DistressPhase 3couplelinksNCT01089764
Couplelinks.ca - An Online Intervention for Couples Affected by Breast Cancer
A Phase 3 study testing Couplelinks.ca website in people with Distress and Breast Cancer, run by Canadian Breast Cancer Research Alliance at 5 sites in Canada.
Trial summary
Women diagnosed with breast cancer (BC) at or before the age of 50 experience more distress and poorer quality of life than women diagnosed later in life. Although adequate spousal support is a protective factor for women with BC, spouses are often unprepared to handle the myriad practical and emotional demands posed… Read more about this study
- Who is it for?
- Ages 18 to 53 yearsHealthy volunteers can take part
- Conditions the study is for
- Distress, Breast Cancer, Depression
- What is being tested?
- Couplelinks.ca website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 5 sitesCanada
- Study dates
- Nov 2010to Jun 2015
- Phase
- Phase 3
- 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 18 to 53 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- couples where woman has received a diagnosis of nonmetastatic breast carcinoma;
- diagnosis was within the last 36 months;
- woman is age less than or equal to 50 at age of diagnosis;
- completed or are nearing the end of active treatment;
- couples must be in a committed, heterosexual relationship;
- fluent in English with the ability to read and write in English.
Who cannot join
- non-heterosexual couples;
- women older than 50;
- previous diagnosis of moderate to severe psychological problems that may interfere with capacity to benefit from the intervention;
- couples who plan to participate in couple counselling during the 5-month study duration.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites, 5 recruiting
- Recruiting
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7
Deborah McLeod, R.N., PhD, 902 473-2964, deborahl.mcleod@cdha.nshealth.ca
Deborah McLeod, R.N., PhD
- Recruiting
York University
Toronto, Ontario, M3J1P3
Amanda Pereira, BA, 416-736-2100 ext. 44028, coordinator@couplelinks.ca
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Amanda Pereira, BA, 416-736-2100 ext. 44028, coordinator@couplelinks.ca
- Recruiting
British Columbia Cancer Agency Research Centre
Vancouver, British Columbia, V5Z 1L3
Joanne Stephen, PhD, 1.800.663.3333 ext. 4960, jstephen@bccancer.bc.ca
Joanne Stephen, PhD
- Recruiting
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Jill Taylor-Brown, MSW,RSW, 204-787-2109, jill.taylorbrown@cancercare.mb.ca
Jill Taylor-Brown, MSW, RSW
About this study
Official title: A Randomized Controlled Trials of Couplelinks.ca: The First Online Couples Intervention for Young Women Dealing With Breast Cancer and Their Male Partners
Women diagnosed with breast cancer (BC) at or before the age of 50 experience more distress and poorer quality of life than women diagnosed later in life. Although adequate spousal support is a protective factor for women with BC, spouses are often unprepared to handle the myriad practical and emotional demands posed by the illness. Furthermore, despite the growing number of recommendations for couple interventions in relation to BC, traditional counselling approaches may fail to meet the needs of young couples who have unique concerns and tight constraints on their time. The proposed project addresses the void in the psycho-social support available to young couples via an innovative, online psychoeducational intervention tailored specifically to their needs.
Read the detailed description
Couplelinks.ca is a custom-designed website offering a professionally facilitated, couple-centred intervention that entails informational, experiential, and interactive components. Six Dyadic Learning Modules (DLM) form the core of the program and are undertaken on a weekly basis.
A funded pilot study examining the feasibility and benefit of Couplelinks.ca utilized a non-randomized, pre-post test design to assess the process and outcomes of the intervention. Qualitative feedback also informed the evaluation. Preliminary findings were promising and provided justification for further evaluation of the program's effectiveness.
The current study is the next logical step: a larger-scale Phase III study to determine whether this BC-specific, relationship-enhancement program leads to improved relationship and psychological outcomes for young couples affected by BC. It is a randomized controlled trial (RCT) comparing level of distress and dyadic adjustment in couples who have participated in the Couplelinks.ca educational program to those who have not participated and were instead put on a wait-list for participation.
- Conditions
- Distress, Breast Cancer, Depression, Anxiety
- Being tested
- Couplelinks.ca website
- Keywords
- breast neoplasm, breast cancer, behavioral intervention, online support, relationship distress, dyadic coping
- Medical subject headings
- Breast Neoplasms, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couplelinks.ca websiteBehavioural
Also called Couplelinks.ca program
Participation in the Couplelinks.ca program, an online intervention.
| Study group | Role | What they receive |
|---|---|---|
| Couplelinks.ca Intervention | Experimental | Intervention arm - Couple participates in the Couplelinks.ca program. Receives: Behavioral: Couplelinks.ca website |
| No Intervention | No intervention | Couple is waitlisted for participation in the Couplelinks.ca program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revised Dyadic Adjustment Survey RDAS
The Revised Dyadic Adjustment Survey (RDAS) is a brief version of the 33 question Dyadic Adjustment Survey that assesses relationship adjustment.
Measured: T0= 0 weeks, T1= 8 weeks, T3= 3 months
Dyadic Coping
Dyadic Coping assesses the degree to which partners feel that their coping efforts are reciprocal
Measured: T0= 0 weeks, T1= 8 weeks, T3= 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study startNov 2010
- Primary completionMay 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DistressStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Breast Cancer Research Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- York University, Sunnybrook Health Sciences Centre, British Columbia Cancer Agency, CancerCare Manitoba, Queen Elizabeth II Health Sciences Centre
- Responsible party
- Principal investigator, Karen Fergus, Canadian Breast Cancer Research Alliance
- Investigators
- Karen Fergus, PhD, Principal investigator, York University/Sunnybrook Health Sciences Centre (Odette Cancer Centre)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089764
- Sponsor's protocol ID
- H10-00300
- Acronym
- couplelinks
- Status last verified
- Aug 2013
- First submitted
- 17 Mar 2010
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Fergus K, Ahmad S, McLeod DL, Stephen J, Gardner S, Pereira A, Warner E, Carter W. Couplelinks - an online intervention for young women with breast cancer and their male partners: study protocol for a randomized controlled trial. Trials. 2015 Jan 29;16:33. doi: 10.1186/s13063-014-0534-8.
PubMed 25630357
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trials of Couplelinks.ca: The First Online Couples Intervention for Young Women Dealing With Breast Cancer and Their Male Partners
- ClinicalTrials.gov ID
- NCT01089764
- Acronym / sponsor ID
- couplelinks / H10-00300
- Conditions
- Distress, Breast Cancer, Depression, Anxiety
- Keywords
- breast neoplasm, breast cancer, behavioral intervention, online support, relationship distress, dyadic coping
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Canadian Breast Cancer Research AllianceUniversity, hospital or other
- Collaborators
- York University, Sunnybrook Health Sciences Centre, British Columbia Cancer Agency, CancerCare Manitoba, Queen Elizabeth II Health Sciences Centre
- Study start
- Nov 2010
- Primary completion
- May 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 19 Mar 2010 (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.
Women diagnosed with breast cancer (BC) at or before the age of 50 experience more distress and poorer quality of life than women diagnosed later in life. Although adequate spousal support is a protective factor for women with BC, spouses are often unprepared to handle the myriad practical and emotional demands posed by the illness. Furthermore, despite the growing number of recommendations for couple interventions in relation to BC, traditional counselling approaches may fail to meet the needs of young couples who have unique concerns and tight constraints on their time. The proposed project addresses the void in the psycho-social support available to young couples via an innovative, online psychoeducational intervention tailored specifically to their needs.
Detailed description
Couplelinks.ca is a custom-designed website offering a professionally facilitated, couple-centred intervention that entails informational, experiential, and interactive components. Six Dyadic Learning Modules (DLM) form the core of the program and are undertaken on a weekly basis.
A funded pilot study examining the feasibility and benefit of Couplelinks.ca utilized a non-randomized, pre-post test design to assess the process and outcomes of the intervention. Qualitative feedback also informed the evaluation. Preliminary findings were promising and provided justification for further evaluation of the program's effectiveness.
The current study is the next logical step: a larger-scale Phase III study to determine whether this BC-specific, relationship-enhancement program leads to improved relationship and psychological outcomes for young couples affected by BC. It is a randomized controlled trial (RCT) comparing level of distress and dyadic adjustment in couples who have participated in the Couplelinks.ca educational program to those who have not participated and were instead put on a wait-list for participation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Couplelinks.ca Intervention | Experimental | Behavioral: Couplelinks.ca websiteIntervention arm - Couple participates in the Couplelinks.ca program. |
| No Intervention | No intervention | –Couple is waitlisted for participation in the Couplelinks.ca program. |
Who may qualify
- Ages
- 18 to 53 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- couples where woman has received a diagnosis of nonmetastatic breast carcinoma;
- diagnosis was within the last 36 months;
- woman is age less than or equal to 50 at age of diagnosis;
- completed or are nearing the end of active treatment;
- couples must be in a committed, heterosexual relationship;
Key exclusion criteria (4 listed)
- non-heterosexual couples;
- women older than 50;
- previous diagnosis of moderate to severe psychological problems that may interfere with capacity to benefit from the intervention;
- couples who plan to participate in couple counselling during the 5-month study duration.
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 |
|---|---|---|
| Couplelinks.ca websiteAlso: Couplelinks.ca programParticipation in the Couplelinks.ca program, an online intervention. | Behavioural | Couplelinks.ca Intervention |
Primary outcome
Revised Dyadic Adjustment Survey RDAS
Time frame: T0= 0 weeks, T1= 8 weeks, T3= 3 months
The Revised Dyadic Adjustment Survey (RDAS) is a brief version of the 33 question Dyadic Adjustment Survey that assesses relationship adjustment.
Dyadic Coping
Time frame: T0= 0 weeks, T1= 8 weeks, T3= 3 months
Dyadic Coping assesses the degree to which partners feel that their coping efforts are reciprocal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2013.
- Derived from this study: PubMed 25630357Fergus K, Ahmad S, McLeod DL, Stephen J, Gardner S, Pereira A, Warner E, Carter W. Couplelinks - an online intervention for young women with breast cancer and their male partners: study protocol for a randomized controlled trial. Trials. 2015 Jan 29;16:33. doi: 10.1186/s13063-014-0534-8.
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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
York University/Sunnybrook Health Sciences Centre (Odette Cancer Centre)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Couplelinks.ca website in people with Distress and Breast Cancer, run by Canadian Breast Cancer Research Alliance at 5 sites 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen Fergus, PhD (416-480-5000 ext. 1243, Karen.Fergus@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revised Dyadic Adjustment Survey RDAS (time frame: T0= 0 weeks, T1= 8 weeks, T3= 3 months). 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?
On the ClinicalTrials.gov record for NCT01089764, which also lists 1 linked publication.
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 14 Aug 2013.