ Time Frame: T1: 10 weeks after start of therapy (intervention group) or 13 weeks after completion of baseline (control group) ] [ Designated as safety issue: No ]
    Sexuality problems are assessed using the Sexual Activity Questionnaire, Female Sexual Function Scale, and Female Sexual Distress Scale.

  • Sexuality problems [ Time Frame: T2: 20 weeks after start of therapy (intervention group) or 23 weeks after completion of baseline (control group) ] [ Designated as safety issue: No ]
    Sexuality problems are assessed using the Sexual Activity Questionnaire, Female Sexual Function Scale, and Female Sexual Distress Scale.

  • Sexuality problems [ Time Frame: T3: 3 months after completion of T2 (intervention group) ] [ Designated as safety issue: No ]
    Sexuality problems are assessed using the Sexual Activity Questionnaire, Female Sexual Function Scale, and Female Sexual Distress Scale.

  • Intimacy problems. [ Time Frame: T1: 10 weeks after start of therapy (intervention group) or 13 weeks after completion of baseline (control group) ] [ Designated as safety issue: No ]
    Intimacy problems are assessed using the Personal Assessment of Intimacy in Relationships (PAIR) Inventory.

  • Intimacy problems. [ Time Frame: T2: 20 weeks after start of therapy (intervention group) or 23 weeks after completion of baseline (control group) ] [ Designated as safety issue: No ]
    Intimacy problems are assessed using the Personal Assessment of Intimacy in Relationships (PAIR) Inventory.

  • Intimacy problems. [ Time Frame: T3: 3 months after completion of T2 (intervention group) ] [ Designated as safety issue: No ]
    Intimacy problems are assessed using the Personal Assessment of Intimacy in Relationships (PAIR) Inventory.


Secondary Outcome Measures:
  • Body image. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Body image is assessed using the QLQ-BR23.

  • Menopausal symptoms. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Menopausal symptoms are assessed using the FACT-ES.

  • Marital functioning. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Marital functioning is assessed using the Maudsley marital Questionnaire.

  • Psychological distress [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Psychological distress is assessed using the Hospital Anxiety and Depression Scale.

  • Health-related quality of life [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Health-related quality of life is assessed using the MOS SF-36.

  • Body image. [ Time Frame: T1: 10 weeks after start of therapy (intervention group) or 13 weeks after completion of baseline (control group) ] [ Designated as safety issue: No ]
    Body image is assessed using the QLQ-BR23.

  • Body image. [ Time Frame: T2: 20 weeks after start of therapy (intervention group) or 23 weeks after completion of baseline (control group) ] [ Designated as safety issue: No ]
    Body image is assessed using the QLQ-BR23.

  • Body image. [ Time Frame: T3: 3 months after completion of T2 (intervention group) ] [ Designated as safety issue: No ]
    Body image is assessed using the QLQ-BR23.

  • Menopausal symptoms. [ Time Frame: T1: 10 weeks after start of therapy (intervention group) or 13 weeks after completion of baseline (control group) ] [ Designated as safety issue: No ]
    Menopausal symptoms are assessed using the FACT-ES.

  • Menopausal symptoms. [ Time Frame: T2: 20 weeks after start of therapy (intervention group) or 23 weeks after completion of baseline (control group) ] [ Designated as safety issue: No ]
    Menopausal symptoms are assessed using the FACT-ES.

  • Menopausal symptoms. [ Time Frame: T3: 3 months after completion of T2 (intervention group) ] [ Designated as safety issue: No ]
    Menopausal symptoms are assessed using the FACT-ES.

  • Marital functioning. [ Time Frame: T1: 10 weeks after start of therapy (intervention group) or 13 weeks after completion of baseline (control group) ] [ Designated as safety issue: No ]
    Marital functioning is assessed using the Maudsley marital Questionnaire.

  • Marital functioning. [ Time Frame: T2: 20 weeks after start of therapy (intervention group) or 23 weeks after completion of baseline (control group) ] [ Designated as safety issue: No ]
    Marital functioning is assessed using the Maudsley marital Questionnaire.

  • Marital functioning. [ Time Frame: T3: 3 months after completion of T2 (intervention group) ] [ Designated as safety issue: No ]
    Marital functioning is assessed using the Maudsley marital Questionnaire.

  • Psychological distress [ Time Frame: T1: 10 weeks after start of therapy (intervention group) or 13 weeks after completion of baseline (control group) ] [ Designated as safety issue: No ]
    Psychological distress is assessed using the Hospital Anxiety and Depression Scale.

  • Psychological distress [ Time Frame: T2: 20 weeks after start of therapy (intervention group) or 23 weeks after completion of baseline (control group) ] [ Designated as safety issue: No ]
    Psychological distress is assessed using the Hospital Anxiety and Depression Scale.

  • Psychological distress [ Time Frame: T3: 3 months after completion of T2 (intervention group) ] [ Designated as safety issue: No ]
    Psychological distress is assessed using the Hospital Anxiety and Depression Scale.

  • Health-related quality of life [ Time Frame: T1: 10 weeks after start of therapy (intervention group) or 13 weeks after completion of baseline (control group) ] [ Designated as safety issue: No ]
    Health-related quality of life is assessed using the MOS SF-36.

  • Health-related quality of life [ Time Frame: T2: 20 weeks after start of therapy (intervention group) or 23 weeks after completion of baseline (control group) ] [ Designated as safety issue: No ]
    Health-related quality of life is assessed using the MOS SF-36.

  • Health-related quality of life [ Time Frame: T3: 3 months after completion of T2 (intervention group) ] [ Designated as safety issue: No ]
    Health-related quality of life is assessed using the MOS SF-36.


Estimated Enrollment: 160
Study Start Date: December 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Minimal intervention control group
Women who are assigned to the control group will be contacted by telephone by a member of the study staff to inform them about this allocation. They will receive a booklet per mail that addresses 80 questions about sexuality and cancer. Six weeks later, they will receive an empathetic phone call from one of the sexologists, during which there is also time available to discuss further questions the participants may have concerning sexuality and cancer. The purpose of keeping in contact with the control group, as opposed to a pure waiting list control group, is creating the opportunity to provide some control for a possible attention placebo-effect. The final questionnaire will be completed twenty weeks post study entry, after which women will be given the opportunity to undergo the internet-based cognitive behavioral program.
Experimental: Internet-based cognitive behavioral therapy
Each woman who is allocated to the intervention group is assigned a personal sexologist (therapist) who guides her through the internet-based cognitive behavioral therapy (CBT) program and provides feedback on the homework assignments. The CBT program comprises a maximum of ten treatment modules that can be used in varying order. Each module contains three interventions and a personal evaluation form to report on the intervention. Each intervention comprises the following elements: 1) introduction, 2) psycho-education about symptoms, 3) "homework" assignments (e.g. relaxation techniques (pelvis); discuss intimacy with partner; sensate focus) and 4) reporting back to the therapist and receiving feedback on the "homework" assignments. Each week there are two "practice" sessions of 30 minutes each and one hour per week to report on/evaluate the intervention. The therapy has a mean duration of 20 weeks.
Behavioral: Internet-based cognitive behavioral therapy.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02091765

Contacts
Contact: Neil K. Aaronson, PhD +31205122481 n.aaronson@nki.nl
Contact: Lisanne Hummel, MSc +31205126098 l.hummel@nki.nl

Locations
Netherlands
Netherlands Cancer Institute Recruiting
Amsterdam, Netherlands, 1066 CX
Contact: Neil K. Aaronson, PhD    +31205122481    n.aaronson@nki.nl   
Contact: Lisanne Hummel, MSc    +31205126098    l.hummel@nki.nl   
Principal Investigator: Neil K. Aaronson, PhD         
Sub-Investigator: Lisanne Hummel, MSc         
Sponsors and Collaborators
The Netherlands Cancer Institute
Dutch Cancer Society
Pink Ribbon
Investigators
Principal Investigator: Neil K. Aaronson, PhD The Netherlands Cancer Institute
Principal Investigator: Jacques J.D.M. van Lankveld, PhD Open University, the Netherlands
Principal Investigator: Hester S.A. Oldenburg, PhD The Netherlands Cancer Institute
Principal Investigator: Daniela Hahn, MSc The Netherlands Cancer Institute
  More Information

Publications:
Bredart A, Dolbeault S, Savignoni A et al. Prevalence and associated factors of sexual problems after early-stage breast cancer treatment: results of a French exploratory survey. Psychooncology. 2010.

Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT02091765     History of Changes
Other Study ID Numbers: NKI 2012-5388 / NL44153.031.13
Study First Received: March 7, 2014
Last Updated: March 31, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by The Netherlands Cancer Institute:
Sexual dysfunction.
Intimacy problems.
Breast cancer survivors.
Internet-based.
Cognitive behavioral therapy.

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014