Clinical trial NCT03442686: Compass Course: Efficacy Study
Official title: Compass Course: Efficacy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Allina Health System
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 41
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study uses a wait list control design. One group of participants will be evaluated before receiving the intervention (in Spring 2018) and compared to those who receive the intervention in Spring 2018. The first group will go on to receive the intervention in Fall 2018.
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in psychological well-being
timeFrame: Will be administered at Week 0 (pre-testing), at Week 12 (session 8), and at 3 month follow up
Secondary outcomes:
measure: Recruitment
timeFrame: Up to 1 month after IRB approval
measure: Time of pre-testing session
timeFrame: Duration of pre-testing session (approximately 2 hours) at week 0 to week 1
measure: Time of testing session
timeFrame: Each week from week 2 through week 8, approximately 2 hours at each session
measure: Time of post-testing session
timeFrame: Duration of session 8 (at week 12), approximately 1 hour
measure: Homework completion
timeFrame: Each week from week 2 through week 8
measure: Intervention fidelity
timeFrame: Each week from week 2 through week 8
measure: Change in Meaning in life
timeFrame: At week 0 and at week 12, and at 3 month follow up
measure: Engagement in Meaningful Activities
timeFrame: At week 0 and at week 12
measure: Purpose Status and Expectations
timeFrame: At week 0, at week 12, and at 3 month follow up
measure: Participant Experience of Compass Course
timeFrame: At week 12 and at week 14-20
Other outcomes:
Locations:
city: Golden Valley
country: United States
facility: Courage Kenny Rehabilitation Institute
state: Minnesota
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Shoreview
country: United States
facility: Allina Health Shoreview Clinic
state: Minnesota
Study officials:
affiliation: Allina Health
name: Mary Radomski, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References: