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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Getting Back on Track

• Registration Number: NCT01305915
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2009-09
• Study Completion: 2009-11
• Study First Submitted: 2011-02-25
• Study First Submitted QC: 2011-02-25
• Study First Posted: 2011-03-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 444

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Getting Back on Track	patient will receive standard print material and a single session group psychoeducational intervention (GBOT)

Primary Outcome Measures

Name	Time	Method
Change in Self Efficacy	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	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	baseline, 3 months, 6 months	Profile of Mood States Scale-Short Form (POMS-SF)
Change in Knowledge	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).
Change in Preparedness	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

Trial Locations

Locations (1)

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada