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Compass Course: Efficacy Study

Compass Course: Efficacy Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03442686
Enrollment
41
Registered
2018-02-22
Start date
2018-03-02
Completion date
2021-05-01
Last updated
2021-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

BEHAVIORALCompass 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.

Sponsors

Allina Health System
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

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.

Eligibility

Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in psychological well-beingWill be administered at Week 0 (pre-testing), at Week 12 (session 8), and at 3 month follow upUsing the Psychological Scales of Wellbeing questionnaire (Ryff, 1989; Ryff, & Keyes, 1995), psychological wellbeing pre- and post- intervention will be tracked.

Secondary

MeasureTime frameDescription
Time of pre-testing sessionDuration of pre-testing session (approximately 2 hours) at week 0 to week 1Actual length (in minutes) of pre-testing session.
Time of testing sessionEach week from week 2 through week 8, approximately 2 hours at each sessionActual length (in minutes) of testing session.
Time of post-testing sessionDuration of session 8 (at week 12), approximately 1 hourActual length (in minutes) of testing session.
Homework completionEach week from week 2 through week 8Whether or not homework was attempted
RecruitmentUp to 1 month after IRB approvalNumber of prospective participants approached by clinicians and number of self-referred prospective participants who contact PI or Study Coordinator with inquiries about the study
Change in Meaning in lifeAt week 0 and at week 12, and at 3 month follow upMeaning 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).
Engagement in Meaningful ActivitiesAt week 0 and at week 12Engagement 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.
Purpose Status and ExpectationsAt week 0, at week 12, and at 3 month follow upA 2-question self-report developed by the study team to better understand what participants' hope to gain during the study and perceived changes.
Participant Experience of Compass CourseAt week 12 and at week 14-20Participant experience of Compass Course as measured by self-report questionnaire and post-intervention focus group.
Intervention fidelityEach week from week 2 through week 8Which key intervention elements were provided during a given session

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026