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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Getting Back on Track
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring single-session group, psychoeducational intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Princess Margaret Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

participant will receive standard print material

patient will receive standard print material and a single session group psychoeducational intervention (GBOT)

Outcomes

Primary Outcome Measures

Change in Self Efficacy
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
Change in Health distress
using the modified Health Distress Scale to assess change in health distress from baseline at 3 months, and at 6 months
Mood State
Profile of Mood States Scale-Short Form (POMS-SF)
Change in Preparedness
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
Change in Knowledge
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).

Secondary Outcome Measures

Full Information

First Posted
February 25, 2011
Last Updated
February 25, 2011
Sponsor
University Health Network, Toronto
Collaborators
Weekend Walkers Fund, Princess Margaret Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01305915
Brief Title
Getting Back on Track: An Educational Group for Women With Breast Cancer
Acronym
GBOT
Official Title
Getting Back on Track: A Single-session Psychoeducational Group Intervention for Women With Breast Cancer Completing Adjuvant Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto
Collaborators
Weekend Walkers Fund, Princess Margaret Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
single-session group, psychoeducational intervention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
444 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
participant will receive standard print material
Arm Title
Intervention
Arm Type
Experimental
Arm Description
patient will receive standard print material and a single session group psychoeducational intervention (GBOT)
Intervention Type
Behavioral
Intervention Name(s)
Getting Back on Track
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Self Efficacy
Description
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
Time Frame
Base line, 3 months, 6 months
Title
Change in Health distress
Description
using the modified Health Distress Scale to assess change in health distress from baseline at 3 months, and at 6 months
Time Frame
baseline, 3 months, 6 months
Title
Mood State
Description
Profile of Mood States Scale-Short Form (POMS-SF)
Time Frame
baseline, 3 months, 6 months
Title
Change in Preparedness
Description
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
Time Frame
baseline, 3 months, 6 months
Title
Change in Knowledge
Description
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).
Time Frame
baseline, 3 months, 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer M Jones, PhD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20432117
Citation
Jones JM, Cheng T, Jackman M, Rodin G, Walton T, Catton P. Self-efficacy, perceived preparedness, and psychological distress in women completing primary treatment for breast cancer. J Psychosoc Oncol. 2010;28(3):269-90. doi: 10.1080/07347331003678352.
Results Reference
result

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

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