RCT of an Internet-based CBT Program for Sexuality and Intimacy Problems in Women Treated for Breast Cancer

NCT02091765 | Completed Phase 3

• 1 other identifier: NKI 2012-5388 / NL44153.031.13
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sexual Dysfunction; Intimacy Problems; Breast Cancer Survivors

Keywords

Sexual dysfunction; Intimacy problems; Breast cancer survivors; Internet-based; Cognitive behavioral therapy

Outcome Measures

Primary Outcomes (10)

• Sexuality problems

  Sexuality problems are assessed using the Sexual Activity Questionnaire, Female Sexual Function Scale, and Female Sexual Distress Scale.

  Baseline

• Intimacy problems.

  Intimacy problems are assessed using the Personal Assessment of Intimacy in Relationships (PAIR) Inventory.

  Baseline

• 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)

• 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)

• 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)

• 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)

• 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)

• Intimacy problems.

  Intimacy problems are assessed using the Personal Assessment of Intimacy in Relationships (PAIR) Inventory.

  T3: 3 months after T2 (intervention group)

• 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)

• Intimacy problems

  Intimacy problems are assessed using the Personal Assessment of Intimacy in Relationships (PAIR) Inventory.

  T4: 6 months after T3 (intervention group)

Secondary Outcomes (20)

• Body image.

  Baseline

• Menopausal symptoms.

  Baseline

• Marital functioning.

  Baseline

• Psychological distress

  Baseline

• Health-related quality of life

  Baseline

Study Arms (2)

Minimal intervention control group

NO INTERVENTION

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.

Internet-based cognitive behavioral therapy

EXPERIMENTAL

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.

Interventions

Internet-based cognitive behavioral therapy. BEHAVIORAL

Internet-based cognitive behavioral therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• Dutch Cancer Society: collaborator
• Pink Ribbon Inc.: collaborator

Study Sites (1)

Netherlands Cancer Institute

Amsterdam, 1066 CX, Netherlands

Location

Related Publications (24)

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MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Neil K. Aaronson, PhD

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

• Jacques J. van Lankveld, PhD

  Open University, the Netherlands

  PRINCIPAL INVESTIGATOR

• Hester S. Oldenburg, PhD

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

• Daniela Hahn, MSc

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2014
• First Posted: March 19, 2014
• Study Start: December 1, 2012
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 28, 2019

Record last verified: 2016-10

Locations

NL (1)