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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Getting Back on Track


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>participant will receive standard print material | |
| Experimental: Intervention<br>patient will receive standard print material and a single session group psychoeducational intervention (GBOT) | Behavioral: Getting Back on Track<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Base line, 3 months, 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 | baseline, 3 months, 6 months | 
| Mood State | Profile of Mood States Scale-Short Form (POMS-SF) | baseline, 3 months, 6 months | 
| 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 | baseline, 3 months, 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). | baseline, 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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single-session group, psychoeducational intervention