Clinical trial · Interventional
RCT of an Internet-based CBT Program for Sexuality and Intimacy Problems in Women Treated for Breast Cancer
A Randomized Study of an Internet-based Cognitive Behavioral Therapy Program for Sexuality and Intimacy Problems in Women Treated for Breast Cancer.
NCT02091765CI-TRIAL-00040293KIScompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Survivors | — | UNRESOLVED | — |
| Intimacy Problems | — | UNRESOLVED | — |
| Sexual Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Internet-based cognitive behavioral therapy. | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Minimal intervention control group
- description
- 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.
- type
- EXPERIMENTAL
- label
- Internet-based cognitive behavioral therapy
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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).
References
Publications (24)
- BACKGROUNDColeman MP, Quaresma M, Berrino F, Lutz JM, De Angelis R, Capocaccia R, Baili P, Rachet B, Gatta G, Hakulinen T, Micheli A, Sant M, Weir HK, Elwood JM, Tsukuma H, Koifman S, E Silva GA, Francisci S, Santaquilani M, Verdecchia A, Storm HH, Young JL; CONCORD Working Group. Cancer survival in five continents: a worldwide population-based study (CONCORD). Lancet Oncol. 2008 Aug;9(8):730-56. doi: 10.1016/S1470-2045(08)70179-7. Epub 2008 Jul 17. PMID 18639491
- BACKGROUNDDutch Comprehensive Cancer Centre. Breast cancer survival in the Netherlands. 2011. Ref Type: Report
- BACKGROUNDBasson 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. doi: 10.1111/j.1743-6109.2004.10107.x. PMID 16422982
- BACKGROUNDBeckmann J, Johansen L, Richardt C, Blichert-Toft M. Psychological reactions in younger women operated on for breast cancer. Amputation versus resection of the breast with special reference to body-image, sexual identity and sexual function. Dan Med Bull. 1983 Dec;30 Suppl 2:10-3. No abstract available. PMID 6673909
- BACKGROUNDBloom JR, Stewart SL, Chang S, Banks PJ. Then and now: quality of life of young breast cancer survivors. Psychooncology. 2004 Mar;13(3):147-60. doi: 10.1002/pon.794. PMID 15022150
- BACKGROUNDGilbert E, Ussher JM, Perz J. Sexuality after breast cancer: a review. Maturitas. 2010 Aug;66(4):397-407. doi: 10.1016/j.maturitas.2010.03.027. Epub 2010 May 2. PMID 20439140
- BACKGROUNDFobair P, Stewart SL, Chang S, D'Onofrio C, Banks PJ, Bloom JR. Body image and sexual problems in young women with breast cancer. Psychooncology. 2006 Jul;15(7):579-94. doi: 10.1002/pon.991. PMID 16287197