Compass Course: Efficacy Study

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Compass Course

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Golden Valley, Minnesota, United States, 55422
      • Courage Kenny Rehabilitation Institute
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hospital
    • Shoreview, Minnesota, United States, 55126
      • Allina Health Shoreview Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spring 2018 Compass Course Group; Two groups of up to 15 participants (30 total) will receive the study intervention during Spring 2018. All participants will complete study questionnaires before and after the Spring sessions.	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.
No Intervention: Spring 2018 Comparison Group; Two groups of up to 15 participants will receive the study intervention in Fall 2018. All participants will complete study questionnaires before and after the Spring sessions. Those who enroll in the study and agree to participate in the Fall sessions will serve as a no-treatment comparison group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Homework completion	Whether or not homework was attempted	Each week from week 2 through week 8
Intervention fidelity	Which key intervention elements were provided during a given session	Each week from week 2 through week 8
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
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
Time of post-testing session	Actual length (in minutes) of testing session.	Duration of session 8 (at week 12), approximately 1 hour
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
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
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

Collaborators and Investigators

• Sponsor: Allina Health System

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2018
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: February 16, 2018
• First Submitted That Met QC Criteria: February 16, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 10, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CKMW-1801

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No