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

NCT01305915 | Completed DMC

• 1 other identifier: 07-0271-CE
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

single-session group; psychoeducational intervention

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Control

NO INTERVENTION

participant will receive standard print material

Intervention

EXPERIMENTAL

patient will receive standard print material and a single session group psychoeducational intervention (GBOT)

Behavioral: Getting Back on Track

Interventions

Getting Back on Track BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• The Princess Margaret Cancer Foundation: collaborator

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

• 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.

  PMID: 20432117 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jennifer M Jones, PhD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 25, 2011
• First Posted: March 1, 2011
• Study Start: November 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: November 1, 2009
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

CA (1)