Compass Course: Efficacy Study

Breast Cancer Clinical Trial

Official title:

Compass Course: Efficacy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03442686
• Other study ID #: CKMW-1801
• Status: Completed
• Phase: N/A
• Start date: March 2, 2018
• Est. completion date: May 1, 2021

Study information

• Verified date: May 2021
• Source: Allina Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Compass Course is an 8-session progressive structure that was developed based on theoretical and scientific evidence from psychology and occupational therapy. The goal of the intervention is to provide participants with information, tools, and support that help them move towards reclaiming a sense of self-grounded purpose in daily life. The study will use a convenience sample of breast cancer survivors to evaluate the efficacy of the Compass Course intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

Inclusion criteria:

1. 25 years of age or older

2. Completed treatment (such as chemotherapy, radiation, surgery) for Stage 0, 1, 2, or 3 breast cancer at least 2 months prior to participating in the Compass Course intervention

3. English speaking

4. High school diploma or GED

5. Able to see, hear, speak (with or without assistive devices)

6. Able to provide own transportation to sessions

7. Willing and able to commit to attend all 8 intervention sessions

Exclusion criteria (all self-reported):

1. Stage 4 breast cancer or any other stage 4 cancer

2. Actively receiving chemotherapy or radiation treatments for cancer. (However, patients may be on Herceptin and/or endocrine treatment and participate in the study.)

3. History of neurologic disorder (such as stroke or brain injury) with residual impairments that likely interfere with learning

4. Any medical condition (physical or mental health) that interferes with the performance of everyday activities and roles.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Behavioral:
• Compass Course
An 8-session group intervention that integrates education, support, self-reflection, and action-expectation to help people reaffirm or reconstruct self-grounded purpose after significant life events/transitions. The 8 sessions extend over 2-3 months, with 7 weekly sessions and the final session 1 month after Session 7. The intervention, called the Compass Course is structured around the 6 dimensions of flourishing (autonomy, self-acceptance, personal growth, relationships, purpose in life, external mastery), the goal of which is to help people enact behaviors that move them forward in reframing a sense of self and reaffirming or reconstructing a sense of purpose in their daily lives.

Locations

Country	Name	City	State
United States	Courage Kenny Rehabilitation Institute	Golden Valley	Minnesota
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	Allina Health Shoreview Clinic	Shoreview	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Allina Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in psychological well-being	Using the Psychological Scales of Wellbeing questionnaire (Ryff, 1989; Ryff, & Keyes, 1995), psychological wellbeing pre- and post- intervention will be tracked.	Will be administered at Week 0 (pre-testing), at Week 12 (session 8), and at 3 month follow up
Secondary	Recruitment	Number of prospective participants approached by clinicians and number of self-referred prospective participants who contact PI or Study Coordinator with inquiries about the study	Up to 1 month after IRB approval
Secondary	Time of pre-testing session	Actual length (in minutes) of pre-testing session.	Duration of pre-testing session (approximately 2 hours) at week 0 to week 1
Secondary	Time of testing session	Actual length (in minutes) of testing session.	Each week from week 2 through week 8, approximately 2 hours at each session
Secondary	Time of post-testing session	Actual length (in minutes) of testing session.	Duration of session 8 (at week 12), approximately 1 hour
Secondary	Homework completion	Whether or not homework was attempted	Each week from week 2 through week 8
Secondary	Intervention fidelity	Which key intervention elements were provided during a given session	Each week from week 2 through week 8
Secondary	Change in Meaning in life	Meaning in Life Questionnaire (Steger et al., 2006): A 10-item questionnaire designed to measure 2 dimensions of meaning in life: Presence of Meaning (how much respondents feel their lives have meaning) and Search for Meaning (how much respondents strive to find meaning and understanding in their lives).	At week 0 and at week 12, and at 3 month follow up
Secondary	Engagement in Meaningful Activities	Engagement in Meaningful Activities Survey (Eakman, 2010):A 12-item self-report questionnaire designed to measure the extent to which a person experiences meaningfulness in his/her daily life activities.	At week 0 and at week 12
Secondary	Purpose Status and Expectations	A 2-question self-report developed by the study team to better understand what participants' hope to gain during the study and perceived changes.	At week 0, at week 12, and at 3 month follow up
Secondary	Participant Experience of Compass Course	Participant experience of Compass Course as measured by self-report questionnaire and post-intervention focus group.	At week 12 and at week 14-20