Getting Back on Track: An Educational Group for Women With Breast Cancer (GBOT)

April 12, 2024 updated by: Jennifer Jones, University Health Network, Toronto

Getting Back on Track: A Single-session Psychoeducational Group Intervention for Women With Breast Cancer Completing Adjuvant Treatment

As the number of women who survive breast cancer continues to grow, more attention is being paid to their quality of life and the disease's long-term effects. The transition from patient to survivor, also termed the "re-entry transition", can be a very difficult and stressful time. A brief psychosocial intervention delivered at this important transition time may address the challenges that women face at re-entry, facilitating greater adaptation and more optimal recovery. The purpose of the proposed RCT is to test the acceptability and effectiveness of a single-session group psychoeducational intervention led by a multi-disciplinary team on adjustment to survivorship. A randomized controlled trial design (RCT) will be used to recruit 440 women attending the breast clinic at Princess Margaret Hospital in Toronto. Participants will be recruited while completing their adjuvant radiotherapy and those who agree to participate will complete the baseline questionnaire package (T0). They then will be randomized to receive either: (1) standard print material (CRL group n=220); or (2) standard print material and a single session group psychoeducational intervention (INT group n=220). Two weeks following randomization, participants in the CRL group will be given the "Getting Back on Track: Life after Treatment" booklet (current standard care), which includes information on the new health care team, physical side-effects, diet and exercise, emotional and social needs and returning to everyday life. Participants in the INT group will receive the same booklet and will also attend a 2- hour psychoeducational group session facilitated by a multidisciplinary team. Participants in both groups will be asked to complete the questionnaire package again at 3 months (post-1) and 6 -months (post-2) following the completion of cancer treatment. Participants in the INV group will also be asked to rate their satisfaction with the class and provide feedback on the content. The proposed intervention will be one of the few clinical interventions designed to address the service gap in helping women to make the transition from patients to survivors by using a single-session psychoeducational group intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
444

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • outpatients attending treatments at PMH
  • have a diagnosis of breast cancer;
  • have undergone initial treatment for breast cancer;
  • are receiving adjuvant radiation therapy as last hospital-based component of treatment;
  • are able to speak, read and write English.

Exclusion Criteria:

  • metastatic disease
  • local recurrence
  • cognitive impairment
  • if they are an inpatient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
participant will receive standard print material
Experimental: Intervention
patient will receive standard print material and a single session group psychoeducational intervention (GBOT)
Behavioral: Getting Back on Track
The intervention, entitled Getting Back on Track, is two hours in duration and delivered by a multidisciplinary team representing nursing, radiation therapy, social work, rehabilitation services, and nutrition from the Breast Cancer Clinic at Princess Margaret Hospital. Relying on the content of the Getting Back on Track booklet, clinical experience and the principles of adult education, this team developed scripts for each component of the class.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Self Efficacy
Time Frame: Base line, 3 months, 6 months
Using the Self-Efficacy for Managing Chronic Disease (SEMCDS) questionnaire to measure the change in self efficacy from baseline, to 3 months, and 6 months
Base line, 3 months, 6 months
Change in Health distress
Time Frame: baseline, 3 months, 6 months
using the modified Health Distress Scale to assess change in health distress from baseline at 3 months, and at 6 months
baseline, 3 months, 6 months
Mood State
Time Frame: baseline, 3 months, 6 months
Profile of Mood States Scale-Short Form (POMS-SF)
baseline, 3 months, 6 months
Change in Preparedness
Time Frame: baseline, 3 months, 6 months
Using the Preparedness scale: a 4-item Likert scale questionnaire regarding preparedness adapted from Stanton and Ganz et al (2005), in order to evaluate the change in preparedness from baseline, at 3 months, and at 6 months
baseline, 3 months, 6 months
Change in Knowledge
Time Frame: baseline, 3 months, 6 months
measuring changes in knowledge at 3 months and 6 months, compared to baseline using a knowledege questionnaire. This is an 18-item multiple choice questionnaire based on the information booklet and class content will be used to assess knowledge (developed for this study).
baseline, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Health Network, Toronto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Princess Margaret Cancer Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer M Jones, PhD, Princess Margaret Hospital, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2011

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 07-0271-CE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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