MedDataX Logo

Couplelinks.ca - An Online Intervention for Couples Affected by Breast Cancer

NCT ID: NCT01089764

Last Updated: 2013-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Distress Breast Cancer Depression Anxiety

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

breast neoplasm breast cancer behavioral intervention online support relationship distress dyadic coping

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Couplelinks.ca Intervention

Intervention arm - Couple participates in the Couplelinks.ca program.

Group Type EXPERIMENTAL

Couplelinks.ca website

Intervention Type BEHAVIORAL

Participation in the Couplelinks.ca program, an online intervention.

No Intervention

Couple is waitlisted for participation in the Couplelinks.ca program.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Couplelinks.ca website

Participation in the Couplelinks.ca program, an online intervention.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Couplelinks.ca program

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

53 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

York University

OTHER

Sponsor Role collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role collaborator

British Columbia Cancer Agency

OTHER

Sponsor Role collaborator

CancerCare Manitoba

OTHER

Sponsor Role collaborator

Queen Elizabeth II Health Sciences Centre

OTHER

Sponsor Role collaborator

Canadian Breast Cancer Research Alliance

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Karen Fergus

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Karen Fergus, PhD

Role: PRINCIPAL_INVESTIGATOR

York University/Sunnybrook Health Sciences Centre (Odette Cancer Centre)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

British Columbia Cancer Agency Research Centre

Vancouver, British Columbia, Canada

Site Status RECRUITING

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status RECRUITING

York University

Toronto, Ontario, Canada

Site Status RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Karen Fergus, PhD

Role: CONTACT

Phone: 416-480-5000

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Joanne Stephen, PhD

Role: primary

Jill Taylor-Brown, MSW,RSW

Role: primary

Deborah McLeod, R.N., PhD

Role: primary

Amanda Pereira, BA

Role: primary

Amanda Pereira, BA

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25630357 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H10-00300

Identifier Type: -

Identifier Source: org_study_id