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A Multisite Randomized Controlled Trial of The First Online Intervention for Young Women With Breast Cancer and Their Male Partners

Phase 3
18 Years
45 Years
Not Enrolling
Distress, Breast Cancer

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Trial Information

A Multisite Randomized Controlled Trial of The First Online Intervention for Young Women With Breast Cancer and Their Male Partners 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 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 educational program to those who have not participated
and were instead put on a wait-list for participation.

Inclusion Criteria:

- couples where woman has received a diagnosis of invasive breast carcinoma;

- diagnosis was within the last 36 months;

- woman is age less than or equal to 45;

- 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 45;

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Reduced distress

Outcome Description:

Women and their male partners who participate in the Couplelinks program may demonstrate significant improvement on measures of relationship adjustment, mutuality, and intimacy as compared to couples assigned to a wait-list control condition; and that, participants in the treatment condition wmay also demonstrate significant improvement on measures of psychological distress and adjustment as compared to participants in the control condition.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Karen Fergus, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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


Canada: Ethics Review Committee

Study ID:




Start Date:

November 2010

Completion Date:

June 2015

Related Keywords:

  • Distress
  • Breast Cancer
  • breast neoplasm
  • behavioral intervention
  • online support
  • Distress associated with breast cancer diagnosis
  • Breast Neoplasms