The proposed study will evaluate the efficacy of an internet-based cognitive behavioral intervention program designed to alleviate sexuality and intimacy problemens of women who have been treated for breast cancer.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Sexual dysfunctions, disturbances and gender identity disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study outcomes are sexuality problems, as assessed with the Sexual
Activity Questionnaire (SAQ), the Female Sexual Dysfunction Index (FSFI), and
the Female Sexual Distress Scale (FSDS), and intimacy problems, as assessed
with the PAIR Inventory.
Secondary outcome
The secondary study outcomes are body image (QLQ-BR23), menopausal symptoms
(FACT-ES), marital functioning (MMQ), psychological distress (HADS), and health
related quality of life (MOS SF-36).
Background summary
Approximately half of breast cancer survivors report sexual problems, and
upwards 50% of these women express interest in receiving professional help.
Nevertheless, despite the availability of effective treatment, very few women
actually undergo formal, face-to-face counselling/therapy for their sexual
complaints. There is evidence that many breast cancer survivors consider
clinic-based, face-to-face therapy to be too confrontational. There is growing
evidence that internet-based cognitive behavioral therapy (CBT) can effectively
treat a range of psychosocial problems (e.g., anxiety, depression, PTSD, and
more recently sexual dysfunction). There are a number of advantages to
internet-based therapy, including relatively low cost, convenience,
accessibility, and privacy. The proposed study will evaluate the efficacy of an
internet-based CBT program in alleviating sexuality and intimacy problems, and
enhancing the HRQL of women with breast cancer. If demonstrated to be
effective, the availability of internet-based cognitive behavioral therapy
program will be a welcome addition to regular medical care offered to breast
cancer patients with sexuality and intimacy problems.
Hypotheses:
1. Women who follow the internet-based intervention program will report
significantly greater improvement from baseline to post-treatment and 3 months
follow-up in sexual functioning, as assessed by the Sexual Activity
Questionnaire (SAQ), the Female Sexual Function Index (FSFI), and the Female
Sexual Distress Scale (FSDS), and in intimacy, as assessed by the PAIR
Inventory, than women in the minimal intervention control group.
2. Women exposed to the intervention will report significantly more improvement
in body image, menopausal symptoms, marital satisfaction, psychological
distress, and generic health related quality of life than women in the minimal
intervention control group.
Study objective
The proposed study will evaluate the efficacy of an internet-based cognitive
behavioral intervention program designed to alleviate sexuality and intimacy
problemens of women who have been treated for breast cancer.
Study design
For this multicentre trial patients will be recruited from 14 hospitals in the
Amsterdam region. Participants will be randomly allocated to either the
intervention condition or the control condition (N=80 per group). Upon
completion of the study, the patients assigned to the control group will be
given the opportunity to undergo the internet-based cognitive behavioral
therapy program.
Women in the intervention group and control group will be asked to complete a
battery of questionnaires prior to randomization (T0), at 10 weeks (T1), and at
post-treament (intervention condition)/20 weeks (control condition). Women in
the intervention condition will complete a final questionnaire at 3 months
follow-up. Main outcome measures are sexuality and intimacy problems, body
image, menopausal symptoms, marital/relational functioning, psychological
distress, and health-related quality of life. Partners of women in the
intervention condition are asked (on voluntary basis) to complete
questionnaires about their experience of the relationship and sexuality. If
they have agreed, the questionnaires are offered to the partners at the same
moments during the study as the women in the intervention condition.
Intervention
The intervention consists of an internet-based cognitive behavioral therapy
program with a maximum duration of 20 weeks. Women will be motivated by the
sexologist to involve their partner in the treatment. The CBT program comprises
a maximum of 10 treatment modules that can be used in varying order. These
include: 1) Put your problems into words, 2) How is my relationship doing?, 3)
Sex and my body, 4) Focus my attention, 5) Explore my body, 6 & 7) Discovering
my sexual arousal feelings (versions for the woman and for her partner), 8)
Change my thoughts, 9) My sexual preferences, and 10) Relapse prevention. The
choice of modules to be used by any given woman is based on the information
obtained via the screening questionnaires and the intake evaluation by the
therapist. Each module contains three interventions and a personal evaluation
form to report on the intervention. Each intervention comprises the following
elements: introduction, psycho-education about symptoms, *homework* assignments
(e.g. relaxation techniques (pelvis); discuss intimacy with partner, sensate
focus) and reporting back to the therapist and receiving feedback on homework
assignments. The purpose of the internet-based therapy is to provide women with
information, skills, and support to handle their sexuality and intimacy
problems better or to let the problems decrease/disappear.
Study burden and risks
A potential disadvantage of participation in the study is the investment of
time and the effort it takes to complete the therapy program.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
The study sample will be composed of 160 women, between 18 and 65 years of age, with histologically confirmed breast cancer, who received treatment in one of the participating hospitals. All women will have completed treatment (with the exception of endocrine therapy), received their diagnosis between 6 months and 5 years prior to study entry, and will be disease-free at time of study entry. Potentially eligible women will be screened for the presence of sexuality and intimacy problems.
Exclusion criteria
Women will be excluded from the study if they: lack basic proficiency in Dutch; do not have access to the internet; exhibit serious cognitive or psychiatric problems (i.e. major depression, alcohol dependency, or psychotic disorders); report severe relationship problems for which the internet-based program is not designed (and which need to be addressed prior to undergoing sex therapy); are participating in a concurrent therapy program to alleviate their sexuality/intimacy problems; or have been treated for another type of cancer besides breast cancer (with the exception of cervical carcinoma in situ and basal cell carcinoma).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL44153.031.13 |