Clinical trial NCT01305915: Getting Back on Track: An Educational Group for Women With Breast Cancer
Official title: Getting Back on Track: A Single-session Psychoeducational Group Intervention for Women With Breast Cancer Completing Adjuvant Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: single-session group
psychoeducational intervention
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: The Princess Margaret Cancer Foundation
First posted: 2011-03-01
Enrollment: 444
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in Self Efficacy
timeFrame: Base line, 3 months, 6 months
measure: Change in Health distress
timeFrame: baseline, 3 months, 6 months
measure: Mood State
timeFrame: baseline, 3 months, 6 months
measure: Change in Preparedness
timeFrame: baseline, 3 months, 6 months
measure: Change in Knowledge
timeFrame: baseline, 3 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Jennifer M Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.