Getting Back on Track: A Single-session Psychoeducational Group Intervention for Women With Breast Cancer Completing Adjuvant Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 444
- Locations
- 1
- Primary Endpoint
- Mood State
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control
participant will receive standard print material
Intervention
patient will receive standard print material and a single session group psychoeducational intervention (GBOT)
Intervention: Getting Back on Track (Behavioral)
Outcomes
Primary Outcomes
Mood State
Time Frame: baseline, 3 months, 6 months
Profile of Mood States Scale-Short Form (POMS-SF)
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
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).
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Jennifer Jones
Principal Investigator
University Health Network, Toronto
