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Spots Global Cancer Trial Database for Getting Back on Track: An Educational Group for Women With Breast Cancer

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Trial Identification

Brief Title: 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 ID: NCT01305915

Conditions

Breast Cancer

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Princess Margaret Hospital, Toronto, Ontario, Canada

Contact Details

Name: Jennifer M Jones, PhD

Affiliation: Princess Margaret Hospital, Canada

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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