Breast CancerOPICNCT01342302
An Online Psychoeducational Intervention for Young Women With Breast Cancer and Their Partners
A study testing Psychosocial Intervention for Couples in people with Breast Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Breast cancer is distressing for couples in general but even more so when the illness strikes at a relatively young age. In addition to common relationship challenges, younger couples have to contend with the loss or disruption of age-appropriate goals for themselves. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Psychosocial Intervention for Couples
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2008to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- woman has received a diagnosis of breast carcinoma within the last 18 months at any point in her treatment trajectory.
- Women must be free of known local recurrence or metastatic disease at the time of enrolment.
- Patients will have been 40 years of age or younger when diagnosed.
- Partners must be 45 years of age or younger at the time of diagnosis. - Couples must be heterosexual, and married, cohabitating, or engaged. - Participants must be fluent in English with the ability to read and write in English.
- All participants will require convenient access to a computer with internet connection.
Who cannot join
- All participants will be screened for mental illness that would interfere with their capacity to benefit from the program (e.g., suicidality, psychotic disorders, substance abuse) and excluded on this basis.
- Couples who plan to participate in couple or individual counselling during the 7-week study duration will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Breast cancer is distressing for couples in general but even more so when the illness strikes at a relatively young age. In addition to common relationship challenges, younger couples have to contend with the loss or disruption of age-appropriate goals for themselves. Presently, there are virtually no resources designed specifically to assist young couples coping with breast cancer. The purpose of this study is to develop and evaluate an online educational program geared to the unique needs and demanding schedules of young couples. The purpose of the program is to improve couples' relationships and mutual coping. Seventeen couples will take part in the 7-week program. They will complete questionnaires before and after participating to evaluate the program's helpfulness. This study will allow for the creation of a user-friendly, cost-effective tool that could help to improve the lives of all young couples coping with breast cancer in the years to come.
Read the detailed description
Women diagnosed with breast cancer at or before the age of 40 experience greater distress and poorer quality of life than women diagnosed later in life. In addition to having to cope with the range of issues common to all women with breast cancer, young women face unique challenges such as loss of fertility, concerns for young children, and interruptions to early-stage careers. The presence of adequate social support is a mitigating factor for distress in young women, and spousal support in particular has been shown to play a crucial and distinctive role in determining how well a woman adjusts to breast cancer. Unfortunately, the evidence suggests well-spouses are significantly distressed themselves, and often fall short in their attempts to meet the needs of their ill partners despite generally good intentions. Consequently, researchers have recommended that psychosocial interventions be geared to couples. However, traditional counseling interventions may not appeal to younger couples with numerous responsibilities and time constraints.
The purpose of this study is to examine the feasibility, process, and outcomes of an innovative online intervention tailored to the unique needs of young women and their partners. The primary goal is to improve partners' relationship functioning and capacity to work together as a team in relation to the illness. The secondary goal is to combat feelings of isolation by creating a community of similarly affected couples. The intervention will be delivered via a professionally moderated, password-protected website and entail: Information relevant to young couples with breast cancer; structured, interactive learning modules; and a discussion board. The online modality is particularly suited to the younger demographic targeted by this project because of its familiarity, comfort, convenience, and flexibility.
A non-randomized, repeated measures analysis of variance design will be used to test the intervention. Seventeen couples will be recruited within the Greater Toronto Area. Questionnaires assessing relationship functioning, psychological adjustment, and quality of life will be administered to participants at baseline and at completion of the 7-week program. Qualitative data from the website and treatment satisfaction questionnaire will be analyzed thematically in order to improve the intervention and its delivery.
The potential for this online intervention to fill a void in support options available to both young women with breast cancer and their partners is vast. Following completion of the project, not only will there be a demonstrable product in the website, but the investigators will have the knowledge with which to further test the intervention in a RCT. The ultimate impact of the proposed project will be the creation of an accessible, cost-effective, empirically validated tool that could help to improve the quality of life of all young couples coping with breast cancer, regardless of geographic location, in the years to come.
- Conditions
- Breast Cancer
- Being tested
- Psychosocial Intervention for Couples
- Keywords
- Breast Cancer, Couples, Distress, Online Support, e-health, Intervention, Relationships
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial Intervention for CouplesBehavioural
Intervention delivered on line
| Study group | Role | What they receive |
|---|---|---|
| Couples Intervention | Other | Single arm study design Receives: Behavioral: Psychosocial Intervention for Couples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dyadic Adjustment Scale (DAS) scores from pre (0 weeks) to post-treatment (7 weeks)
The DAS assesses couple's level of relationship satisfaction. The DAS will be used to assess change in couples' level of relationship satisfaction following participation in the Couplelinks program over a 7 week period, from pre-treatment (0 weeks) to post-treatment (7 weeks).
Measured: pre-treatment (0 weeks) and immediate post-treatment (7 weeks)
Change in Personal Assessment of Intimacy in Relationships scale scores from pre (0 weeks) to post-treatment (7 weeks)
The Personal Assessment of Intimacy in Relationships scale assesses the degree of feelings of intimacy between partners. This primary outcome measure will be used to assess changes in the degree of the feelings of intimacy between partners following participation in the Couplelinks program over a 7 week period, from pre-treatment (0 weeks) to post-treatment (7 weeks).
Measured: pre-treatment (0 weeks) and immediate post-treatment (7 weeks)
Secondary outcomes (6)
Mental Psychological Development Questionnaire (MPDQ)
The MPDQ assesses individual psychological adjustment.
Measured: Pre-treatment (0 weeks) and immediate post-treatment (12 weeks).
Mental Health Inventory (MHI)
The MHI assesses individual psychological adjustment.
Measured: pre-treatment (0 weeks) and post-treatment (7 weeks)
Hospital Anxiety and Depression Scale (HADS)
The HADS assesses individual psychological adjustment.
Measured: pre-treatment (0 weeks) and immediate post-treatment (7 weeks)
Functional Assessment of Cancer Therapy-Breast (FACT-B)
The FACT-B assesses women's individual physical and psychological adjustment to breast cancer treatment.
Measured: pre-treatment (0 weeks) and immediate post-treatment (7 weeks
Breast Cancer and Relationship Measure
This measure assesses the impact of breast cancer on couple mutuality.
Measured: pre-treatment (0 weeks) and immediate post-treatment (7 weeks
Treatment Expectancy and Motivation Measure (TEMM)
The TEMM assesses the degree to which individuals believe that the treatment will be helpful to them prior to starting the treatment.
Measured: pre-treatment (0 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startSep 2008
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Breast Cancer Foundation
- Responsible party
- Principal investigator, Karen Fergus, Sunnybrook Health Sciences Centre
- Investigators
- Karen Fergus, PhD, Principal investigator, Toronto Sunnybrook Regional Cancer CentreDebbie McLeod, PhD, RN, Study director, Cancer Care Program, Nova Scotia Cancer CentreEllen Warner, MD, Study director, Toronto Sunnybrook Regional Cancer CentreSandra Gardner, PhD, Study director, Toronto Sunnybrook Regional Cancer CentreMargaret Fitch, RN, Study director, Toronto Sunnybrook Regional Cancer CentreBarbara Fitzgerald, RN, Study director, Princess Margaret Hospital, CanadaLeeat Granek, PhD, Study director, Toronto Sunnybrook Regional Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342302
- Sponsor's protocol ID
- 200-2008
- Acronym
- OPIC
- Status last verified
- Apr 2011
- First submitted
- 15 Oct 2009
- Last updated
- 10 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Online Psychoeducational Intervention for Young Women With Breast Cancer and Their Partners
- ClinicalTrials.gov ID
- NCT01342302
- Acronym / sponsor ID
- OPIC / 200-2008
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Couples, Distress, Online Support, e-health, Intervention, Relationships
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Canadian Breast Cancer Foundation
- Study start
- Sep 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 27 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast cancer is distressing for couples in general but even more so when the illness strikes at a relatively young age. In addition to common relationship challenges, younger couples have to contend with the loss or disruption of age-appropriate goals for themselves. Presently, there are virtually no resources designed specifically to assist young couples coping with breast cancer. The purpose of this study is to develop and evaluate an online educational program geared to the unique needs and demanding schedules of young couples. The purpose of the program is to improve couples' relationships and mutual coping. Seventeen couples will take part in the 7-week program. They will complete questionnaires before and after participating to evaluate the program's helpfulness. This study will allow for the creation of a user-friendly, cost-effective tool that could help to improve the lives of all young couples coping with breast cancer in the years to come.
Detailed description
Women diagnosed with breast cancer at or before the age of 40 experience greater distress and poorer quality of life than women diagnosed later in life. In addition to having to cope with the range of issues common to all women with breast cancer, young women face unique challenges such as loss of fertility, concerns for young children, and interruptions to early-stage careers. The presence of adequate social support is a mitigating factor for distress in young women, and spousal support in particular has been shown to play a crucial and distinctive role in determining how well a woman adjusts to breast cancer. Unfortunately, the evidence suggests well-spouses are significantly distressed themselves, and often fall short in their attempts to meet the needs of their ill partners despite generally good intentions. Consequently, researchers have recommended that psychosocial interventions be geared to couples. However, traditional counseling interventions may not appeal to younger couples with numerous responsibilities and time constraints.
The purpose of this study is to examine the feasibility, process, and outcomes of an innovative online intervention tailored to the unique needs of young women and their partners. The primary goal is to improve partners' relationship functioning and capacity to work together as a team in relation to the illness. The secondary goal is to combat feelings of isolation by creating a community of similarly affected couples. The intervention will be delivered via a professionally moderated, password-protected website and entail: Information relevant to young couples with breast cancer; structured, interactive learning modules; and a discussion board. The online modality is particularly suited to the younger demographic targeted by this project because of its familiarity, comfort, convenience, and flexibility.
A non-randomized, repeated measures analysis of variance design will be used to test the intervention. Seventeen couples will be recruited within the Greater Toronto Area. Questionnaires assessing relationship functioning, psychological adjustment, and quality of life will be administered to participants at baseline and at completion of the 7-week program. Qualitative data from the website and treatment satisfaction questionnaire will be analyzed thematically in order to improve the intervention and its delivery.
The potential for this online intervention to fill a void in support options available to both young women with breast cancer and their partners is vast. Following completion of the project, not only will there be a demonstrable product in the website, but the investigators will have the knowledge with which to further test the intervention in a RCT. The ultimate impact of the proposed project will be the creation of an accessible, cost-effective, empirically validated tool that could help to improve the quality of life of all young couples coping with breast cancer, regardless of geographic location, in the years to come.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Couples Intervention | Other | Behavioral: Psychosocial Intervention for CouplesSingle arm study design |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- woman has received a diagnosis of breast carcinoma within the last 18 months at any point in her treatment trajectory.
- Women must be free of known local recurrence or metastatic disease at the time of enrolment.
- Patients will have been 40 years of age or younger when diagnosed.
- Partners must be 45 years of age or younger at the time of diagnosis. - Couples must be heterosexual, and married, cohabitating, or engaged. - Participants must be fluent in English with the ability to read and write in English.
- All participants will require convenient access to a computer with internet connection.
Key exclusion criteria (2 listed)
- All participants will be screened for mental illness that would interfere with their capacity to benefit from the program (e.g., suicidality, psychotic disorders, substance abuse) and excluded on this basis.
- Couples who plan to participate in couple or individual counselling during the 7-week study duration will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosocial Intervention for CouplesIntervention delivered on line | Behavioural | Couples Intervention |
Primary outcome
Change in Dyadic Adjustment Scale (DAS) scores from pre (0 weeks) to post-treatment (7 weeks)
Time frame: pre-treatment (0 weeks) and immediate post-treatment (7 weeks)
The DAS assesses couple's level of relationship satisfaction. The DAS will be used to assess change in couples' level of relationship satisfaction following participation in the Couplelinks program over a 7 week period, from pre-treatment (0 weeks) to post-treatment (7 weeks).
Change in Personal Assessment of Intimacy in Relationships scale scores from pre (0 weeks) to post-treatment (7 weeks)
Time frame: pre-treatment (0 weeks) and immediate post-treatment (7 weeks)
The Personal Assessment of Intimacy in Relationships scale assesses the degree of feelings of intimacy between partners. This primary outcome measure will be used to assess changes in the degree of the feelings of intimacy between partners following participation in the Couplelinks program over a 7 week period, from pre-treatment (0 weeks) to post-treatment (7 weeks).
6 secondary outcomes
Mental Psychological Development Questionnaire (MPDQ)
Time frame: Pre-treatment (0 weeks) and immediate post-treatment (12 weeks).
Mental Health Inventory (MHI)
Time frame: pre-treatment (0 weeks) and post-treatment (7 weeks)
Hospital Anxiety and Depression Scale (HADS)
Time frame: pre-treatment (0 weeks) and immediate post-treatment (7 weeks)
Functional Assessment of Cancer Therapy-Breast (FACT-B)
Time frame: pre-treatment (0 weeks) and immediate post-treatment (7 weeks
Breast Cancer and Relationship Measure
Time frame: pre-treatment (0 weeks) and immediate post-treatment (7 weeks
Treatment Expectancy and Motivation Measure (TEMM)
Time frame: pre-treatment (0 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Fergus, PhD principal investigator
Toronto Sunnybrook Regional Cancer Centre
Debbie McLeod, PhD, RN study director
Cancer Care Program, Nova Scotia Cancer Centre
Ellen Warner, MD study director
Toronto Sunnybrook Regional Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial Intervention for Couples in people with Breast Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dyadic Adjustment Scale (DAS) scores from pre (0 weeks) to post-treatment (7 weeks) (time frame: pre-treatment (0 weeks) and immediate post-treatment (7 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2013.