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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01305915
First Posted: March 1, 2011
Last Update Posted: March 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Weekend Walkers Fund, Princess Margaret Hospital
Information provided by:
University Health Network, Toronto
  Purpose
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.

Condition Intervention
Breast Cancer Behavioral: Getting Back on Track

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Getting Back on Track: A Single-session Psychoeducational Group Intervention for Women With Breast Cancer Completing Adjuvant Treatment

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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

  • 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

  • Mood State [ Time Frame: baseline, 3 months, 6 months ]
    Profile of Mood States Scale-Short Form (POMS-SF)

  • 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

  • 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).


Enrollment: 444
Study Start Date: November 2007
Study Completion Date: November 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01305915


Locations
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Weekend Walkers Fund, Princess Margaret Hospital
Investigators
Principal Investigator: Jennifer M Jones, PhD Princess Margaret Hospital, Canada
  More Information

Publications:
Responsible Party: Jennifer Jones, Princess Margaret Hospital
ClinicalTrials.gov Identifier: NCT01305915     History of Changes
Other Study ID Numbers: 07-0271-CE
First Submitted: February 25, 2011
First Posted: March 1, 2011
Last Update Posted: March 1, 2011
Last Verified: February 2011

Keywords provided by University Health Network, Toronto:
single-session group
psychoeducational intervention

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases